Search Results

… the international scientific guidelines adopted in Australia, see AUS-74 . Contact Information Per AUS-23 , the contact information for the TGA is as follows: Postal Address: P.O. Box 100 Woden ACT 2606 Australia For general questions: Phone: 1 800 020 653 (free call within Australia) or +61 2 6289 4124 (international calls) Fax: 02 6203 1605 E-mail: use online form (see AUS-11 ) For clinical trial questions: E-mail: clinical.trials@health.gov.au AUS-47 notes that the TGA info team … Go to Australia > Regulatory Authority

In Bangladesh, the Ministry of Health and Family Welfare (MOHFW) ’s Directorate General of Drug Administration (DGDA) and the Bangladesh Medical Research Council (BMRC) are involved in clinical trial oversight and coordination. Directorate General of Drug Administration As per the DrugsCosAct , the BGD-GCP , and the G-IndCTA , the DGDA is the regulatory authority responsible for clinical trial oversight and inspections in Bangladesh. According to the DrugsCosAct , the DGDA also licenses establishments involved with manufacturing, sale, importing, and exporting of drugs; implements pharmacovigilance activities; and inspects and supervises establishments that manufacture and sell drugs. The BGD-GCP indicates that the DGDA provides the legal framework for clinical trials. The DGDA’s responsibilities include approval and inspection of clinical trial facilities, study protocol approval, and authorizing the import of clinical trial investigational products, with the goal of protecting the … Go to Bangladesh > Regulatory Authority

National Health Surveillance Agency (ANVISA) As delineated in ResNo945 and ResNo705 (amending ResNo585 ), the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) is the regulatory authority responsible for clinical trial oversight, approval, and inspection of drugs to be registered in Brazil. ANVISA grants permission for clinical trials to be conducted in accordance with the provisions of ResNo945 and ResNo705 (amending ResNo585 ). LawNo9.782 states ANVISA is an independent administrative agency linked to the Ministry of Health (MOH) that is responsible for regulating, controlling, and supervising products and services involving public health risks. LawNo9.782 and ResNo585 explain that the goods and products under the agency’s purview include medicines for human use and their active ingredients; immunobiologicals and their active substances, and blood and blood products, and; advanced therapy products and their active components, and other inputs, … Go to Brazil > Regulatory Authority

… states that the HC grants permission for clinical trials to be conducted in the country, and regulates the sale and importation of drugs for use in clinical trials in accordance with the CanadaFDR provisions. As per CAN-29 , HC is one (1) of five (5) federal agencies within Canada’s “Health Portfolio” overseen by the Minister of Health. Per CAN-31 , HC assesses clinical trial protocols to evaluate participant protection and safety; reviews drug quality; assures institutional … it is not clear whether a product should be classified as a drug or device. The committee makes recommendations on the classification of a product as either a drug, medical device, or combination product. If a product does not readily meet one (1) of the statutory definitions, other regulatory areas of HC are asked to participate in the committee's discussion. As per CAN-41 , Health Canada has established a regulatory innovation agenda, which aims to provide more regulatory flexibility … Go to Canada > Regulatory Authority

… State Council’s NHC is responsible for China’s management of human genetic resources (HGR). (Note that per SC-Order777 and NHC-HGRmgt , management of HGR was transferred from the Ministry of Science and Technology (MOST) to NHC, effective May 1, 2024). The NHC-HGRmgt states that the original application process and online platform ( CHN-6 ) remain unchanged. As indicated in CHN-24 , the NHC is responsible for formulating health policies and systems in China, including health services, … plants, animals, and microbes). For more information, see CHN-55 . Contact Information National Medical Products Administration (NMPA) Per CHN-31 , the following is the NMPA’s contact information: National Medical Products Administration No. 1 Beiluyuan Zhanlan Road Xicheng District Beijing 100037 P.R. China Per CDE-Reloctn , the following is CDE’s contact information: National Medical Products Administration Center for Drug Evaluation Building 1-5 District 2, No. 22 Guangde Street Beijing Economic and Technological Development Zone Beijing, 100076 P.R. China Phone number: 010-68585566 National Health Commission Per HGR-WorkUpdt , HGR-AppGuide , and CHN-4 , following is the contact … Go to China > Regulatory Authority

… establishing accountability; and assessing the relative risk. See DRC-16 for more information on ACOREP’s Pharmacovigilance Department. Other Considerations Please note: DRC is party to the Nagoya Protocol on Access and Benefit-sharing ( DRC-1 ), which may have implications for studies of investigational products developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see DRC-7 . Contact Information Per DRC-5 and DRC-9 , … Go to DRC > Regulatory Authority

… de la Santé et de l'Hygiène Publique (MSHP)) is the regulatory authority responsible for national drug marketing authorization. Per DecreeNoD218 , the MSHP is responsible for the regulation of clinical trials in the Republic of Guinea. Per GIN-1, the two (2) branches within the MSHP directly involved with the clinical trial approval process are the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)) and the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)) . Per DecreeNoD218 , CNERS is in charge of the clinical trial application review and approval process for studies conducted in humans, and per GIN-1, the DNPM is responsible for drug product registration, authorization, and importation. National Directorate of Pharmacy and Medicine (DNPM) Per GIN-20 , the DNPM’s mission is to develop and monitor the implementation of government policy in the … Go to Guinea > Regulatory Authority

… and data generation in accordance with regulatory provisions and applicable guidelines to enhance the quality of clinical trials and applications. The 2019-CTRules and Order13Jan20 further note that the DCGI may, when required, constitute one (1) or more of these expert committees or group of experts with specialization in relevant fields to evaluate scientific and technical drug-related issues. In accordance with the 2019-CTRules and with the approval of the MOHFW, Order13Jan20 … Go to India > Regulatory Authority

Clinical research in Kenya is regulated and overseen by the Pharmacy and Poisons Board (PPB) and the National Commission for Science, Technology and Innovation (NACOSTI) . Pharmacy and Poisons Board As per the PPA , the CTRules , and the G-KenyaCT , Kenya’s PPB is the regulatory authority responsible for clinical trial approvals, oversight, and inspections. As described in KEN-21 , the PPB and its Expert Committee on Clinical Trials (ECCT) evaluate all matters relating to clinical trials and grant permission for clinical trials to be conducted in Kenya. See KEN-20 , KEN-21 , and KEN-16 for more information about PPB. Per the PPA and the CTRules , the PPB is authorized to undertake various mandated duties regarding regulation of medicines including (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements): Advise the government in all matters relating to the safety, packaging, labelling, distribution, and … Go to Kenya > Regulatory Authority

Liberia Medicines and Health Products Regulatory Authority As per the LMHRA-Act , the LibCTReg , and the G-LibClinTrial , the Liberia Medicines and Health Products Regulatory Authority (LMHRA) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections. According to the LMHRA-Act , the LMHRA operates as an autonomous government agency that reports to the President of the Republic of Liberia. In addition to its role in authorizing clinical trials, the LMHRA-Act indicates that the LMHRA’s responsibilities also include drug and health care product registration, inspections, import/export control, licensing, quality control, advertising and promotion, and pharmacovigilance and post-marketing surveillance. Per LBR-30 , the Clinical Trials Unit within LMHRA’s Pharmacovigilance & Clinical Trials Department is responsible for coordinating all aspects of clinical trials in Liberia including: Receiving and assessing all clinical trial applications submitted … Go to Liberia > Regulatory Authority

… for Science and Technology Per MWI-57 , the NCST contact information is as follows: Mailing Address: National Commission for Science and Technology 1st Floor Lingadzi House, Robert Mugabe Crescent Private Bag B303 Lilongwe 3, Malawi Phone: +265 1 771 550 Email: infor@ncst.mw … Go to Malawi > Regulatory Authority

Directorate of Pharmacy and Medicine (DPM) Per DecreeNo2011-753 , the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) is the competent authority responsible for regulating clinical trials, examining applications to import investigational drugs, and reviewing clinical trial authorization records for drugs to be registered in Mali. In addition, as stated in LawNo09-059 , prior to a clinical trial’s commencement, the DPM must review the clinical trial application research data submitted by the sponsor or principal investigator, as well as the opinion(s) of the ethics committee(s) consulted. As set forth in DecreeNo2011-753 , the DPM is a regulatory body under the Ministry of Health and Social Development (Ministère de la Santé et du Développement Social (MSDS)) . An MSDS-appointed director is authorized to direct, coordinate, oversee, and control the directorate’s pharmaceutical activities. LawNo01-040 and Law-MOHOrg also note that the DPM’s … Go to Mali > Regulatory Authority

Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) As set forth in GenHlthLaw , Reg-COFEPRIS , HlthResRegs , NOM-012-SSA3-2012 , and COFEPRIS-GCP , the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) is the regulatory authority responsible for approving all clinical studies in human beings and/or their biological samples, for scientific research purposes. COFEPRIS is authorized to monitor and verify approved clinical studies to be conducted in Mexico in accordance with the provisions of the aforementioned documents. Under the terms of Reg-COFEPRIS and GenHlthLaw , the Ministry of Health (Secretaría de Salud) supervises the regulation, control, and promotion of health through COFEPRIS. Per MOH-Org , COFEPRIS, a decentralized administrative body, is overseen by the Ministry of Health’s head of the Undersecretariat of Prevention and Health Promotion. Reg-COFEPRIS and GenHlthLaw … Go to Mexico > Regulatory Authority

… - Chorrillos Lima 9 Perú National Authority for Pharmaceutical Products, Medical Devices and Medical Products (ANM) PER-109 indicates the ANM’s contact information is as follows: DIGEMID Av. Parque de las Leyendas 240 San Miguel Perú Phone: 1-631-4300 Extension: 6700, 6705, and 6501 Email: atenciontramite@minsa.gob.pe … Go to Peru > Regulatory Authority

Pharmacy Board of Sierra Leone As per the G-SLAppClinTrial and the SL-GCPs , the Pharmacy Board of Sierra Leone (PBSL) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections in the country. SLE-22 states that the PBSL was originally established through an Act of Parliament in 1988, and re-established in 2001 by the PDA2001 , to regulate pharmaceutical products, medical devices, cosmetic chemical substances, food and dietary supplement and herbal products, the practice of pharmacy, and any other related matters. The PBSL operates within the Ministry of Health and Sanitation (MoHS) . Per SLE-13 , the PBSL is responsible for the safety, efficacy, and quality of all locally manufactured, imported, exported, distributed, sold or used drugs, medical devices, cosmetics, and nutritional agents. Per the G-SLAppClinTrial , the PBSL monitors a clinical trial from beginning to end in order to ensure adequate protection of the general public against the … Go to Sierra Leone > Regulatory Authority

South African Health Products Regulatory Authority As stated in the MRSA and ZAF-9 , the South African Health Products Regulatory Authority (SAHPRA) is the regulatory authority overseeing medicines and clinical research, as well as medical devices and radiation safety. A s stated in the MRSA and GRMRSA , SAHPRA is responsible for clinical trial oversight, approval, and inspections in South Africa. The agency grants permission for clinical trials to be conducted in South Africa in accordance with the provisions of the GRMRSA . Per the MRSA and ZAF-39 , the SAHPRA is an independent, state-owned entity established to oversee the regulation of medicines in South Africa. According to ZAF-39 , this agency is responsible for: The regulation of health products intended for human and animal use The licensing of manufacturers, wholesalers, and distributors of medicines and medical devices; radiation emitting devices; and radioactive nuclides The conduct of clinical trials in a manner that is … Go to South Africa > Regulatory Authority

Clinical research in Tanzania is regulated and overseen by the Tanzania Medicines and Medical Devices Authority (TMDA) and the Tanzania Commission for Science and Technology (COSTECH) . Tanzania Medicines and Medical Devices Authority As per the TMMDAct and TZA-4 , the TMDA is the regulatory authority responsible for clinical trial approvals, oversight, and inspections in Tanzania. (Note: while the TMMDAct is formatted as a “Revised Draft,” it incorporates the final changes from 2019 that are codified in the FinanceAct .) The TMDA grants permission for clinical trials to be conducted in the country in accordance with the TMMDAct and the CT-Regs . Per TZA-29 , the TMDA is an executive agency under the Ministry of Health (MoH) . The TMDA is responsible for regulating the safety, quality, and effectiveness of medicines, medical devices, and diagnostics. Per the TMMDAct , the agency has a Ministerial Advisory Board (MAB), which consists of: The MoH Permanent Secretary who serves as … Go to Tanzania > Regulatory Authority

Thai Food and Drug Administration As per the DrugAct , ClinSampleProd , and ClinImprtOrdr , the Thai Food and Drug Administration (Thai FDA) is the regulatory authority responsible for controlling the import of drugs for research purposes, and it also uses this authority to indirectly regulate drug clinical trials in humans. Per ClinSampleProd and DrugProdReqs , the Thai FDA is also responsible for approving requests for permission to produce drug samples for the registration of drug formulas for human research studies. As set forth in the DrugAct and THA-33 , the Thai FDA is a regulatory body under the Ministry of Public Health (MOPH) and is granted control by the MOPH to protect consumer health. The agency is also authorized to ensure the quality, safety, and efficacy of health products including foods, drugs, cosmetics, and medical devices in Thailand. In addition, per the DrugAct ’s 2019 amendments and according to THA-6 , the MOPH has the authority to establish and/or amend drug … Go to Thailand > Regulatory Authority

In Uganda, the National Drug Authority (NDA) and the Uganda National Council for Science and Technology (UNCST) , in collaboration with the Uganda National Health Research Organisation (UNHRO) , are involved in clinical trial oversight. National Drug Authority As per the NDPA-CTReg , the G-CTConduct , and the G-TrialsGCP , the NDA is the regulatory authority responsible for clinical trial approval and inspections in Uganda. The NDA grants permission for clinical trials to be conducted in Uganda in accordance with the provisions of the NDPA-Act . As stated in the NGHRP , the NDA regulates safety, quality, efficacy, handling, and use of drugs or drug related products and devices in research. According to UGA-29 , the Clinical Trials Unit in the NDA’s Directorate of Product Safety is responsible for reviewing and approving clinical trial applications, conducting clinical trial site inspections for compliance with good clinical practices, and developing guidance documents. Uganda National … Go to Uganda > Regulatory Authority

Medicines and Healthcare Products Regulatory Agency As per the MHCTR and the MHCTR2006 , the Medicines and Healthcare Products Regulatory Agency (MHRA) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections in the United Kingdom (UK). The MHRA grants permission for clinical trials to be conducted in the UK in accordance with the MHCTR and the MHCTR2006 . MHRA-More states that MHRA regulates medicines, including vaccines, supplied in the UK, spanning the whole of a medicine’s lifecycle. MHRA decides whether medicines should be granted licenses (i.e., marketing authorizations) and whether licenses can be varied. These decisions are based on safety, quality, and effectiveness data submitted. Further, MHRA conducts several regulatory activities including the following: Inspecting facilities that manufacture and carry out safety tests on medicines to ensure they comply with Good Manufacturing Practice and Good Laboratory Practice standards … Go to United Kingdom > Regulatory Authority

… which are referred to as Common Rule departments/agencies throughout the profile. The RevComRule applies to all human subjects research that is federally funded or sponsored by a Common Rule department/agency (as identified in USA-65 ), and: 1) was initially approved by an EC on or after January 21, 2019; 2) had EC review waived on or after January 21, 2019; or 3) was determined to be exempt on or after January 21, 2019. (Per USA-55 and USA-74 , the RevComRule is also known as the … Go to United States > Regulatory Authority

Ministry of Health As per the ClinDrugTrialGCP , PharmLaw-VNM , DecreeMOH , and ASTTReg , Vietnam’s Ministry of Health (MOH) is the regulatory authority responsible for clinical trial approvals, registration, oversight, and inspections. The MOH grants permission for clinical trials to be conducted in Vietnam. As indicated in DecreeMOH , the MOH is a governmental agency whose mission is to oversee public health care management and protection for the Vietnamese population. With regard to pharmaceuticals, the MOH’s activities include, but are not limited to, formulating and promulgating legal documents, regulations, and national standards; granting and withdrawing pharmaceutical practice certificates; and issuing certificates of eligibility, registration permits, medicine import/export permits, and certificates of good manufacturing practice (GMP). The ClinDrugTrialGCP and ASTTReg specify that the MOH’s Administration of Science, Technology and Training (ASTT) is responsible for managing … Go to Vietnam > Regulatory Authority

Clinical research in Zimbabwe is regulated and overseen by the Medicines Control Authority of Zimbabwe (MCAZ) , the Research Council of Zimbabwe (RCZ) , and the National Biotechnology Authority of Zimbabwe (NBA) . Medicines Control Authority of Zimbabwe Per the MSCAct and the MSC-Regs , the MCAZ is a statutory body that has authority for regulating and authorizing clinical trials in Zimbabwe. Further, the MSCAct authorizes MCAZ’s functions related to registering medicines, providing a national laboratory, and appointing a Director-General. The Minister of Zimbabwe’s Ministry of Health and Child Care (MOHCC) appoints MCAZ members. ZWE-3 indicates that the MCAZ is responsible for protecting public health by ensuring that medicines, allied substances, and medical devices are safe, effective, and of good quality by manufacturers and distributors. Per the CT-AppAuth and the ZWE-GCP , all clinical trials of medicines in Zimbabwe involving human participants must not be initiated until the … Go to Zimbabwe > Regulatory Authority

… good, compliance with applicable Therapeutic Goods Orders (TGOs) (see AUS-93 ), compliance with international guidelines, and labelling (including traceability). The evaluation process usually consists of two (2) rounds of evaluation and one (1) round of request for information from the sponsor. Additional rounds may be required if there is outstanding information required to support the evaluation process or decision. As delineated in AUS-88 , evaluation reports with recommendations … G-GCP-Inspect , clinical trials of medicines and biologicals regulated under the CTN or CTA schemes are subject to the TGA’s Good Clinical Practice (GCP) inspection program. The TGA can conduct a GCP inspection, which typically occurs over one (1) to three (3) consecutive days, at any stage of the clinical trial lifecycle from the early phase of participant recruitment to completed trials. Additionally, the TGA can request certain information or documents about therapeutic goods exempt … Go to Australia > Scope of Assessment

… application. (Note: Conversely, the G-IndCTA states that the sponsor is responsible for submitting the application.) As delineated in the DrugsCosAct , the DGDA may obtain a legal opinion or technical analysis/opinion on any matter from one (1) or more persons who are experts or have special knowledge/experience in the matter concerned or may invite them to attend meetings. The BGD-GCP states that the MOHFW’s Clinical Trial Advisory Committee, an expert committee comprised of medical … Go to Bangladesh > Scope of Assessment

… in Brazil). Per ResNo945 and the G-DDCMManual , clinical trials with drugs must have all or part of their clinical development in Brazil. ResNo945 also notes that the DDCM may be submitted at any stage of clinical drug development for one (1) or more phases of clinical trials. However, Phase IV post-marketing trials and non-interventional clinical research are not covered by this regulation, and should be initiated after obtaining the relevant ethical approvals in accordance with … (COPEC)) is responsible for conducting the review and approval of clinical trial applications (DDCMs). Per ResNo945 and the G-DDCMManual , ANVISA’s technical analysis of a primary DDCM petition will only occur after the filing of at least one (1) Specific Clinical Trial Dossier (Dossiê Específico de Ensaio Clínico (DEEC)). A DEEC is defined as a collection of documents submitted as part of the Investigational Drug Development Plan (PDME) in the DDCM. ResNo945 explains that the absence of the DEEC will result in the rejection of the DDCM without technical analysis, except in cases of clinical trials involving more than one (1) experimental drug, with a primary DEEC petition that has already been linked to one (1) of the DDCMs of these drugs. See the Timeline of Review section for ANVISA’s petition review timelines. See also BRA-40 for information on ANVISA drug … Go to Brazil > Scope of Assessment

… trial. HC’s scope of assessment includes clinical trials (Phases I - III) using: Drugs not authorized for sale in Canada in development and in comparative bioavailability studies Marketed drugs where the proposed use of the drug for one (1) of the following is different: indication(s) and clinical use; target patient population(s); route(s) of administration; or dosage regimen(s) Clinical Trial Review Process As set forth in the G-CanadaCTApps and CAN-23 , HC’s Health Products and … Go to Canada > Scope of Assessment

… registered in China, as required. The DRR clarifies that the NMPA regulates clinical trials for drugs in development that are ultimately seeking market approvals in China. Per the DAL and the DRR , and as explained in CHN-7 , CHN-18 , and CHN-1 , China adopted a drug marketing authorization holders (MAHs) system across China. All entities or drug research institutions holding drug marketing authorizations must take responsibility for drug safety, effectiveness, and quality … review and approval process. Per the DRR , the registration of drugs must be classified and managed in accordance with three (3) broad categories of Chinese medicines, chemical medicines, and biological products. The NMPA-No44-2020 and CHN-1 delineate the classifications within the chemical medicine category as follows: Class 1: Innovative drugs that have not been marketed in China or overseas (i.e., drugs that contain new compounds with clear structures and pharmacological effects, and have clinical values) Class 2: Modified new drugs that have not been marketed in … Go to China > Scope of Assessment

Overview According to D-ACOREP , the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) of the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention) is the regulatory authority responsible for regulating clinical trials, as well as authorizing and controlling drug imports and exports, in the Democratic Republic of the Congo (DRC). In addition, the G-EthicalEval indicates that an ethics committee (EC) must review the scientific validity and ethical acceptability of any research proposal involving human subjects. As per the G-EthicalEval , the study protocol must be submitted to the EC for review concurrently with a request to ACOREP for study authorization and registration. Therefore, regulatory and ethics reviews are conducted in parallel. However, ACOREP approval is contingent upon EC approval. Per DRC-12, ACOREP accepts ethics review from any approved local EC. Clinical … Go to DRC > Scope of Assessment

… Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)) must approve the health research protocol involving human participants before a clinical trial can commence. Furthermore, according to GIN-1, the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)) must issue a drug import license prior to the sponsor or the representative (typically the principal investigator (PI)) initiating the clinical trial. According to GIN-1, CNERS must approve the clinical trial protocol before the drug import license application is submitted to the DNPM. Therefore, the CNERS and DNPM reviews may not be conducted in parallel. Clinical Trial Review Process According to GIN-1, the sponsor or the designated representative (typically the PI) is responsible for hand delivering the drug import license application to the DNPM’s Pharmacovigilance, Drugs and Quality Control section for review and approval. The DNPM may … Go to Guinea > Scope of Assessment

… therapeutic areas, including pharmacologists/clinical pharmacologists, and medical specialists. However, Order13Jan20 , issued in accordance with the 2019-CTRules , amended the SEC composition to eight (8) medical experts, specifically one (1) pharmacologist and seven (7) medical specialists. The G-SECs also indicates that SECs are comprised of eight (8) experts (one (1) pharmacologist and seven (7) specialists). A minimum of four (4) members should be present during meetings, including one (1) pharmacologist, to meet the quorum requirements. In the case of vaccines, the quorum should include a pediatrician and an immunologist. Per the Hdbk-ClinTrial , SECs are responsible for advising CDSCO with in-depth evaluations of non-clinical … Go to India > Scope of Assessment

… researcher may apply for renewal of the license and pay the requisite fee. The researcher is expected to apply for renewal by attaching a progress report instead of a proposal. KEN-31 indicates that the duration of the research license is one (1) year. … Go to Kenya > Scope of Assessment

… with the current state of scientific knowledge, and especially, the clinical trial is unsuitable for providing proof of IP(s) safety or efficacy, or In the case of trials involving human participants, the documentation requirements (see Section 1 (4) of LibCTReg ), particularly insurance coverage for trial participants, are not fulfilled The LMHRA is in possession of findings which indicate that the testing facility is not suitable to conduct the clinical trial The LMHRA is of the … number of clinical trial participants to be recruited in the trial is not scientifically justified, or The requirements provided for in the general conditions and special preconditions for conducting a clinical trial (see Chapter II (Sections 1-2) of LibCTReg ) are no longer fulfilled The LibCTReg indicates that in a clinical trial of an IP consisting of a genetically modified organism, consisting of a combination of genetically modified organisms, or containing such organisms, … requirements and the Timeline of Review section for additional LMHRA timeline information.) The LibCTReg further explains that a clinical trial authorization must be suspended by the LMHRA for a limited period of time if at least one (1) of the following is true: It becomes known that one (1) of the grounds for refusal previously indicated existed at the time the trial authorization was issued (see also Chapter II (Section 5 (3)) of LibCTReg ) The conditions surrounding the … Go to Liberia > Scope of Assessment

Overview In accordance with the PMRAAct , the Pharmacy and Medicines Regulatory Authority (PMRA) is responsible for reviewing and approving clinical trial applications for new drugs, generic drugs, and imported drugs to be registered in Malawi. The R-HlthResCoord indicates that before submitting a clinical trial application to the PMRA, the sponsor or principal investigator (PI) must obtain full ethical approval from either of the two (2) National Commission for Science and Technology (NCST) -approved ethics committees (ECs)—the National Health Sciences Research Committee (NHSRC) or the College of Medicine Research and Ethics Committee (COMREC). Parallel submissions of a clinical trial application to an EC and the PMRA are prohibited. As per the SciTechOrder , an NCST-issued license is required for research activities involving humans; research involving clinical trials; and research activities of multicentered research. The SciTechOrder does not specify whether the process of … Go to Malawi > Scope of Assessment

… approval process may not be conducted in parallel with the EC review. Per DecreeNo2017-0245 , all clinical research conducted in Mali must benefit the country in general and its local populations. Clinical Trial Review Process According to MLI-1 , upon receipt of the completed and signed application, the research and evaluation section of the DPM completes the reviewer section of the form (see MLI-1 ). This section requires the reviewer to provide the following information: date/time of application receipt; file number; reviewer name and signature; date/time, if additional information is requested; date of receipt of additional information … Go to Mali > Scope of Assessment

Overview In accordance with GenHlthLaw , Reg-COFEPRIS , HlthResRegs , NOM-012-SSA3-2012 , and COFEPRIS-GCP , the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) is the regulatory authority responsible for reviewing, evaluating, and approving all requests for research protocol authorization in human beings and/or their biological samples using registered or unregistered investigational products (IPs). Per NOM-257-SSA1-2014 , COFEPRIS requires biotechnological drugs used in clinical research studies to follow the same protocol authorization procedure as is required for all IPs. COFEPRIS-GCP and HlthResRegs specify that the scope of COFEPRIS’s assessment includes all clinical trials (Phases I-IV). As indicated in HlthResRegs , NOM-012-SSA3-2012 , G-HumResProt , MEX-84 , and G-DIGIPRiS-ResProts , COFEPRIS’s review and approval of a protocol authorization request is dependent upon obtaining a favorable … Go to Mexico > Scope of Assessment

… trial authorization is in PER-24 . In addition, per Decree021-2017 , the sponsor must also ensure authorization by the research institution where the clinical trial will be carried out. Decree021-2017 states that the IP must meet at least one (1) of the following conditions to be authorized for use in clinical trials in Peru: Must be approved for use in humans by drug regulatory authorities of countries with high health surveillance Is produced in Peru, is used in preclinical research, … for additional information on REPEC’s trial data record requirements. Refer to the INS-CTManual and Res252-2022 for details on the DIIS application review process and a flowchart delineating the clinical trial authorization process (see Annex 1). As explained in the INS-CTManual and Res252-2022 , as part of the application evaluation process, the Documentary Processing Area ( Área de Trámite Documentario (ATO)) reviews the file to ensure completeness. The applicant has a maximum of two … personnel carry out inspections in accordance with G-CTInspec requirements and good clinical practice (GCP) standards. Decree021-2017 and the G-CTInspec specify that based on the severity of the inspection findings, the DIIS will apply one (1) or more safety measures, and sanctions, if appropriate, directed at the sponsor, the CRO, the research institution, or the PI before, during, and after the trial is conducted. Decree021-2017 also notes that in the case of violations by foreign … Go to Peru > Scope of Assessment

… to the query. If the PBSL requires changes to the application and the applicant fails to modify the application correspondingly within a maximum of 90 days following the reasoned objections, the application will be deemed rejected. See Figure 1 in Section 5.17 of the G-SLAppClinTrial for more details on the PBSL’s clinical trial authorization process. The G-SLAppClinTrial indicates that any proposed amendment to the trial application, trial arrangements, and IP must be submitted to the … Go to Sierra Leone > Scope of Assessment

… review cycle. Next, the CTU’s Clinical Trial Committee (CTC) (which includes an expert committee of specialists, as needed) reviews the proposed clinical trials pursuant to the schedule on SAHPRA’s website. (See ZAF-11 for 2025 dates). Per ZAF-1 , clinical trial reviews will result in one (1) of the following outcomes: Category 1A: Approved; no items pending Category 1B: Approved; ethics approval pending Category 2A: Not approved; for approval by in-house evaluators, 1-2 or more items outstanding as deemed by the committee Category 2B: Not approved; for approval by the original evaluator and in-house if a need arises Category 3: Not approved; items outstanding to be discussed at the next CTC meeting Category … Go to South Africa > Scope of Assessment

… of a clinical trial application, the TMDA initially screens the application for completeness. If complete, the TMDA officer acknowledges receipt of the application by returning a signed copy of the cover sheet to the applicant (see Annex 1 of the G-AppConductCT ). The TMMDAct states that the TMDA Director General must issue a Clinical Trial Certificate to authorize the trial to be conducted. (See the Submission Content section for submission requirements.) TZA-4 indicates that the … process will stop until the TMDA receives a written response to the query. The response should be submitted within six (6) months after being issued with a query letter. All queries issued in the same letter must be submitted together in one (1) transaction. Non-compliance to these requirements in content and format will lead to rejection of the clinical trial. Evaluation of applications will be completed within 60 working days of receiving the application. A new clinical trial … pending further information. If approved, researchers should collect their permit within 90 days after the decision is communicated, and failure to do so requires a new application. Per the G-ResearchClearance , permits are valid for one (1) year, and can be renewed, provided that COSTECH receives satisfactory progress reports for the previous periods. COSTECH must review the research to ensure compliance with the approved permit and see if any material changes have occurred in the … Go to Tanzania > Scope of Assessment

… the relevant EC. Clinical Trial Review Process As set forth in ClinImprtOrdr , ClinSampleProd , and G-CT-DIPApp , the Thai FDA coordinates the review of applications submitted to obtain drug import licenses for clinical research purposes (N.Y.M.1) and applications submitted to request permission to produce drug samples for human research studies (P.Y.8). Per ClinImprtOrdr and ClinSampleProd , an applicant should submit the application along with supporting documents to the Medicines Regulation Division . Per G-CT-DIPApp , upon receipt of a drug import license application (N.Y.M.1) package, the Thai FDA’s One Stop Service & Consultation Center (OSSC) ( THA-35 ) sends the application package to an officer in the Thai FDA’s International Affairs and Investigational Drug Section. After administrative processing and … to initiating the following: Changes to clinical trial drug supplies Changes to an approved protocol (protocol amendment) or changes related to or affecting participant safety In cases where the sponsor is required to immediately make one (1) or more amendments because the clinical trial or the use of investigational products in the trial endangers the health of a clinical trial participant or other person, the applicant may immediately make the amendment without prior review by the … Go to Thailand > Scope of Assessment

… and insurance for the clinical trial participants Terms of the agreement between the sponsor and the PI Per the G-CTConduct , complete applications are given a Clinical Trial Application code. Applications verified as complete will undergo one (1) of three (3) types of reviews: Internal review, which is further subdivided into expedited or routine review Expert review, which involves external reviewers co-opted by the NDA following internal procedures Joint reviews, which are carried out … b) request additional information to support the application; or c) reject the clinical trial application, providing reasoning. The NDA’s decision is communicated to the applicant in writing. The clinical trial certificate is valid for one (1) year from the date it is awarded. Per the NDPA-CTReg , the NDA may also issue a clinical trial certificate with conditions. See Appendix XI of the G-CTConduct for the NDA clinical trial process flowchart and Form 34 in Schedule 1 of the NDPA-CTReg for the format of the clinical trial certificate. See the Submission Content section for detailed information on the contents of the clinical trial application. The G-CTConduct states that any new information that becomes … Go to Uganda > Scope of Assessment

… or unregistered investigational products (IPs). (Note: IPs are known as investigational medicinal products (IMPs) in the United Kingdom (UK)). The G-CTApp specifies that the scope of the MHRA’s assessment includes all clinical trials (Phases 1-4). Per G-CTApp and G-IRASCombRev , all new clinical trial applications must be prepared, submitted, and reviewed via the combined review process, which offers a single application route and parallel/coordinated review from MHRA and the ethics … leads to a single decision from both reviews. The G-CTApp states that the initial combined review assessment will be completed within 30 days of application submission. Applications for healthy volunteer trials and sponsor-determined phase 1 trials in non-oncology participants may qualify for a shortened assessment time and the MHRA will work with the EC to expedite these applications. When applications need expert advice, the MHRA will seek advice from the Clinical Trials, … establish a dialogue with the MHRA and seek advice. The G-CTApp states that under the combined review process, the MHRA will inform applicants of the outcome of the submission along with the EC’s review and decision. The outcomes could be one (1) of the following: Acceptance of the request for a clinical trial authorization Acceptance of the request for a clinical trial authorization subject to conditions Grounds for non-acceptance of the request for a clinical trial authorization As … Go to United Kingdom > Scope of Assessment

… has authority over clinical investigations for drug and biological products regulated by the agency. 21CFR312 specifies that the scope of the FDA’s assessment for investigational new drug applications (INDs) includes all clinical trials (Phases 1-4). Based on 21CFR56 and 21CFR312 , institutional ethics committee (EC) review of the proposed clinical investigation may be conducted in parallel with the FDA review of the IND. However, EC approval must be obtained prior to the sponsor being … exemption conditions for marketed drugs. Clinical Trial Review Process As delineated in 21CFR312 , the FDA's primary objectives in reviewing an IND are to ensure human participant safety and rights in all phases of the investigation. Phase 1 submission reviews focus on assessing investigation safety, and Phase 2 and 3 submission reviews also include an assessment of the investigation’s scientific quality and ability to yield data capable of meeting marketing approval statutory requirements. An IND may be submitted for one (1) or more phases of an investigation. As per USA-41 and USA-94 , the FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) receive IND submissions for drugs, therapeutic biological … Go to United States > Scope of Assessment

… and control, and overcoming the consequences of natural calamities and catastrophes for which other drugs are not yet available on the market To treat rare and serious diseases The drug has been licensed for circulation by at least one (1) of the reference regulatory agencies specified in Article 2 of the DrugRgstrtn based on clinical records exempted according to the regulations of these agencies The DrugRgstrtn adds that the new drugs and vaccines must simultaneously meet the following criteria: The drug has been licensed for circulation in at least one (1) country in the world There is clinical data that is not complete or there is complete clinical data, as prescribed in Article 18 of the DrugRgstrtn , but there is no full assessment of racial factors that may affect the safety and effectiveness of the drug The DrugRgstrtn further indicates that certain generic drugs, new drugs (except vaccines), and herbal medicines that have been granted a circulation registration certificate before January 1, 2017 are exempt from clinical trials. See the DrugRgstrtn and the PharmLaw-VNM for more information on drugs that are exempted from a trial or certain phases of a trial. … Go to Vietnam > Scope of Assessment

… trials conducted in Zimbabwe. The Clinical Trial Unit receives, processes, and evaluates applications for approval to conduct studies within Zimbabwe, as well as amendments during the conduct of a study. The Clinical Trials Registry ( ZWE-1 ) will allocate an in-house reference number and send a letter of acknowledgement of receipt of clinical trial application (CTA) to the principal investigator (PI). As set forth in the CT-AppAuth , the CTA will be reviewed by external and … permit application by a foreign researcher. If approved, a Registration Certificate is issued to the institute of affiliation for onward transmission to the foreign researcher. Research permits are issued for a continuous period of one (1) year. After the expiration date, the research may continue upon renewal of the research permit. See ProcForeignReg and ZWE-17 for details on the renewal submission process and ZWE-60 for the renewal application form. In addition, see … Go to Zimbabwe > Scope of Assessment

… under the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) scheme for evaluation. Per the G-FeesCharges , the fees are as follows: $443 Australian dollars for unapproved medicines CTN, and for each notification of one (1) or more additional trial sites $2,111 Australia dollars for unapproved medicines CTA (30-day evaluation) $580 Australian dollars for unapproved medicines CTA – variation (30-day evaluation) $26,240 Australian dollars for unapproved medicines CTA (50-day evaluation) $7,162 Australian dollars for unapproved medicines CTA – variation (50-day evaluation) $443 Australian dollars for unapproved biologicals CTN, and for each notification of one (1) or more additional trial sites $31,955 Australian dollars for unapproved biologicals CTA $8,718 Australian dollars for unapproved biologicals CTA – variation For additional fee information, refer to Schedules 9 and 9A of the TGR and the … Go to Australia > Regulatory Fees

National Health Surveillance Agency (ANVISA) As set forth in ResNo857 , the sponsor is responsible for paying a Health Surveillance Inspection Fee (Taxa de Fiscalização de Vigilância Sanitária (TFVS)) to submit a clinical trial application (Clinical Drug Development Dossier (Dossier de Desenvolvimento Clínico de Medicamento (DDCM))) to the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) . As per ResNo857 and BRA-47 , once the sponsor has completed the process of submitting a primary DDCM petition, ANVISA’s Solicita Electronic Petition Request System ( BRA-56 ) generates a document known as the Union Collection Guide (Guia de Recolhimento da União (GRU)). According to ResNo857 , ANVISA uses the GRU as its primary method to generate TFVS fees. In addition to ResNo857 , see also BRA-51 for detailed information on the GRU, and BRA-69 for information on the TFVS fee. See also BRA-38 and BRA-47 for additional information on accessing BRA-56 . Per … Go to Brazil > Regulatory Fees

… Yuan New drugs made outside China: 376,000 Yuan Generic drugs made in China: 318,000 Yuan Generic drugs made outside China: 502,000 Yuan One-time import of drugs: 2,000 Yuan As specified in NMPA-No75-2020 and CHN-14 , the fees are based on one (1) active pharmaceutical ingredient or one (1) preparation as one (1) variety. If another specification is added, the registration fee will be increased by 20% according to the corresponding category. For further guidance on fees associated with submitting supplementary applications and registering renewals for … Go to China > Regulatory Fees

Congolese Pharmaceutical Regulatory Authority (ACOREP) According to DRC-12, the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) of the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention) charges a fee for the submission of a clinical trial application, in accordance with a fee schedule. Applicants should contact ACOREP for the fee schedule. Payment Instructions No information is available regarding payment … Go to DRC > Regulatory Fees

… National Directorate of Pharmacy and Medicine (DNPM) Per GIN-1, the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)) does not charge a fee to review the drug import license application. However, at times there may be related processes that the … Go to Guinea > Regulatory Fees

… for a paying a fee to the Drugs Controller General of India (DCGI), head of the Central Drugs Standard Control Organization (CDSCO) , to submit a clinical trial application. The 2019-CTRules specify that Form CT-04 should be accompanied by one (1) of the following officially mandated fees: 3,00,000 Rupees for Phase I (human) clinical trials 2,00,000 Rupees for Phase II (exploratory) clinical trials 2,00,000 Rupees for Phase III (confirmatory) clinical trials 2,00,000 Rupees for Phase IV … fee is 5,00,000 Rupees to register as a new user. Notice4Mar25 indicates that the fee is also 5,00,000 Rupees to renew an existing registration. In the case of a rejected application, the 2024-CTRulesAmdt further specifies that the fee is 1,00,000 Rupees for a submitted application to be reconsidered by CDSCO. Per IND-24 , for applications submitted to the National Single Window System (NSWS) portal ( IND-3 ), users should pay any required fees directly to CDSCO or any other … Go to India > Regulatory Fees

… the G-KenyaCT , the sponsor or the representative is responsible for paying a fee to the Pharmacy and Poisons Board (PPB) to submit a clinical trial application for authorization. The PPB currently requires a non-refundable application fee of $1,000 USD, or the equivalent in Kenya Shillings at the prevailing bank rates. Payment Instructions As stated in Annex 2 of the G-KenyaCT , payment is to be made by a bank check payable to the “Pharmacy and Poisons Board” and presented to the PPB’s … section. Student, Undergraduate/Diploma: East African Community (EAC) Countries – 100 Kenya Shillings; Kenyan Citizens – 100 Kenya Shillings; Rest of Africa – 200 Kenya Shillings; Non-Africans - $150 USD Research (Masters): EAC Countries – 1,000 Kenya Shillings; Kenyan Citizens – 1,000 Kenya Shillings; Rest of Africa – 2,000 Kenya Shillings; Non-Africans - $350 USD Research (PhD): EAC Countries – 2,000 Kenya Shillings; Kenyan Citizens – 2,000 Kenya Shillings; Rest of Africa – 4,000 Kenya Shillings; Non-Africans - $400 USD … Go to Kenya > Regulatory Fees

… Funded Phase I: $10,000 USD CRO Funded Phase II: $8,000 USD CRO Funded Phase III: $6,000 USD Investigator/Local Phases III & IV: $2,500 USD Academic Research Trial (Individual): $2,000 USD Amendment (Substantial) to Clinical Trial Protocol: $1,000 USD Payment Instructions No information is available regarding payment instructions. … Go to Liberia > Regulatory Fees

… Directorate of Pharmacy and Medicine (DPM) According to MLI-1 , applicants are required to pay application fees to submit an application to the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) . Applicants should contact the DPM for application fee information. … Go to Mali > Regulatory Fees

Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) As indicated in G-HumResProt , G-BioequivStud , G-ObsrvStdies , G-ResProtocolAmd , MEX-84 , G-DIGIPRiS-ResProts , the applicant is responsible for paying a non-refundable fee (also referred to as “Proof of Payment of Rights”) to submit a request for protocol authorization to the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) . According to MEX-37 and MEX-15 , applicants may obtain the fee information for a specific procedure or service using COFEPRIS’s Comprehensive Service Center (Centro Integral de Servicios (CIS)) ( MEX-37 ). Per MEX-15 , CIS is a public service system established by the Mexican government to facilitate the processing of the agency’s standardized procedures and services. MEX-15 and MEX-37 indicate that applicants may call CIS ( MEX-37 ) or schedule an appointment for assistance with determining the COFEPRIS … Go to Mexico > Regulatory Fees

National Institute of Health (INS) Per Decree021-2017 , the sponsor or the contract research organization (CRO) is responsible for paying a fee, as applicable, to the National Institute of Health (Instituto Nacional de Salud (INS)) to submit a clinical trial application for authorization. Additionally, INS payments are required as delineated by Decree010-2025 below. Request for clinical trial authorization: 3446.50 Peruvian Soles Request for clinical trial cancellation: 304.80 Peruvian Soles Authorization to change a clinical trial title: 305.10 Peruvian Soles Authorization to amend a report: 726.60 Peruvian Soles Request to expand the number of research centers: 450.60 Peruvian Soles Request to change the sponsor or contract research organization: 433.40 Peruvian Soles Request to change the principal investigator: 299.00 Peruvian Soles Request for a clinical trial extension: 306.40 Peruvian Soles Request for closure of a research Center: 308.40 Peruvian Soles Request for Suspension … Go to Peru > Regulatory Fees

… vaccines, and other biological products are as follows: Industry Funded (Phase I): $6,500 USD Industry Funded (Phase II): $6,500 USD Industry Funded (Phase III): $7,000 USD Research Institution Funded: $5,000 USD Protocol Amendment: $1,000 USD Expedited Protocol Review: $1,200 USD Renewal of Clinical Trial Certificate (yearly): $100 USD For locally sponsored clinical trials of therapeutics, vaccines, and other biological products the fees are as follows: Investigator/Local Phases: $2,000 USD Protocol Amendment: … Go to Sierra Leone > Regulatory Fees

… dashes (/) may be omitted Fee payments may be transferred directly into the bank account of SAHPRA via an electronic or manual deposit process No check payments will be accepted For administrative control purposes, applicants should make one (1) payment per service Payment should only be made once the application and required dossiers are ready for submission Payments do not have to be made upon request of an application number; however, the applications and required dossiers should be … Go to South Africa > Regulatory Fees

… the payment identification number (Control Number). However, the payer should select “OUR” in the charge mode section 71A. Any payment made without a Control Number will not be reflected in any invoice. Further, payments of more than one (1) Control Number(s) cannot be combined. Note that deposited money in the TMDA’s account cannot be refunded. Tanzania Commission for Science and Technology As delineated in the G-ResearchClearance , the Tanzania Commission for Science and … Go to Tanzania > Regulatory Fees

… the Thai Food and Drug Administration (Thai FDA) to submit an application to request permission to import or order drugs for research purposes in Thailand. The ClinDrugFees states that the Thai FDA requires an administrative processing fee of 1,000 Baht to review and verify the correctness of certain application requests related to authorization, including: Applications to request permission to import or order drugs into the Kingdom for research purposes without registering a drug formula (N.Y.M.1 form) (See ClinImprtOrdr (Appendix 2) and THA-18 (Appendix 2) for N.Y.M.1 form) Applications for drug samples produced for research studies (P.Y.8 form) (See ClinSampleProd (Appendix 1) and THA-76 (Appendix 1) for P.Y.8 form) In addition, per ClinDrugFees and THA-78 , the Thai FDA charges the following fees for the … Go to Thailand > Regulatory Fees

National Drug Authority In accordance with the NDPA-CTReg , the G-CTConduct , and the NDPA-FeesReg , applicants are responsible for paying a non-refundable processing fee to submit a clinical trial application for human drugs and vaccines (except for locally manufactured herbal drugs) to the National Drug Authority (NDA) . As set forth in the NDPA-FeesReg , the following fees apply: Application to undertake a clinical trial for a registered drug – $2,500 USD Application to undertake a clinical trial for an unregistered drug – $4,000 USD Application to amend a clinical trial application – $200 USD Payment Instructions According to the G-CTConduct , the application fee payment details are as follows: National Drug Authority: TIN 1000054563 Bank: Stanbic Bank Uganda Account numbers: 9030008068851 (US Dollars) and 9030005759829 (Ugandan shillings) Swift code: SBICUGKXXXX Sort Code: 040147 Acceptable forms of payment: cash in the bank, real time gross settlement (RTGS), electronic funds … Go to Uganda > Regulatory Fees

… for any unpaid amounts. As delineated in the G-MHRAFees , the MHRA levies the following clinical trial processing fees: 4,656 British Pounds – Applications with an Investigational Medicinal Product (IMP) dossier (higher fee for phase 1, full and simplified IMP dossier) 343 British Pounds – Applications without an IMP dossier (lower fee for phase IV, cross referral, additional protocol) 343 British Pounds – Clinical trial variation/amendment No cost – Phase IV notification 343 … Go to United Kingdom > Regulatory Fees

… application to conduct a clinical trial of registered and unregistered human medicines. The CT-Fees prescribes the following fees for an application to conduct a clinical trial funded by a local sponsor: Human medicine: $2,000 USD Sub-study: $1,000 USD Operational research study: $1,000 USD Observational study: $200 USD Any other case: $100 USD Initial or subsequent amendments to original application funded by a local sponsor: $50 USD Expedited review: the regular fees outlined above plus 50% of the process-specific fee For … trial funded by a foreign sponsor, the CT-Fees prescribes the following fees: Human medicine in a phase I study: $5,000 USD Human medicine in a phase II study: $4,000 USD Human medicine in a phase III or IV study: $3,000 USD Operational: $1,000 USD Bioavailability/bioequivalence: $500 Observational: $200 USD Any other case: $200 USD Initial or subsequent amendments to original application funded by a local sponsor: $100 USD Expedited review: the regular fees outlined above plus 50% … Go to Zimbabwe > Regulatory Fees

… G-NatlStmt further specifies that any research that involves greater than low risk must be reviewed by an EC. (Note: Institutional ECs are referred to as Human Research Ethics Committees (HRECs) in Australia.) The G-NatlStmt indicates that one (1) or more institutions can individually or jointly establish an EC or any other ethics review body. Institutions that establish an EC are responsible for adequately resourcing and maintaining it, including providing sufficient administrative … an EC must be composed of at least eight (8) members in the following categories: A chairperson with suitable experience Two (2) people who bring a broader community or consumer perspective and have no paid affiliation with the institution One (1) person with knowledge of and current experience in the professional care, counseling, and/or treatment of people One (1) person who performs a pastoral care role in the community One (1) qualified lawyer, who may or may not be currently practicing and, where possible, is not engaged to advise the institution on research-related or any other matters Two (2) people … Go to Australia > Ethics Committee

… number of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is recommended that the EC include at least five (5) members, at least one (1) member whose primary area of interest is in a nonscientific area, and at least one (1) member who is independent of the institutional/trial site. The IRB-Manual further specifies that there must be adequate experience, knowledge, and variety among the members to make an educated judgment. In addition, the EC: Will have a chairman appointed to it Must include men and women Should be interdisciplinary and cross-sectoral Should include both scientific and non-scientific specialists, such as a lawyer, a religious expert, and laypeople Must have at least one (1) member (if it is a five (5) member committee) who is not linked with the institution. For bigger committees, at least 40% of the members should be external to the institute/organization See the BGD-GCP and the IRB-Manual for additional details … Go to Bangladesh > Ethics Committee

… human beings and for approving the research protocols when applicable, as explained in ResNo466 , ResNo446 , OSNo001 , and ResNo706 . ResNo466 further notes that institutions conducting research involving human participants may establish one (1) or more ECs (CEPs) according to their institution’s requirements. For those institutions lacking an EC (CEP), or in the case of an investigator without an institutional affiliation, CONEP is required to suggest an EC (CEP) to conduct the … qualifications and experience to analyze all aspects inherent to the research, including medical, scientific, ethical aspects and those related to good clinical practice (GCP). The EC (CEP) is also required to have in its composition one (1) Research Participant Representative (Representante de Participante de Pesquisa (RPP)). National Research Ethics Commission (CONEP) As per OMREC , the EC (CEP) is required to be composed of a minimum of seven (7) members having proven expertise … have complete autonomy to issue their opinions, in compliance with GCP. In addition, LawNo14.874 explains that depending on the degree of risk involved in the research, the role of the research ethics review body will be exercised by one (1) of the following: An EC (CEP) accredited or certified by the National Research Ethics Authority, in the case of low or moderate risk research An EC (CEP) accredited by the National Research Ethics Authority, in the case of high-risk research … Go to Brazil > Ethics Committee

… representing a mixed gender composition, the majority of which are Canadian citizens or permanent residents, and must include: Two (2) members from a scientific discipline, with broad experience in the relevant research methods and areas, one (1) of whom is from a medical or dental discipline One (1) member knowledgeable in ethics One (1) member knowledgeable in relevant Canadian biomedical research laws One (1) member from a nonscientific discipline One (1) community representative The G-TCPS2 mirrors these EC composition requirements, and also requires a Chair who is … Go to Canada > Ethics Committee

… provide a fair scientific and ethics review. The RegEthics states that in areas where minority ethnic groups reside, the institution should consider including members of those groups on the EC. The EC-Guide indicates that there should be one (1) member who does not belong to the institution and has no close relationship with the project researchers (the same member can meet both requirements). As delineated in the Measures-Ethics , EC members must be selected from experts in the fields … in continuing education should be on a continuous basis to ensure improvement. As delineated in the Measures-Ethics , the term of office for members of ECs that review life sciences and medical research involving people must not exceed one (1) year, and they may be re-elected. The EC must have one (1) chairman and several vice chairmen, who must be elected by EC members through consultation and then appointed by the institution. EC members, independent consultants, and their staff must sign confidentiality agreements on sensitive information … Go to China > Ethics Committee

… having special interests, direct or indirect, in a research proposal must exclude themselves from the evaluation of the proposal. National Committee of Health Ethics (CNES) As per Order1250-ZKM043 , the CNES has 40 members, including: One (1) delegate per province from institutional ECs Scientific individuals (at most 10) Religious individuals (at most five (5)) A delegate from the Order of Physicians A delegate of the Order of the Pharmacists A delegate from other health … to reach a quorum The professional qualifications required and distribution of these requirements within the quorum No quorum shall be composed exclusively of members of the same profession or the same sex The quorum must include at least one (1) member whose primary area of expertise is not scientific and at least one (1) independent member of the institution or research site The G-EthicalEval further requires that an EC meet regularly, on scheduled dates announced in advance in a publicly available calendar. The meeting requirements must include or specify at … Go to DRC > Ethics Committee

… for CNERS’s review Manage the documentation and archives of CNERS Help the committee prepare for its sessions Write committee meeting minutes Disseminate CNERS recommendations and decisions CNERS has three (3) technical working committees: one (1) committee deals with advocacy, communication, and awareness actions; one (1) committee is responsible for training activities; and one (1) committee is responsible for monitoring and evaluating CNERS’s achievements. Terms of Reference, Review Procedures, and Meeting Schedule According to DecreeNoD218 , the CNERS committee is required to follow standard operating procedures (SOPs) … Go to Guinea > Ethics Committee

… should include the following (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements): Chairperson from outside the institute (Vice Chairperson (optional)) One (1) to two (2) basic medical scientists (preferably one (1) pharmacologist) One (1) to two (2) clinicians from various institutions Legal expert(s) or retired judge One (1) social scientist/representative of non-governmental voluntary agency One (1) philosopher/ethicist/theologian One (1) lay person from the community Member … Go to India > Ethics Committee

… Overview As per the G-KenyaCT , the G-ECBiomedRes , and KEN-30 , Kenya requires an independent review of research through a National Commission for Science, Technology and Innovation (NACOSTI) -accredited ethics committee (EC) in one (1) of the local institutions charged with the responsibility of conducting research in human participants. KEN-25 provides a list of the accredited institutional ECs. Ethics Committee Composition As delineated in the G-ECAccred , institutional ECs … encompass relevant scientific expertise, balanced age and gender distribution, and include laypersons representing community interests and concerns. Per the G-ECAccred , the composition should meet the following requirements: At least one (1) member with knowledge and understanding of Kenyan law At least one-third of the members must be female, and one-third must be male At least one (1) member who is unaffiliated with the institution At least two (2) members must have research expertise and experience, one (1) of whom must be in the health field At least one (1) member must be a lay member For ECs reviewing clinical research, … Go to Kenya > Ethics Committee

… a meeting due to unforeseen reasons must inform the NREB director two (2) weeks prior to the scheduled meeting. If unable to attend, members must also advise the NREB director regarding their views or concerns on specific agenda items one (1) week prior to a scheduled meeting. Meeting agendas and research protocols should be distributed to members no later than three (3) weeks before a regular meeting. Refer to the G-NREB and LBR-12 for detailed committee requirements. Atlantic … of the voting board members at any given event. A quorum must consist of regular and/or alternate board members (persons formally selected by the board to substitute for regular members who are unavailable ), and it must include at least one (1) member whose primary background is science related, and one (1) member whose primary background is not science related. Special/independent consultants cannot be used to establish a quorum. Members who are recused from the review of a protocol cannot be used to establish a quorum. A simple majority vote of … Go to Liberia > Ethics Committee

… sound. COMREC’s responsibilities include the following: Review and approve the science and ethics of proposed research and amendments to previously approved protocols Annual continuing reviews of approved studies running for more than one (1) year Follow the progress of studies until the termination of the research Monitor and report to institutional or regulatory authorities any serious or continuing non-compliance with ethical standards Recommend suspension or termination of … National Health Sciences Research Committee As per the G-NHSRC , NHSRC must consist of members with varying backgrounds, including the social sciences, to promote complete and adequate research proposal review. The committee should include one (1) lay person, as well as members from the following organizations: National Research Council of Malawi (one (1) member) MOH headquarters (two (2) members) COMREC (two (2) members) Community Health Sciences Unit (one (1) member) National AIDS Commission (one (1) member) Center for Social Research (one (1) member) Queen Elizabeth Central Hospital (one (1) … Go to Malawi > Ethics Committee

… a jurist; and a chemist. D-No2021-0415 states that the CIESS/USTTB is presided over by a scientific person appointed by the rector and selected from among the committee members for a period of three (3) years, which is renewable one (1) time. The president is seconded by a vice-president. The CIESS/USTTB may also call upon a competent person with specific expertise to assist the committee in its work. National Institute of Public Health (INSP) Ethics Committee OrderNo2019-011 … Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB) As explained in D-No2021-0415 , the term of office for CIESS/USTTB members is three (3) years and is renewable one (1) time. Committee membership is free. The president leads the meetings and represents the CIESS/USTTB among various organizations and institutions. When the president is absent, the vice-president performs the president’s duties. In addition, per … within a period of eight (8) days and the committee’s deliberations are then valid regardless of the number of members present. In addition, per D-No2021-0415 , the agenda and the necessary documents are made available to members at least one (1) week prior to the meeting. D-No2021-0415 further states that consensus is the basic principle governing the functioning of the CIESS/USTTB. If consensus is not reached, the decision may be made by a relative majority vote. The president must … Go to Mali > Ethics Committee

… practice, bioethics, and have experience related to the research area they will be evaluating. HlthResRegs further notes that the REC must consist of at least three (3) scientists including both genders and recommends that at least one (1) of them be based outside the health institution. The medical professionals should also represent the moral, cultural, and social values of the research groups. By comparison, NOM-012-SSA3-2012 states that REC health professionals should have … plus community representatives, as deemed necessary, with a total of at least six (6) members and a maximum of 20. G-RECs-Op-2018 , REC-Op , and REC-Op-Ref note that the REC should comprise a president, at least four (4) members, one (1) of whom will serve as secretary, a representative from the affected study group or other health services users, with at least one (1) member who has expertise in bioethics and research ethics, and internal or external specialists to be included on an as needed basis. G-RECs-Op-2018 also notes that the member acting as a representative is not required to have a professional … Go to Mexico > Ethics Committee

… Ethics Committees for Human Subjects Health Research Other than Clinical Trials Res233-2020 , which regulates human subjects research other than clinical trials of drugs or devices, states that health institutions or entities may establish one (1) or more ECs in order to fulfill their requirements to conduct health research with human beings. Per Res233-2020 , ECs that conduct health research with humans are created by statute, resolution, or other document that establishes, as a … of Institutions that Provide Health Services (Registro Nacional de Instituciones Prestadoras de Servicios de Salud (RENIPRESS)). An EC may also be an entity within the Ministry of Health of Peru (Ministerio de Salud del Perú (MINSA)) , one (1) of the Peruvian universities, or a non-profit legal organization. If the entities or institutions do not have an EC, they may select another INS-registered EC to evaluate their investigations. This arrangement may occur following a written … Persons with expertise in ethical matters Persons with expertise in legal matters Community representatives, whose primary function is to share their views on the communities where research participants are likely to come from At least one (1) full member must be from the community and not belong to the health field, or to the research institution In addition, Decree021-2017 specifies that all members must have at least one (1) certificate of basic training in research ethics and one … Go to Peru > Ethics Committee

… the qualifications and experience required to review and evaluate the scientific, medical, and ethical aspects of a proposed clinical trial. Specifically, it is recommended that the EC should include: At least five (5) members At least one (1) member whose primary area of interest is nonscientific At least one (1) member who is independent of the institution/trial site Terms of Reference, Review Procedures, and Meeting Schedule As set forth in the SL-GCPs , the EC (i.e., the SLESRC) must perform its functions according to written standard operating … Go to Sierra Leone > Ethics Committee

… and should have leadership experience. If the chairperson is an external appointee, the institution must provide the chairperson with the necessary support and authority to perform the role. The chairperson should be assisted by at least one (1) deputy chairperson, who is elected by the EC members and assists the chairperson and serves as the role of chairperson when necessary. As delineated in the G-EthicsHR-ZAF , the composition of ECs should promote optimal human participant … of research ethics training, refreshed at least once. EC membership should consist of: A minimum of nine (9) members with a quorum being a simple majority; where the number of members is more than 15, the quorum may be 33% At least one (1) layperson At least one (1) member with knowledge of, and current experience in, the professional care, counselling, or health-related treatment of people, (e.g., a social worker, nurse, psychologist, or medical practitioner) At least one (1) member with professional … Go to South Africa > Ethics Committee

… in Tanzania to establish institutional ECs or Institutional Review Boards (IRBs) Accrediting health research institutions’ ECs Per the G-AppConductCT , G-EthicsHR-TZA , the G-ResearchIntegrity , the G-RevPrtcl , TZA-18 , TZA-5 , and TZA-1 , all health research involving foreign collaborators must get ethics approval from both the institutional EC and NatHREC. In addition, TZA-5 specifies that the following also require review by both NatHREC and the zonal or institutional EC: all … be invited to meetings where such protocols will be reviewed. Regular rotation of members is desirable for balancing the advantage of experience with that of fresh perspectives. In addition, each institutional EC must include at least one (1) member who is not affiliated with the institution and is not part of the immediate family of a person who is affiliated with the institution. Further, an EC may invite individuals with competence in particular areas to assist in the review of … in health research, leadership, and have basic knowledge of bioethics An EC must comprise at least five (5) members or more, and the total must be an odd number At least one-third of the members of the EC must be of either gender At least one (1) member should come from outside the institution At least two (2) members should have research expertise and experience, and one (1) of these should be in the health field At least one (1) member should represent a lay group For ECs reviewing … Go to Tanzania > Ethics Committee

… clinical research project to reduce redundancy during the review process and to develop joint human research ethics guidelines. (See THA-18 and THA-76 for the forms included in the appendices in ClinSampleProd and ClinImprtOrdr .) Per THA-1 , the ECMOPH and the CREC represent the two (2) central ECs recognized by the Thai FDA to review and approve clinical research protocols involving humans. THA-1 further explains that both the ECMOPH and the CREC are categorized as central ECs because they can accept all clinical research studies for review, regardless of the trial sites involved. See THA-94 for a CREC-maintained list of … and other related or assigned academic projects. See THA-13 for additional details about the ECMOPH, and THA-13 and THA-39 for requirements specifically related to studies approved by the ECMOPH. Central Research Ethics Committee Per THA-1 , the CREC was formed in 2014 through the cooperative efforts of 26 public and private institutions in Thailand, including the Thai FDA. THA-44 explains that the goal of the CREC, which operates under the National Research Council of Thailand … Go to Thailand > Ethics Committee

… the composition should include: Individuals of varying backgrounds, including consideration of gender, cultural backgrounds, and sensitivity to social issues in the community from which research participants are drawn At least one (1) individual whose primary concern is scientific, and at least one (1) whose primary concern is non-scientific At least one (1) individual who is unaffiliated with the institution At least one (1) lay person from the community, whose primary background is not in scientific research involving human participants, and who is capable of sharing insights about the community … Go to Uganda > Ethics Committee

… care professionals, clinical researchers, or managers of clinical research (also known as lay members). Additionally, GAfREC states that a quorate meeting must be attended by at least seven (7) members and include the chair, at least one (1) expert member, and one (1) lay member. GBR-9 mirrors this requirement, but adds that when investigational products are reviewed, a lay member must be present. See GBR-113 for additional recommendations for composition. Per GBR-9 , in order to accommodate the United … application is given within the relevant time limit (or to discuss matters relating to the establishment or operating procedures of the EC or for training purposes). Meetings to review applications should normally be held at intervals of one (1) month unless there are holidays. The schedule of EC meetings for the financial year commencing on April 1 st should be agreed to by December 1 st in the previous financial year. The schedule should set out the dates and times of meetings, and … Go to United Kingdom > Ethics Committee

… to such research. However, the RevComRule does require federal departments or agencies implementing the policy to work with data experts to reexamine the meaning of “identifiable private information” and “identifiable specimen” within one (1) year of the effective date and at least every four (4) years thereafter. In particular, these agencies will collaboratively assess whether there are analytic technologies or techniques that could be used to generate identifiable private … acceptability of proposed research based on institutional commitments and regulations, applicable laws, and standards. In addition, if an EC regularly reviews research involving vulnerable populations, the committee must consider including one (1) or more individuals knowledgeable about and experienced in working with those participants. See the Vulnerable Populations section for details on vulnerable populations. At a minimum, each EC must also include the following members: One (1) primarily focused on scientific issues One (1) focused on nonscientific issues One (1) unaffiliated with the institution, and not part of the immediate family of a person affiliated with the institution No EC member may participate in the … Go to United States > Ethics Committee

… GCP principles and the EC’s SOPs. Administrative secretaries must have a college degree or higher and knowledge of the EC’s SOPs. Council of Ethics in Biomedical Research at the Grass Root Level The ECReg states that a CEBRGL consists of one (1) chair, at least one (1) vice chair, EC members, alternate members (if any), a standing body, and specialized subcommittees (when necessary). The number of vice chairs, EC members, alternate members (if any), professional secretaries, administrative secretaries, and … assist the CEBRGL with application processing and other administrative tasks. See the ECReg and the CEBRGLReg for additional CEBRGL membership criteria. National Ethics Committee in Biomedical Research The ECReg requires the NECBR to have one (1) chair, at least three (3) vice chairs, members, alternate members (if any), specialized subcommittees, and the National Ethics Committee Office. The National Ethics Committee Office, a supporting agency of the NECBR, is located at the MOH’s … Go to Vietnam > Ethics Committee

… Include at least two (2) lay persons who have no affiliation to the institution, are not currently involved in medical or scientific research, and are preferably from the community in which the research is to take place Include at least one (1) member with knowledge of, and current experience in, areas of research that are likely to be regularly considered by the EC Include at least one (1) member with knowledge of, and current experience in, the professional care, counseling, or treatment of people (e.g., medical practitioner, psychologist, social worker, or nurse) Include at least one (1) member who has professional training in both qualitative and quantitative research methodologies Include at least one (1) member who is legally trained The institution or organization must ensure that the membership is equipped to address all … Go to Zimbabwe > Ethics Committee

… research governance requirements. Role in Clinical Trial Approval Process According to the G-CTHandbook , the G-TrialsSOP , and AUS-86 , ECs are responsible for reviewing and approving protocols involving unapproved therapeutic goods under one (1) of two (2) regulatory schemes—the Clinical Trial Notification (CTN) scheme or the Clinical Trial Approval (CTA) scheme—prior to the sponsor initiating a trial. According to AUS-40 , all public and private health organizations must also … complexity of the research. Monitoring responsibilities that are performed by the institution’s EC should be based on the EC’s review of the project. However, where research that will take place at multiple sites has been reviewed by only one (1) EC, the ECs of the other institutions participating in the project do not have knowledge of the project. In such cases, only the reviewing EC can take on those elements of monitoring a research project that are commonly performed by ECs. Per … of the research, researchers should request a grant of exemption from an EC. Research that may be eligible for exemption from ethics review includes research that carries a lower risk to participants or the community, and satisfies one (1) or more of the following conditions: The research involves the use of collections of information or data from which all personal identifiers have been removed prior to being received by the researchers, and where researchers explicitly agree: … Go to Australia > Scope of Review

Overview As per the BGD-GCP , ethics committees (ECs) (referred to as independent ethics committees (IECs)/institutional review boards (IRBs) in Bangladesh) are responsible for ensuring the protection of the rights, safety, and well-being of human participants involved in a clinical trial. It is also an EC’s responsibility to provide public assurance of that protection, by, among other things, reviewing and approving/providing a favorable opinion on the trial protocol, as well as the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial participants. The EC also provides continuing review of the trial protocol and amendments, and of the methods and material to be used. The BGD-GCP further indicates that special attention should be paid to trials that may include vulnerable participants. An EC should follow the rules, regulations, and ethical guidelines of the Ministry of Health and Family … Go to Bangladesh > Scope of Review

… timelines to classify research and the processing of research protocols involving human beings in the CEP/CONEP System based upon study type and level of intervention in the human body. The regulation divides research into two (2) groups: 1) studies seeking to describe or understand phenomena that has happened or happen in the research participant’s daily life; and 2) studies that aim to verify the effect of an investigational product (IP) or technique used in research, … in the collegiate meeting to provide clarifications about the research, but the investigator is prohibited from attending the meeting while the final decision is being made. Upon completion of its review, the EC (CEP) opinion will be one (1) of the following: approval of the research; non-approval of the research; or, suspension, when approved research that is already in progress needs to be interrupted for safety reasons. The decision contained in the EC’s (CEP's) opinion may be initially appealed to the EC (CEP) that issued the opinion and, subsequently, the opinion may be appealed one (1) final time to the National Research Ethics Authority. All those involved in conducting, monitoring, evaluating, or approving the research who have direct access to its records, to verify compliance with the procedures and applicable legislation … Go to Brazil > Scope of Review

… In line with a proportionate approach to research ethics review, if research is of minimal risk and spans multiple jurisdictions, institutions that have approved the use of the single EC review model authorize the review of the research by one (1) EC. See the G-TCPS2 for more information about the various review models for multi-jurisdictional research. Per CAN-8 , an attestation must be completed by the EC that reviewed and approved the clinical trial. The completed attestation must be … Go to Canada > Scope of Review

… legal rights or exempts researchers, institutions, or sponsors from being responsible Whether the method, content, and timing of the release of research results are reasonable Per the Measures-Ethics and the EC-Guide , the EC will make one (1) of the following decisions (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements): Approval: The EC unconditionally approves an initial review of the research protocol … Go to China > Scope of Review

Overview The G-EthicalEval indicates that the main task of an ethics committee (EC) is to review research proposals and supporting documents, with particular attention to the process of obtaining informed consent, documentation, and the relevance and feasibility of the protocol. The EC must take into account previous scientific and ethical assessments, if any, and the requirements of applicable laws and regulations. An EC may perform its function at the institutional, local, regional, or national level. According to the G-EthicalEval , ECs are responsible for protecting the rights of research participants, their safety, and their well-being. ECs must act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants; confirming the suitability of the investigator(s), facilities, methods, and scientific design of the study; assessing the participant recruitment process; and verifying the … Go to DRC > Scope of Review

… ethical review guidelines. Role in Clinical Trial Approval Process As per the Guinea-PHC , GIN-6 , and GIN-5 , the PI or the representative is responsible for submitting a research application to CNERS for review and approval. According to GIN-1, CNERS must approve the clinical trial protocol before the sponsor or the representative (typically the PI) submits the drug import license application to the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et … as well as the details pertaining to the CNERS review and decision-making process. Please refer to the Timeline of Review section for additional ethics committee (EC) timeline information. Per GIN-5 and GIN-12 , CNERS approval is valid for one (1) year and is renewable upon request by the PI/sponsor. Additionally, per GIN-12 and GIN-6 , any amendments to protocols currently being implemented must also be submitted to CNERS. Guinea-PHC states that when research is related to an epidemic … epidemics or disasters), an accelerated procedure is adopted without prejudice to the requirements of submitting the protocol and including the following: Reduction of the minimum and maximum periods of review and decision to 48 hours and one (1) week respectively Reduction of the required quorum of the members of CNERS to five (5) Possibility of calling on other national and international experts Acceptances of online submission and evaluation Sending the response letter within 48 … Go to Guinea > Scope of Review

… any other reason that requires closer review and attention. See the G-ICMR for additional participating site requirements when a primary EC is selected for common EC review. Per the G-ICMR , when the multicenter research study designates one (1) main EC, the nominated EC members that represent the participating sites may attend the meeting of the elected EC. The designated EC should also be in India and be registered with the relevant authority (either the DCGI or the DHR depending on … Go to India > Scope of Review

Overview According to G-ECBiomedRes , the primary scope of information assessed by the institutional ethics committees (ECs) relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. The G-ECAccred further states that the National Commission for Science, Technology and Innovation (NACOSTI) accredits ECs in order to uphold the standard of ethics review in the country; develop public confidence and trust in the national research system; facilitate equitable access to research and human health records in health facilities; and facilitate coordination and collaboration among ECs. See the G-ECAccred and the G-ECBiomedRes for detailed ethical review guidelines. Role in Clinical Trial Approval Process As per the G-KenyaCT and KEN-21 , the Pharmacy and Poisons Board (PPB) ’s review and approval of a clinical trial application is dependent upon obtaining approval by an accredited … Go to Kenya > Scope of Review

… scientific knowledge, and especially, the clinical trial is unsuitable for providing IP(s) proof of safety or efficacy, or; the applicable requirements specified in the general conditions for conducting clinical trials (see Chapter II (Section 1) of LibCTReg ) are not fulfilled. Per the G-NREB , a principal investigator (PI) will be contacted by written communication (letter or email) if the NREB determines that additional materials are required to complete its review. PIs may also be … review. Additionally, per LibCTReg , the NREB’s written permission must be withdrawn if the NREB subsequently becomes aware that grounds for a refusal as referred to in the clinical trial authorization procedures (see Chapter II (Section 5 (1)) of LibCTReg ) existed at the time the authorization was issued. The authorization must be withdrawn if the NREB becomes aware of the fact that subsequently at least one (1) of the following is true: Requirements regarding the suitability of the investigator, the investigator’s deputy, or the trial site are no longer fulfilled Trial participants are no longer properly insured or the prerequisites for an exception … Go to Liberia > Scope of Review

… NHSRC determines that substantive changes/clarifications must be made before approval may be granted, the study will be deferred for a full NHSRC meeting. The G-COMREC specifies that the COMREC’s approval of a new application is valid for one (1) year. However, the R-HlthResCoord indicates that EC approval of a study is valid for the period of the study as described in the protocol, which is effective from the date of approval as indicated in the approval letter. The R-HlthResCoord , … protocols for a multicenter study submitted by different investigators provided that such protocols are submitted simultaneously. Protocols for the same multicenter trial to be implemented at different institutions may also be merged into one (1) protocol that the NHSRC will treat as a joint submission for review. Continuing Review According to the G-NHSRC and the G-COMREC , all approved studies running for more than one (1) year are subject to continuing annual review by the approving EC (the NHSRC or COMREC). If the materials for continuing EC review are not received within one (1) month following the expiration date of the previous approval, then the study will … Go to Malawi > Scope of Review

… (INSP))’s mission is to set up a health watch system and epidemiological surveillance and to promote health policy and systems research. In accordance with LawNo2019-023 , which ratifies OrderNo2019-011 , the INSP established an EC as one (1) of its administrative and management bodies. Per OrderNo2019-011 , taking into account the socio-cultural context, the INSP EC is charged with giving its opinions on response measures to health threats and crises, research projects and … Go to Mali > Scope of Review

… five (5) working days after the committee has met, or if applicable, not to exceed 30 calendar days from the review request date. G-RECs-Op-2018 and G-DIGIPRiS-ResProts also state that the approval of a new application is valid for one (1) year. After obtaining a favorable opinion from the REC that validated the initial project or protocol, per NOM-012-SSA3-2012 , the principal investigator (PI) must submit an amended protocol to the Ministry of Health (Secretaría de Salud) to … Go to Mexico > Scope of Review

… the welfare of certain classes of participants deemed to be vulnerable. Per Decree021-2017 , when a clinical trial is proposed for subordinate groups (e.g., students, health workers, employees, military members, police, prisoners, etc.), one (1) or more members of the population under study, or another person within this community capable of guarding the conditions and human rights that correspond to the group in question, should participate in the EC review. (See the Vulnerable … Go to Peru > Scope of Review

… ( TZA-32 ) (also referred to as the National Health Research Management Information System (NHRMIS)), an online web application for the submission of research protocols for NatHREC’s review, validation of protocols per NatHREC checklist ( TZA-1 ), online review of proposals, and application status tracking. The G-RevPrtcl indicates that the NatHREC Secretariat will validate submissions for completeness upon receipt in REIMS. The G-RevPrtcl recommends the following review sequence after … the reviewers of the original submission; in absence of the original reviewers, the Secretariat must appoint and send the amendment application to another reviewer with the same or similar expertise. The number of reviewers will range from one (1) to three (3), depending on the number of the amendments. Minor amendments may be reviewed by members of the Secretariat. If the committee requires modifications to any of the documents, specific changes required must be communicated to the PI … individual centers have the authority to adapt the informed consent document provided by the lead institution to make it culturally appropriate. To avoid lengthy procedures, multicenter research within Tanzania should be reviewed by only one (1) EC and other applicable ECs should accept that review. To be informed of the necessary approach, the study team should be consulted. In cases of multicenter research, if a local review committee proposes changes to the original protocol that it … Go to Tanzania > Scope of Review

… further specify that for both types of approval requests, the application is either submitted to the Thai FDA after the research project and all the research sites have been approved by an EC, or in parallel, pending review by at least one (1) EC involved in the study. G-ResEthics further states that research conducted in public hospitals or public health care facilities involves expenditures such as laboratory tests and lump sum fees determined by the institution. The disclosure of … to the ECMOPH. However, it can be used to obtain a better understanding of the EC process within Thailand. Central Research Ethics Committee As indicated in THA-24 , a research project is eligible to apply for CREC review when it meets one (1) of the following criteria: It is a pharmaceutical-sponsored multi-center clinical trial It is an investigator-initiated, multi-site study granted by a research funding organization (e.g., the National Research Council of Thailand (NRCT) , the … Go to Thailand > Scope of Review

… for its disapproval in the written notification. As per the NGHRP , ECs may use an expedited review process for research involving no more than minimal risk or for minor changes in previously approved research protocols during a period of one (1) year or less from which approval was given. Minor changes include an addition of a collaborator, a small change in the number of research participants, or spelling corrections. Expedited review processes may also be applied to annual renewal of … Go to Uganda > Scope of Review

… and privacy safeguards. See GAfREC , the MHCTR , the MHCTR2006 , and GBR-9 for detailed ethics review guidelines. GBR-112 indicates that certain ECs are flagged for special expertise including gene therapy or stem cell clinical trials; Phase 1 studies in healthy volunteers; Phase 1 studies in participants; research involving adults lacking capacity; research involving children; research involving prisoners or prisons; or fast-track ECs. Role in Clinical Trial Approval Process As described in GBR-9 , GBR-66 , and GBR-95 , … of the electronic application must be made to IRAS on the same day that a booking is made to schedule an EC review through the NHS REC’s Online Booking Service ( GBR-95 ). According to the MHCTR , GAfREC , and GBR-9 , for all studies, only one (1) EC review is needed for a project taking place in the UK, regardless of the number of sites. Furthermore, GBR-9 states that the Chief Investigator (CI) should be based in the UK and that the REC may agree exceptionally to an application being … Go to United Kingdom > Scope of Review

… the expedited review procedure to review the following: Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk Minor changes in previously approved research during the period (of one (1) year or less) for which approval is authorized Under the RevComRule , research for which limited EC review is a condition of exemption 21CFR56 , the Pre2018-ComRule , and the RevComRule specify that under an expedited review procedure, the review may be carried out by the EC chairperson or by one (1) or more experienced reviewers designated by the chairperson from among the EC’s members. In reviewing the research, the reviewers may exercise all of the authorities of the EC except that the reviewers may not disapprove the research. A … see the G-IRBTransfer for FDA guidance on the regulatory responsibilities of ECs, clinical investigators, and sponsors when oversight of a previously approved, ongoing clinical investigation under the FDA’s jurisdiction is transferred from one (1) EC to another EC. Cooperative Research Studies In the event of multicenter clinical studies, also known as cooperative research studies, taking place at US institutions that are subject to the RevComRule , the institutions must rely on a single … Go to United States > Scope of Review

… case of parallel submission. Per ZWE-GCP , the study’s institutional EC must apply for ethical clearance by the MRCZ. However, the CTEthics states that the PI submits the application to the MRCZ. The clinical trial application is sent to one (1) primary reviewer and two (2) external reviewers who document their comments at the NHRDC/MRCZ meetings. After 3-6 weeks, the reviewers’ and NHRDC/MRCZ’s comments are sent to the researcher for feedback. Per ZWE-9 , all health research conducted … has been approved or not approved by the NHRDC, as appropriate. The CTEthics states that if conditional approval is granted, the sponsor should register with the RCZ if it has foreign researchers. The MRCZ’s approval is issued upon payment of a 1% levy and production of a RCZ registration permit, if applicable. For continuing review, ZWE-41 states that MRCZ requires investigators to submit an annual review form ( ZWE-42 ). ZWE-11 indicates that if investigators wish to amend or modify an … Go to Zimbabwe > Scope of Review

Institutional Ethics Committee Per the BGD-GCP , ethics committees (ECs) (referred to as independent ethics committees (IECs)/institutional review boards (IRBs) in Bangladesh) may charge fees for their services, such as ethical evaluations of protocols and ethical/good clinical practice (GCP) compliance inspections (as required). Fees are fixed by the EC and endorsed by the organization. An annual financial audit system should be in place, and transparency of income and expenditure should be maintained. Payment Instructions No information is currently available regarding payment instruction standards for institutional ECs. National Research Ethics Committee According to BGD-15 and BGD-16 , there is a review and processing fee for Bangladesh Medical Research Council (BMRC) ethical approval via its National Research Ethics Committee (NREC). The fee is based on 2% of the total cost of the approved research project, not exceeding 500,000 Bangladeshi Taka. For clinical trials or drug … Go to Bangladesh > Ethics Committee Fees

… decide whether to charge fees to conduct protocol reviews. For example, an institutional EC may require industry sponsors or other for-profit organizations to pay a fee. See specific examples of institutional fee requirements in CAN-3 and CAN-1 . … Go to Canada > Ethics Committee Fees

… clinical trial protocol and related documents. For protocol amendments or extension of approval validation, the fee is 3,000,000 Guinean Francs. For doctoral students, the fee for amending a protocol or extending the validation of approval is 1,500,000 Guinean Francs. Payment Instructions Per GIN-17, payment to CNERS can be made by bank transfer, check, or cash depending on the options available to the applicant. GIN-5 further notes that when the investigator submits the documents to … Go to Guinea > Ethics Committee Fees

… As per the G-KenyaCT , G-ECBiomedRes , and KEN-30 , Kenya requires an independent review of research through a National Commission for Science, Technology and Innovation (NACOSTI) -accredited ethics committee (EC) in one (1) of the local institutions charged with the responsibility of conducting research in human participants. The EC fee to review a clinical trial application will vary depending on the institution. See KEN-25 and KEN-38 for lists of … Go to Kenya > Ethics Committee Fees

… involving IPs is based on a project’s scope, duration, sample size, and complexity as well as the types and quantities of IPs, among other criteria. The fees delineated in the G-NREB are as follows: Clinical trial: $7,000 USD Re-submission: $1,500 USD Continuing Review: $1,500 USD Amendment: $1,500 USD Payment Instructions No information is available regarding payment instructions for the NREB. Atlantic Center for Research and Evaluation Institutional Review Board As per the G-ACRE-IRB , the Atlantic Center for Research and Evaluation … Go to Liberia > Ethics Committee Fees

… details: Account Name: NHSRC NCST Review Fees Account Number: 1010759176 Bank Name: National Bank of Malawi Bank Address: Capital City Branch, Lilongwe 3, Malawi Swift Code: NBMAMWMW008 College of Medicine Research and Ethics Committee Per MWI-1 and MWI-40 researchers must provide evidence of payment of $150 USD to the College of Medicine Research and Ethics Committee (COMREC) upon the submission of a research proposal. MWI-1 states that COMREC is also mandated to charge a College of Medicine (COM) fee of 10% of the total budget indicated in the proposal. The COM’s Dean of Postgraduate Studies and Research can grant waivers for the 10% fee. However, the G-COMREC … Go to Malawi > Ethics Committee Fees

Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB) Per the FMPOS-USTTB-ECProcs , the cost to submit a protocol for review by the Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB) (Comité Institutionnel d'Éthique de la Recherche en Santé et en Sciences de la Vie/Université des Sciences, des Techniques et des Technologies de Bamako) is 20,000 West African CFA francs. However, according to MLI-17, CIESS/USTTB investigators are required to pay a fee of 300,000 West African CFA francs to submit a protocol for EC review and approval. Payment Instructions No information is available regarding payment instructions for the CIESS/USTTB. National Ethics Committee for Health and Life Sciences (CNESS) No information is available regarding fees or payment instructions for the National Ethics Committee for … Go to Mali > Ethics Committee Fees

As set forth in G-RECs-Op-2018 , COFEPRIS-GCP , and REC-Op , Research Ethics Committees (RECs) ( Comités de Ética en Investigación (CEIs) ) do not charge sponsors/investigators for their review. Rather, the health institution must finance REC operating expenses, without this causing any conflict of interest in the committee’s functions. G-RECs-Op-2018 further states that the institution may also receive support from external sources for evaluating protocols. However, this funding should not be given directly to any of the REC members, and the contributions should not lead to a conflict of interest between the funding source and the REC’s functions. Similarly, the committee’s evaluations should not result in financial gains as a result of these contributions. Per G-RECs-Op-2018 , REC financial support should not be used for purposes other than for its operation, and all activities should be handled with full transparency. Support is provided for the following activities: Time for … Go to Mexico > Ethics Committee Fees

Review fees are determined by each accredited institutional ethics committee (EC) (Comité Institucional de Ética en Investigación (CIEI)). EC Accreditation Fees As delineated in Decree010-2025 , the fee for accreditation of an EC is 3927.10 Peruvian Soles. Payment Instructions As indicated in Decree010-2025 , the EC accreditation must be paid directly to the National Institute of Health (Instituto Nacional de Salud (INS)) via the following options: In person at the INS Via the Virtual Submission Platform (Mesa de Partes Virtual (MPV)) ( PER-106 ) See also PER-105 and G-MPVManual for more information on PER-106 or via the MPV link on the INS webpage. Refer to the Oversight of Ethics Committees section for additional information on EC accreditation requirements. Decree010-2025 indicates that payments may also be made via electronic transfer. Transfers should be sent to: Account Name: Banco de la Nación CTA Account Number: 0000282413 Interbank Account Code: CCI 01800000000028241304 For … Go to Peru > Ethics Committee Fees

… Leones For international NGOs based in Sierra Leone and international universities conducting non-clinical research: 4,000,000 Leones For multinational institutions, donor agencies, and institutions not ordinarily based in Sierra Leone: $1,500 USD For exclusively government funded studies: 500,000 Leones (must be submitted with a cover letter from the Permanent Secretary of the relevant Ministry or the Chief Medical Officer in the case of the Ministry of Health and Sanitation … Go to Sierra Leone > Ethics Committee Fees

National Health Research Ethics Committee According to the G-TMRCC , the National Health Research Ethics Committee (NatHREC) requires the sponsor, the contract research organization, or the principal investigator (PI) to pay a nonrefundable fee to submit a clinical trial research protocol for ethical review and approval. As per TZA-17 , the fees are as follows: Tanzanian researchers, expedited review – 3,875,000 Tanzanian Shillings Tanzanian researchers, ordinary review – 2,625,000 Tanzanian Shillings Tanzanian researchers, amendment – 750,000 Tanzanian Shillings Tanzanian researchers, extension – 300,000 Tanzanian Shillings Tanzanian students, expedited review – 390,625 Tanzanian Shillings Tanzanian students, ordinary review – 390,625 Tanzanian Shillings Tanzanian students, amendment – 250,000 Tanzanian Shillings Tanzanian students, extension – 125,000 Tanzanian Shillings International researchers, expedited review – $5,125 USD International researchers, ordinary review – $2,625 USD … Go to Tanzania > Ethics Committee Fees

… (site-specific amendment): No fees charged Reporting adverse events, reporting non-compliance, notifying the CREC of a research project closure, and various other reports: No fees charged Edit the Certificate of Approval (CoA) document: 1,000 Baht (see THA-108 for additional information on CoA amendment fees) Edit certification/acknowledgement: 500 Baht Edit document with certified seal: 500 Baht For research projects funded by government agencies, royal colleges, medical … Go to Thailand > Ethics Committee Fees

… in Biomedical Research (NECBR) and institutional level ECs (known as Councils of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs)) charge a fee to review clinical trial documentation. The current NECBR and CEBRGL fees are $1,000-$2,000 USD. … Go to Vietnam > Ethics Committee Fees

… of Zimbabwe (MRCZ) , are as follows (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements): Normal registration for new study: $500 USD Expedited review for new study: $1,000 USD Exemption review for new study: $200 USD Undergraduate students: $10 USD Masters level dissertation: $50 USD PhD students: $200 USD Penalty for late submission of annual continuing review application: $200 USD after 30 days; $1,200 USD exceeding six (6) months Application for study extension: $100 USD per study Levies: 1% of total study for MRCZ monitoring and administration or a flat fee of $100 USD with a budget of less than $10,000 USD) Inspection fee: $300 USD and only applicable if inspection is requested Amendment application: $50 USD per amendment … Go to Zimbabwe > Ethics Committee Fees

… consideration of ethical issues relating to health. Research Governance Pursuant to the G-NatlStmt , institutions may fulfill their research governance responsibilities by establishing and overseeing different levels of ethics review. One (1) or more institutions can individually or jointly establish an EC or any other ethics review body. Institutions that establish an EC are responsible for adequately resourcing and maintaining it, including providing sufficient administrative … Go to Australia > Oversight of Ethics Committees

… of conflict of interest. If any committee members are affiliated with any EC, they must abstain from participating in access, voting, or inspection activities related to that particular EC. The committee has the authority to co-opt one (1) or more members if necessary. The DGDA also has the authority to cancel or suspend an EC’s approval if it fails to adhere to the BGD-GCP . The BGD-GCP indicates that the DGDA will approve and oversee the activities of the EC, with renewal … Go to Bangladesh > Oversight of Ethics Committees

Overview New National System of Ethics in Research with Human Beings LawNo14.874 introduces the National System of Ethics in Research with Human Beings (Sistema Nacional de Ética em Pesquisa com Seres Humanos). The system consists of the Ministry of Health (MOH) ’s National Research Ethics Authority and the research ethics committees (ECs) (Comitês de Ética em Pesquisa (CEPs)), which must be accredited by the National Research Ethics Authority. In this framework, the ECs (CEPs) are solely responsible for the ethical review of clinical trial protocols involving human participants. During the transition to the new system, the current National Research Ethics Commission (Comissão Nacional de Ética em Pesquisa (CONEP)) system will continue to be implemented and described in this profile. The ClinRegs team will provide additional information on the implementation of LawNo14.874 as it becomes available. See also BRA-117 for additional information. National Research Ethics Authority Per … Go to Brazil > Oversight of Ethics Committees

Overview Per the NMPA-NHC-No101-2019 , the National Medical Products Administration (NMPA) oversees and supervises the registration and filing of clinical trial institutions. Drug clinical trials must be conducted in registered clinical trial institutions that meet the applicable requirements, which include having an ethics committee (EC). Registration, Auditing, and Accreditation The RegEthics states that all biomedical research institutions in China should establish their own ECs. Per SC-Opinions-No42 , the NMPA adopted a registration system for institutions with qualifying conditions to be entrusted to conduct clinical trials and operate ECs. An institution is entrusted to conduct clinical trials if it has an EC and the main investigators of clinical trials have senior professional titles and have participated in more than three (3) clinical trials, among other conditions. To apply for qualification, institutions must submit an application via the online filing system ( CHN-82 ) … Go to China > Oversight of Ethics Committees

Overview Order1250-ZKM043 indicates that the Democratic Republic of the Congo’s (DRC) national ethics committee (EC), the National Committee of Health Ethics (Comité National d'Éthique de la Santé (CNES)), is responsible for promoting the creation of and accrediting institutional ECs across the country. According to Order1250-ZKM043 , the CNES coordinates the national network of institutional ECs, both public and private, throughout the country, and mobilizes funds for the functioning of the network of ECs. Registration, Auditing, and Accreditation No information is available on registration, auditing, and accreditation responsibilities by the … Go to DRC > Oversight of Ethics Committees

… d’Ethique pour la Recherche en Santé (CNERS)) . CNERS is responsible for reviewing and approving clinical research protocols for studies conducted in humans at the national level. Registration, Auditing, and Accreditation According to GIN-1, CNERS is accredited by the MSHP. … Go to Guinea > Oversight of Ethics Committees

… or cancel the EC registration for such period as deemed necessary. The suspended or cancelled EC can appeal to the DCGI within the period specified in the notice demonstrating cause, and, after consideration, the DCGI may respond by taking one (1) or more of the following actions: Withdraw the notice Issue a warning to the EC describing the deficiency or defect observed during an inspection Reject the results of the clinical trial Suspend for a specified period or cancel the … . Also, note that the portal link is located at the bottom of the IND-54 webpage.) Per the 2019-CTRules , the EC must submit an application to the DHR using Form CT-01 along with the required information and documentation specified in Table 1 of the Third Schedule of the 2019-CTRules . Upon receipt of the application, the DHR must grant provisional registration to the EC for a period of two (2) years. Final registration will be granted to the EC on Form CT-03 when the DHR has … should not be passed, prepare an order in writing to suspend or cancel the EC registration for such period as deemed appropriate. The suspended or cancelled EC can appeal to the DHR, and after consideration, the DHR may respond by taking one (1) or more of the following actions: Issue a warning to the EC describing the deficiency or defect observed, which may adversely affect the rights or well-being of the study participants Suspend the EC for a specified period or cancel the … Go to India > Oversight of Ethics Committees

Overview As set forth in the STI-Act and KEN-32 , the National Commission for Science, Technology and Innovation (NACOSTI) is the central body responsible for the oversight, promotion, and coordination of research. NACOSTI’s role is to regulate and ensure quality in the science, technology, and innovation sector, and to advise the Kenyan government on related matters. As per the G-ECAccred , NACOSTI has delegated the task of reviewing research proposals for ethical clearance to accredited institutional ethics committees (ECs) to ensure that research conducted in the country observes high research ethics standards. Per the G-ECBiomedRes , Kenya's National Bioethics Committee (NBC) advises NACOSTI on research ethics. In addition, NBC offers dispute resolution if an applicant is dissatisfied with the decision of an EC. Finally, the NBC must terminate research at any stage if it is found to be harmful to the participants. Registration, Auditing, and Accreditation As per the STI-Regs and … Go to Kenya > Oversight of Ethics Committees

Overview No information is available regarding ethics committee (EC) authorization in Mali. However, per DecreeNo2017-0245 , the state, the local authorities, the development partners, and the clinical research promoters provide financing and capacity building for ECs. Registration, Auditing, and Accreditation No information is available on registration, auditing, and accreditation. … Go to Mali > Oversight of Ethics Committees

… registration is valid for three (3) years. Per G-CHBs-Op , the Hospital Bioethics Committee registration form must be submitted electronically through CONBIOÉTICA’s website. The application for registration renewal can be submitted one (1) month prior to the registration’s expiration date. Refer to G-CHBs-Op , MEX-56 , MEX-59 , and G-CHBReg for additional Hospital Bioethics Committee registration information. … Go to Mexico > Oversight of Ethics Committees

Overview As set forth in Decree021-2017 , the INS-CTManual , and PER-61 , the INS’s Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) is responsible for registering and accrediting institutional ethics committees (ECs) (Comités Institucional de Ética en Investigación (CIEIs)) listed in the INS’s REPEC ( PER-89 ) (also referred to as REPECv2) to review and approve clinical trials. The DIIS must evaluate and verify EC compliance with the registration and accreditation standards established in the INS-CTManual . Per Decree021-2017 , the INS-CTManual , PER-71 , and PER-61 , Peru requires clinical trial approval from an EC that is accredited by the INS’s National Registry of Accredited Institutional Ethics Committees ( Registro Nacional de Comités de Ética en Investigación) ( PER-61 ). See PER-102 for a list of accredited ECs and see PER-126 for EC registration instructions. Ethics Committees for Human Subjects Health Research Other … Go to Peru > Oversight of Ethics Committees

Overview As stipulated in the NHA , ethics committees (ECs) in South Africa are governed by the National Health Research Ethics Council (NHREC) , which is a statutory body established under the NHA . NHREC determines guidelines for the functioning of ECs and registers and audits ECs, among other functions. The NHREC was created by the Minister of Health to provide ethical oversight of clinical research and to safeguard the rights and welfare of human participants involved in clinical studies. According to ZAF-52 , NHREC gives direction on ethical issues relating to health and develops guidelines for the conduct of research involving humans and animals. Further, NHREC upholds the principle that research involving human participants is based on a moral commitment to advancing human welfare, knowledge, and understanding, and to exploring cultural dynamics, especially in large-scale trials conducted in developing countries. Of fundamental importance is the duty to conduct scientifically … Go to South Africa > Oversight of Ethics Committees

… relating to EC authorization in ClinImprtOrdr and ClinSampleProd .) As per ECRegProc , an acceptance letter issued to the ECs by the Thai FDA is valid for two (2) years and may be obtained by applying to the agency using the Jor Thor Form EC-1 ( THA-23 ). Each EC is also required to submit an annual report ( THA-21 ) to the Thai FDA, and to apply for an acceptance extension no later than 60 days before the expiration date. See THA-107 for additional relevant forms. ECRegProc states … Pacific Region (FERCAP) The Association for the Accreditation of Human Research Protection Programs (AAHRPP) Other Thai FDA-approved quality accreditation agencies Per EC-QualAccredReq , EC submissions will be reviewed and completed within one (1) business day. … Go to Thailand > Oversight of Ethics Committees

… products (CTIMPs). The UK Health Departments have authorized England’s Health Research Authority (HRA) to perform some of the RES functions (more details below). As indicated in GBR-9 , the UKECA recognizes ECs for new CTIMPs: Phase 1 trial in healthy volunteers (including patients without the target disease or condition) – Any recognized EC Phase 1/2a trial in both healthy volunteers and patients with the target disease or condition – Any recognized National Health System (NHS) EC Phase 2a trials – Any recognized NHS EC Trial of medicinal products for gene therapy – Gene Therapy Advisory … Go to United Kingdom > Oversight of Ethics Committees

… its own EC (an “internal” EC) or designate an already registered EC operated by another organization (“external” EC) after establishing a written agreement with that other organization. Additionally, each FWA must designate at least one (1) EC registered with the OHRP. The FWA is the only type of assurance of compliance accepted and approved by the OHRP. See 45CFR46-B-E , USA-58 , and USA-61 for detailed registration requirements and instructions. … Go to United States > Oversight of Ethics Committees

Overview The ECReg requires that institutional level ethics committees (ECs), known as Councils of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs) in Vietnam, notify the Ministry of Health (MOH) ’s Administration of Science, Technology and Training (ASTT) regarding their establishment and consolidation according to the form in Appendix VI of the ECReg . The EC must also update the information on the institution’s website within 15 days from the date of the decision to establish or consolidate the EC. Registration, Auditing, and Accreditation The ECReg indicates that the ASTT is responsible for maintaining a list of ECs on the ASTT website. The ASTT must update the list within 15 days from the date of receiving a notice of establishment from the EC. ECs are periodically inspected by the ASTT to ensure that they comply with the requirements specified in the ECReg . If the EC is found to be noncompliant, the ASTT will withdraw the EC’s name from the updated list on the … Go to Vietnam > Oversight of Ethics Committees

Overview In accordance with the G-CTHandbook , the G-TrialsSOP , and AUS-86 , Australia requires the sponsor to obtain clinical trial authorization from the Therapeutic Goods Administration (TGA) for the supply of unapproved therapeutic goods for clinical trials for experimental purposes in humans. The sponsor can apply under two (2) regulatory schemes—the Clinical Trial Notification (CTN) scheme and the Clinical Trial Approval (CTA) scheme. Under either regulatory scheme, per the TGR , the G-CTHandbook , the G-TrialsSOP , and AUS-86 , an ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia) must approve the research protocol. The G-NatlStmt further specifies that any research that involves greater than low risk must be reviewed by an EC. AUS-87 notes that some ECs and institutions may need the TGA’s acknowledgement before beginning their own approval processes. In these cases, the TGA will accept a CTN submission while the sponsor gets the required approvals … Go to Australia > Submission Process

… each heading should be linked to the file(s) or relevant document(s) for easy tracking in the CDs. The table of contents should be hyperlinked to the main document to facilitate the review process. The sponsor/manufacturer should preserve one (1) hard copy and soft copy of the submitted documents for any future reference, if required. There is no specified language requirement for all the documents to be submitted to the DGDA. Ethics Review Submission BGD-16 indicates that all research … Go to Bangladesh > Submission Process

… system has fully transitioned to the new national system enacted by LawNo14.874 . Regulatory Submission Primary Petitions As per ResNo945 , the primary DDCM petition may be submitted to ANVISA at any stage of clinical drug development for one (1) or more clinical trial phases. ResNo945 and the G-DDCMManual further note that the DDCM must also be filed with at least one (1) Specific Clinical Trial Dossier (Dossiê Específico de Ensaio Clínico (DEEC)) for analysis. A DEEC is defined as a collection of documents submitted as part of the Investigational Drug Development Plan (PDME) in the DDCM. DEECs must be filed in … begins its technical evaluation of the corresponding DDCM petition. Per ResNo945 and RegNo338 , for the purposes of admissibility for analyzing primary and secondary petitions, the related documents must have been approved by at least one (1) of the Equivalent Foreign Regulatory Authorities (Autoridades Reguladoras Estrangeiras Equivalentes (AREEs)) recognized by ANVISA. The AREE approved documents must also be the same versions as those presented to ANVISA. The G-DDCMManual further … Go to Brazil > Submission Process

… request at no-reply.ereview.non-reponse@hc-sc.gc.ca . Please ensure the text 'non eCTD Guidance Document' is in the subject line of the email.) Per the G-Non-eCTD , CTA submissions to the appropriate Directorate within HC’s HPFB must be in one (1) of these accepted media formats: Compact Disc-Recordable (CD-R) conforming to the Joliet specification USB 2.0 or 3.0 drive Digital Versatile Disc (DVD-RAM and DVD+R/-R) in Universal Disk Format (UDF) standard All media should be labelled and … requirements: The maximum email size accepted by the corporate mail server is 20 megabytes. If the clinical trial submission is larger than 20 megabytes, the submission may be split and sent as separate emails (e.g., an email for Module 1, and another email for Module 2/3). The subject line of the emails should clearly link to each other (e.g., "Email 1 of 2" in the relevant subject line) A duplicate copy must not be provided by mail The submission should be organized in folders and the body of the email should only contain the zipped regulatory submission Zipped files and documents contained … Go to Canada > Submission Process

… Commission (NHC) is responsible for China’s management of human genetic resources (HGR). (Note that per SC-Order777 and NHC-HGRmgt , management of HGR was transferred from the Ministry of Science and Technology (MOST) to NHC, effective May 1, 2024). The NHC-HGRmgt states that the original application process and platform ( CHN-6 ) remain unchanged. Per the Rules-MgmtHGR , the collection, preservation, use, and external provision of China’s HGR must comply with ethical principles and … Drug Evaluation (CDE) in accordance with the requirements of the NMPA-No48-2020 , which includes requirements for different categories of meetings involving applications for new drugs. The NMPA-No48-2020 includes the application form (Appendix 1) and communication meeting materials (Appendix 2). The meeting’s purpose is to determine the integrity of the clinical trial application data and the sponsor’s ability to ensure the participant’s safety. If existing or supplemental data can … can submit a clinical trial application after the meeting or after supplementing the data. The NMPA-No51-2023 reaffirms the required pre-trial meeting and states that the applicant must submit a communication application to the CDE before 1) applying for the first clinical trial of a new drug and 2) before completing the exploratory clinical trial and conducting the confirmatory (or critical) clinical trial. The NMPA-No23-2023 provides guidance on common issues and general … Go to China > Submission Process

… de la Santé (CNES)), should be sent to: National Committee of Health Ethics Local 5, Immeuble PNMLS, 1er Niveau, Commune of Kasa-Vubu Kinshasa, Democratic Republic of the Congo Per a subject matter expert as of March 2019, CNES requires one (1) copy of the dossier, in addition to seven (7) copies of the protocol. Documents submitted to CNES must be in French. … Go to DRC > Submission Process

… approval to conduct health research involving human participants from the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)) before a clinical trial can commence. In addition, per GIN-1, the sponsor or the representative (typically the PI) is responsible for obtaining a drug import license from the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)) prior to initiating a study. According to GIN-1, CNERS must approve the clinical trial protocol before the drug import license application is submitted to the DNPM. Therefore, the CNERS and DNPM reviews may not be conducted in parallel. Additionally, according to GIN-12 and GIN-6 , any amendments to protocols currently being implemented must also be submitted to CNERS. Regulatory Submission According to GIN-1, the sponsor or the representative (typically the PI) should hand deliver one (1) hard copy of the drug import license application along with other required documentation to the DNPM’s Division of Pharmaceutical Products. (Refer to the … Go to Guinea > Submission Process

Overview In accordance with the 2019-CTRules , the Hdbk-ClinTrial , the G-ICMR , and IND-31 , the sponsor (applicant) is required to submit a clinical trial application to the Drugs Controller General of India (DCGI), head of the Central Drugs Standard Control Organization (CDSCO) , to obtain authorization to conduct a clinical trial in India. The investigator must also obtain ethics committee (EC) approval from a DCGI-registered EC prior to initiating a study. According to IND-31 , the DCGI review and approval process may be conducted in parallel with the EC review for each clinical trial site. However, per the 2019-CTRules and the Hdbk-ClinTrial , CDSCO must confirm the EC approvals for each participating site have been obtained per the protocol prior to approving the initiation of the study. (Note: the Hdbk-ClinTrial has not yet been updated to fully align with the 2019-CTRules .) For specific guidelines regarding gene therapy and stem cell therapy clinical trial submissions, see … Go to India > Submission Process

… the clinical trial application electronically via the PPB online system ( KEN-16 ). The clinical trial application form is available in KEN-16 . Per the G-KenyaCT , in the event of a multicenter clinical trial, the sponsor should only file one (1) application to the PPB. According to KEN-34 , all application documents should be signed, dated, and version referenced, if applicable, and should be in English. See Annex 7 of the G-KenyaCT to view a flowchart of the submission and approval … Go to Kenya > Submission Process

… opinion. According to the G-NREB , PIs must submit typed, dated, and signed submissions electronically and by hard copy to the NREB. The documents should be formatted in standard font size 12, double-spaced, with the pages printed on one (1) side only. The NREB requires 15 comb-bound copies of the full research protocol along with the attachments listed in the G-NREB , and where applicable, an email version that includes the protocol title and the PI’s name. In addition, all … Go to Liberia > Submission Process

… MWI-15 states that applications should be submitted to the NHSRC at the following address: The Chairperson National Health Sciences Research Committee Ministry of Health Research Department Area 2/124 P.O. Box 30377 Lilongwe 3, Malawi Tel: +265 1 789 400 The electronic copy should be submitted at the same time to research@health.gov.mw and mohdoccentre@gmail.com . MWI-15 indicates that three (3) copies of each item indicated in the NHSRC Checklist ( MWI-4 ) must be submitted in the … for a list of these items). Three (3) copies for Malawian student proposals (up to master’s level) must also be submitted to the NHSRC secretariat for expedited review. The submission must be bound in the order indicated by MWI-4 as one (1) PDF document. (See the Submission Content section for more details on the individual elements of the NHSRC research proposal submission.) According to MWI-15 and MWI-4 , the data collection tools and informed consent forms must be provided to … Rwanda, and Kenya also participate in REIMS. See MWI-10 for more information on the REIMS submission portal. MWI-19 provides the following additional contact information for COMREC: Tel: +265 888 118 993 Email: comrec@medcol.mw However, MWI-1 indicates that all documents should be submitted to COMREC by email to comrec@medcol.mw in one (1) PDF file, if the file size does not exceed 5MB. If the file size is over 5MB, then the file should be sent as a compressed zipped file. The data … Go to Malawi > Submission Process

… its review. Therefore, the DPM review and approval process may not be conducted in parallel with the EC review. (See the Submission Content section for detailed submission requirements). Regulatory Submission As per DPM-ClinTrialDocs and MLI-1 , applicants must submit an application for clinical trial authorization. DPM-ClinTrialDocs states that one (1) hard copy of the application should be submitted with a commitment signed by the sponsor along with one (1) hard copy of each of the clinical trial application documents. However, MLI-1 indicates that two (2) copies of the application file should be submitted in paper format along with one (1) copy in electronic format (specifying CD or USB drive). … Go to Mali > Submission Process

Overview In accordance with GenHlthLaw , Reg-COFEPRIS , HlthResRegs , and NOM-012-SSA3-2012 , Mexico requires the applicant to obtain research protocol authorization from the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) . Per HlthResRegs , NOM-012-SSA3-2012 , G-HumResProt , MEX-84 , and G-DIGIPRiS-ResProts , the applicant must also obtain a favorable decision from the Research Ethics Committee (REC) ( Comité de Ética en Investigación (CEI) ) and the Research Committee at the health institution where the study is being conducted, and when applicable, a favorable decision from the Biosafety Committee. Because COFEPRIS’s review and approval of a protocol authorization request is dependent upon obtaining a favorable decision from the REC and Research Committee, the COFEPRIS and ethics committee (REC and Research Committee) reviews may not be conducted in parallel. Regulatory Submission MEX-15 states … Go to Mexico > Submission Process

… investigator (PI) PER-29 for the application to change the sponsor/CRO PER-31 for the application to cancel a clinical trial Res090-2025 for the form and requirements to request INS approval to supervise a clinical trial virtually (See Annex 1) See also PER-123 for additional clinical trial forms. Refer to the INS-CTManual , Res252-2022 , and PER-71 for additional submission information. See Annex 1 in Res252-2022 for a flowchart delineating the clinical trial authorization process. See also the Submission Content section for detailed documentation requirements. Ethics Review Submission Because the submission process at individual … Go to Peru > Submission Process

… in the case of a public health emergency or as deemed fit by the PBSL. Regulatory Submission The G-SLAppClinTrial indicates that applicants must submit 15 hard copies of all clinical trial application documents to the PBSL, as well as one (1) soft copy in Microsoft Word format (Acrobat PDF files are also acceptable). As per the G-SLAppClinTrial , the delivery address for a clinical trial application is as follows: The Registrar Pharmacy Board of Sierra Leone Central Medical Stores … Go to Sierra Leone > Submission Process

… proof of payment, and proof of insurance. In the subject of the e-mail, the applicant should provide the application type, protocol number, SAHPRA predetermined cycle (see ZAF-11 ), and email number in case of multiple emails (e.g., “email 1 of 5”). Note that the submission email must include organized zipped folders for various sections of the clinical trial application. Individual site documents for each staff member must be uploaded into one (1) document and labelled with the staff name and arranged in folders according to the site which they belong to. Per G-CTA-Electronic , to respond to SAHPRA’s screening checklist or to CTU’s expert committee review, the applicant must submit all … provide the type of application, protocol number, and SAHPRA database tracking number. Responses to the CTU’s expert committee recommendations can be in MSWord or PDF formats. All other accompanying documents should be in PDF format v1.4, 1.5, 1.6, or 1.7 and legible with the Acrobat Reader search plugin or any other freeware viewer. PDF files should be saved as “Optimized” to reduce the size and allow faster opening when viewed online. The use of additional software to navigate … Go to South Africa > Submission Process

… that the electronic documents should be in MS Word format, Bookman Old Style font size 11 and submitted on CD-ROM. TZA-36 requires electronic format on CDs. The number of copies to be submitted is not specified in the G-AppConductCT . Annex 1 of the G-AppConductCT provides the Clinical Trial Application Form template. Applicants should submit their applications as per the Modules in the G-AppConductCT and the CTD highlighted in the G-AppConductCT . The overall organization of the CTD … fee. An application for ethical review of a research study should be made by the PI for that study. Applications may not be submitted by the sponsor(s) on behalf of the PI. Applications must be accompanied by a completed checklist ( TZA-1 ). As described in the G-RevPrtcl , TZA-5 , and TZA-31 , applicants should submit the form to the online Research Ethics Information Management System (REIMS) ( TZA-32 ) (also referred to as the National Health Research Management Information … Go to Tanzania > Submission Process

… further specify that for both types of approval requests, the application is either submitted to the Thai FDA after the research project and all the research sites have been approved by an EC, or in parallel, pending review by at least one (1) EC involved in the study. (Note: Per ClinImprtOrdr , the sponsor is also referred to as the applicant or importer.) Regulatory Submission OSSC Pre-Submission Permission According to THA-77 and THA-75 , prior to submitting a drug import license application (N.Y.M.1 form), an applicant must first request permission from the Thai FDA’s One Stop Service & Consultation Center (OSSC) ( THA-35 ) to use the OSSC’s online consultation system (E-Consult) ( THA-77 ). Per THA-65 , requesting E-Consult permission is a … ), and Application Form for Medicine Importation ( THA-84 ). See THA-85 for additional related forms, and THA-104 for information on submitting power of attorney to access the Skynet E-Submission System ( THA-54 ) as an agent. Submissions N.Y.M.1 As delineated in ClinImprtOrdr , the Thai FDA accepts paper and electronic clinical trial application submission packages for requests to import or order drugs for clinical research. However, paper applications are only to be submitted at the … Go to Thailand > Submission Process

… institutional EC in consultations with the UNCST. Regulatory Submission National Drug Authority According to the NDPA-CTReg , an application to the NDA for authorization to conduct a clinical trial is submitted by a sponsor, who must be one (1) of the following: The drug patent holder A licensed person The drug manufacturer An agent of the drug patent holder or the drug manufacturer The NDPA-CTReg states that where an agent submits the clinical trial application, the agent must also submit a power of attorney verifying their appointment as an agent or a letter of authorization (See Form 30 in Schedule 1 of the NDPA-CTReg or UGA-18 ). Where an application for authorization to conduct a clinical trial is for a drug under patent, the principal investigator (PI) must submit a letter of authorization from the manufacturer of the drug. Furthermore, … based on the clinical trial agreement between the sponsor and the PI, the NDA will liaise with the in-country PI representing the sponsor regarding the application. As per the G-CTConduct , the sponsor or authorized person should submit one (1) copy of the completed clinical trial application form for each application. The application must be bound in a single volume (or series of volumes), and the pages numbered sequentially. Appended documents should be bound together with the … Go to Uganda > Submission Process

… see GBR-18 . Also see the Initiation, Agreements & Registration section for information on obtaining a trial identification number during trial registration. The UKwide-Rsrch provides guidance and requirements for research in more than one (1) United Kingdom (UK) nation, and specifies that the four (4) nations of the UK take a consistent approach to study-wide reviews so that sponsors only need to submit one (1) application on GBR-125 in most circumstances. Each UK nation will take assurances from the site-wide review conducted by the lead nation (the nation conducting the initial review). As described in GBR-78 , other relevant approvals can be sought … Go to United Kingdom > Submission Process

Overview As delineated in 21CFR312 , USA-42 , and USA-52 , the United States (US) requires the sponsor to submit an investigational new drug application (IND) for the Food & Drug Administration (FDA) 's review and authorization to obtain an exemption to ship investigational drug or biological products across state lines and to administer these investigational products in humans. Per 21CFR312 and the G-IND-Determination , whether an IND is required to conduct an investigation of a drug to be marketed (this includes biological products under the FDCAct ) primarily depends on the intent of the investigation, and the degree of risk associated with the use of the drug in the investigation. See the Scope of Assessment section for more information. In addition, per 21CFR56 and 21CFR312 , institutional ethics committee (EC) (institutional review board (IRB) in the US) review of the clinical investigation may be conducted in parallel with the FDA review of the IND. However, EC approval must be … Go to United States > Submission Process

… ASTT at the address found in VNM-11 : Ministry of Health Administration of Science, Technology and Training No. 138B Giang Vo Ba Dinh District Hanoi City, Vietnam As per the ClinDrugTrialGCP , the sponsor must submit, directly or via post, one (1) copy of the clinical trial registration dossier signed by the sponsor’s representative(s) to the ASTT. Separately, research institution(s) must submit one (1) copy of the study approval dossier, signed by the principal investigator (PI) and the head of the testing facility, directly or via post to the ASTT. See Appendix III of the ClinDrugTrialGCP for the registration form and the forms that comprise … Go to Vietnam > Submission Process

… Regulatory Submission Medicines Control Authority of Zimbabwe Per the CT-AppAuth , to obtain MCAZ review and authorization, the sponsor must file a clinical trial application (CTA) on form MC 10 ( ZWE-28 ) via the Clinical Trials Registry ( ZWE-1 ) and include the appropriate fee and all the relevant documents. For guidance on how to navigate ZWE-1 , refer to the user manual ( ZWE-85 ). While there is no language requirement indicated, the application form ( ZWE-28 ) is in English. Note that per the ZWE-GCP , both the English and vernacular versions (e.g., Shona/Ndebele) must be used in consent materials. CT-AppAuth indicates that a letter of acknowledgement of receipt of the CTA will be sent to the principal investigator (PI) by ZWE-1 . Note the CT-AppAuth indicates that researchers may request a pre-submission meeting or submit pre-submission questions prior to submission of CTAs. Requests for pre-submission meetings should be submitted in writing to the MCAZ Director … Go to Zimbabwe > Submission Process

… is being conducted in other countries Preceding trial details Trial site details See AUS-49 for detailed descriptions of each required item. Clinical Trial Approval (CTA) Scheme AUS-89 states that the CTA scheme includes two (2) forms – Part 1: the CTA application ( AUS-56 ), which is submitted along with supporting data, and Part 2: Notification of the conduct of a trial under the CTA scheme ( AUS-57 ). Part 1: the CTA application ( AUS-56 ) requires general information (sponsor name, data details, and sponsor declaration) and details on the medicine (active ingredient)/biological be submitted to the TGA. Part 2: Notification of the conduct of a trial … Go to Australia > Submission Content

Regulatory Authority Requirements As per BGD-22 , the following documentation must be submitted to the Ministry of Health and Family Welfare (MOHFW) ’s Directorate General of Drug Administration (DGDA) before the commencement of a clinical trial: Protocol approved by the Bangladesh Medical Research Council (BMRC) /institutional review board (IRB)/independent ethics committee (IEC) (Note: ethics committees (ECs) are referred to as IRBs/IECs in Bangladesh) Investigator’s Brochure (IB) Informed consent form (ICF) Signed agreements between the sponsor and the contract research organization (CRO), trial center, and/or principal investigator (Pl) Curriculum vitae(s) (CV(s)) of PI and associates Good manufacturing practice (GMP) certificate of investigational product (IP) Certificate of Analysis of IP Details on funding of the trials Case record form (CRF) Standard operating procedures (SOPs) of different activities Good clinical practice (GCP) training certificate of PI and team members The … Go to Bangladesh > Submission Content

Regulatory Authority Requirements Clinical Drug Development Dossier (DDCM) As delineated in ResNo945 and the G-DDCMManual , the following documentation must be submitted to the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) to file a clinical trial application (Clinical Drug Development Dossier (Dossier de Desenvolvimento Clínico de Medicamento (DDCM))) via the Solicita Electronic Petition Request System ( BRA-56 ) (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements): DDCM Petition Consent Form ( BRA-21 ) Declaration of commitment to distribute to clinical trial centers and use investigational products (IPs) only after authorization from the corresponding DDCM and Specific Clinical Trial Dossier (Dossiê Específico de Ensaio Clínico (DEEC)), when import is authorized prior to publication of the approval/rejection in the Official Gazette of the Union (Diário Oficial da … Go to Brazil > Submission Content

… trial authorization by submitting a clinical trial application (CTA) to HC. As specified in the G-CanadaCTApps and the G-QCM-PharmCTAs , the CTA should be organized into three (3) modules in Common Technical Document (CTD) format: Module 1 - Administrative and clinical information about the proposed trial Module 2 - Quality (Chemistry and Manufacturing) summaries about the drug product(s) to be used in the proposed trial Module 3 - Additional supporting quality information Per the … ICFs and participant information Participant recruitment procedures IB Safety information Participant payments and compensation Investigator(s) current curriculum vitaes (CVs) Additional required institutional EC documentation See section 3.1.2 of CAN-52 for additional submission content requirements. The G-TCPS2 , which sets the ethical benchmark for all Canadian institutional ECs, requires clinical trial researchers to include a plan for monitoring safety, efficacy/effectiveness … Go to Canada > Submission Content

… Commission (NHC) is responsible for China’s management of human genetic resources (HGR). (Note that per SC-Order777 and NHC-HGRmgt , management of HGR was transferred from the Ministry of Science and Technology (MOST) to NHC, effective May 1, 2024. Please note that SC-Order777 amends the MgmtHumanGen to reflect the transfer of HGR management from MOST to the NHC)). The NHC-HGRmgt states that the original application process and platform ( CHN-6 ) remain unchanged. The MgmtHumanGen … Go to China > Submission Content

Regulatory Authority Requirements Per DRC-12, the following documents are required in a clinical trial application to the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) of the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention) : Cover letter Non-refundable application fee in accordance with ACOREP’s prescribed fee schedule Application forms completed by ACOREP for the conduct of clinical trials and signed by authorized persons (principal investigator (PI) and authorized representative of the sponsor) Clinical trial protocol Proof of enrollment in a clinical trial registry Investigator's brochure (IB) Investigational product (IP) dossier Certificate of good manufacturing practice (GMP) Certificate of good clinical practice (GCP) and PI curriculum vitae (CV) for each site Ethics committee (EC) approval Insurance cover Financial statement Data and Safety Monitoring Board … Go to DRC > Submission Content

… Regulatory Authority Requirements Per GIN-1, the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)) does not have a drug import license application form. Rather, the application is comprised of the materials submitted by the sponsor or the representative (typically the principal investigator (PI)) along with a request to obtain a drug import license. Per GIN-1, along with the application, the sponsor or the representative must submit the following: One (1) copy of the protocol Ethical approval Informed consent form (ICF) Investigator(s) curriculum vitaes (CVs) Investigator’s Brochure (IB) All investigational product (IP) documentation Product license request Ethics Committee Requirements … Go to Guinea > Submission Content

… ) (for GCTs) Sponsor authorization letter (for GCTs) Details of biological specimens to be exported and the online application for export no objection certificate (NOC) for biological samples on the SUGAM portal ( IND-59 ) (for GCTs) (See IND-1 for the application form to request a NOC to export biological samples) (Refer to the Specimens topic for more information on specimen import/export) Case Report Form (CRF) Informed consent form (ICF) and patient information sheet (See Required … Go to India > Submission Content

… ) No conflict of interest declaration by the sponsor and PI Signed declarations by the sponsor, PI, and the monitor that the study will be carried out according to the protocol and applicable laws, regulations, and GCP requirements ( KEN-1 and Annex 4 of the G-KenyaCT ) Indemnity cover for PI, investigators, and study pharmacist Clinical trials insurance cover for the study participants Copy of favorable opinion letter from local ethics committee (EC) Copy of current practice … or PNG format Scanned ID/passport in PDF format Introductory letter from relevant institution signed by an authorized officer Affiliation letter from relevant local institution for foreigners signed by an authorized officer and valid for one (1) year Grant letter from the funding agency to support the amount indicated to fund the research PPB clinical trial approval Prior Informed Consent (PIC), Mutually Agreed Terms (MAT), or Material Transfer Agreement (MTA) where applicable, for … commencement Excavation, filming, and collection of specimens are subject to further permissions from relevant government agencies The research license does not give authority to transfer research materials The licensee shall submit one (1) hard copy and upload a soft copy of their final report within one (1) year of completion of the research NACOSTI reserves the right to modify the conditions of the research license including its cancellation without prior notice KEN-31 states … Go to Kenya > Submission Content

Regulatory Authority Requirements As set forth in the LibCTReg and the G-LibClinTrial , the sponsor, the legal representative, the principal investigator (PI), or the sponsor-investigator is required to obtain clinical trial authorization from the Liberia Medicines and Health Products Regulatory Authority (LMHRA) and written permission from the National Research Ethics Board of Liberia (NREB) . However, per the G-NREB , the PI must obtain ethics committee (EC) approval. As per the LibCTReg and the G-LibClinTrial , the following documentation must be submitted to the LMHRA (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements): Cover letter (signed, witnessed, and notarized) including list of documents submitted and their version numbers and date Clinical trial application form including cover page Clinical trial protocol (see below for detailed protocol requirements) A list of the planned clinical trial sites … Go to Liberia > Submission Content

… MWI-9 ) Current version of the study protocol signed and dated by the sponsor and investigator (in the format provided in the International Council for Harmonisation’s (ICH) good clinical practice (GCP) guidelines and/or in line with Attachment 1 of MWI-60 ) Investigator’s Brochure (IB), where applicable (in the format provided in the ICH GCP guidelines) Certificate of Good Manufacturing Practice (GMP) of the investigational product (IP) (also referred to as an investigational medicinal … from the sponsor/funder (where applicable) MWI-4 requires that if any of the above items are not included in the submission to the NHSRC, an explanation must be provided. College of Medicine Research and Ethics Committee The COMREC-Format , MWI-1 , and MWI-40 indicate that for submissions to the College of Medicine Research and Ethics Committee (COMREC), a single PDF file should include the following information (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements): Completed copy of the COMREC checklist ( MWI-1 ) Cover letter from the PI Protocol according to COMREC’s format ( COMREC-Format ) ICFs in both English and Chichewa for adult participants ages 18 and above, parental consent forms for all minors, and assent forms (in addition to the parental … Go to Malawi > Submission Content

… Regulatory Authority Requirements As specified in DPM-ClinTrialDocs and MLI-1 , the following documentation must be submitted by the sponsor (also known as the promoter in Mali) to the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) (Note: Each of the items listed below will not … Go to Mali > Submission Content

… and documents submitted for research protocol authorization (original) Response to COFEPRIS prevention letter requesting missing or additional information should be submitted in a new request letter Research protocol (original and one (1) copy) Acceptance letter from research institution head and responsible principal investigator (PI) Sponsor letter of acceptance of position and delegation of responsibilities (must include at least sponsor contact information, description of obligations and protocol rights, sponsor legal representative/authorized person signature, protocol number, when applicable, a certified copy of the apostilled, notarized, and translated power of attorney) (one (1) copy) Letter of No Conflict of Interest from the sponsor (one (1) copy) Document proving applicant’s legal identity (e.g., health license, operating notice or, where appropriate, the Federal Taxpayer Registry (Registro Federal de Contribuyentes (RFC)) (one (1) copy) Follow-up letter from sponsor providing … Go to Mexico > Submission Content

… and unique elements): Application for clinical trial authorization and proof of payment ( PER-24 ) (per Annex B in Res655-2019 ) Approval(s) issued by legal representative of institution(s) where research will be conducted (per Annex 1 in INS-CTManual and Annex 2 in Res252-2022 ) Copy of the approved research protocol and informed consent form (ICF) stamped and signed by the ethics committee (EC) (El Comité Institucional de Ética en Investigación (CIEI)) in its entirety (per … (per Annex B in Res655-2019 ) Refer to Decree021-2017 , Res655-2019 , the INS-CTManual , Res252-2022 , and PER-71 for detailed submission information . See also the Submission Process section for additional submission requirements, and Annex 1 in Res252-2022 for a flowchart delineating the clinical trial authorization process. Trial Extensions Decree021-2017 , Res655-2019 , Decree010-2025 , PER-72 , PER-27 , and PER-93 indicate that the sponsor or the CRO must submit the following … section for additional information) Statistical considerations Data collection and monitoring Data management and record maintenance Ethical aspects Publications results Bibliography Appendices For complete protocol requirements, refer to Annex 1 of Decree021-2017 . … Go to Peru > Submission Content

Regulatory Authority Requirements As per the G-SLAppClinTrial and SLE-9 , the following documentation must be submitted to the Pharmacy Board of Sierra Leone (PBSL) (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements): Cover letter, including the list of documents submitted and their version number and date Non-refundable application fee as specified in the PBSL’s Fee Schedule (see Appendix I of the G-SLAppClinTrial ) Protocol with all the relevant sections including site-specific addendums (see below for detailed protocol requirements) Two (2) copies of the completed clinical trial application forms signed by authorized persons, including cover page (see Appendix II of the G-SLAppClinTrial ) Proof of registration with the Pan African Clinical Trial Registry (PACTR) ( SLE-19 ) or an internationally recognized PBSL-approved online registry Investigator’s Brochure (IB) Synopsis of previous trial(s) with the … Go to Sierra Leone > Submission Content

… Regulatory Authority Requirements As per ZAF-23 , the following documentation must be submitted to the South African Health Products Regulatory Authority (SAHPRA) : The clinical trial application form ( ZAF-23 ) Two (2) cover letters (one (1) signed in PDF and one (1) in MS-Word format) Two (2) completed copies of the clinical trial application (one (1) signed in PDF and one (1) in MS-Word format) ( ZAF-23 and ZAF-20 (for amendments)) Checklist Protocol Patient information leaflets (PILs) and informed consent forms (ICFs); include standardized SAHPRA contact details (Annex 1 of ZAF-23 ) … Go to South Africa > Submission Content

… submitted to the Tanzania Medicines and Medical Devices Authority (TMDA) : Comprehensive table of contents Cover letter Application form (See the Regulatory Information Management System (RIMS) Customer Self Service Portal ( TZA-34 ) or Annex 1 of the G-AppConductCT and First Schedule of the CT-Regs ) General investigational plan Capacity building plans (including plans for staff training and updates) Overall summary of the protocol (See Annex 2 of the G-AppConductCT ) Protocol, signed … updated CVs, and an extension table form. Ethics Committee Requirements National Health Research Ethics Committee As per the G-TMRCC , the G-RevPrtcl , and the NatHREC’s Checklist for Ethical Clearance Application Submission (see TZA-1 ), the NatHREC requires applicants to submit the following documentation for ethics approval (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements): Application Form for … fees (Bank slip) Completed Data Transfer Agreement (see TZA-8 ) and/or Material Transfer Agreement (see TZA-10 ), where applicable IBs and CRFs Proof of insurance coverage List of Data and Safety Monitoring Board members (with at least one (1) Tanzanian) Per TZA-5 , a request for amendment of a previously approved protocol must describe the requested amendment, provide the rationale for the amendment, and describe the impact, if any, of the amendment on the protocol’s risk-benefit … Go to Tanzania > Submission Content

… Regulatory Authority Requirements N.Y.M.1 As per ClinImprtOrdr and G-CT-DIPApp , sponsors must submit the following documents to the Thai Food and Drug Administration (Thai FDA) to request a drug import waiver request (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements): Cover letter Application for Permission to Import or Order Drugs for Research Purposes in the Kingdom (N.Y.M.1 form) (see ClinImprtOrdr (Appendix 2) and THA-18 (Appendix 2)) Checklists and Attached Documents for N.Y.M.1 form (see appendices in ClinImprtOrdr and THA-18 ) Drug labels for every package size in Thai or English Package inserts (for registered drugs) Prescriptions (for registered drugs) Investigator’s Brochure (IB) (for unregistered drugs) Informed … Go to Thailand > Submission Content

… Regulatory Authority Requirements National Drug Authority As per the NDPA-CTReg , the G-CTConduct , UGA-39 , and UGA-1 , the following documentation must be submitted to the National Drug Authority (NDA) in a clinical trial application (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements): Proof of payment of the prescribed fees Applications for import and/or export of biological materials (if required) Application Form for Clinical Trial (See Form 29 in Schedule 1 of the NDPA-CTReg , Appendix I of the G-CTConduct , or UGA-39 ) Trial protocol (See Schedule 2 of the NDPA-CTReg ) Investigator’s Brochure (See UGA-4 or Schedule 2 of the NDPA-CTReg ) If the investigational product (IP) is unregistered, a … the NDA (valid evidence of insurance for the participants by a local insurance company and of professional indemnity for the principal investigator (PI)) Signed and completed declarations by all investigators (See UGA-16 or Form 31 in Schedule 1 of the NDPA-CTReg ) Approval of ECs for the protocol Uganda National Council for Science and Technology (UNCST) approval Full, legible copies of key, peer-reviewed published articles supporting the application Sample of the label for the IP … Go to Uganda > Submission Content

… , a clinical trial submission package to the Medicines and Healthcare Products Regulatory Agency (MHRA) should contain the following documents: Cover letter (when applicable, the subject line should state that the submission is for a Phase 1 trial and is eligible for a shortened assessment time, or if it is submitted as part of the notification scheme); this letter should clearly highlight the Purchase Order (PO) number to help the MHRA invoice and allocate payments promptly and … Go to United Kingdom > Submission Content

Regulatory Authority Requirements As specified in 21CFR312 , an investigational new drug application (IND) to the Food & Drug Administration (FDA) must include the following documents, in the order provided below: Cover sheet (Form FDA 1571 ( USA-76 )) (including, but not limited to: sponsor contact information, investigational product (IP) name, application date, phase(s) of clinical investigation to be conducted, and commitment that the institutional ethics committee (EC) (institutional review board (IRB) in the United States (US)) will conduct initial and continuing review and approval of each study proposed in the investigation) Table of contents Introductory statement and general investigational plan Investigator’s brochure (IB) Protocols Chemistry, manufacturing, and control data Pharmacology and toxicology data Previous human experience with the IP Additional information (e.g., drug dependence and abuse potential, radioactive drugs, pediatric studies) Relevant information … Go to United States > Submission Content

… must submit the following application materials to obtain a research permit from the RCZ: Clear statement of the purpose of their intended research on the application forms Ten copies of the completed application form ( ZWE-59 ), and one (1) research proposal per project must be submitted to The Executive Director, Research Council of Zimbabwe (See the Regulatory Authority section for contact details); for joint projects, one (1) comprehensive research proposal is required and each applicant must submit 13 copies of the completed application form ( ZWE-59 ) Ten copies of completed Specimens Transfer Agreement form ( ZWE-63 ) if the application involves shipment of … Go to Zimbabwe > Submission Content

Overview The BGD-GCP and BGD-22 indicate that a protocol approved by an ethics committee (EC) (referred to as an independent ethics committee (IEC)/institutional review board (IRB) in Bangladesh)/the Bangladesh Medical Research Council (BMRC) is a required element of a clinical trial application to the Directorate General of Drug Administration (DGDA) . Therefore, DGDA review and ethics review may not be conducted in parallel. (Note: According to the G-BMRC and BGD-16 , the BMRC’s National Research Ethics Committee (NREC) is registered with the US Office for Human Research Protections (OHRP) as an official IRB.) In addition, as delineated in the G-BMRC and BGD-16 , scientific validity should be approved by a valid Scientific Review Committee before submission of a research project to the NREC. Regulatory Authority Approval The BGD-GCP indicates that if there are no issues, the clinical trial protocol should be approved by the DGDA within 60 working days. For fast-track clinical trial … Go to Bangladesh > Timeline of Review

… substantial amendments to the clinical protocol. See Scope of Assessment section for detailed DDCM and DEEC submission requirements. Additionally, per ResNo945 , ANVISA’s analysis of the DDCM will only occur after the filing of at least one (1) DEEC, which must be carried out within 15 business days from the DDCM’s issue date. The absence of the DEEC, after the 15-day deadline, will result in the rejection of the DDCM without technical analysis, except in cases of clinical trials involving more than one (1) investigational product (IP), whose DEEC has already been linked to one of the DDCMs of these drugs. LawNo14.874 and ResNo945 further explain that ANVISA may request, one (1) time only, by means of a technical requirement, additional clarifications and documents during the analysis of primary DDCM and DEEC petitions and secondary petitions for substantial IP modification or substantial clinical protocol amendment. … Go to Brazil > Timeline of Review

Overview As delineated in the CanadaFDR and the G-CanadaCTApps , the review and approval of a clinical trial application (CTA) by Health Canada (HC) and an institutional ethics committee (EC) (known as Research Ethics Board (REB) in Canada) may be conducted in parallel. However, per the CanadaFDR , the G-CanadaCTApps , CAN-6 , and CAN-30 , HC will not authorize the sponsor to begin the clinical trial until an institutional EC approval (provided in the required Clinical Trial Site Information (CTSI) form) for each participating trial site is submitted. For HC’s interpretation of the relevant provisions of the CanadaFDR , see the G-FDR-0100 . Regulatory Authority Approval According to the CanadaFDR and the G-CanadaCTApps , an authorized clinical trial is one that has been filed with HC and has not received an objection within 30 days. All CTAs are subject to the 30-day default period from the date of receipt of the completed application at the appropriate Directorate within HC’s Health … Go to Canada > Timeline of Review

… Commission (NHC) is responsible for China’s management of human genetic resources (HGR). (Note that per SC-Order777 and NHC-HGRmgt , management of HGR was transferred from the Ministry of Science and Technology (MOST) to NHC, effective May 1, 2024). The Bioscrty-Law , the MgmtHumanGen , and the Rules-MgmtHGR , delineate that MOST (now the NHC) is responsible for China's management of HGR, which includes reviewing and approving research. Per the Rules-MgmtHGR , the collection, … 30 business days (a reduction from the 60 days as described above in the normal procedures). The applicant must initiate the clinical trial within 12 weeks after the approval of the clinical trial application. The pilot work will last for one (1) year and the experience of the pilot work will be summarized in July 2025. For application and eligibility details see NMPA-No21-2024 and Scope of Assessment section . For additional details on other expedited review pathways, see the Scope of … section . National Health Commission Per the HGR-AppGuide , for HGR license applications, the NHC will pre-screen the electronic application to ensure it is complete. If the application does not pass, then the applicant will have one (1) opportunity to correct the submission. Per Rules-MgmtHGR , MOST (now the NHC) must make an administrative licensing decision on HGR license applications within 20 working days of acceptance. HGR-AppGuide reiterates the 20 working-day deadline … Go to China > Timeline of Review

Overview As per D-ACOREP , the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) of the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention) is the regulatory authority responsible for regulating clinical trials in the Democratic Republic of the Congo (DRC). The G-EthicalEval indicates that for research involving human subjects, the study protocol must be submitted to an ethics committee (EC) for review concurrently with a request to ACOREP for study authorization and registration. Therefore, regulatory and ethics reviews are conducted in parallel. However, the principal investigator (PI) must obtain the EC’s approval of the protocol before ACOREP may approve the trial. Regulatory Authority Approval No official timelines are specified in the available regulatory documentation. Ethics Committee Approval As per the G-EthicalEval , the EC must communicate its opinion on the … Go to DRC > Timeline of Review

… Overview According to GIN-1, the National Ethics Committee for Health Research (Comité National d’Ethique pour la Recherche en Santé (CNERS)) must approve the clinical trial protocol before the drug import license application is submitted to the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)) . Therefore, the CNERS and DNPM reviews may not be conducted in parallel. Regulatory Authority Approval According to GIN-1, the DNPM’s approval of a drug import license application typically takes two (2) weeks. Ethics Committee Approval Per the Guinea-PHC , CNERS must give its opinion on any research protocol submitted within a period not exceeding 60 days from the … from the project’s filing date. GIN-5 and GIN-12 indicate that the sponsor or PI who submitted the protocol will be notified of the opinion of CNERS within 10 days of the committee meeting via email and that CNERS approval is valid for one (1) year and is renewable upon request by the PI/sponsor. Special Circumstances Guinea-PHC states that when research is related to an epidemic or calamity, the proposal must be submitted within 30 days from the project’s filing date. GIN-5 further … Go to Guinea > Timeline of Review

… application along with a summary of their evaluation and a statement referring to the proposal to a Subject Expert Committee (SEC) for further technical review. The 2019-CTRules further notes that the DCGI may, when required, constitute one (1) or more of these expert committees or group of experts with the specialization in relevant fields to evaluate scientific and technical drug-related issues. The committee/group may submit its recommendations within 60 days from the date of the … the SEC’s review should be completed within seven (7) days. Per the Hdbk-ClinTrial , CDSCO will then compile any written SEC comments requiring sponsor (applicant) clarification or modification and send this feedback to the sponsor within one (1) week of receipt. The applicant must submit a written reply to CDSCO within four (4) weeks of receiving the comments, which will, in turn, be sent to the SEC for review. Following receipt of the sponsor’s response, the Hdbk-ClinTrial states that … As per IND-82 , the EC review and approval process, which occurs at the same time as the DCGI review and approval, generally takes from four (4) to eight (8) weeks. The G-ICMR indicates that EC members should be given enough time (at least one (1) week) to review the proposal and related documents, except in the case of expedited review. While all EC members should review all submitted proposals, each EC may adopt different procedures for protocol review per their standard operating … Go to India > Timeline of Review

Overview Based on the CTRules and the G-KenyaCT , the Pharmacy and Poisons Board (PPB) 's review and approval of an application to conduct a clinical trial is dependent upon obtaining ethics approval from a National Commission for Science, Technology and Innovation (NACOSTI) -accredited ethics committee (EC). Therefore, the PPB and EC reviews may not be conducted in parallel. In addition, the STI-Act and KEN-31 specify that all applicants must obtain a research license from NACOSTI prior to initiating a study. Regulatory Authority Approval Pharmacy and Poisons Board Per the G-KenyaCT , sponsors (or applicants) can request pre-submission meetings to discuss pertinent issues prior to making a formal submission. The request must be made via the PPB online system ( KEN-16 ) or in an official letter addressed to the Chief Executive Officer of the PPB and sent to admin@pharmacyboardkenya.org and copied to cta@pharmacyboardkenya.org . The request for a meeting should propose two (2) … Go to Kenya > Timeline of Review

… days upon receipt of the written decision from the NREB. Ethics Committee Approval National Research Ethics Board of Liberia Pursuant to the G-NREB , principal investigators (PIs) are required to submit new research protocols no later than one (1) month prior to the next bi-monthly board meeting. The NREB should notify PIs in writing of its decision within two (2) weeks following a board meeting, where applicable, following a complete review of the protocols. The G-NREB does not specify … Go to Liberia > Timeline of Review

… Overview As stated in the R-HlthResCoord , one (1) of the two (2) government approved ethics committees (ECs), the National Health Sciences Research Committee (NHSRC) or the College of Medicine Research and Ethics Committee (COMREC), must review and approve a clinical trial application prior to … Go to Malawi > Timeline of Review

… its review of the protocol within a minimum period of 15 days. Only those members who attended the meeting or communicated their opinion at the meeting are permitted to be involved in the decision-making process. The decision will be one (1) of the following: approved, conditional approval (modifications/response to stipulations), or rejected. The FMPOS-USTTB-ECProcs further states that in the event the president is requested to provide an urgent protocol review (referred to as a … Go to Mali > Timeline of Review

… (5) working days after the committee has met, or if applicable, not to exceed 30 calendar days from the date of request for its review. G-RECs-Op-2018 and G-DIGIPRiS-ResProts also state that the approval of a new application is valid for one (1) year. In addition, G-RECs-Op-2018 indicates that the REC should establish procedures for monitoring approved studies, from the point at which the decision was made until the completion of the investigation and reporting of results. RECs should conduct at least one (1) review a year. … Go to Mexico > Timeline of Review

Overview Based on Decree021-2017 , Res655-2019 (amending Decree021-2017 ), the INS-CTManual , and Res252-2022 (amending the INS-CTManual ), the INS’s review and approval of an application to conduct a clinical trial is dependent upon obtaining ethics committee (EC) (El Comité Institucional de Ética en Investigación (CIEI)) approval from an INS-accredited EC. Therefore, the INS and EC reviews may not be conducted in parallel. Regulatory Authority Approval As per Law27444 , Decree004-2019 (amending Law27444 ), and Decree010-2025 , the INS is required to complete its review and approval of a clinical trial application in a maximum of 30 working days. Per Decree021-2017 , this timeline includes the 30-day requirement for the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)) to issue a binding technical opinion on the safety and quality of the … Go to Peru > Timeline of Review

… rejected. If the PBSL requires changes to the application and the applicant fails to modify the application correspondingly within a maximum of 90 days following the reasoned objections, the application will be deemed rejected. See Figure 1 in Section 5.17 of the G-SLAppClinTrial for more details on the PBSL’s clinical trial authorization process. According to the G-SLAppClinTrial , if expedited review of a clinical trial during a public health emergency is anticipated, the … Go to Sierra Leone > Timeline of Review

… within 10 weeks of the submission due date. There are cases where this turnaround time might be prolonged, such as an unfamiliar investigational product which may be referred to external reviewers or other SAHPRA committees for input. Per ZAF-1 , during the preliminary screening, the CTU screens the application and sends an official letter to the applicant with the outcome and follow-up questions on a screening checklist. The applicant receives the screening checklist within 15 working … and the SAHPRA submission due dates. It is advisable to submit clinical trial applications before these due dates. Once the reviewer approves the application, the CTC presents the committee’s/reviewer’s recommendations to the SAHPRA. ZAF-1 states that applicants receive a response within 10 working days from the CTC meeting, and they must send an answer within seven (7) working days after receipt of comments. If an applicant would like to request a meeting with the CTC, the … Go to South Africa > Timeline of Review

… of a clinical trial application, the TMDA initially screens the application for completeness. If complete, the TMDA officer acknowledges receipt of the application by returning a signed copy of the cover sheet to the applicant (see Annex 1 of the G-AppConductCT or First Schedule of the CT-Regs ). Per the G-AppConductCT , the TMDA may request clarification, certificates, and/or samples through a query letter. Once a query has been raised and sent to the applicant, the evaluation … Go to Tanzania > Timeline of Review

… clinical research purposes is submitted to the Thai Food and Drug Administration (Thai FDA) after the research project and all the research sites have been approved by the ethics committee (EC), or in parallel, pending review by at least one (1) EC involved in the study. Per ClinSampleProd and DrugProdReqs , the application to produce drug samples for the registration of drug formulas for human research studies must also be submitted to the Thai FDA either after the research project and all the research sites have been approved by an EC, or in parallel, pending review by at least one (1) EC involved in the study. Regulatory Authority Approval As specified in THA-78 , the Thai FDA has 60 working days to evaluate an application to import or order drugs in the country for clinical research (N.Y.M.1); 60 working days to evaluate an application to produce drug samples to request modern drug registration for human research studies (P.Y.8); 20 working days to review an application to amend a N.Y.M.1 or P.Y.8 submission; one (1) working day to … Go to Thailand > Timeline of Review

Overview Per the NDPA-CTReg , the National Drug Authority (NDA) ’s review and approval of a clinical trial application are dependent upon the applicant submitting proof in the application of institutional ethics committee (EC) (research ethics committee (REC) in Uganda) approval and a research permit from the Uganda National Council for Science and Technology (UNCST) . However, the G-TrialsGCP indicates that parallel submissions may be made to the NDA and the UNCST. In that instance, the NDA would not make a final decision until after the trial receives ethical clearance. NDA approval will be dependent on receipt of the protocol’s approval by the institutional EC in consultations with the UNCST. Regulatory Authority Approval National Drug Authority Per the G-CTConduct , NDA reviews for clinical trials are performed following a first-in first-out principle, except for clinical trials conducted in public health emergencies such as disease outbreaks, which may be exempted. According to … Go to Uganda > Timeline of Review

… timelines. Per GBR-68 , the EC will notify the sponsor of its initial/provisional decision, usually within 10 working days of the EC meeting. The G-CTApp indicates that applications for healthy volunteer trials and sponsor-determined phase 1 trials in non-oncology participants may qualify for a shortened assessment time and MHRA will work with the EC to expedite these applications. The MHRA and the EC will inform applicants of the outcome of a submission. If there are grounds for … received effective date, and the application will continue under the full authorization assessment with a decision communicated within the 30-day statutory timeframe. In addition, as stated in the G-CTApp , certain first-in-human (Phase 1) trials of investigational products with higher risk or greater elements of uncertainty require the MHRA to seek advice from the Clinical Trials, Biologicals, and Vaccines Expert Advisory Group (CTBV EAG) of the Commission on Human Medicines … Go to United Kingdom > Timeline of Review

Overview As delineated in 21CFR56 and 21CFR312 , institutional ethics committee (EC) (institutional review board (IRB) in the United States (US)) review of the clinical investigation may be conducted in parallel with the Food & Drug Administration (FDA) 's review of the investigational new drug application (IND). However, EC approval must be obtained prior to the sponsor being permitted to initiate the clinical trial. Regulatory Authority Approval Per the FDCAct and 21CFR312 , initial INDs submitted to the FDA’s Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) automatically go into effect in 30 calendar days, unless the FDA notifies the sponsor that the IND is subject to a clinical hold, or the FDA has notified the sponsor earlier that the trial may begin. As indicated in 21CFR312 , the FDA will provide the sponsor with a written explanation of the basis for the hold as soon as possible, and no more than 30 days after the imposition … Go to United States > Timeline of Review

Overview As per the ClinDrugTrialGCP , evidence of institutional ethics committee (EC) approval from a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL) is a required element of the study approval dossier submitted to the Ministry of Health (MOH) ’s Administration of Science, Technology and Training (ASTT) , so CEBRGL and ASTT approval cannot be conducted in parallel. Additionally, the National Ethics Committee in Biomedical Research (NECBR)’s review of the protocol is initiated by the MOH as part of the ASTT’s study approval dossier review procedures. Per the ClinDrugTrialGCP and the PharmLaw-VNM , ASTT review is finalized once NECBR approval is obtained and the entire study approval dossier is sent to the Minister of Health for final approval. Regulatory Authority Approval Registration Dossier Review As delineated in the ClinDrugTrialGCP , the ASTT initially checks the validity of the sponsor-submitted registration dossier (which includes the registration … Go to Vietnam > Timeline of Review

Overview Per ZWE-GCP , parallel submissions are encouraged among the regulatory authorities, which comprise the Medicines Control Authority of Zimbabwe (MCAZ) , the National Biotechnology Authority of Zimbabwe (NBA) , and the Research Council of Zimbabwe (RCZ) , and to the national ethics committee (EC)—the Medical Research Council of Zimbabwe (MRCZ) . However as indicated in ProcForeignReg , approval by the MRCZ is a prerequisite for the RCZ’s consideration of a research permit application by a foreign researcher. Regulatory Authority Approval Medicines Control Authority of Zimbabwe As described in the CT-AppAuth , the review and approval process in Zimbabwe should take 60 working days from the time the completed application is received by the MCAZ’s Pharmacovigilance and Clinical Trials (PVCT) Division up until approval. This timeline excludes the time when the applicant is addressing any follow-up questions from the PVCT. In addition, MCAZ implements an expedited review pathway for … Go to Zimbabwe > Timeline of Review

Overview In accordance with the G-TrialsSOP , the G-CTHandbook , and AUS-86 , clinical trials involving unapproved therapeutic goods can only commence under the Clinical Trial Notification (CTN) scheme or the Clinical Trial Approval (CTA) scheme. According to the G-GovHndbk and the G-TrialsSOP , under either scheme, both institutional ethics committee (EC) (Human Research Ethics Committees (HRECs) in Australia) approval and research governance authorization are required before a research project can commence at a site. AUS-87 notes that for trials conducted under the CTN scheme, it is the sponsor’s responsibility to have all relevant approvals in place. All approvals must be obtained before supplying the unapproved therapeutic good(s) in the clinical trial. After submission of the online CTN form with payment of the relevant fee is made to the TGA, the clinical trial is deemed to have been notified. Once this notification occurs, the sponsor may lawfully supply the unapproved … Go to Australia > Initiation, Agreements & Registration

Overview The G-BGD-IP states that the sponsor may not start a clinical trial until authorization has been granted for the trial; all conditions of the authorization have been met; an ethics committee (EC) (referred to as an independent ethics committee (IEC)/institutional review board (IRB) in Bangladesh) favorable opinion has been granted; and each trial site has been approved. (Note: According to the G-BMRC and BGD-16 , the Bangladesh Medical Research Council (BMRC) ’s National Research Ethics Committee (NREC) is registered with the US Office for Human Research Protections (OHRP) as an official IRB.) As per the BGD-GCP , the principal investigator (PI) or contract research organization (CRO) must submit an application to the Ministry of Health and Family Welfare (MOHFW) ’s Directorate General of Drug Administration (DGDA) for permission to conduct a clinical trial in Bangladesh. However, the G-IndCTA states that the sponsor is responsible for submitting the application. Clinical … Go to Bangladesh > Initiation, Agreements & Registration

Overview New National System of Ethics in Research with Human Beings LawNo14.874 introduces the National System of Ethics in Research with Human Beings (Sistema Nacional de Ética em Pesquisa com Seres Humanos). The system consists of the Ministry of Health (MOH) ’s National Research Ethics Authority and the research ethics committees (ECs) (Comitês de Ética em Pesquisa (CEPs)), which must be accredited by the National Research Ethics Authority. In this framework, the ECs (CEPs) are solely responsible for the ethical review of clinical trial protocols involving human participants. During the transition to the new system, the current National Research Ethics Commission (Comissão Nacional de Ética em Pesquisa (CONEP)) system will continue to be implemented and described in this profile. The ClinRegs team will provide additional information on the implementation of LawNo14.874 as it becomes available. See also BRA-117 for additional information. In accordance with ResNo945 and the … Go to Brazil > Initiation, Agreements & Registration

… to HC, and a new QIU form must be maintained by the sponsor. See CAN-6 , CAN-8 , and CAN-19 for additional clinical trial forms. Clinical Trial Registration As per the G-CanadaCTApps , sponsors should register their clinical trials on one (1) of two (2) publicly accessible registries accepting international clinical trial information and recognized by the World Health Organization (WHO) , ClinicalTrials.gov ( CAN-45 ), and the International Standardized Randomized Controlled Trial … Go to Canada > Initiation, Agreements & Registration

… Commission (NHC) is responsible for China’s management of human genetic resources (HGR). (Note that per SC-Order777 and NHC-HGRmgt , management of HGR was transferred from the Ministry of Science and Technology (MOST) to NHC, effective May 1, 2024). The Bioscrty-Law , the MgmtHumanGen , and the Rules-MgmtHGR delineate that MOST (now the NHC) is responsible for China's management of HGR, which includes reviewing and approving research before initiation. Per the Rules-MgmtHGR , … Go to China > Initiation, Agreements & Registration

Overview As per D-ACOREP and the G-EthicalEval , the Democratic Republic of the Congo (DRC) requires clinical trial authorization from the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) of the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention) . According to DRC-12, the sponsor, through the principal investigator (PI), obtains this authorization from ACOREP. As stated in the G-EthicalEval , for research proposals involving human participants, the PI must also obtain approval from an ethics committee (EC) before ACOREP can approve the trial. Per DRC-12, ACOREP accepts ethics review from any approved local EC. According to DRC-12, an import license is required for the shipment of the investigational product (IP) to be used in the trial. The sponsor may apply for IP import approval through ACOREP’s Digital Platform ( DRC-13 ). (See the Manufacturing & Import section for … Go to DRC > Initiation, Agreements & Registration

… approval to conduct health research involving human participants from the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)) before a clinical trial can commence. In addition, per GIN-1, the sponsor or the representative (typically the PI) is responsible for obtaining a license to import study drugs from the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)) prior to … informs the investigator/institution these documents are no longer needed The sponsor and the investigator/institution should sign the protocol, or an alternative document, to confirm this agreement. Clinical Trial Registration According to GIN-1, the Ministry of Health and Public Hygiene (Ministère de la Santé et de l'Hygiène Publique (MSHP)) does not currently require the clinical trial to be registered with either a domestic or international clinical trial registry. … Go to Guinea > Initiation, Agreements & Registration

Overview As set forth in the 2019-CTRules , the Hdbk-ClinTrial , the G-ICMR , and IND-31 , a clinical trial can only commence in India after the sponsor (applicant) receives permission from the Drugs Controller General of India (DCGI) and approval from the respective ethics committees (ECs). The DCGI is head of the Central Drugs Standard Control Organization (CDSCO) . According to the 2019-CTRules and IND-31 , non-regulatory clinical trials intended for academic purposes only require institutional EC approval. (See the Scope of Review section for additional details). There is no waiting period required following the sponsor’s receipt of these approvals. (Note: the Hdbk-ClinTrial has not yet been updated to fully align with the 2019-CTRules .) The 2022-CTRules-3rdAmdt , which amends the 2019-CTRules , further indicates that once the sponsor obtains approval from the DCGI for a new drug, an investigational new drug, or a new drug already approved outside India, the sponsor must notify … Go to India > Initiation, Agreements & Registration

Overview In accordance with the PPA , the STI-Act , the G-KenyaCT , the G-ECBiomedRes , KEN-21 , and KEN-16 , a clinical trial can only commence after the sponsor or the representative receives authorization from Kenya’s Pharmacy and Poisons Board (PPB) , and ethics committee (EC) approval from an institutional EC that has been accredited by the National Commission for Science, Technology and Innovation (NACOSTI) prior to initiating a study. ECs are accredited pursuant to the requirements delineated in the G-ECAccred . The G-KenyaCT specifies that the PPB review and approval process may not be conducted in parallel with the EC review. In addition, the STI-Act and KEN-31 state that all applicants must obtain a research license from NACOSTI prior to initiating a study. No waiting period is required following the applicant’s receipt of these approvals. Regarding notifications, KEN-31 requires the licensee to inform the relevant County Director of Education, County Commissioner, and … Go to Kenya > Initiation, Agreements & Registration

… of each institution where the research activities take place. The DPM-ClinTrialDocs also states that before the trial begins, the sponsor(s) should sign the protocol and a statement of commitment to comply with ethical principles. Per MLI-1 , prior to initiating the trial, the sponsor should also sign the statement of commitment in the application form for clinical trial authorization (see MLI-1 ) certifying the accuracy of the information provided in the application; that the trial will comply with the protocol, Malian regulations, and good clinical practice (GCP) principles; and that unexpected serious adverse effects will be declared … Go to Mali > Initiation, Agreements & Registration

Overview In accordance with GenHlthLaw , Reg-COFEPRIS , HlthResRegs , NOM-012-SSA3-2012 , COFEPRIS-GCP , G-HumResProt , and MEX-84 , a clinical trial can only commence after an applicant receives authorization from Mexico’s Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) . Per HlthResRegs , G-HumResProt , NOM-012-SSA3-2012 , G-HumResProt , MEX-84 , and G-DIGIPRiS-ResProts , the applicant must also obtain a favorable decision from the Research Ethics Committee (REC) ( Comité de Ética en Investigación (CEI) ) and the Research Committee at the health institution where the study is being conducted, and when applicable, a favorable decision from the Biosafety Committee. No waiting period is required following the applicant’s receipt of these approvals. As per GenHlthLaw , an applicant must be a resident of Mexico and is required to obtain an import license from COFEPRIS for the shipment of an … Go to Mexico > Initiation, Agreements & Registration

Overview In accordance with Decree021-2017 , Res655-2019 (amending Decree021-2017 ), the INS-CTManual , and Res252-2022 (amending the INS-CTManual ), a clinical trial can only commence after the sponsor or the contract research organization (CRO) receives authorization from Peru’s INS and approval from an INS-accredited institutional ethics committee (EC) (El Comité Institucional de Ética en Investigación (CIEI)). No waiting period is required following the applicant’s receipt of these approvals. According to Decree021-2017 , Decree016-2011 , the INS-CTManual , and Res252-2022 , the sponsor or the CRO must also obtain approval from the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)) to manufacture or import investigational products (IPs) and to obtain an import license for the shipment of IPs to be used in the trial. (Note: The ANM is also referred … Go to Peru > Initiation, Agreements & Registration

Overview In accordance with the G-SLAppClinTrial , a clinical trial can only commence after the sponsor and the principal investigator (PI) receive authorization from Sierra Leone’s Pharmacy Board of Sierra Leone (PBSL) via a Clinical Trial Certificate. Additionally, per the G-SLAppClinTrial , the Sierra Leone Ethics and Scientific Review Committee (SLESRC) fulfills the functions of the ethics committee (EC) (known as an Independent Ethics Committee (IEC) in Sierra Leone) in the country. Ethics approval must be obtained from the SLESRC prior to initiating a study. The G-SLEthics indicates that the PI must obtain the SLESRC approval. In addition, as per SLE-23, no waiting period is required following the applicant’s receipt of PBSL and SLESRC approval. According to the G-SLAppClinTrial , the PBSL must be informed of the trial’s initiation in writing on the exact date the study commences. If the trial does not begin or is delayed, then the PBSL must be informed of the new commencement … Go to Sierra Leone > Initiation, Agreements & Registration

Overview In accordance with the TMMDAct , the CT-Regs , and the G-AppConductCT , a clinical trial can only commence after an applicant receives permission from the Tanzania Medicines and Medical Devices Authority (TMDA) and approval from the national ethics committee (EC), the National Institute for Medical Research (NIMR) ’s National Health Research Ethics Committee (NatHREC) . Per the G-ResearchClearance , following TMDA and NatHREC approvals, the applicant must also apply to the Tanzania Commission for Science and Technology (COSTECH) for review, registration, and to obtain a research permit prior to initiating a study. No waiting period is required following the applicant’s receipt of these approvals. In addition, as per the TMMDAct , the CT-Regs , the TFDCA-ImptExpt , and the G-AppConductCT , the sponsor or the principal investigator (PI) is required to obtain an import license for the shipment of an investigational product to be used in the trial. (See the Manufacturing & Import … Go to Tanzania > Initiation, Agreements & Registration

… specified by and entered into with fellow researchers, funding agencies, and their affiliates. Clinical Trial Registration The ClinImprtOrdr application document checklist (Appendix 3) includes clinical trial registry information as one (1) of the items to be included in the application submission package, specifying that sponsors may register with either the Thai Clinical Trials Registry (TCTR) ( THA-31 ) or a foreign registry. Sponsors may register in more than one (1) location. … Go to Thailand > Initiation, Agreements & Registration

Overview In accordance with the MHCTR , the MHCTR2006 , and GAfREC , a clinical trial can only commence after the sponsor or the designated representative receives authorization from the Medicines and Healthcare Products Regulatory Agency (MHRA) and the chief investigator (CI) receives an approval from a recognized ethics committee (EC). In addition, GBR-9 clarifies that a favorable EC opinion does not imply that research activity at sites can begin. Confirmation of management permission or approval from relevant care organization(s) to proceed with the research also needs to be in place. In addition, if the EC issued a favorable opinion with additional conditions, the clinical trial cannot start until these conditions are met. GBR-18 indicates that once all the relevant approvals are in place, all documentation has been finalized, and all participating sites have the information they need, the trial can begin. This process is often achieved by holding a start-up meeting at each site … Go to United Kingdom > Initiation, Agreements & Registration

Overview In accordance with 21CFR312 , USA-41 , and USA-42 , a clinical trial can only commence after the investigational new drug application (IND) is reviewed by the Food & Drug Administration (FDA) , which will provide a written determination within 30 days of receiving the IND. No waiting period is required following the 30-day FDA review period, unless the agency imposes a clinical hold on the IND or sends an earlier notification that studies may begin. Per 21CFR312 and 21CFR56 , ethics approval from an institutional ethics committee (EC) (known as institutional review board (IRB) in the United States (US)) is also required before a clinical trial can commence. As per 21CFR312 , once an IND has been submitted and following the 30-day review period, the sponsor is permitted to import an investigational product (IP). (See the Manufacturing & Import section for additional information). Clinical Trial Agreement Prior to the trial’s commencement, as addressed in the 21CFR312 and the … Go to United States > Initiation, Agreements & Registration

Overview As delineated in the ClinDrugTrialGCP , the PharmLaw-VNM , and the ASTTReg , a clinical trial can only commence in Vietnam after authorization from the Ministry of Health (MOH) has been received. The MOH’s Administration of Science, Technology and Training (ASTT) manages the clinical trial review process. The ClinDrugTrialGCP indicates that the ASTT is responsible for reviewing the clinical trial registration and study approval dossiers. The MOH’s national level ethics committee (EC), the National Ethics Committee in Biomedical Research (NECBR), is responsible for approving the research protocol. Once the ASTT has completed its review and the NECBR has reviewed and approved the research protocol, the Minister of Health must give final approval to the entire study approval dossier. The ECReg further indicates that institutional level ECs, known as Councils of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs) in Vietnam, are responsible for reviewing clinical … Go to Vietnam > Initiation, Agreements & Registration

… guidelines for GCP. See the Site/Investigator Selection section for details on selection requirements for investigators and clinical trial sites. Clinical Trial Registration As per the CT-AppAuth , the Clinical Trials Registry ( ZWE-1 ) is the platform for both submitting clinical trial applications and registering approved clinical trials. In addition, the PI must submit the approved clinical trial to a publicly accessible registry platform, such as the Pan African Clinical … Go to Zimbabwe > Initiation, Agreements & Registration

… other similar document may also serve as the annual safety report. See the G-SftyRpt for more information. Form Completion & Delivery Requirements As per the G-CTHandbook , all SUSARs from Australian sites must be reported to the TGA using one (1) of three (3) formats: The Electronic Data Interchange (EDI) functionality, which allows sponsors to submit AE reports directly from their system to the TGA (more information can be found at AUS-26 ) The online reporting form, which can be … Go to Australia > Safety Reporting

Safety Reporting Definitions As per the BGD-GCP , the following definitions provide a basis for a common understanding of Bangladesh’s safety reporting requirements: Adverse Event (AE) – Any untoward medical occurrence in a clinical investigation participant who is administered an investigational product (IP) that does not necessarily have a causal relationship with this treatment Adverse Drug Reaction (ADR) – All noxious and unintended responses to a medicinal product related to any dose Serious Adverse Event (SAE)/Serious Adverse Drug Reaction (SADR) – Any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolonged existing hospitalization, results in persistent or significant disability/incapacity, or results in a congenital anomaly/birth defect Unexpected Adverse Drug Reaction – An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator’s … Go to Bangladesh > Safety Reporting

… and express their opinion regarding the causality between the AE and the IP. Per the G-SUSARs , upon becoming aware of an AE, the investigator should classify it for causality, severity, intensity, and expected/unexpectedness as per Annex 1 in the G-SUSARs . Further, if the investigator becomes aware of an AE after the completion or termination of the clinical trial, and there is suspicion of a possible causal relationship with the IP, the sponsor should be informed as soon as … Go to Brazil > Safety Reporting

Safety Reporting Definitions According to the CanadaFDR and G-CanadaCTApps , and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ), the following definitions provide a basis for a common understanding of Canada’s safety reporting requirements: Adverse Event (AE) – Any adverse occurrence in the health of a clinical trial subject who is administered a drug that may or may not be caused by the administration of the drug, and includes an adverse drug reaction. Adverse Drug Reaction (ADR) – Any noxious and unintended response to a drug that is caused by the administration of any dose of the drug. Serious Adverse Drug Reaction (SADR) or Serious Adverse Event (SAE) – Any untoward medical occurrence that at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or causes a congenital anomaly/birth defect. … Go to Canada > Safety Reporting

… characteristics In addition, the G-SftyRptStds includes “Serious Adverse Drug Reactions” (SADRs) as well as other important medical events, which require medical judgement to determine if measures are needed to prevent the occurrence of one (1) of the preceding. See the NMPA-No31-2024 for NMPA’s guidance on evaluating the correlation between AEs and drugs used in clinical trials. Safety Reporting Requirements Investigator Responsibilities Per the NMPA-GCP-No57-2020 , the investigator … Go to China > Safety Reporting

Safety Reporting Definitions As delineated in the G-PV , the following definitions provide a basis for a common understanding of the Democratic Republic of the Congo’s (DRC) safety reporting requirements: Adverse Event (AE) – Any medical event occurring after the administration of a drug to a patient or subject of a clinical trial, without necessarily being caused by that drug. This includes any harmful and unwanted reaction such as a clinical or paraclinical sign or symptom, or a disease associated with taking a drug Adverse Drug Reaction (ADR) – Any response to the administration of a drug that is harmful and undesirable. An ADR may result from the use of a drug at therapeutic doses, overdose, misuse, or medication error Serious Adverse Event (SAE) – Any adverse reaction that causes death, is life-threatening, requires hospitalization or prolongation of hospitalization, leads to significant or persistent disability, or causes congenital malformation Unexpected Adverse Event (UAE) – … Go to DRC > Safety Reporting

Safety Reporting Definitions Per G-PV-GIN , the following definitions provide a basis for a common understanding of Guinea’s safety reporting requirements: Adverse Event (AE) – Any harmful and unintended manifestation occurring in a subject during treatment. The term "adverse event", unlike "adverse effect", does not prejudge a causal link with exposure, particularly to a drug. Adverse Reaction (AR) – A harmful and unintended reaction to a drug or other health product, occurring at dosages normally used in humans for the prophylaxis, diagnosis, or treatment of disease or for the recovery, rectification, or modification of a physiological function, or resulting from misuse of the drug or product Adverse Drug Effect (ADR) – A harmful and unwanted reaction, occurring at dosages normally used in humans for the prophylaxis, diagnosis, or treatment of a disease or the modification of a physiological function or resulting from a misused drug, constituting a withdrawal syndrome when stopping … Go to Guinea > Safety Reporting

… congenital anomaly or birth defect, or is otherwise life threatening. Per IND-42 , Important Medical Events may be considered SAEs when they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one (1) of the outcomes listed in this definition Unexpected Adverse Drug Reaction – an ADR, the nature or severity of which is not described in the informed consent/information sheet or the applicable product information, such as an investigator’s … Go to India > Safety Reporting

… G-KenyaCT state that the sponsor must also submit a safety report to the PPB once a year throughout the clinical trial, or upon request. The purpose of the annual safety report is to briefly describe all new safety information relevant to one (1) or more clinical trial(s), and to assess the safety conditions of the participants enrolled in these trial(s). The safety report must include a log of SAE and SUSAR events. The SAE and SUSAR log should include the following: Patient … Go to Kenya > Safety Reporting

Safety Reporting Definitions According to the LibCTReg , the G-LibPV , and the G-ACRE-IRB , the following definitions provide a basis for a common understanding of Liberia’s safety reporting requirements (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements): Adverse Event (or Adverse Experience) (AE) – Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product, or any abnormal sign (e.g., any abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant’s involvement in the research; AEs encompass both physical and psychological harms Adverse Drug Reaction (ADR) – Any noxious and unintended responses in a participant to an investigational medicinal product which is related to any dose administered to that participant. A causal … Go to Liberia > Safety Reporting

… in persistent or significant disability, is a birth defect or congenital anomaly; or is an important medical event that, based upon appropriate medical judgment, may jeopardize the participant, and may require intervention to prevent one (1) of the listed outcomes. Safety Reporting Requirements As stated in the G-SAEs-PMRA , the sponsor or the investigator(s) is required to report all SAEs that meet the Pharmacy and Medicines Regulatory Authority (PMRA) ’s reporting requirements as … Go to Malawi > Safety Reporting

… effect relating to the products they market Anyone who has had an AE can report to the health worker and/or the nearest health structure Sponsor Responsibilities Per the DPM’s application form for clinical trial authorization in Mali ( MLI-1 ), the sponsor (also known as the promoter in Mali) is required to declare unexpected serious adverse effects and to submit safety reports in accordance with the regulations in force in Mali. Form Completion & Delivery Requirements No … Go to Mali > Safety Reporting

… is inconsistent with the applicable product information, or in the documentation presented for its sanitary registration Suspected Adverse Drug Reaction (SRAM) – Any clinical or laboratory manifestation that occurs after administration of one (1) or more drugs Safety Reporting Requirements As specified in NOM-220-SSA1-2016-Mod , for clinical study related incidents involving health professionals (public and private) or institutions conducting health research, notifications to the … COFEPRIS’s Comprehensive Service Center (Centro Integral de Servicios (CIS)) ( MEX-37 ). Per NOM-220-SSA1-2016 , a clinical safety report is also required to be submitted to the CNFV for all trials, sponsored or not, that have at least one (1) site or research center in Mexico. In addition, G-ClinResPV explains that a final safety report must be submitted to the CNFV in the following circumstances: A study is completed that has included at least one (1) research center in Mexico A study has been cancelled, discontinued, or definitively suspended A bioequivalence, bioavailability, and pharmacokinetics study is concluded Refer to G-ClinResPV and G-PharmPerSafRpt for additional report writing … Go to Mexico > Safety Reporting

… and the G-SafeRpt , the PI is also responsible for notifying the sponsor or the CRO or the ethics committee (EC) (El Comité Institucional de Ética en Investigación (CIEI)) of any SAEs/SARs and SUSARs within a period not exceeding one (1) calendar day from the date the event occurs, or, the PI becomes aware of the incident. Decree021-2017 notes that the PI must also follow up with a detailed written report. Per the G-SafeRpt , the PI must record the SAEs/SARs and notify the … Medical Sciences (CIOMS) whether they have occurred in the authorized trial, in other trials with the same IP, or in a context of different use. The G-SafeRpt specifies that the information should be presented on magnetic media. Refer to Annex 1 in the G-SafeRpt for data requirements. PER-72 further indicates that the sponsor should send the SUSAR reports for events that have occurred abroad as soon as possible to the investigator using CIOMS Form I ( PER-18 ). The investigator, in … Go to Peru > Safety Reporting

Safety Reporting Definitions According to the G-SLAppClinTrial and the SL-GCPs , the following definitions provide a basis for a common understanding of Sierra Leone’s safety reporting requirements: Adverse Event (or Adverse Experience) (AE) – Any untoward medical occurrence in a participant to whom an investigational product (IP) has been administered, including occurrences which are not necessarily caused by or related to that product Adverse Drug Reaction (ADR) – Any noxious and unintended response to an IP which is related to any dose administered to that participant Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (SADR) – Any untoward medical occurrence that at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect Unexpected Adverse Event/Adverse Drug Reaction – An adverse reaction where the nature or … Go to Sierra Leone > Safety Reporting

… (e.g., changes in nature, severity, or frequency of risk factors) should be submitted within 15 days of knowledge of the concern; a follow-up report should be submitted within an additional six (6) months. DSURs should be submitted within one (1) year from approval of the study and annually thereafter. In addition, SAHPRA reserves the right to impose additional reporting timelines on an individual protocol basis, and it may require expedited reporting of AEs of special interest, whether … Go to South Africa > Safety Reporting

… address and contact information is as follows: P.O. Box 1253, Dodoma or P.O. Box 77150, Dar es Salaam, Tanzania Telephone: +255 22 262961989 / 262961990 Fax: +255 22 2450793 Email: info@tmda.go.tz See Annex 15 of the G-AppConductCT and Appendix 1 of the G-ReptSafetyData for the reporting forms. … Go to Tanzania > Safety Reporting

… and end of study safety reports must be provided to the New Drugs and Drug Research Promotion Group within the Thai FDA’s Medicines Regulation Division . The annual report must be submitted as a document within three (3) months of the one (1) year anniversary of the study, and the final safety report must be submitted as a document within six (6) months after the study has concluded. In addition, a list of all SAE/SADR incidents involving research participant(s) should be included … Go to Thailand > Safety Reporting

Safety Reporting Definitions In accordance with the NDPA-CTReg , the NDPA-PVReg , the NDPA-PVRegAmdt , the G-CTConduct , the NGHRP , and the G-TrialsGCP , the following definitions provide a basis for a common understanding of Uganda’s safety reporting requirements: Adverse Event (AE) – Any untoward medical occurrence in a research participant who is administered an investigational product (IP), and which does not necessarily have a causal relationship with this treatment Adverse Drug Reaction (ADR) – All noxious and unintended responses to a medicinal product related to any dose Serious Adverse Event (SAE) – Any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in a congenital anomaly/birth defect Unexpected Adverse Drug Reaction – An adverse reaction, the nature or severity of which is not consistent … Go to Uganda > Safety Reporting

… Safety Reporting Definitions According to GBR-1 and GBR-64 , the following definitions provide a basis for a common understanding of the United Kingdom’s (UK’s) safety reporting requirements: Adverse Event or Adverse Experience (AE) – Any untoward medical occurrence in a participant, … as an urgent safety measure. Unrelated and unacceptable changes may result in rejection. For more details on how submissions should be made using MHRA Submissions, see G-CTAuth-GBR . Investigator Responsibilities As specified in the MHCTR , GBR-1 , and GBR-30 , the investigator is responsible for reporting all SAEs/SADRs immediately to the sponsor. The report may be made orally or in writing and followed by a detailed report no later than 24 hours after the event. When the reported event … according to the protocol or the Investigator’s Brochure (IB), the investigator should report an SAE/SADR within the appropriate timeframe based on the trial requirements, the seriousness of the SAE/SADR, and protocol or IB guidelines. Per GBR-1 , the investigator and the sponsor share responsibility for the assessment and evaluation of adverse events with regard to seriousness, causality, and expectedness. See GBR-18 for a safety reporting flowchart that gives an overview of the … Go to United Kingdom > Safety Reporting

… adverse events All adverse events, other than serious adverse events, that exceed a frequency of five (5) percent in any arm of the trial All-cause mortalities Per 42CFR11 and USA-70 , this information must be submitted no later than one (1) year after the primary completion date of the clinical trial. Submission of trial results may be delayed as long as two (2) years if the sponsor or PI submits a certification to ClinicalTrials.gov ( USA-78 ) that either: 1) the FDA has not yet approved, licensed, or cleared for marketing the investigational product (IP) being studied; or 2) the manufacturer is the sponsor and has sought or will seek approval within one (1) year. See 42CFR11 for detailed adverse event reporting requirements. See the G-SESftyRprtng for the FDA’s guidance to help small businesses understand and comply with safety reporting regulations for human drug and biological products that are … Go to United States > Safety Reporting

Safety Reporting Definitions As delineated in the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP ) and the AERprtingD62 , the following definitions provide a basis for a common understanding of Vietnam’s safety reporting requirements: Adverse Event (or Adverse Experience) (AE) – Any untoward medical occurrence (including any signs, symptoms, illnesses, or test results) in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product Serious Adverse Event (SAE) – Any untoward medical occurrence that may lead to death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or permanent incapacity, creates a congenital anomaly/birth defect, or requires appropriate medical intervention to prevent the aforementioned situations or medically important event Unexpected AE – AEs in which the essence, severity, specificity, or … Go to Vietnam > Safety Reporting

Safety Reporting Definitions According to the ZWE-GCP , the following definitions provide a basis for a common understanding of Zimbabwe’s safety reporting requirements: Adverse Event (AE) – Any undesirable experience occurring to a participant during a clinical trial, whether or not considered related to the investigational product(s) (IP). An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the IP. Adverse Event Following Immunization (AEFI) – Any untoward medical occurrence that follows immunization and does not necessarily have a causal relationship with the usage of the vaccine. The AE may be any unfavorable or unintended sign, abnormal laboratory finding, symptom, or disease. Adverse Drug Reaction (ADR) – A response to a medicinal product that is noxious and unintended, and which occurs at doses normally … Go to Zimbabwe > Safety Reporting

Interim and Annual Progress Reports As per the AU-ICH-GCP , the G-NatlStmt , and the G-TrialsSOP , the investigator(s) is responsible for submitting progress reports to the ethics committee (EC) (known as Human Research Ethics Committee in Australia) annually, or more frequently if requested. The AU-ICH-GCP and the G-TrialsSOP state that if there are significant changes in trial conduct or safety, the investigator should submit a written report to the sponsor, the EC, and where applicable, the institution. The G-NatlStmt indicates that at regular periods (reflecting the degree of risk, and at least annually), researchers should provide reports to the relevant EC(s) and institution(s), including information on: Progress to date The security of project-related data and information Compliance with the approved proposal Compliance with any conditions of approval According to the G-NatlStmt , progress report forms should be designed to collect information that can provide meaningful … Go to Australia > Progress Reporting

Interim and Annual Progress Reports As per the BGD-GCP , the investigator should submit written summaries of the trial status every six (6) months to the Ministry of Health and Family Welfare (MOHFW) ’s Directorate General of Drug Administration (DGDA) and the ethics committee (EC) (referred to as an independent ethics committee (IEC)/institutional review board (IRB) in Bangladesh), or more frequently, if requested by the DGDA and the EC. The investigator should promptly provide written reports to the sponsor, the EC, and the institution (where applicable) on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants. BGD-16 indicates that reports should be submitted periodically at intervals prescribed by the Bangladesh Medical Research Council (BMRC) ’s National Research Ethics Committee (NREC) for review. Final Report The BGD-GCP delineates that upon completion of the trial, the investigator, where applicable, should inform the … Go to Bangladesh > Progress Reporting

Interim and Annual Progress Reports As per ResNo945 and the G-CTReptsManual , the sponsor must file a progress report, known as an annual clinical trial protocol monitoring report, to the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) in the form of a secondary petition electronically attached to the respective protocol to which it is linked. The G-DDCMManual also specifies that the annual clinical trial monitoring report should be linked to the Specific Clinical Trial Dossier (Dossiê Específico de Ensaio Clínico (DEEC)). ResNo945 states that the report should be filed within 60 calendar days of the start date of the clinical trial in Brazil. The annual report should contain the following information for each clinical trial protocol, in tabulated form, exclusively from Brazilian centers: Clinical trial title and protocol code Recruitment status and breakdown of the number of participants recruited by center in Brazil and worldwide … Go to Brazil > Progress Reporting

… issues, including, but not limited to: Changes to the research design Evidence of any new risks Unanticipated issues that have possible health or safety consequences for participants New information that decisively proves the benefits of one (1) intervention over another New research findings, including relevant non-trial findings Unanticipated problems Closure of trials at other sites for reasons that may be relevant to the welfare or consent of participants in the ongoing trial … Go to Canada > Progress Reporting

Interim and Annual Progress Reports The NMPA-GCP-No57-2020 and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CHN-37 ) require the investigator to submit an annual report on the clinical trial to the ethics committee (EC). In addition, the investigator must provide a progress report in accordance with requirements established by the EC. When there is a situation that significantly affects the implementation of clinical trials or increases the risks to participants, the investigator should report it in writing to the sponsor, the EC, and the clinical trial institution as soon as possible. The Measures-Ethics reiterates that the researcher must submit progress reports. The NMPA-No2-2015 requires sponsors and researchers to submit the progress of international multicenter clinical trials to the EC, including but not limited to enrollment, important decisions of the independent data supervision committee (if applicable), and safety … Go to China > Progress Reporting

Interim and Annual Progress Reports The G-EthicalEval also indicates that the principal investigator (PI) must agree to work in accordance with the Declaration of Helsinki ( DRC-11 ), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products ( DRC-10 ), and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( DRC-3 ). DRC-3 notes that the investigator should submit written summaries of the trial status to the institutional ethics committee (EC) annually, or more frequently, if requested by the EC. The investigator should also promptly provide written reports to the sponsor and the institutional EC on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants. As per the G-EthicalEval , the EC must establish a procedure for monitoring the progress of all research that has been approved, from the date the decision was made to the end of the … Go to DRC > Progress Reporting

Interim and Annual Progress Reports According to GIN-5 , the principal investigator (PI) is responsible for submitting a progress report on the status of a clinical trial to be evaluated by the National Ethics Committee for Health Research (Comité National d’Ethique pour la Recherche en Santé (CNERS)) . In addition, per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( GIN-7 ), which states the investigator should promptly provide written reports to the sponsor and the institutional ethics committee, and where applicable, the institution, on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants. Final Report Per GIN-5 , the PI is responsible for submitting a final study report upon the trial’s completion to be evaluated by … Go to Guinea > Progress Reporting

… Status Report documentation requirements to be included in a global clinical trial application. Final Report The final report should comply with the format and content guidelines listed in the 2019-CTRules as follows: Title page Study synopsis (1 to 2 pages) List of abbreviations and definitions Table of contents EC approval letter(s) Study team introduction Study objective Investigational plan Trial participants Efficacy evaluation Safety evaluation Discussion and overall conclusion … Go to India > Progress Reporting

… and publication at the onset of the research. Individual sites or institutions must not publish any data until the appropriate authorities accept the combined report. KEN-31 further indicates that the research license applicant must submit one (1) hard copy and upload a soft copy of the final research report to the National Commission for Science, Technology and Innovation (NACOSTI) within one (1) year of the research’s completion. … Go to Kenya > Progress Reporting

… report form). In addition, per the LibCTReg and the G-LibClinTrial , the applicant must submit a comprehensive end of study report conforming to the ICH’s Structure and Content of Clinical Study Reports (E3) ( LBR-37 ) guidelines, within one (1) year from the trial’s completion. Per the LibCTReg and the G-LibClinTrial , the end of study report must also contain any adverse events reported by the PIs. Per LBR-8 , the investigator, where applicable, should inform the institution; the … must also inform the NREB of any adverse events as part of the end of study report. The LibCTReg further specifies that the applicant must submit a comprehensive end of study report to the NREB conforming to the LBR-37 guidelines, within one (1) year from the trial’s completion. According to LBR-38, the NREB is using LBR-24 for continuing review, for annual reports, and as a final report to close a study. Atlantic Center for Research and Evaluation Institutional Review Board Per the … Go to Liberia > Progress Reporting

… together with accompanying documents to the PMRA Director General at info@pmra.mw . Both hard and soft (electronic) copies must be submitted. The G-NHSRC and the G-COMREC further state that all approved studies continuing for more than one (1) year are subject to continuing review by the approving EC. As part of this review, applicant(s) are required to submit a progress report describing the number of participants enrolled, any problems that occurred during the prior approval … Go to Malawi > Progress Reporting

… No information is available regarding progress reporting requirements for the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) . However, DecreeNo2017-0245 notes that if the study lasts longer than one (1) year, an annual report must be provided to the ethics committee (EC). According to MLI-17, Mali’s ECs follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( … of Sciences, Techniques and Technologies of Bamako (USTTB) (Comité Institutionnel d’Éthique de la Recherche en Santé et en Sciences de la Vie/Université des Sciences, des Techniques et des Technologies de Bamako). Final Report Per MLI-1 , the sponsor (promoter) is required to submit a final clinical trial report to the DPM no later than one (1) year after the end of the trial. Per the FMPOS-USTTB-ECProcs , the PI must submit a final report to the CIESS/USTTB following the trial’s conclusion. In addition, per DecreeNo2017-0245 , researchers must provide the results of the research in … Go to Mali > Progress Reporting

Interim and Annual Progress Reports Per HlthResRegs , NOM-012-SSA3-2012 , and MEX-28 , the principal investigator (PI) must prepare and submit a progress report (also referred to as a partial technical or technical-descriptive report) ( MEX-31 ) to the Ministry of Health (Secretaría de Salud) at any time, but at least once a year, to communicate progress and partial research study results. In addition, per NOM-012-SSA3-2012 , information related to any investigation that the PI submits to the Ministry of Health must be classified as confidential. NOM-012-SSA3-2012 further states that the PI must also provide a copy of every report to the head of the Research Ethics Committee (REC) ( Comité de Ética en Investigación (CEI) ) and the Research Committee, and if applicable, the Biosafety Committee of the institution where the research takes place. NOM-012-SSA3-2012 specifies that the progress reports should describe the results obtained and at a minimum should include the following … Go to Mexico > Progress Reporting

Interim and Annual Progress Reports National Institute of Health (INS) As delineated in Decree021-2017 , the INS-CTManual , PER-72 , PER-47 , and PER-14 , the sponsor or the contract research organization (CRO) must submit a progress report for each institution in which a trial is conducted from the date of the study’s authorization to the Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) within Peru’s INS. The report should be submitted quarterly or biannually to the INS’s REPEC ( PER-89 ) (also referred to as REPECv2) for each of the approved research centers. Per the INS-CTManual , this report should be submitted regardless of the enrollment status in each site. The INS-CTManual and PER-14 further specify that the submission deadline is up to seven (7) calendar days after completing the quarterly or half-yearly period. The sponsor or the CRO should print and sign the electronic form and deliver it to the INS’s Document … Go to Peru > Progress Reporting

Interim and Annual Progress Reports Per the SL-GCPs , the investigator should submit written summaries of the trial status to the Pharmacy Board of Sierra Leone (PBSL) as required in the G-SLAppClinTrial , or more frequently, if requested by the PBSL. The investigator should also promptly provide written reports to the PBSL on any changes that significantly affect the conduct of the trial and/or increase the risk to participants. As set forth in the G-SLAppClinTrial , quarterly reports must be submitted starting from the date the Clinical Trial Certificate is issued using the Quarterly Progress Report Form provided in Appendix VIIb. The reports must be submitted to the PBSL within 21 days following the end of the previous quarter, and an interim report must be submitted within 21 days after the end of the first half of the trial period, and as stipulated in the protocol. If the trial is interrupted, the reason must be communicated in writing to the PBSL within 10 working days. See the … Go to Sierra Leone > Progress Reporting

… that the sponsor must ensure that trial results and outcomes are reported to the investigators, the SAHPRA, and the National Department of Health (NDOH) via the South African National Clinical Trials Register (SANCTR) ( ZAF-48 ) within one (1) year of the study’s completion. The sponsor and the PI are responsible for appropriate dissemination of the trial findings. … Go to South Africa > Progress Reporting

Interim and Annual Progress Reports As delineated in the G-AppConductCT , the sponsor or the principal investigator (PI) must submit progress reports to the Tanzania Medicines and Medical Devices Authority (TMDA) on a six (6)-month basis from the date of the clinical trial’s commencement. The content should be as prescribed in TZA-11 . In addition, the TMDA provides a six (6)-month progress report form for clinical trials of investigational products ( TZA-3 ). The CT-Regs states that progress reports should be submitted annually, or more frequently, as required by the TMDA. Per the G-EthicsHR-TZA , researchers must submit progress reports to the ethics committee (EC). The investigator must ensure appropriate and timely feedback on the research process including progress reports at regular intervals as stipulated by the EC. Periodic progress reports enable the EC to determine whether the research study is progressing according to the approved protocol. According to TZA-5 , the … Go to Tanzania > Progress Reporting

… THA-28 . In addition, according to ClinImprtOrdr and ClinSampleProd , the sponsor must submit a study progress report annually to the Director of the Thai Food and Drug Administration (Thai FDA) 's Medicines Regulation Division between October 1 and 31 every year until the study ends. Per ClinImprtOrdr , for N.Y.M.1/investigational product (IP) import applications, this report should be submitted using the progress report form in Appendix 15 in THA-18 , and accompanied by a delivery letter to the Thai FDA’s Director of the Bureau of Medicine using the … the FDA’s Skynet E-Submission System ( THA-54 ) must submit documents according to the system’s procedures. See Submission Process section for detailed information on submitting information via THA-54 . The ExprssChnnl indicates that for N.Y.M.1 and P.Y.8 applications reviewed through the express channel in the case of a public health emergency, reporting on the progress of research operations must be submitted monthly from the date of receiving permission. See the Scope of Assessment … Go to Thailand > Progress Reporting

Interim and Annual Progress Reports As per the G-TrialsGCP , the principal investigator (PI) is obliged to submit progress reports as required by the sponsor, the institutional ethics committees (ECs) (research ethics committees (RECs) in Uganda), the Uganda National Council for Science and Technology (UNCST) , and the National Drug Authority (NDA) . These reports should contain information on: How the study is progressing The number of participants included in relation to the number screened and the target sample size The number of dropouts and withdrawals Adverse events If the planned time schedule is still appropriate The format and frequency of reporting is as prescribed by the relevant authorities. The NDPA-CTReg and the G-CTConduct also state that the NDA may request the sponsor to submit an interim report. See Schedule 2 of the NDPA-CTReg or UGA-6 for the format of the clinical trial report. Additionally, per the G-UNCSTreg , although annual renewal of a study is not required, … Go to Uganda > Progress Reporting

… declaration has been received within a reporting period, or within 60 days following the data lock point, the corresponding DSUR will not be required. Per the G-CTAuth-GBR , the timeframe for publishing the summary of results is within one (1) year of the end of trial. Sponsors should publish summary results within this timeframe in the public register(s) where they registered the clinical trial. While it is not required to submit this clinical trial summary report to the MHRA, … link. As per GBR-9 , for all project-based research that have received a favorable ethics opinion from an EC, a final report on the research should be submitted to the UK Health Departments’ Research Ethics Service (RES) ( GBR-62 ) within one (1) year of the trial’s conclusion. In the case of early termination, the provision of a final report is at the discretion of the sponsor. All final reports will be acknowledged within 30 days. The EC should be notified of receipt of the report, … Go to United Kingdom > Progress Reporting

… information obtained during the previous year’s clinical and nonclinical investigations Description of the general investigational plan for the coming year Updated investigator’s brochure, if revised Description of any significant Phase 1 protocol modifications not previously reported in a protocol amendment Brief summary of significant foreign marketing developments with the drug A log of any outstanding business for which the sponsor requests a reply, comment, or meeting As … Additionally, per 42CFR11 and USA-70 , the sponsor or the principal investigator (PI) designated by the sponsor must submit results for applicable investigational product (IP) clinical trials to USA-78 no later than one (1) year following the study’s completion date. Submission of trial results may be delayed as long as two (2) years if the sponsor or PI submits a certification to USA-78 that indicates either: 1) the FDA has not yet approved, licensed, or cleared the IP being studied for marketing; or 2) the manufacturer is the sponsor and has sought or will seek approval within one (1) year. The results information must include data on the following: … Go to United States > Progress Reporting

Interim and Annual Progress Reports According to the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP ), investigators are responsible for providing periodic and unscheduled reports. The ECReg states that ethics committees (EC) should evaluate the following content when reviewing ongoing research: Compliance with the approved research protocol Protection of rights, health, and safety of research participants Recording, handling, and reporting of adverse events (AEs) and serious adverse events (SAEs) occurring during the study (if any) Violation of the research protocol and remediation and prevention of violations (if any) Amendments and/or supplements to the research protocol and related documents (if any) Final Report The BioequivTrial and the ClinDrugTrialGCP indicate that the principal investigator ( PI), the sponsor, and the host institution are responsible for submitting a final report to the Ministry of Health (MOH) when a study is completed. The final report, … Go to Vietnam > Progress Reporting

… report, institution of affiliation letter, Medical Research Council of Zimbabwe (MRCZ) conditional approval letter, summary protocol, proof of funding, and the proof of payment of RCZ registration. This must be submitted not later than one (1) month before the expiration date. Institutional Ethics Committees Per the CTEthics , the ethics committee (EC) must ensure that the conduct of all research is monitored. At least annually, the EC must request reports from the PI on matters … results without prior submission of the same results to the MCAZ. Research Council of Zimbabwe ProcForeignReg requires that foreign researchers submit a detailed report and end of study form to the RCZ and the National Archives within one (1) year of completing the research. Institutional Ethics Committees Because each EC has its own requirements, investigators and sponsors should review their EC’s final report procedures. Medical Research Council of Zimbabwe Per ZWE-11 , the … Go to Zimbabwe > Progress Reporting

… the initiation, management, or financing of a clinical trial. LawNo14.874 further explains that a sponsor may authorize a contract research organization (CRO) (clinical research representative organization (CRPO) in Brazil) to perform one (1) or more trial-related tasks and functions. ResNo945 specifies that a CRO is any company regularly installed in Brazil contracted by the sponsor or by the sponsor-investigator, which partially or totally assumes, together with the National … Go to Brazil > Definition of Sponsor

As per the CanadaFDR and the G-CanadaCTApps , a sponsor is defined as an individual, corporate body, institution, or organization that conducts a clinical trial. The International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ), which Canada has implemented per CAN-50 , expands on this definition to include individuals, companies, institutions, or organizations that take responsibility for the initiation, management, and/or financing of a clinical trial. In accordance with CAN-52 , Canada also permits a sponsor to transfer any or all of its trial-related duties and functions to a contract research organization (CRO) and/or institutional site(s). However, the ultimate responsibility for the trial data’s quality and integrity always resides with the sponsor. Any trial-related responsibilities transferred to a CRO should be specified in a written agreement. The CRO should implement quality assurance and quality control. Note that per CAN-50 , … Go to Canada > Definition of Sponsor

As per the DRR , the NMPA-GCP-No57-2020 , and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CHN-37 ), a sponsor is defined as a company, institution, or organization that initiates a clinical trial, and is responsible for managing, financing, and monitoring the trial. The DRR further specifies that the enterprise or institution applicant must be able to bear corresponding legal responsibilities. Per the DRR , applicants who are approved to carry out clinical trials of drugs are referred to as “sponsors” of clinical trials. If the sponsor changes, the changed sponsor must bear the relevant responsibilities and obligations of the drug clinical trial. Per the NMPA-GCP-No57-2020 and CHN-37 , a sponsor can authorize a contract research organization (CRO) to carry out certain work and obligations regarding the clinical trial. The sponsor can entrust part or all of the work and tasks of its clinical trial to the CRO, but the sponsor is … Go to China > Definition of Sponsor

As per the G-EthicalEval , the sponsor is defined as the person, company, institute, or organization responsible for launching, managing, and/or financing a clinical trial, as well as legally responsible for the trial. In non-commercial research, it is often the case that the sponsor and the funding agency are different entities. In this case, the legal responsibility rests with the sponsor. The G-EthicalEval indicates that for biomedical research on humans, the sponsor is the person who initiates, manages, and verifies the funding of the research. The G-EthicalEval also indicates that the principal investigator (PI) must agree to work in accordance with the Declaration of Helsinki ( DRC-11 ), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products ( DRC-10 ), and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( DRC-3 ). DRC-3 specifies that a sponsor-investigator is an … Go to DRC > Definition of Sponsor

Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( GIN-7 ), which defines a sponsor as an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. In accordance with GIN-7 , Guinea permits a sponsor to transfer any or all of its trial-related duties and functions to a contract research organization (CRO) and/or institutional site(s). However, the ultimate responsibility for the trial data’s quality and integrity always resides with the sponsor. Any trial-related responsibilities transferred to a CRO should be specified in a written agreement. The CRO should implement quality assurance and quality … Go to Guinea > Definition of Sponsor

As per the 2019-CTRules and the G-ICMR , a sponsor (applicant) is defined as an individual, a company, or an institution that takes responsibility for the initiation, management, or financing of a clinical study. The G-ICMR further states that an investigator who independently initiates and takes full responsibility for a trial automatically assumes the role of a sponsor. Although not specified in the 2019-CTRules , IND-46 notes that a foreign sponsor should appoint a local representative or contract research organization to fulfill local responsibilities , must document the transfer of duties, and is ultimately still responsible for the data quality and integrity. Additionally, as delineated in the 2024-CTRulesAmdt , a clinical research organization is defined as a sponsor or a body (commercial, academic, or from another category), which is owned by an individual or an organization with a legal entity status, and to which the sponsor may delegate or transfer in writing, some or all … Go to India > Definition of Sponsor

As per the G-KenyaCT , a sponsor is defined as an individual, a company, an institution, or an organization who takes legal responsibility for the initiation, management, and financing of a trial. According to the G-KenyaCT , a sponsor, in a written document, may agree to transfer all related activities of the clinical trial to designated research institutions. However, all responsibility for the trial lies with the sponsor. The G-ECBiomedRes indicates that sponsors may be foreign, but must comply with certain conditions including affiliating themselves to institutions recognized in Kenya. Per the G-KenyaCT , research must be conducted in accordance with requirements set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( KEN-14 ). In accordance with KEN-14 , Kenya permits a sponsor to transfer any or all of its trial-related duties and functions to a contract research organization (CRO) and/or institutional site(s). However, the … Go to Kenya > Definition of Sponsor

… The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. In addition, per the LibCTReg , the sponsor may hire a contract research organization (CRO) (commercial, academic, or other) to perform one (1) or more of the sponsor’s trial-related duties and functions. LBR-8 further explains that although a sponsor may transfer responsibility for any or all of the sponsor’s obligations to a CRO, the ultimate responsibility for the trial data’s … Go to Liberia > Definition of Sponsor

As per LawNo09-059 , a sponsor (also referred to as a promoter in Mali) is defined as a natural or legal person, an institution, or an organization that supports research through the initiation or financing of a clinical trial. According to MLI-17, Mali’s ethics committees follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( MLI-7 ), which also specifies that a sponsor-investigator is an individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a participant. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. MLI-7 also notes that a sponsor may transfer any or all of its trial-related duties and … Go to Mali > Definition of Sponsor

… Per COFEPRIS-GCP and MEX-32 , a sponsor is an individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. A sponsor may also hire a CRO to conduct one (1) or more of the activities related to health research that are sponsored in the country. The sponsor must specify in writing any trial-related duty and function that is transferred to and assumed by a CRO. However, the ultimate responsibility … Go to Mexico > Definition of Sponsor

Decree021-2017 defines a sponsor as an individual, group of individuals, company, institution, organization, including academic organizations, with legal representation in the country, and duly registered in the corresponding public registries. The sponsor assumes responsibility for the initiation, maintenance, completion, and financing of a clinical trial. The sponsor must be registered in the INS’s REPEC ( PER-89 ) (also referred to as REPECv2) prior to requesting trial authorization. When an independent researcher initiates and assumes full responsibility for a clinical trial, they assume the role of sponsor. Decree021-2017 also states that sponsors not based in Peru are required to appoint a legal representative who channels all the communication with the INS’s Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) or the trial’s duration. In addition, per Decree021-2017 , a sponsor can authorize a contract research organization … Go to Peru > Definition of Sponsor

… organization that takes ultimate responsibility for the initiation, management, and financing of a trial. In accordance with the G-SLAppClinTrial and the SL-GCPs , the sponsor may authorize a contract research organization (CRO) to perform one (1) or more of its trial-related duties and functions. However, the ultimate responsibility for the trial’s data quality and integrity always resides with the sponsor. The SL-GCPs further requires that any trial-related duty and function that is … Go to Sierra Leone > Definition of Sponsor

… institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. The Tanzanian government also permits a sponsor to authorize a contract research organization (CRO) to perform one (1) or more of a sponsor’s trial-related duties and functions. As required in the G-EthicsHR-TZA , the sponsor is responsible for providing all the necessary financial support for the initiation and completion of the research study. Additional … Go to Tanzania > Definition of Sponsor

… financing of a clinical trial. Per ClinImprtOrdr , clinical trials in Thailand must comply with THA-28 . Per G-ResEthics and THA-28 , the Thai government also permits a sponsor to authorize a contract research organization (CRO) to perform one (1) or more of a sponsor’s trial-related duties and functions. However, the ultimate responsibility for the trial data’s quality and integrity always resides with the sponsor. Any trial-related responsibilities to be transferred and assumed by a … sponsor and those of an investigator. According to THA-13 , the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH) requires the sponsor and/or CRO to be legally registered in Thailand. The ECMOPH is one (1) of the ethics committees approved by the Thai Food and Drug Administration (Thai FDA) to approve clinical research protocols. See THA-13 for additional ECMOPH sponsor requirements. Per ClinImprtOrdr , the sponsor is also referred to as the … Go to Thailand > Definition of Sponsor

… assigns responsibility to the sponsor for providing all the necessary financial support to initiate and complete a research study. The NDPA-CTReg also specifies that in order to submit a clinical trial application, the sponsor must be one (1) of the following: The drug patent holder A licensed person (a pharmacist) The drug manufacturer An agent of the drug patent holder or the drug manufacturer As stated in the G-TrialsGCP , a sponsor may transfer any or all of the sponsor's … Go to Uganda > Definition of Sponsor

… would also be regarded as a co-sponsor and would then require insurance or indemnity cover The MHCTR also permits two (2) or more parties to take responsibility for the sponsor’s functions. When this applies, the MHCTR requires one (1) of the parties to submit the clinical trial application for authorization to the Medicines and Healthcare Products Regulatory Agency (MHRA) , and to specify who is responsible for carrying out the following functions: Communications relating to … Go to United Kingdom > Definition of Sponsor

As per 21CFR312 , 21CFR50 , and the US-ICH-GCP , a sponsor is defined as a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. 21CFR312 , 21CFR50 , and the US-ICH-GCP define a sponsor-investigator as an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational product is administered or dispensed. In addition, 21CFR312 and the US-ICH-GCP state that a sponsor may transfer responsibility for any or all obligations to a contract research organization (CRO). Any trial-related responsibilities transferred to and assumed by a CRO should be specified in writing, and those obligations not covered by the written description will be deemed not to have been … Go to United States > Definition of Sponsor

… clinical and laboratory findings, and on completing the CRFs Communication among investigators is facilitated As noted in the G-TeletrialPrncpls , Australian jurisdictions agree that “traditionally” multicenter clinical trials assume one (1) PI per geographic site, differing from teletrials. However, for the purposes of teletrials, multicenter trials may include some sites that have satellite sites supervised under teletrial guidance, including the Clinical Oncology Society of … Go to Australia > Site/Investigator Selection

… a vote is required. DSMB members often include individuals with scientific knowledge of the disease/participant population under investigation, as well as practical expertise and skill in current clinical trial conduct and technique, and one (1) or more epidemiologist(s) and statistician(s). Items reviewed by the DSMB include: Interim/cumulative data to look for evidence of adverse events related to the study If applicable, interim/cumulative data for evidence of efficacy in accordance … Go to Bangladesh > Site/Investigator Selection

Overview As set forth LawNo14.874 and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( BRA-28 ), which Brazil has adopted per ResNo945 , the sponsor is responsible for selecting the investigator(s) and the institution(s) for a clinical trial. The sponsor must also ensure that the investigator(s) are qualified by education, training, and experience to assume responsibility for the proper conduct of the trial. BRA-28 also notes that the investigator(s) should provide evidence of all the qualifications specified by the applicable regulatory requirements through up-to-date curriculum vitae(s) (CVs) and/or other relevant documentation requested by the sponsor, the research ethics committee (EC) (Comitê de Ética em Pesquisa (CEP)), and/or the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) . As delineated in BRA-28 , prior to entering into an agreement with the investigator(s) and the institution(s) to … Go to Brazil > Site/Investigator Selection

Overview As set forth in the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ), which Canada has implemented per CAN-50 , the sponsor should select the investigator(s) and the institution(s) for the clinical trial, taking into account the appropriateness and availability of the study site and facilities. The sponsor must also ensure that the investigator(s) are qualified by training and experience. Furthermore, the sponsor must sign an agreement or contract with the participating institution(s). Note that per CAN-50 , Health Canada (HC) -implemented ICH guidance takes precedence over other HC guidance when they are not consistent. In accordance with the G-CanadaCTApps , prior to initiating a clinical trial, the sponsor must ensure that a Qualified Investigator Undertaking (QIU) form ( CAN-37 ) (or similar documentation that meets the CanadaFDR requirements) has been completed and kept on file by the sponsor; it should be retained by … Go to Canada > Site/Investigator Selection

… Commission (NHC) is responsible for China’s management of human genetic resources (HGR). (Note that per SC-Order777 and NHC-HGRmgt , management of HGR was transferred from the Ministry of Science and Technology (MOST) to NHC, effective May 1, 2024). Per the Rules-MgmtHGR , when data or information on human genetic resources (HGR) is provided or made available for use by foreign organizations, individuals, and institutions, the Chinese entity must notify MOST (now the NHC) in advance … Go to China > Site/Investigator Selection

… sponsor is a foreign person or entity, the sponsor must work closely with the PI(s) from the partner institution(s) with which the sponsor has signed a memorandum of understanding. Each PI, who must be based in the DRC, in turn works with one (1) or more local investigators at their site. Data and Safety Monitoring Board The G-EthicalEval indicates that, as appropriate, the EC should evaluate the adequacy of the arrangements made for monitoring and auditing research, including setting … Go to DRC > Site/Investigator Selection

Overview Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( GIN-7 ), which provides guidance to sponsors on investigator and site selection. According to GIN-7 : The sponsor is responsible for selecting the investigator(s)/institution(s). Each investigator should be qualified by training and experience and should have adequate resources to properly conduct the trial for which the investigator is selected. If the organization of a coordinating committee and/or selection of coordinating investigator(s) are to be utilized in multicenter trials, their organization and/or selection are the sponsor’s responsibility. Before entering an agreement with an investigator/institution to conduct a trial, the sponsor should provide the investigator(s)/institution(s) with the protocol and an up-to-date Investigator’s Brochure, and the investigator/institution should be provided with sufficient time to review the … Go to Guinea > Site/Investigator Selection

Overview As stated in the 2019-CTRules , all investigators must possess appropriate qualifications, training, and experience, and should conduct the trials in compliance with good clinical practice (GCP) and good laboratory practice (GLP). (See GCLP for the G-ICMR for good clinical laboratory practice (GCLP) guidelines, IND-31 for additional laboratory requirement information, and IND-76 for international GCLP guidelines. Investigators should also have access to investigational and treatment facilities as relevant to the protocol. The 2024-CTRulesAmdt also notes that clinical research organizations must have adequate facilities, resources, and qualified and trained staff for handling any oversight of clinical trials and bioavailability or bioequivalence studies, and such staff must be trained regularly to update their skills. See the 2024-CTRulesAmdt for additional clinical research organization requirements. In addition, applications to add a clinical trial site and/or to change a … Go to India > Site/Investigator Selection

Overview The G-KenyaCT , which requires sponsors to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( KEN-14 ), states that the sponsor is responsible for selecting the investigator(s) and the institution(s) for the clinical trial and for ensuring that the investigator(s) are qualified by education, training, and experience. Per the CTRules and the G-KenyaCT , investigators must also meet the following requirements (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements): Provide evidence of their qualifications and experience through an up-to-date curriculum vitae (CV) Have a current practice license from the relevant regulatory authority Be familiar with the characteristics and appropriate use of the investigational product (IP) as described in the protocol, current Investigator’s Brochure (IB), in the product information, and in other information sources Have … Go to Kenya > Site/Investigator Selection

… trials and patient care as needed for the conduct of the trial must be provided for the investigators to prove their qualifications. The principal investigators (PIs) should have acted as PI or at least as an investigator in at least one (1) prior clinical trial and must provide proof of residency in Liberia in the clinical trial application submission package. The LibCTReg also states that the trial is to be conducted in an appropriate facility by a suitably qualified investigator … Go to Liberia > Site/Investigator Selection

… Overview The G-CTAProcsVacBiol specifies that the investigator(s) must be qualified, experienced, and have specific good clinical practice (GCP) training. The principal investigator (PI) should have acted as a sub-investigator in at least one (1) prior clinical study. The investigator must also commit to complying with the clinical trial protocol, have no conflicts of interest, and have no history of GCP noncompliance. Per MWI-25, clinical trials in Malawi are required to follow the … Go to Malawi > Site/Investigator Selection

… is responsible for selecting the investigator(s) and the institution(s) for the clinical research study, taking into account the appropriateness and availability of the study site and facilities. When the research is to be conducted in one (1) or more public or private institutions, the sponsor or the principal investigator (PI) is required to inform the director(s) of these institutions prior to initiating the study. Per DecreeNo2017-0245 , all members of the research team must be … Go to Mali > Site/Investigator Selection

Overview According to COFEPRIS-GCP , the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) requires the sponsor or the contract research organization (CRO) to comply with the Guideline for Good Clinical Practice E6 (R1) ( MEX-32 ) for conducting clinical trials. COFEPRIS-GCP states the sponsor or the CRO is responsible for selecting each research center and ensuring that COFEPRIS has authorized its operation as well as the human and material resources needed to conduct research. MEX-32 indicates the sponsor should ensure the investigator(s) have adequate resources to properly conduct the trial for which they are selected. Additionally, MEX-32 , explains the investigator should have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely. Per COFEPRIS-GCP , the sponsor must establish in writing each of the … Go to Mexico > Site/Investigator Selection

… Request to expand the number of research centers, justifying the reasons for the expansion and including information on proof of payment Approval(s) issued by legal representative of institution(s) where research will be conducted (per Annex 1 in INS-CTManual and Annex 2 in Res252-2022 ) Copy of the approved research protocol and ICF issued by the accredited EC (CIEI) (per Annex 3 in INS-CTManual and Annex 3 in Res252-2022 ) ICF(s) prepared (per Annex 4 of Decree021-2017 ) Affidavit … the sponsor should specify where to find other details about the by-laws not included in the protocol or explain why a DSMB is not necessary. Multicenter Studies Per Decree021-2017 , multicenter clinical trials are carried out by more than one (1) investigator and require an appointed coordinator responsible for processing all of the data and analyzing the results. In addition, according to PER-53 , in the event of a multicenter clinical trial, the sponsor must ensure that: All … Go to Peru > Site/Investigator Selection

… conduct, and delegation of trial responsibilities, analysis, and reporting. The PI is accountable to the sponsor and regulatory authorities. The PI can designate and supervise sub-principal investigator(s) (Sub-PI) of which at least one (1) must be a clinician and registered with the appropriate statutory entity to provide clinical oversight within their scope of practice. Further, the SAHPRA recognizes a category of co-principal investigator (co-PI), which allows for a team consisting of two (2) co-PIs to lead a study at a site. At least one (1) of the co-PIs must be a clinician registered with the appropriate statutory body and qualified to provide clinical oversight within their scope of practice. For multi-center studies, there must be a national PI appointed, who may or may not be … regulatory requirements, and researchers must adapt the trial design and informed consent procedures to take into account local conditions and characteristics. The G-EthicsHR-ZAF states that for international multi-site research, at least one (1) PI or co-PI must be physically in South Africa. … Go to South Africa > Site/Investigator Selection

… For multi-country clinical trials, the DSMB must include regional representation, and a Tanzanian must be among the members. Where necessary, NatHREC may request that the sponsor submit the most recent report from the DSMB. In contrast, per TZA-1 , for clinical trials that require a DSMB, the PI must submit a list of DSMB members, including at least one (1) Tanzanian, to the National Institute for Medical Research (NIMR) . Additionally, the CT-Regs requires the following information: Trial objectives and terms of reference Member composition, qualifications, specific roles, and relationship to the … Go to Tanzania > Site/Investigator Selection

Overview In accordance with G-ResEthics and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( THA-28 ), the sponsor is responsible for selecting the investigator(s) and the institution(s) for the clinical trial, and for ensuring that the investigator(s) are qualified by training and experience. Per ClinImprtOrdr , clinical trials in Thailand must comply with THA-28 . THA-14 also states that researchers must have basic knowledge in the field of research. Additionally, per THA-28 and G-ResEthics , the sponsor must define and allocate all study related duties and responsibilities to the relevant parties participating in the study. Prior to entering into an agreement with the investigator(s) and the institution(s) to conduct a study, the sponsor should provide the investigator(s) with the protocol and an investigator’s brochure. Foreign Sponsor Responsibilities No information is available regarding foreign sponsor regulatory requirements. Data … Go to Thailand > Site/Investigator Selection

… clinical practice (GCP) and the applicable regulatory requirements. According to the NDPA-CTReg , an application for additional investigators, change of investigator, or additional clinical trial sites must be made using Form 36 in Schedule 1 of the NDPA-CTReg or using UGA-13 . The application must be accompanied by evidence of ethical approval of the clinical trial protocol amendment, where applicable, and the prescribed fees. In accordance with the G-UNCSTreg , all investigators … from the holder of the patent of the drug, licensed person, or manufacturer of the drug to be the agent in the clinical trial that is responsible for all matters pertaining to the NDA clinical trial certificate. See Form 30 in Schedule 1 of the NDPA-CTReg or UGA-18 for the letter of authorization, and Form 34 in Schedule 1 of the NDPA-CTReg for the clinical trial certificate. Data and Safety Monitoring Board According to the NGHRP , the G-TrialsGCP , and the NDPA-CTReg , the sponsor is responsible for establishing a Data and Safety Monitoring Board (DSMB) (also … Go to Uganda > Site/Investigator Selection

Overview As set forth in the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( GBR-113 ), the sponsor is responsible for selecting the investigator(s) and the institution(s) for the clinical trial, taking into account the appropriateness and availability of the study site and facilities. The MHCTR2006 indicates that the sponsor must also ensure that the investigator(s) are qualified by training and experience. Additionally, the sponsor must define and allocate all study related duties and responsibilities to the relevant parties participating in the study. GBR-9 states that the chief investigator (CI) should be based in the United Kingdom (UK). In rare cases when this is not required, adequate arrangements must be in place for supervision of the study in the UK. Further, it is possible to accept a co-CI (joint lead applicants) as this can help less experienced researchers develop new skills. The details of the arrangement should be outlined in the … Go to United Kingdom > Site/Investigator Selection

Overview As set forth in 21CFR312 and the US-ICH-GCP , the sponsor is responsible for selecting the investigator(s) and the institution(s) for the clinical trial and for ensuring that the investigator(s) are qualified by training and experience. Prior to permitting an investigator(s) to conduct a study, the sponsor must obtain the following: Signed investigator’s statement (Form FDA 1572 ( USA-77 )) Curriculum vitae Clinical protocol Financial disclosure information As addressed in the G-1572FAQs , Form FDA 1572 ( USA-77 ) serves as the investigator’s agreement to provide certain information to the sponsor and to assure compliance with the Food & Drug Administration (FDA) 's clinical investigation regulations. Refer to the G-1572FAQs and USA-40 for further information. In addition, 21CFR312 and the US-ICH-GCP indicate that prior to the start of the study, the sponsor must provide the investigator(s) with the protocol and the investigator’s brochure. See G-InvstgtrResp for more … Go to United States > Site/Investigator Selection

Overview As set forth in the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP ) and PharmLaw-VNM , the sponsor is responsible for selecting the investigator(s), the principal investigator (PI), the consultant experts, and the research institutions, taking into account the appropriateness and availability of the study site and facilities. As stated in the BioequivTrial , all investigators must possess appropriate qualifications, training, and experience. All investigators involved in the trial must obtain completion certificates for a good clinical practice (GCP) course and a safety reporting course, each to be updated every three (3) years, from the Ministry of Health (MOH) or an authorized training facility. See the BioequivTrial for information on PI and investigator rights and responsibilities. Foreign Sponsor Responsibilities No information is currently available on foreign sponsor requirements. Data and Safety Monitoring Board According to VNM-12, there are no … Go to Vietnam > Site/Investigator Selection

… DSMB and other types of safety reports in relation to the benefit/risk assessment of the study safety and subsequent protocol amendments or clarification memorandums should also be submitted to MCAZ via the Clinical Trials Registry ( ZWE-1 ). Multicenter Studies According to CTEthics , multicenter studies should be appropriate to the local setting and modifications should be made when required to suit the local conditions. It is unacceptable for developed-country participants to … Go to Zimbabwe > Site/Investigator Selection

Insurance As set forth in the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( BRA-28 ), which Brazil has adopted per ResNo945 , the sponsor is responsible for providing insurance or should indemnify the investigator/institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence. Compensation Injury or Death As specified in the LawNo14.874 and ResNo945 , the sponsor is responsible for providing compensation and health assistance to research participants who have suffered as a result of their participation in the research. ResNo945 further specifies that the sponsor is responsible for all expenses related to procedures and examinations, especially those related to diagnosis, treatment, monitoring, and hospitalization of the clinical trial participant, and should take other actions necessary to resolve adverse events related to the clinical trial. Additionally, per ResNo466 , the … Go to Brazil > Insurance & Compensation

Insurance As set forth in the NMPA-GCP-No57-2020 , the sponsor is responsible for providing the investigator and clinical trial institution with legal and economic insurance or a guarantee related to the clinical trial, which must be compatible with the nature and degree of risk of the clinical trial. This insurance should not include damage caused by the investigator and the clinical trial institution itself. The International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( CHN-37 ) guides sponsors on providing insurance. See CHN-11 for an analysis of clinical trial insurance in China. Per NMPA-No2-2015 , for insurance provided by overseas insurance companies in international multicenter clinical trials, the sponsor should ensure that participants in China can effectively and fully claim compensation, and give priority to protecting the rights and interests of participants. Compensation Injury or Death Per the Measures-Ethics , when research participants … Go to China > Insurance & Compensation

Insurance As per the G-EthicalEval , the sponsor is required to carry a valid insurance policy to cover research participants. A copy of the sponsor’s insurance policy must be submitted to the ethics committee (EC) as part of the application for ethics review of the proposed research. If the insurance policy is in a language other than French, a French translation must also be provided. Per DRC-12, insurance cover documentation must also be included in the clinical trial application to the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) of the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention) . Compensation The G-EthicalEval indicates that the principal investigator (PI) must agree to work in accordance with the Declaration of Helsinki ( DRC-11 ), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products ( … Go to DRC > Insurance & Compensation

Insurance According to GIN-17, sponsors must submit proof of insurance as part of the clinical trial application submission to the National Ethics Committee for Health Research (Comité National d’Ethique pour la Recherche en Santé (CNERS)) . Compensation Injury or Death According to the Guinea-PHC , in the event of any temporary or permanent trial-related injury or disability, the participant should be compensated. In the case of the participant’s death, the legal heirs are entitled to financial compensation. In addition, per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( GIN-7 ), which provides guidance for sponsors on providing compensation to research participants in the event of trial-related injuries or death. The sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries. Trial Participation Per GIN-7 , the participant should … Go to Guinea > Insurance & Compensation

Insurance The G-ICMR specifies that the sponsor (applicant) should provide insurance coverage or a provision in the budget for possible compensation for trial-related injuries. The G-ICMR also states that it is preferable to have the insurance certificate and the policy for study participants. Further, the policy should explain the conditions of coverage, date of commencement, and expiration date for risk coverage (if applicable). In addition, institutional mechanisms must be established to allow for insurance coverage of trial-related or unrelated illnesses (ancillary care). The 2019-CTRules states that the ethics committee (EC) also requires a copy of the insurance policy or details regarding compensation for participation and for serious adverse events (SAEs) occurring during the study as part of its submission review process. With regard to indemnity coverage, the G-ICMR states that an indemnity policy must be included in the documentation for EC review. The policy should clearly … Go to India > Insurance & Compensation

Insurance As set forth in the G-KenyaCT and the G-ECBiomedRes , the sponsor must provide insurance cover for the study participants and ensure that the clinical trial institution, contract research organization (CRO), and researchers have sufficient insurance cover for the clinical trial. Per the G-KenyaCT , the sponsor’s policies and procedures should address the treatment costs for trial participants in the event of trial-related injuries, and the sponsor should submit this information as part of the clinical trial application (see KEN-34 ). In addition, a no-fault insurance cover must be obtained for all controlled human infection studies. The International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( KEN-14 ) guides sponsors on providing insurance. Per the G-KenyaCT , research must be conducted in accordance with requirements set forth in KEN-14 . Per the G-KenyaCT , for all sponsor-initiated studies, insurance coverage must be provided by an insurer … Go to Kenya > Insurance & Compensation

… Per LBR-29, both clinical trial insurance and indemnification certificates must be included in the clinical trial application dossier in accordance with the African Vaccine Regulatory Forum (AVAREF) ’s Clinical Trial Application Checklist ( LBR-1 ). According to LBR-4 , the AVAREF was established by the World Health Organization (WHO) in 2006 to promote the harmonization of ethics and regulatory processes in Africa. In addition, per the G-LibClinTrial , under certain circumstances, the … Go to Liberia > Insurance & Compensation

Insurance As set forth in the G-CTInsurance-MWI , the G-CTAProcsVacBiol , the G-CTARevVacBiol , and the G-COMREC , the sponsor or the investigator(s) are responsible for providing insurance coverage for any unforeseen injury to research participants. Before a clinical trial begins, the sponsor should also provide insurance or indemnify the investigator and the institution against claims arising from malpractice or negligence. See the G-CTInsurance-MWI , the G-CTAProcsVacBiol , the G-CTARevVacBiol , and the G-COMREC for detailed information on when insurance is required. As per the G-CTInsurance-MWI , the sponsor or the investigator(s) must provide the participants with a no-fault insurance policy and certificate for the duration of the trial, and for five (5) years following the trial’s completion. “No-fault” is defined as insurance for which proof of negligence or other wrongful conduct need not be established. However, the causal connection between the trial and harm, bodily injury, … Go to Malawi > Insurance & Compensation

… sponsor and all involved parties, regardless of the nature of the relationship between the parties and the sponsor. Furthermore, a sponsor whose civil liability is not guaranteed by an insurance policy is at risk of being imprisoned for one (1) to six (6) months and/or fined 300,000 to 1,000,000 West African CFA francs. In addition, MLI-1 indicates that an updated and valid certificate of clinical trial insurance should be included in the application submission package (see MLI-1 for the application form). Compensation Injury or Death According to MLI-17, Mali’s ethics committees … Go to Mali > Insurance & Compensation

Insurance As set forth in COFEPRIS-GCP , the sponsor or the contract research organization (CRO) must establish a financial fund or have insurance to cover serious adverse events that result from the medication or the research study. Additionally, per COFEPRIS-GCP , which requires the sponsor or the CRO to comply with the Guideline for Good Clinical Practice E6 (R1) ( MEX-32 ), the sponsor should provide insurance or should indemnify (legal and financial coverage) the investigator/institution against claims arising from the trial, except for those claims arising from malpractice and/or negligence. Per MEX-32 , if required by the applicable regulatory requirement(s), the sponsor should provide insurance or should indemnify (legal and financial coverage) the investigator and the institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence. Compensation As specified in COFEPRIS-GCP , the sponsor or the designated CRO must establish a … Go to Mexico > Insurance & Compensation

Insurance As set forth in Decree021-2017 , the G-EC-CTRev , and PER-71 , it is a legal requirement for the sponsor or the contract research organization (CRO) to carry a valid insurance policy for the expected duration of the study for any unforeseen injury to research participants. Per Res0423-2019 , the sponsor or the CRO should sign an affidavit ( PER-51 ) guaranteeing an active insurance policy is in place according to requirements in the INS-CTManual . Decree021-2017 also specifies that the sponsor or the CRO must obtain insurance coverage in Peru or have a legal representative in Peru who will represent the sponsor or the CRO, if the policy is from a foreign company. The insurance policy must be in force until the date of submission of the National Final Report. At the end of this period, it should be renewed whenever there is still a possibility of late damages arising from the adjudication of injuries resulting from the clinical trial. Compensation Injury or Death According to … Go to Peru > Insurance & Compensation

… any risks related to a research participant being injured by an investigational product, or from any procedure deemed necessary by the protocol. The sponsor and the institution’s chief executive officer must sign the indemnity. See Appendix 1 of the G-CTInsurance-TZA for a sample agreement. Per the CT-Regs , the sponsor must also indemnify the investigator against claims arising from the trial, except for claims that arise from malpractice or negligence. The G-CTInsurance-TZA states … Go to Tanzania > Insurance & Compensation

… insurance information should be included in the study protocol and protocol summary. If not included in the protocol and research project summary, a financial/insurance agreement should be attached separately in the application package as one (1) of the documents that the ethics committee (EC) considers approved or certified (e.g., Patient Information Sheets, etc.). G-ResEthics also states that the sponsor should provide insurance or indemnify the investigator/institution against claims … Go to Thailand > Insurance & Compensation

… for clinical negligence involving investigators and participants. GBR-33 , specifically addresses the sponsor’s or the designated representative’s requirement to insure or indemnify the investigator participating in industry-sponsored Phase 1 clinical trials. The International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( GBR-113 ) also guides sponsors on providing insurance. Compensation Injury or Death As specified in the MHCTR , the sponsor or the designated representative is responsible for providing compensation to research participants and/or their legal heirs in the event of Phase 1 trial-related injuries or death. According to GBR-33 , the sponsor must have agreed with the research participant to provide compensation for injury whenever a causal relationship with participation is demonstrated. This undertaking can be … Go to United Kingdom > Insurance & Compensation

Insurance The United States (US) regulations do not require insurance. Compensation The G-IRBFAQs state that institutional policy, not Food & Drug Administration (FDA) regulation, determines whether compensation and medical treatment(s) will be offered and the conditions that might be placed on participant eligibility for compensation or treatment(s). Injury or Death According to the US-ICH-GCP , the sponsor's policies and procedures should address the costs of treatment of trial subjects in the event of trial-related injuries in accordance with the applicable regulatory requirement(s). As specified in 21CFR50 , the Pre2018-ComRule , the RevComRule , and US-ICH-GCP , for research involving more than minimal risk, participants must be informed as to whether any compensation or medical treatments are available in the event of trial-related injuries. See the Required Elements section for additional information. Trial Participation As per the FDA’s G-SbjctPayment , compensation for … Go to United States > Insurance & Compensation

Insurance According to VNM-12, there is no specific Vietnamese guidance that addresses indemnity agreements between the sponsor and the contract research organization (CRO), investigator(s), or institution(s). However, the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP ) lists an insurance contract as an essential document to be obtained by the principal investigator (PI), institution, and sponsor before conducting a clinical trial. The purpose of the insurance contract is to ensure that research participants will be compensated in the event of a trial-related injury. Compensation Injury or Death As specified in the PharmLaw-VNM , the sponsor is responsible for providing compensation to research participants in the event of trial-related injuries. The BioequivTrial also states investigators are responsible for compensating participants when an adverse event that seriously impacts the participant’s health was caused by the investigator’s violation of the research … Go to Vietnam > Insurance & Compensation

… exposed to will be different across phase I-IV trials and the type of clinical trial. The sponsor and principal investigator must provide insurance cover that will be adequate to match the risk involved in the clinical trial, but not less than $1,000 US dollars for each participant. Compensation In the case of external (foreign) sponsors, the ZWE-GCP imposes an ethical obligation to provide healthcare services that are essential to the safe conduct of the research, and the beneficial … Go to Zimbabwe > Insurance & Compensation

Quality Assurance/Quality Control As per the AU-ICH-GCP , the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. The quality management system should use a risk-based approach that includes: Identifying processes and data that are critical to ensure participant protection and the reliability of trial results during protocol development Identifying risks to critical trial processes and data Evaluating the identified risks against existing risk controls Deciding which risks to reduce and/or accept Documenting quality management activities and communicating to those involved in or affected by these activities Periodically reviewing risk control measures to ascertain whether the implemented quality management activities are effective and relevant Describing the quality management approach implemented in the trial and summarizing … Go to Australia > Risk & Quality Management

Quality Assurance/Quality Control As set forth in LawNo14.874 and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( BRA-28 ), which Brazil adopted per ResNo945 , the sponsor is responsible for the implementation and maintenance of quality assurance (QA) and quality control (QC) systems, based on standard operating procedures (SOPs), in order to ensure that research is conducted and data is generated, documented, and reported in compliance with the protocol, good clinical practices (GCP), and other applicable regulatory requirements. The sponsor is responsible for QC during each stage of data processing, with a view to ensuring its reliability and correct processing; and for maintaining the quality and integrity of research data, even if some or all functions have been transferred to a contract research organization (CRO) (clinical research representative organization (CRPO) in Brazil). Per BRA-28 , the CRO should also implement a QA/QC … Go to Brazil > Risk & Quality Management

Quality Assurance/Quality Control Per the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ), which Canada has implemented per CAN-50 , the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. Per CAN-50 , Canada implements the ICH Guidance E8(R1): General Considerations for Clinical Studies ( CAN-49 ), which provides guidance on conduct during the clinical trial. Note that per CAN-50 , Health Canada (HC) -implemented ICH guidance takes precedence over other HC guidance when they are not consistent. As indicated in CAN-52 , the quality management system should use a risk-based approach that includes: During protocol development, identifying processes and data that are critical to ensure participant protection and the reliability of trial results Identifying risks to critical trial … Go to Canada > Risk & Quality Management

… The key links and data that protect the rights and safety of participants and ensure the reliability of clinical trial results must be clearly defined when the sponsor formulates the trial plan. Risk should be considered from two (2) levels: 1) system level, such as facilities and equipment, standard operating procedures (SOPs), computerized systems, personnel, and suppliers; and 2) clinical trial level, such as trial drugs, trial design, data collection and recording, and the … Go to China > Risk & Quality Management

Quality Assurance/Quality Control The G-EthicalEval indicates that the principal investigator (PI) must agree to work in accordance with the Declaration of Helsinki ( DRC-11 ), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products ( DRC-10 ), and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( DRC-3 ). DRC-3 provides guidance for sponsors on clinical trial quality management. Per DRC-3 , the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. The quality management system should use a risk-based approach that includes: During protocol development, identify processes and data that are critical to ensure participant protection and the reliability of trial results Identify risks to critical trial processes and data Evaluate … Go to DRC > Risk & Quality Management

Quality Assurance/Quality Control Per GIN-17, Guinea is required to comply with the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( GIN-7 ), which provides guidance to sponsors on quality, data, and records management. GIN-7 indicates that the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. The quality management system should use a risk-based approach that includes: During protocol development, identifying processes and data that are critical to ensure participant protection and the reliability of trial results Identifying risks to critical trial processes and data Evaluating the identified risks against existing risk controls Deciding which risks to reduce and/or which risks to accept Documenting quality management activities and communicating to those involved in or affected by … Go to Guinea > Risk & Quality Management

Quality Assurance/Quality Control In accordance with the 2019-CTRules and the G-ICMR , the sponsor (applicant) is responsible for implementing and maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data generated, recorded, and reported in compliance with the protocol, good clinical practice (GCP) guidelines, and all applicable laws and regulations. Per 2024-CTRulesAmdt , clinical research organizations must also implement QA and QC as per well-documented SOPs, the protocol, GCP guidelines, the 2019-CTRules , and the 2024-CTRulesAmdt provisions. Monitoring Requirements Per the 2024-CTRulesAmdt , clinical research organizations must ensure that clinical trials and bioavailability or bioequivalence studies are adequately monitored and the trial or study related responsibilities transferred to it, partially or fully, by the sponsor are carried out effectively and efficiently. As per … Go to India > Risk & Quality Management

Quality Assurance/Quality Control As stated in the CTRules and the G-KenyaCT , the sponsor is responsible for maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data are generated, recorded, and reported in compliance with the protocol, the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( KEN-14 ), the STI-Regs , and other applicable regulatory requirements. QC should be applied to each stage of data handling to ensure that all data are reliable and have been correctly processed. In addition, per the STI-Regs , all persons and research institutions (i.e., sponsors) undertaking research in Kenya must ensure the highest standards and quality of research for the realization of institutional mandates and national priorities. In addition to complying with KEN-14 , the G-KenyaCT indicates QA processes should be developed to ensure: Regular and … Go to Kenya > Risk & Quality Management

Quality Assurance/Quality Control As specified in the LibCTReg and the G-LibClinTrial , the Liberia Medicines and Health Products Regulatory Authority (LMHRA) has adopted the International Council for Harmonisation (ICH)'s Guideline for Good Clinical Practice E6(R2) ( LBR-8 ) for use along with the LMHRA guidelines. Per LBR-8 , sponsors are responsible for implementing and maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data are generated, recorded, and reported in compliance with the protocol. Per LBR-8 , the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. The quality management system should use a risk-based approach that includes: During protocol development, identifying processes and data that are critical to ensure … Go to Liberia > Risk & Quality Management

… are being enrolled in a trial, on a routine basis, when triggered by a complaint, or if there is a suspicion of serious non-compliance integrity issues and/or scientific/ethical misconduct. In general, the inspectee will be notified one (1) to four (4) weeks prior to the proposed announced inspection date and asked to confirm availability. The notification will identify the study and the proposed sites to be inspected. In relation to triggered inspections, the PMRA may provide a … Go to Malawi > Risk & Quality Management

Quality Assurance/Quality Control According to MLI-17, Mali’s ethics committees (ECs) follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( MLI-7 ), which provides details on quality, data, and records management. Per MLI-7 , the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. The quality management system should use a risk-based approach that includes: During protocol development, identifying processes and data that are critical to ensure participant protection and the reliability of trial results Identifying risks to critical trial processes and data Evaluating the identified risks against existing risk controls Deciding which risks to reduce and/or which risks to accept Documenting quality management activities and communicating to those … Go to Mali > Risk & Quality Management

Quality Assurance/Quality Control According to COFEPRIS-GCP , the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) requires the sponsor or the contract research organization (CRO) to comply with the Guideline for Good Clinical Practice E6 (R1) ( MEX-32 ), and to ensure and control the quality of the research during a study. Per COFEPRIS-GCP and MEX-32 , the sponsor or the CRO is also responsible for establishing written standard operating procedures (SOPs) for each stage of the investigation. In addition, the sponsor or the CRO must implement and maintain quality assurance (QA) and quality control (QC) systems to make certain the trial is conducted, and data are generated, recorded, and reported in compliance with the protocol. MEX-32 further delineates the sponsor or the CRO is required to obtain agreement from all involved parties to ensure direct access to all trial related sites, source … Go to Mexico > Risk & Quality Management

Quality Assurance/Quality Control As stated in Decree021-2017 , the sponsor or the contract research organization (CRO) is responsible for ensuring that all the information on the investigational product (IP) and the additional documentation corresponds to the research protocol and complies with good clinical practice (GCP) as provided in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( PER-53 ), as well as the requirements established in Decree021-2017 . PER-53 further explains that the sponsor or the CRO is responsible for implementing and maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, PER-53 , Decree021-2017 , and other applicable regulatory requirements. Per Decree021-2017 , the sponsor or the CRO must sign a declaration guaranteeing that the … Go to Peru > Risk & Quality Management

Quality Assurance/Quality Control As stated in the CT-Regs and the G-AppConductCT , the Tanzanian government complies with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( TZA-13 ) requirement that the sponsor implement and maintain quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data are generated, recorded, and reported in compliance with the protocol. Per the G-EthicsHR-TZA , the investigator is responsible for documenting all steps in data management to allow a step-by-step retrospective assessment of the quality of the data and the performance of the research study. Per G-EthicsHR-TZA , during the conduct of clinical trials, deviations from the original study might occur, such as changes in the sample size or analysis of the data as described in the protocol. Deviations must be reported to ethics committees (ECs). In the case of permanent … Go to Tanzania > Risk & Quality Management

Quality Assurance/Quality Control As stated in ClinImprtOrdr , ClinSampleProd , and G-ResEthics , the sponsor is responsible for implementing and maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data are generated, recorded, and reported in compliance with the protocol and the International Council for Harmonisation (ICH)'s Guideline for Good Clinical Practice E6(R2) ( THA-28 ). Per ClinImprtOrdr , clinical trials in Thailand must comply with THA-28 . G-ResEthics and THA-28 explain that the sponsor is required to obtain agreement from all involved parties to ensure direct access to all trial related sites, source data/documents, reports for monitoring and auditing purposes, and inspection by domestic and foreign regulatory authorities. G-ResEthics and THA-28 further specify that the sponsor must also obtain the investigator(s) and the institution(s) agreement to: Conduct the … Go to Thailand > Risk & Quality Management

Quality Assurance/Quality Control The NDPA-CTReg states that the sponsor should maintain quality assurance and quality control systems for the conduct of clinical trials and for the generation of documentation, recording, and reporting of data. The G-TrialsGCP indicates that the sponsor is also responsible for implementing the systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, good clinical practice (GCP), and the applicable regulatory requirement(s). Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly. According to the G-TrialsGCP , the sponsor should implement a quality management system throughout all stages of the trial process, and should focus on the trial activities essential to ensuring participant protection and the reliability of trial results. The quality … Go to Uganda > Risk & Quality Management

… after the MHRA notification. Notifications should primarily be sent to the following email address: GCP.SeriousBreaches@mhra.gov.uk . Per the G-RiskAssmt , MHRA recommends that a risk assessment is undertaken for all clinical trials. Phase 1 trials are required to have a documented risk assessment process and to produce a risk assessment for all proposed trials. The risk assessment should be done as early as possible to help the sponsor identify whether the sponsor wishes to proceed … Go to United Kingdom > Risk & Quality Management

Quality Assurance/Quality Control Per the US-ICH-GCP , the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. The quality management system should use a risk-based approach that includes: During protocol development, identify processes and data that are critical to ensure participant protection and the reliability of trial results Identify risks to critical trial processes and data Evaluate the identified risks against existing risk controls Decide which risks to reduce and/or which risks to accept Document quality management activities and communicate to those involved in or affected by these activities Periodically review risk control measures to ascertain whether the implemented quality management activities are effective and relevant In the clinical study report, describe the quality management approach implemented in the … Go to United States > Risk & Quality Management

Quality Assurance/Quality Control As stated in the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP ), the sponsor is responsible for assigning a monitor to assist in maintaining a quality assurance (QA) system with written standard operating procedures (SOPs) that ensure trials are conducted and data are generated, recorded, and reported in compliance with the protocol. In addition, the quality management system applied in clinical trials must meet International Organization for Standardization (ISO) 9001-equivalent standards or higher. Per the BioequivTrial , the principal investigator (PI) is responsible for ensuring the accuracy, truthfulness, confidentiality, integrity, and verifiability of the research data. Correction of data must be in accordance with applicable regulations, which indicate that the original data should not be deleted, and the assigned researcher must record their name, sign for confirmation, and specify the date of correction. The lead … Go to Vietnam > Risk & Quality Management

… the relevant institution(s), the review body(ies) that approved the research and, wherever possible, the research participants, if the research project is to be discontinued before the expected date of completion. For research at more than one (1) site, or research where there have been multiple ethical reviews, it must be clearly established, before the research begins, how this information will be communicated. … Go to Zimbabwe > Risk & Quality Management

Electronic Data Processing System When using electronic trial data handling systems, the sponsor must ensure and document that the electronic data processing system conforms to its established requirements for completeness, accuracy, reliability, and consistent intended performance, and that standard operating procedures (SOPs) are maintained for using these systems. Refer to the AU-ICH-GCP for additional information. The Therapeutic Goods Administration (TGA) has adopted the United States Food & Drug Administration (FDA) ’s Use of Electronic Health Record Data in Clinical Investigations - Guidance for Industry ( AUS-82 ). For more information, see AUS-82 . Records Management According to the G-CodeConduct and the G-DataInfoMgt , institutions must provide access to facilities for the safe and secure storage and management of research data, records, and primary materials. The G-DataInfoMgt requires that institutional policy include guidance for managing research data and primary … Go to Australia > Data & Records Management

Electronic Data Processing System As set forth in the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( BRA-28 ), which Brazil has adopted per ResNo945 , when using electronic trial data processing systems, the sponsor must ensure that the system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. To validate such systems, the sponsor should use a risk assessment approach that takes into consideration the system’s intended use and potential to affect human participant protection and reliability of trial results. In addition, the sponsor must maintain standard operation procedures (SOPs) that cover system setup, installation, and use. The SOPs should describe system validation and functionality testing, data collection and handling, system maintenance, system security measures, change control, data backup, recovery, contingency planning, and decommissioning. The … Go to Brazil > Data & Records Management

Electronic Data Processing System Per the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ), which Canada has implemented per CAN-50 , when using systems for electronic trial data handling, the sponsor must ensure and document that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. To validate such systems, the sponsor should use a risk assessment approach that takes into consideration the system’s intended use and potential to affect human subject protection and reliability of trial results. In addition, the sponsor must maintain standard operation procedures (SOPs) that cover system setup, installation, and use. The SOPs should describe system validation and functionality testing, data collection and handling, system maintenance, system security measures, change control, data backup, recovery, contingency … Go to Canada > Data & Records Management

Electronic Data Processing System Per the NMPA-GCP-No57-2020 , the sponsor must meet the following requirements in electronic data processing during clinical trials: Select qualified personnel to supervise data processing, data verification, statistical analysis, and the writing of trial summary reports Use an electronic data management system that passes reliable system verification and meets the pre-set technical performance to ensure the integrity, accuracy, and reliability of the test data, and to ensure that the system is always valid for verification during the entire test process Have complete standard operating procedures (SOPs) that cover the setup, installation, and use of electronic data management; the SOPs must describe the verification, functional testing, data collection and processing, system maintenance, system safety, testing, change control, data backup, recovery, and system emergency plans Ensure the SOPs cover the responsibilities and training of sponsors, … Go to China > Data & Records Management

Electronic Data Processing System The G-EthicalEval indicates that the principal investigator (PI) must agree to work in accordance with the Declaration of Helsinki ( DRC-11 ), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products ( DRC-10 ), and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( DRC-3 ). DRC-3 provides guidance for sponsors on clinical trial data and records management. As per DRC-3 , when using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. The sponsor should base their approach to validate such systems on a risk assessment that takes into consideration the intended use and the potential of the system to affect participant protection and reliability of trial results. In … Go to DRC > Data & Records Management

Electronic Data Processing System According to GIN-17, Guinea is required to comply with the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( GIN-7 ). As per GIN-7 , when using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. The sponsor should base their approach to validate such systems on a risk assessment that takes into consideration the intended use and the potential of the system to affect participant protection and reliability of trial results. In addition, the sponsor should maintain standard operating procedures (SOPs) for the systems that cover system setup, installation, and use. The responsibilities of the sponsor, investigator, and other parties should be clear, and the system users should be provided with training. Refer to GIN-7 for … Go to Guinea > Data & Records Management

Electronic Data Processing System No information is currently available on electronic data processing systems. Records Management Per the 2019-CTRules , the sponsor (applicant) must keep a record of new drugs manufactured and persons to whom the drugs have been supplied for clinical trial or bioavailability and bioequivalence study or for examination, testing, and analysis. The licensed sponsor must also maintain records of any imported new drug or substance that indicates the quantity of drug imported, used, and disposed of in any manner including related documentation. In addition, per the 2024-CTRulesAmdt , clinical research organizations must accurately maintain complete data, documentation, and other related records (written documents, electronic, magnetic or optical records, scans, etc.). This includes checking and ensuring the essential documents required for the conduct of the trial are properly maintained by the investigators. All documentation and communication must be … Go to India > Data & Records Management

Electronic Data Processing System Per the G-KenyaCT , research must be conducted in accordance with requirements set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( KEN-14 ). As per KEN-14 , when using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. Per KEN-14 , the sponsor should base their approach to validate such systems on a risk assessment that takes into consideration the intended use and the potential of the system to affect participant protection and reliability of trial results. In addition, the sponsor should maintain standard operating procedures (SOPs) for the systems that cover setup, installation, and use. The responsibilities of the sponsor, investigator, and other parties should be clear, and the system users should be … Go to Kenya > Data & Records Management

Electronic Data Processing System Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( MWI-22 ). As per MWI-22 , when using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. The sponsor should base their approach to validate such systems on a risk assessment that takes into consideration the intended use and the potential of the system to affect participant protection and reliability of trial results. In addition, the sponsor should maintain standard operating procedures (SOPs) for the systems that cover system setup, installation, and use. The responsibilities of the sponsor, investigator, and other parties should be clear, and the system users should be provided with training. Refer to MWI-22 for … Go to Malawi > Data & Records Management

Electronic Data Processing System According to MLI-17, Mali’s ethics committees (ECs) follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( MLI-7 ). Per MLI-7 , when using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. The sponsor's approach to validating such systems should be based on a risk assessment that takes into consideration the intended use and the potential of the system to affect participant protection and reliability of trial results. In addition, the sponsor should maintain standard operating procedures (SOPs) for the systems that cover system setup, installation, and use. The responsibilities of the sponsor, investigator, and other parties should be clear, and the system users should be provided … Go to Mali > Data & Records Management

Electronic Data Processing System According to COFEPRIS-GCP , the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) requires the sponsor or the contract research organization (CRO) to comply with the Guideline for Good Clinical Practice E6 (R1) ( MEX-32 ) for conducting clinical trials. Per MEX-32 , the sponsor should utilize appropriately qualified individuals to supervise the overall conduct of the trial, to handle the data, to verify the data, to conduct the statistical analyses, and to prepare the trial reports. In addition, per MEX-32 , when using electronic trial data processing or handling systems or remote electronic trial data systems, the sponsor should: Ensure and document that the electronic data processing system(s) conform(s) to the sponsor's established requirements for completeness, accuracy, reliability, and consistent intended performance Maintain standard operating procedures … Go to Mexico > Data & Records Management

Electronic Data Processing System No information is currently available. Records Management As set forth in Decree021-2017 , the sponsor or the contract research organization (CRO) is required to possess a documented monitoring record, including the provision of specially selected and specialized personnel (monitors). Additionally, the sponsor or the CRO is responsible for filing in the country all documentation and data obtained for at least 10 years after the conclusion of the study. After two (2) years, the documentation/data may be filed electronically, after communication with the National Institute of Health (Instituto Nacional de Salud (INS)) . Per Decree021-2017 , Peru also complies with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( PER-53 ), which provides guidance to sponsors on records management. PER-53 further specifies that sponsor-specific essential documents should be retained until at least two (2) years after the last … Go to Peru > Data & Records Management

Electronic Data Processing System Per the SA-GCPs , the sponsor must ensure that the electronic data processing system conforms to the specific documented requirements for completeness, accuracy, reliability, and consistency of intended performance, and that standard operating procedures for using these systems are maintained. In addition, the sponsor must: Ensure that the systems are designed to document data changes without deleting previously entered data (i.e., maintain an audit trail) Maintain a security system that prevents unauthorized access to the data Maintain a register of persons authorized to make data changes Maintain adequate data backup Ensure that blinding, if any, is maintained during data entry and processing Ensure the integrity and confidentiality of data, including any that describe the context, content, and structure of the data – especially when making changes to computerized systems If data are transformed during processing, it must be possible to compare the … Go to South Africa > Data & Records Management

Electronic Data Processing System As stated in the CT-Regs and the G-AppConductCT , the Tanzanian government complies with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( TZA-13 ). As per TZA-13 , when using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. Per TZA-13 , the sponsor should base their approach to validate such systems on a risk assessment that takes into consideration the intended use and the potential of the system to affect participant protection and reliability of trial results. In addition, the sponsor should maintain standard operating procedures (SOPs) for the systems that cover system setup, installation, and use. The responsibilities of the sponsor, investigator, and other parties should be clear, and the system users should be … Go to Tanzania > Data & Records Management

Electronic Data Processing System To safeguard personal data within electronic health record (EHR) systems, G-EHRAccess provides guidance on updating these systems to ensure access by sponsors and their representatives (e.g., monitors and investigators) is limited to only the records of clinical trial participants and that this access is auditable. See G-EHRAccess for details on system security, remote access, document sharing, consent, and other considerations. According to GBR-113 , when using electronic trial data handling processing systems, the sponsor must ensure and document that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. To validate such systems, the sponsor should use a risk assessment approach that takes into consideration the system’s intended use and potential to affect human participant protection and reliability of trial results. In addition, … Go to United Kingdom > Data & Records Management

Electronic Data Processing System Per the US-ICH-GCP , when using electronic trial data handling processing systems, the sponsor must ensure and document that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. To validate such systems, the sponsor should use a risk assessment approach that takes into consideration the system’s intended use and potential to affect human subject protection and reliability of trial results. In addition, the sponsor must maintain standard operating procedures (SOPs) that cover system setup, installation, and use. The SOPs should describe system validation and functionality testing, data collection and handling, system maintenance, system security measures, change control, data backup, recovery, contingency planning, and decommissioning. With respect to the use of these computerized systems, the responsibilities of the sponsor, … Go to United States > Data & Records Management

Electronic Data Processing System According to the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP ), when using electronic trial data processing systems, the sponsor should use appropriate data handling programs and have adequate standard operating procedures (SOPs) for these systems. In addition, per the ClinDrugTrialGCP , the research institution’s general documentation must include a brief description of any electronic document system in its technical and professional standards, if applicable. Records Management As per the BioequivTrial , all information on clinical trials must be recorded, handled, managed, and kept in accordance with applicable regulations in order to accurately report, interpret, monitor, and check the accuracy and reliability of clinical trial information and data. Research institution facilities for storing clinical trial records and documents must ensure confidentiality; restricted access; fire and explosion prevention and control; and … Go to Vietnam > Data & Records Management

Electronic Data Processing System As indicated in the ZWE-GCP , the clinical trial should use error-free data processing programs with adequate user documentation. Adequate security and protection should be provided in the computer system for the accuracy of the data entered into the database. Any printout of the data, as well as duplicates, must be signed and dated. Procedures for corrections made at data entry, as well as documentation of corrections in the audit records, should be provided for the electronic data processing and management system or for the network system for remote data entry. Standard operating procedures (SOPs) should be maintained for using electronic systems and cover system setup, installation, and use. The SOPs should describe system validation and functionality testing, data collection and handling, system maintenance, system security measures, change control, data backup, recovery, contingency planning, and decommissioning. The responsibilities of the … Go to Zimbabwe > Data & Records Management

… generally allow an individual to access information held about them. According to the PrivacyAct , agencies and organizations as defined in the PrivacyAct must comply with the Act and the Australian Privacy Principles (APP), found in Schedule 1, and are referred to as APP entities. Data Protection Per the PrivacyAct ’s APP, an APP entity must have a clearly expressed and up-to-date policy about the management of personal information by the entity. Individuals must have the option of … of personal information privacy; the collection of personal information; dealing with personal information; the integrity of personal information; and access to, and correction of, personal information. For the full list of APP, see Schedule 1 of the PrivacyAct . Additionally, see the Office of the Australian Information Commissioner (OAIC) ’s guidelines on the APP ( G-APP ) for more information. Consent for Processing Personal Data The PrivacyAct ’s APP indicate that if an APP entity … was collected for a particular purpose, the entity must not use or disclose the information for another purpose unless consent is obtained from the individual. There are limited exceptions to this requirement, which can be found in Schedule 1 of the PrivacyAct . AUS-70 notes that in certain circumstances, the PrivacyAct permits the handling of health information and personal information for health and medical research purposes, where it is impracticable for researchers to obtain … Go to Australia > Personal Data Protection

… to its use. They can be given the option to withdraw and also have their data withdrawn, or to withdraw but state that they will allow their data to be used. If a focus group is being carried out, it will not be possible to withdraw one (1) participant’s data following the intervention without removing the data for all the participants, because what one (1) participant says will affect the responses from others. It must be made clear on the participant information sheet that it will not be possible to withdraw data in this case. … Go to Bangladesh > Personal Data Protection

… LGPD . CD-ANPD-No15 , which defines a security incident as any confirmed adverse event, related to the violation of the confidentiality, integrity, availability, and authenticity properties of personal data security, and involves at least one (1) of the following criteria: Sensitive personal data Data on children, adolescents, or elderly people Financial data Authentication data in systems Data protected by legal, judicial, or professional secrecy Large-scale data Per CD-ANPD-No15 , the … Consent for Processing Personal Data of Children/Adolescents Per the LGPD , the processing of personal data of children and adolescents must be carried out in their best interest with specific and highlighted consent given by at least one (1) of the parents or the legal guardian. However, the sponsors are permitted to collect personal data from children without the consent of a parent or legal guardian when collection is necessary to contact the parent or legal guardian, used only once and without storage, or for their protection, and in no case may be passed on to a third party without the consent of at least one (1) parent or the legal guardian. The sponsor must make all reasonable efforts to verify that the consent was given by the individual responsible for the child, considering the available technologies. Additionally, information on the processing of … Go to Brazil > Personal Data Protection

… China for people located within the country. In addition, the PIPL and the DataSec-Regs apply to data processing activities conducted outside of China involving personal information of people located in China under the following circumstances: (1) where the processing is for the purposes of providing products or services to individuals located in China, (2) where the processing is for analyzing and evaluating the behavior of individuals located in China, or (3) other circumstances … personal information and important data, they must agree upon their respective rights and obligations. Per the PIPL and the DataSec-Regs , to send personal information outside of China, the personal information processor must meet one (1) of the following conditions (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements): Pass the security assessment organized by the national cybersecurity and … The CAC-No11-2022 states that data export activities that have already been conducted before the implementation of CAC-No11-2022 are noncompliant and must be rectified within six (6) months of the effective date of CAC-No11-2022 (i.e., by March 1, 2023). See the CAC-No11-2022 for additional details on conducting the data export security assessment, the provincial inspections, appeal procedures, and CAC’s review actions and timeline. Consent for Processing Personal Data Per the PIPL , … Go to China > Personal Data Protection

Responsible Parties As per the DigiCode , the data controller is a natural or legal person, public authority, agency, or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data. The representative of the data controller is a natural or legal person permanently established in the territory of the country, who replaces the data controller in fulfilling the obligations provided for in the DigiCode . Additionally, the data controller must appoint a data protection officer to ensure that any processing of personal data is not likely to infringe on the rights and freedoms of the data subjects. The data protection officer is responsible for ensuring, in an independent manner, the internal application of the provisions of the DigiCode , and for keeping a register of the processing carried out by the data controller. Additionally, the DigiCode provides for the establishment of the Data Protection Authority (APD), which will be … Go to DRC > Personal Data Protection

Responsible Parties For the purposes of data protection regulation in India, the ITAct , the ITActAmend , and the IT-SPDIRules delineate responsibilities of the “body corporate.” The body corporate as defined by the ITAct , the ITActAmend , and the IT-SPDIRules refers to any company including a firm, sole proprietorship, or other association of individuals engaged in commercial or professional activities. The IT-SPDIRules further explains that the body corporate or any person on its behalf is the entity responsible for collecting, receiving, possessing, storing, dealing with, or handling personal information, including sensitive personal data and information. Data Protection Data protection in India is currently regulated by the ITAct , the ITActAmend , and the IT-SPDIRules . Per the IT-SPDIRules , the body corporate must provide a privacy policy for the handling of or dealing with personal information including sensitive personal data or information. The IT-SPDIRules specifies that … Go to India > Personal Data Protection

Responsible Parties The DPA delineates that the “data controller” determines the purpose and means of processing personal data. The "data processor" processes personal data on behalf of the data controller. Data controllers and processors must be registered with the Kenya Data Commissioner. Per the DataProtect , an application for registration of a data controller or data processor must be on Form DPR1 (found in the First Schedule of DataProtect ) with supporting materials and the required registration fees as specified in the Second Schedule. See the DataProtect for additional details on registration requirements. Data Protection Per the DPA , the data controller (sponsor) must ensure that personal data is: Processed in accordance with the right to privacy of the data subject Processed lawfully, fairly, and in a transparent manner in relation to any data subject Collected for explicit, specified, and legitimate purposes and not further processed in a manner incompatible with those … Go to Kenya > Personal Data Protection

… when acquired personally or directly from its owner. Whether tacit or express, the consent process must be: Free: without error, bad faith, violence, or intent, which may affect the manifestation of the owner’s will Specific: referring to one (1) or more specific purposes that justify the treatment, and Informed: the owner has knowledge of the privacy notice prior to granting consent to the processing of their data The sponsor must obtain the owner’s express consent when their data is … Go to Mexico > Personal Data Protection

Responsible Parties Law29733 provides that the “person in charge of the personal data bank” is any natural person, private legal entity, or public entity that, alone or acting in conjunction with another, performs the processing of personal data on behalf of the personal data bank owner. Law1353 and Decree016-2024 modify the definition provided by Law29733 stating that the entity “responsible for processing personal data” is any natural person, private legal entity, or public entity that, alone or acting jointly with another, performs the processing of personal data on behalf of the data controller or personal data bank owner by virtue of a legal relationship that binds him to it and defines the scope of its performance. RegDir294-2020 (approved by Res688-2020 ), similarly defines the “holder of the personal data bank” as the natural person, private legal person or public entity, responsible for determining the purpose and content of the personal data bank, its treatment and the … Go to Peru > Personal Data Protection

… for information or access Conduct internal awareness sessions on protection of personal information requirements Provide reasonable assistance free of charge to the data subject in objecting to processing of personal information (using Form 1 in the POPIA-Regs ) and/or correcting or revising a record of personal information (using Form 2 in the POPIA-Regs ) The POPIA provides that records of personal information for research may be retained longer than is necessary for achieving the … Personal Data of Minors Per the POPIA , there is a general prohibition on the processing of personal information of a minor. However, a responsible party may process personal information concerning a minor if the processing meets one (1) of the following conditions: It is carried out with the prior consent of a competent person It is necessary for the establishment, exercise, or defense of a right or obligation in law It is necessary to comply with an obligation of … Go to South Africa > Personal Data Protection

… accurate, up-to-date, complete, and not misleading. Personal data collection must be limited to the extent necessary in relation to the lawful purpose of the data controller. The data controller’s purpose for collecting data must meet one (1) of the purposes specified in the PDPA in order to be permitted to collect personal data, with the data subject’s explicit consent (see Section 23 of PDPA for details). PDPA further specifies that personal data includes health and genetic data … Go to Thailand > Personal Data Protection

Responsible Parties As per the NITA-U-PrivAct , the data controller determines the purposes for and the manner in which personal data is processed or is to be processed. The “data processor” processes personal data on behalf of the data controller. Data controllers and processors must be registered with the Personal Data Protection Office (PDPO) of the National Information Technology Authority - Uganda (NITA-U) . See the NITA-U-PrivAct , the NITA-U-PrivReg , and the PDPO-Note for detailed registration requirements. Data Protection As per the NITA-U-PrivAct , a data controller or processor must: Be accountable to the data subject for data collected, processed, held, or used Collect and process data fairly and lawfully Collect, process, use, or hold adequate, relevant, and not excessive or unnecessary personal data Retain personal data for the period authorized by law or for which the data is required Ensure quality of information collected, processed, used, or held Ensure transparency … Go to Uganda > Personal Data Protection

Responsible Parties For purposes of data protection requirements, the UK-GDPR the UK-DPAct , and the G-GDPR delineate the following responsible parties (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements): Controller – the natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data Processor – a natural or legal person, public authority, agency or other body which processes personal data on behalf of the controller Recipient – a natural or legal person, public authority, agency or another body, to which the personal data are disclosed, whether a third party or not; however, public authorities which may receive personal data in the framework of a particular inquiry in accordance with domestic law must not be regarded as recipients Third party – a natural or legal person, public authority, agency, or … Go to United Kingdom > Personal Data Protection

… a CoC for a study should be resolved by communications among the parties. See the G-CertCnfdntlty for more information on CoCs. 28CFR202 prohibits certain data transactions that involve giving a country of concern or covered person access to: 1) bulk US sensitive personal data that involves bulk human ‘omic data; or 2) to human biospecimens from which bulk human ‘omic data could be derived. Human ‘omic data includes human genomic data, human epigenomic data, human proteomic data, and … more information on countries of concern, exempt transactions, and reporting requirements. NIH Privacy Requirements The NIHPrvcy indicates that the HHS’ National Institutes of Health (NIH) follows the PrvcyAct , which includes procedures for: 1) protecting records that can be retrieved by personal identifiers such as a name, social security number, or other identifying number or symbol, and 2) persons to access their identifiable records and to request correction(s) of these records. … to use and disclose PHI for research with individual authorization, or without individual authorization under limited circumstances. To use or disclose PHI without authorization by the research participant, a covered entity must obtain one (1) of the following: Documented EC or privacy board approval Representations from the researcher that the use or disclosure of the PHI is solely to prepare a research protocol (or for similar purposes preparatory to research), the researcher will … Go to United States > Personal Data Protection

… or through another action that demonstrates consent. When there are multiple purposes for the data collection, the personal data controller/personal data controller and processor must list the purposes for the data subject to agree to one (1) or more of the stated purposes, and consent must be given for each purpose. The data subject’s consent must be expressed in a format that can be printed or reproduced in writing, including in electronic or verifiable formats. Silence or … Go to Vietnam > Personal Data Protection

… country is prohibited unless an adequate level of protection is ensured in the recipient country or international organization. If an adequate level of protection is not assured, the transfer of such information is permissible where one (1) of the following instances takes place: The data subject has unambiguously given their consent to the proposed transfer The transfer is necessary for the performance of a contract between the data subject and the controller or the … Go to Zimbabwe > Personal Data Protection

Obtaining Consent In all Bangladeshi clinical trials, a freely given informed consent is required to be obtained from each participant in accordance with the requirements set forth in the BGD-GCP and the G-BMRC . As per the G-BMRC , BGD-22 , BGD-15 , and BGD-16 , the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by the Bangladesh Medical Research Council (BMRC) ’s National Research Ethics Committee (NREC) and provided to the Ministry of Health and Family Welfare (MOHFW) ’s Directorate General of Drug Administration (DGDA) with the clinical trial application. The BGD-GCP further indicates that the investigator should have the written approval/favorable opinion from an ethics committee (EC) (referred to as an independent ethics committee (IEC)/institutional review board (IRB) in Bangladesh) of the written informed consent form and any other written information to be provided to participants. The BGD-GCP states that in obtaining and … Go to Bangladesh > Documentation Requirements

Obtaining Consent In all Brazilian clinical trials, a freely given informed consent is required to be obtained from each participant in accordance with the requirements set forth in LawNo14.874 and ResNo466 . Per LawNo14.874 and OMREC , the informed consent form (ICF) is known as the Free and Informed Consent Form (Termo de Consentimento Livre e Esclarecido (TCLE)) in Brazil. As per LawNo14.874 , the ResNo466 , and OMREC , the ICF is viewed as an essential document that must be reviewed and approved by a research ethics committee (EC) (Comitê de Ética em Pesquisa (CEP)). CLNo51 further clarifies that the ICF should be written as an invitation rather than as a statement as this may reduce the participant’s autonomy. Refer to CLNo51 for detailed information. See the Required Elements section for details on contents to be included in the form. LawNo14.874 , OMREC , and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( BRA-28 ), which Brazil … Go to Brazil > Documentation Requirements

Obtaining Consent In all Canadian clinical trials, a freely given informed consent is required from each participant in accordance with the requirements set forth in the CanadaFDR , the G-TCPS2 , CAN-35 , and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ), which Canada has implemented per CAN-50 . Note that per CAN-50 , Health Canada (HC) -implemented ICH guidance takes precedence over other HC guidance when they are not consistent. For HC’s interpretation of the relevant provisions of the CanadaFDR , see the G-FDR-0100 . As per the CanadaFDR , the G-TCPS2 , and CAN-52 , the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by an institutional ethics committee (EC) (known as a Research Ethics Board (REB) in Canada) and provided to HC with the clinical trial application (CTA). (See the Required Elements section for details on what should be included in the form.) The G-TCPS2 and … Go to Canada > Documentation Requirements

… a vaccine clinical trial, the investigator is required to obtain a signed ICF from the participant or legal representative/guardian. (Note that per SC-Order777 and NHC-HGRmgt , management of HGR was transferred from MOST to NHC, effective May 1, 2024). The NMPA-GCP-No57-2020 , the Measures-Ethics , and CHN-37 state that the investigator, or a person designated by the investigator, must provide detailed research study information to the participant or the legal representative/guardian. … Go to China > Documentation Requirements

Obtaining Consent For any biomedical research involving humans in the Democratic Republic of the Congo (DRC), the investigator must obtain the free and informed consent of the prospective participant in accordance with the requirements set forth in the G-EthicalEval , the Declaration of Helsinki ( DRC-11 ), the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( DRC-3 ), and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products ( DRC-10 ). As per the G-EthicalEval and DRC-3 , the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by an ethics committee (EC). The G-EthicalEval further states that when reviewing the informed consent process, the EC should review the arrangements for receiving and responding to requests and complaints from research participants or their representatives during the course of a study. (See the Required Elements … Go to DRC > Documentation Requirements

Obtaining Consent In all Guinean clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in the Guinea-PHC . According to GIN-5 and GIN-6 , the informed consent form (ICF) must be reviewed and approved by the National Ethics Committee for Health Research (Comité National d’Ethique pour la Recherche en Santé (CNERS)) with the clinical trial application. Per GIN-5 , CNERS should also review modifications/amendments to the ICF and the assent form. (See the Required Elements section for details on what should be included in the form.) Per the Guinea-PHC , investigator(s) must provide detailed research study information to the participant or legal representative/guardian. The ICF content should be presented in a manner that is easy to understand and without coercion or unduly influencing a potential participant to enroll in the clinical trial. Per GIN-17, Guinea is required to comply with the International … Go to Guinea > Documentation Requirements

… must also be supplied to the Central Drugs Standard Control Organization (CDSCO) ’s Drugs Controller General of India (DCGI), prior to the trial’s initiation. The ICF and patient information sheet are ultimately integrated into one (1) document referred to as the ICF. (See the Required Elements section for details on what should be included in the form.) The 2019-CTRules , the G-ICMR , and the G-Children specify that investigator(s) should provide detailed study information … Go to India > Documentation Requirements

Obtaining Consent In all Kenyan clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in the CTRules , the G-KenyaCT , the G-ECBiomedRes , and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( KEN-14 ). (Per the G-KenyaCT , research must be conducted in accordance with the requirements set forth in KEN-14 .) The informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by a National Commission for Science, Technology and Innovation (NACOSTI) -accredited institutional ethics committee (EC). The ICF must be provided to the Pharmacy and Poisons Board (PPB) with the clinical trial application. (See the Required Elements section for details on what should be included in the form.) The CTRules , the G-KenyaCT , and the G-ECBiomedRes state that the investigator, or the designated representative, must provide detailed research study … Go to Kenya > Documentation Requirements

… is required. Documenting Consent The LibCTReg states that if the trial participant is unable to read or write English, the informed consent should be obtained in the language the participant understands and in the presence of at least one (1) witness. The witness, who should be able to read and write English and understand the local language in which the trial participant is informed, should not be a member of the investigating team. The consent given by the trial participant must … Go to Liberia > Documentation Requirements

… Clinical Practice E6(R2) ( MWI-22 ). As per the G-NHSRC , the G-CTAProcsVacBiol , the G-CTARevVacBiol , the G-COMREC , and MWI-22 , the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by one (1) of the two (2) National Commission for Science and Technology (NCST) -approved ethics committees (ECs)—the National Health Sciences Research Committee (NHSRC) and the College of Medicine Research and Ethics Committee (COMREC)—and provided to … Go to Malawi > Documentation Requirements

Obtaining Consent In all Malian clinical trials, a freely given, written informed consent is required to be obtained from each participant in accordance with the principles set forth in LawNo09-059 and DecreeNo2017-0245 . In addition, DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to MLI-17, Mali’s ethics committees (ECs) follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( MLI-7 ). As per the FMPOS-USTTB-ECProcs , DecreeNo2017-0245 , and MLI-7 , the informed consent form (ICF) and patient information sheet(s) are essential documents that must be reviewed and approved by the EC and provided to the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) for approval with the clinical trial application. (See the Required Elements section for details on what should be included in the form.) LawNo09-059 , … Go to Mali > Documentation Requirements

Obtaining Consent In all Mexican clinical trials, a freely given informed consent is required from each participant in accordance with the requirements set forth in HlthResRegs , GenHlthLaw , NOM-004-SSA3-2012 , and COFEPRIS-GCP . Per COFEPRIS-GCP , the principal investigator (PI) is required to comply with the Guideline for Good Clinical Practice E6 (R1) ( MEX-32 ) in obtaining and documenting informed consent, and per G-RECs-Op-2018 , the PI must also comply with consent requirements as delineated in the Declaration of Helsinki ( MEX-76 ). (Note: Per MEX-2 , the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) is in the process of implementing the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( MEX-22 )). As per HlthResRegs and G-RECs-Op-2018 , the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by a Research … Go to Mexico > Documentation Requirements

Obtaining Consent In all Peruvian clinical trials, a freely given informed consent must be obtained from each participant in accordance with the principles set forth in Law26842 , Decree021-2017 , the G-EC-CTRev , and the Declaration of Helsinki ( PER-76 ). Decree011-2011 further states that all scientific and technological research and applications will be developed with respect for the prior, free, express, and informed consent of the person concerned, based on adequate information. Consent in such terms implies the recognition of the patient's right to be treated as a free person and capable of making their own decisions. Per Decree021-2017 and the G-EC-CTRev , the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by an INS-registered institutional ethics committee (EC) (El Comité Institucional de Ética en Investigación (CIEI)) and provided to the INS with the clinical trial application. PER-83 further specifies that the sponsor or … Go to Peru > Documentation Requirements

… representatives from their liabilities for any negligence. THA-13 provides informed consent documentation guidelines required by the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH) , which is one (1) of the institutional ECs approved by the Thai FDA. As noted in THA-34 , the Central Research Ethics Committee (CREC) does not have its own ICF template and directs investigators to the template provided by the Forum for Ethical Review … Go to Thailand > Documentation Requirements

Obtaining Consent In all United Kingdom (UK) clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in the MHCTR , the MHCTR2006 , and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( GBR-113 ). As per the MHCTR , the MHCTR2006 , and GBR-9 , the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by an ethics committee (EC) recognized by the United Kingdom Ethics Committee Authority (UKECA) (henceforth referred to as a “recognized EC”) and operating according to standard operating procedures ( GBR-9 ) issued by England’s Health Research Authority (HRA) .) Refer to GBR-18 and GBR-69 for more on informed consent in the UK. The MHCTR and G-ConsentPIS , state that the investigator(s) must provide detailed research study information to the participant or legal representative/guardian. The MHCTR and G-ConsentPIS also specify … Go to United Kingdom > Documentation Requirements

… the RevComRule and FDA regulations. (See the Required Elements section for ICF content details.) Per the RevComRule , which took effect January 21, 2019, for each clinical trial conducted or supported by a federal department or agency, one (1) EC-approved ICF used to enroll subjects must be posted by the awardee or the federal department or agency component conducting the trial on a publicly available federal website that will be established as a repository for such ICFs. According … Go to United States > Documentation Requirements

Obtaining Consent In all Vietnamese clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in the ClinDrugTrialGCP , the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP ), and the PharmLaw-VNM . As per the ClinDrugTrialGCP and the BioequivTrial , the informed consent form (ICF) is viewed as an essential document that must be sent to the Ministry of Health (MOH) ’s Administration of Science, Technology and Training (ASTT) as part of the clinical trial study approval dossier, for which the Minister must issue final approval. The ECReg indicates that a research proposal involving humans, including the ICF, must undergo ethical and scientific review by the MOH’s National Ethics Committee in Biomedical Research (NECBR) and an institutional level ethics committee (EC) (known as a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs)). The BioequivTrial states that the principal … Go to Vietnam > Documentation Requirements

… the participant’s participation in the trial The approximate number of participants involved in the trial and criteria for selection of participants The source of the investigational product (IP) that may be culturally unacceptable See Annexure 1 of the BGD-GCP for an ICF template. See Annexure A of the IRB-Manual , the Bangladesh Medical Research Council (BMRC) ’s guidance for institutional ECs, for an example of an ICF in both Bengali and English. Compensation Disclosure As set forth … Go to Bangladesh > Required Elements

The G-EthicalEval indicates that the principal investigator must agree to work in accordance with the Declaration of Helsinki ( DRC-11 ), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products ( DRC-10 ), and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( DRC-3 ). DRC-3 provides guidance on the elements to include in the informed consent form (ICF) and states that information about the research study should be clearly presented in both written and oral form. The G-EthicalEval and DRC-3 state that before seeking the consent of a person to participate in research, the investigator must indicate the following to the person using language or any other form of intelligible communication (Note: the sources provide overlapping and unique elements so each of the items listed below will not necessarily be in each): That the person is invited to participate in the research as a subject, … Go to DRC > Required Elements

Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( GIN-7 ), which provides guidance on the elements to include in the informed consent form (ICF). As described in GIN-7 , both the informed consent discussion and the written ICF and any other written information to be provided to participants should include explanations of the following: The trial involves research The purpose of the trial The trial treatment(s) and the probability for random assignment to each treatment The trial procedures to be followed, including all invasive procedures The participant’s responsibilities Those aspects of the trial that are experimental The reasonably foreseeable risks or inconveniences to the participant and, when applicable, to an embryo, fetus, or nursing infant The reasonably expected benefits. When there is no intended clinical benefit to the participant, the participant should be made aware of this. The … Go to Guinea > Required Elements

Per the 2019-CTRules , the G-ICMR , and the G-Children , the informed consent form (ICF) should include the following statements or descriptions, as applicable (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements): The study involves research and an explanation of its nature and purpose The expected duration of the participant’s participation Any benefits reasonably expected from the research to the participant or others; if no benefit is expected, the participant should be made aware of this The disclosure of specific appropriate alternative procedures or therapies available to the participant The mechanism by which confidentiality of records identifying the participant will be maintained and who will have access to the participant’s medical records An explanation about whom to contact for trial-related queries, participant rights, and in the event of any injury The policy on compensation and/or medical … Go to India > Required Elements

Based on the CTRules , the G-KenyaCT , the G-ECBiomedRes , and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( KEN-14 ), the informed consent form (ICF) should include the following statements or descriptions, as applicable (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements): Title of the project and that the study involves research and an explanation of its nature and purpose The expected duration of the participant’s participation The participant’s responsibilities in participating in the trial Experimental aspects of the study Approximate number of participants involved in the trial Trial treatment schedule and the probability for random assignment to each treatment Principal investigator(s), institution, and ethics committee (EC) contact information, the person(s) to contact for further information regarding the trial and the rights of trial participants, and … Go to Kenya > Required Elements

… level of care to which the participant is otherwise entitled In addition to the required elements listed above, per the G-ACRE-IRB , for research involving the collection of identifiable private information or identifiable biospecimens, one (1) of the following must be included in the informed consent: A statement that identifiers will be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could … Go to Liberia > Required Elements

Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( MWI-22 ). MWI-22 provides guidance on the elements to include in the informed consent form (ICF). The G-NHSRC and MWI-22 state that information about the research study should be clearly presented in both written and oral form. Based on the G-NHSRC , the G-NHSRC-ICF , MWI-22 , MWI-13 , and MWI-56 , the ICF should include the following statements or descriptions, as applicable (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements): The study title, purpose, type, procedures, and duration—in lay terms Experimental aspects of the study The responsibilities and expected duration of the participant's participation The trial treatment(s) and the probability for random assignment to each treatment A statement about why the participant was selected to participate Any … Go to Malawi > Required Elements

According to MLI-17, Mali’s ethics committees (ECs) follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( MLI-7 ). Based on LawNo09-059 , DecreeNo2017-0245 , and MLI-7 , the informed consent form (ICF) should include the following statements or descriptions, as applicable (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements): The study purpose, the procedures, the duration of the trial, and the enrollment conditions The trial treatment(s) and the probability for random assignment to each treatment The participant’s responsibilities and the expected duration of participation Experimental aspects of the study Any expected risks to the participant, including if the study is prematurely concluded. Risks should not be minimized. If applicable, risks to the embryo, fetus, or nursing infant should be described. Explanation of the … Go to Mali > Required Elements

As delineated in G-RECs-Op-2018 and MEX-84 , the informed consent form (ICF) should include the following statements or descriptions, as applicable (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements): Identification data (Title, protocol number, version, version date, research institution data, principal investigator (PI) name, medical emergency establishment data, and Research Ethics Committee (REC) ( Comité de Ética en Investigación (CEI) ), and this data must coincide with the opinions of the ethics committees) The study rationale and objectives Purpose and procedures, including all invasive procedures Identification of experimental aspects of the study Trial duration Participant’s responsibilities Investigator responsibilities Approximate number of participants Circumstances that may terminate the study Duration of study Any expected risks or discomforts to the participant Any expected benefits to the … Go to Mexico > Required Elements

As delineated in Decree021-2017 and the G-EC-CTRev , the informed consent form (ICF) should include the following statements or descriptions, as applicable (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements): Trial title (include version and date) Sponsor(s), research institution, principal investigator (PI), ethics committee (EC) (El Comité Institucional de Ética en Investigación (CIEI)), and the INS contact information Explicit invitation to participate in an experimental research study and the voluntary nature of participation Trial rationale, objectives, and purpose Trial treatments or interventions Randomization and blinding procedures Trial procedures and purpose Expected duration of research participant’s involvement in the trial The approximate number of participants in the study Expected or unforeseeable risks and discomforts arising from the trial Free treatment and procedures used as part of the … Go to Peru > Required Elements

… entitled The participant or legal representative/guardian will be notified in a timely manner if significant new findings develop during the course of the study which may affect the participant's willingness to continue Additionally, see Annex 1 of SLE-6 for standardized wording for the ICF. … Go to Sierra Leone > Required Elements

… project, and the number of participants at each institution in Thailand THA-13 provides information sheet guidelines required by the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH) , which is one (1) of the institutional ethics committees approved by the Thai FDA. As noted in THA-34 , the Central Research Ethics Committee (CREC) does not have its own ICF template and directs investigators to the template provided by the Forum for Ethical … Go to Thailand > Required Elements

Based on the MHCTR , the G-ConsentPIS , and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( GBR-113 ), the informed consent form (ICF) should include the following statements or descriptions, as applicable (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements): The study purpose, procedures, and duration Study title and the study Integrated Research Application System (IRAS) ID are clearly displayed Approximate number of participants involved in the trial The participant’s responsibilities in participating in the trial Trial treatment schedule and the probability for random assignment to each treatment Experimental aspects of the study Any foreseeable risks or discomforts to the participant, and when applicable, to an embryo, fetus, or nursing infant Any benefits or prorated payment to the participant or to others that may reasonably be expected from the research; if … Go to United Kingdom > Required Elements

Based on 21CFR50 , the Pre2018-ComRule , the RevComRule , and the US-ICH-GCP , the informed consent form (ICF) must include the following statements or descriptions, as applicable (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements): The study purpose, procedures, and expected duration of the trial Identification of any experimental procedures Any expected risks or discomforts to the participant, and when applicable, to an embryo or fetus Any expected benefits to the participant Disclosure of appropriate alternative procedures that might be advantageous to the participant Confidentiality of records identifying the participant will be maintained and the possibility that the Food & Drug Administration (FDA) may inspect the records Compensation and/or treatment available for the participant in the case of trial-related injury Contact information for relevant individuals to contact in the event of a … Go to United States > Required Elements

Overview The BGD-GCP states that in obtaining and documenting informed consent, the investigator should comply with good clinical practice (GCP) and the ethical principles that have their origin in the Declaration of Helsinki ( BGD-33 ). In accordance with the BGD-GCP , the G-BMRC , BGD-15 , and BGD-16 , a participant’s rights must be clearly addressed in the informed consent form (ICF) and during the informed consent process. The Right to Participate, Abstain, or Withdraw As set forth in the BGD-GCP , a participant should be informed that participation is voluntary and that refusal to participate or withdraw from the trial is allowed, without penalty or loss of benefits to which the participant is otherwise entitled. According to the G-BMRC , it is also necessary to make it as easy as possible for people to withdraw, bearing in mind that they might not feel comfortable telling the investigator directly that they no longer wish to participate. Options, such as posting a slip, will … Go to Bangladesh > Participant Rights

Overview In accordance with LawNo14.874 and ResNo466 , Brazil’s ethical standards promote respect for all human beings and safeguard the rights and dignity of research participants. A participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. (See the Required Elements ; Vulnerable Populations ; Children/Minors ; Pregnant Women, Fetuses & Neonates ; Prisoners ; and Mentally Impaired sections for additional information regarding requirements for participant rights.) See CLNo1-2021 for National Research Ethics Commission (Comissão Nacional de Ética em Pesquisa (CONEP)) guidelines for investigators and research ethics committees (ECs) (Comitês de Ética em Pesquisa (CEPs)) related to contact with research participants (e.g., obtaining informed consent and ensuring confidentiality) and/or data collection at any phase of a research study in a virtual environment. See also CLNo039 for CONEP guidance on accessing and using a … Go to Brazil > Participant Rights

Overview In accordance with the CanadaFDR , the G-TCPS2 , and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ), Canada’s ethical standards promote respect for all human beings and safeguard the rights of research participants. The G-TCPS2 and CAN-52 , which Canada has implemented per CAN-50 , state that a participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. Note that per CAN-50 , Health Canada (HC) -implemented ICH guidance takes precedence over other HC guidance when they are not consistent. For HC’s interpretation of the relevant provisions of the CanadaFDR , see the G-FDR-0100 . The informed consent template in CAN-35 provides that if a participant has any questions about their rights, they should contact: Health Canada-PHAC Research Ethics Board Secretariat 70 Colombine Driveway, Room 941C, PL: 0909C Brooke Claxton Building, Tunney's Pasture Ottawa, … Go to Canada > Participant Rights

Overview As delineated in the G-EthicalEval , a participant’s rights must be clearly addressed in the informed consent form (ICF) and during the informed consent process. In addition, the G-EthicalEval states that the principal investigator (PI) should closely follow the guidelines provided by the Declaration of Helsinki ( DRC-11 ), the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( DRC-3 ), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products ( DRC-10 ), and the Council for International Organizations of Medical Sciences’ (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects ( DRC-2 ). (See the Required Elements, Vulnerable Populations, and Children/Minors sections for additional information regarding requirements for participant rights.) The Right to Participate, Abstain, or Withdraw As set forth in the G-EthicalEval and DRC-3 , the … Go to DRC > Participant Rights

Overview In accordance with the Guinea-PHC , Guinea’s ethical standards promote respect for all human beings and safeguard the rights of research participants. The Guinea-PHC states that a participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. GIN-6 requires the principal investigator to respect the fundamental ethical principles of research involving human beings. Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( GIN-7 ). The Right to Participate, Abstain, or Withdraw As set forth in the Guinea-PHC and GIN-7 , a potential research participant or legal representative/guardian should be informed that participation is voluntary and that the participant may refuse to participate or withdraw from the research study at any time. The Right to Information As delineated in the Guinea-PHC and GIN-7 , a potential research participant or … Go to Guinea > Participant Rights

Overview In accordance with the 2019-CTRules and the G-ICMR , India’s ethical standards promote respect for all human beings and safeguard the rights of research participants. The G-ICMR upholds the Declaration of Helsinki ( IND-63 ). The 2019-CTRules , the G-ICMR , and the G-Children state that a participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. The Right to Participate, Abstain, or Withdraw As stated in the 2019-CTRules , the G-ICMR , and the G-Children , the participant or the legal representative/guardian should be informed that participation is voluntary, the participant may withdraw from the research study at any time, and refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled. The Right to Information As per the 2019-CTRules , the G-ICMR , and the G-Children , a potential research participant or the legal representative/guardian has the … Go to India > Participant Rights

Overview In accordance with the Declaration of Helsinki ( KEN-33 ) principles upheld in the CTRules , the G-KenyaCT , the G-ECBiomedRes , and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( KEN-14 ), Kenya’s ethical standards promote respect for all human beings and safeguard the rights of research participants. A participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. Per the G-KenyaCT , research must be conducted in accordance with requirements set forth in KEN-14 . The Right to Participate, Abstain, or Withdraw As set forth in the CTRules , the G-KenyaCT , the G-ECBiomedRes , and KEN-14 , a participant or legal representative/guardian should be informed that participation is voluntary, that the participant may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is … Go to Kenya > Participant Rights

Overview As delineated in LawNo09-059 and DecreeNo2017-0245 , a participant’s rights must be clearly addressed in the informed consent form (ICF) and during the informed consent process. According to MLI-17, Mali’s ethics committees follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( MLI-7 ), which addresses participant rights. (See the Required Elements; Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; and Prisoners sections for additional information regarding requirements for participant rights.) The Right to Participate, Abstain, or Withdraw As set forth in LawNo09-059 , DecreeNo2017-0245 , and MLI-7 , the participant should be informed that participation is voluntary, that the participant may withdraw from the research study at any time without liability and without detriment to the overall scientific quality of the results. The Right to Information As delineated in … Go to Mali > Participant Rights

Overview In accordance with HlthResRegs , NOM-012-SSA3-2012 , G-RECs-Op-2018 , and the Guideline for Good Clinical Practice E6 (R1) ( MEX-32 ), Mexico’s ethical standards promote respect for all human beings and safeguard the rights of research participants. ( COFEPRIS-GCP requires the principal investigator (PI) to comply with MEX-32 ). HlthResRegs and MEX-32 state that a participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. (Note: Per MEX-2 , the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) is in the process of implementing the International Council for Harmonisation's Guideline for Good Clinical Practice E6 (R2) ( MEX-22 )). The Right to Participate, Abstain, or Withdraw As stated in HlthResRegs , NOM-012-SSA3-2012 , G-RECs-Op-2018 , MEX-32 , and MEX-84 , the participant or legal representative/guardian should be … Go to Mexico > Participant Rights

Overview In accordance with Law26842 , Decree021-2017 , the G-EC-CTRev , Res233-2020 , the PeruConstitution , Decree011-2011 , and the Declaration of Helsinki ( PER-76 ), Peru’s ethical standards promote respect for all human beings and safeguard the rights of research participants. Per Decree021-2017 , the G-EC-CTRev , and Res233-2020 , a participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. The Right to Participate, Abstain, or Withdraw Decree021-2017 , Decree027-2015 , and the G-EC-CTRev state that the participant or the legal representative/guardian should be informed that participation is voluntary, that study withdrawal may occur at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled. The Right to Information As explained in Decree021-2017 , Decree027-2015 , and the G-EC-CTRev , a potential research participant or legal … Go to Peru > Participant Rights

Overview As stated in the G-AppConductCT , the Tanzanian government complies with the ethical principles set forth in the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( TZA-13 ) and the Declaration of Helsinki ( TZA-30 ), which promote respect for all human beings and safeguard the rights of research participants. A participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. (See the Required Elements and Vulnerable Populations sections for additional information regarding requirements for participant rights.) The Right to Participate, Abstain, or Withdraw As set forth in the G-AppConductCT and the G-EthicsHR-TZA , the participant or the legal representative/guardian should be informed that participation is voluntary, that the participant may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which … Go to Tanzania > Participant Rights

Overview In accordance with G-ResEthics and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( THA-28 ), Thailand’s ethical standards promote respect for all human beings and safeguard the rights of research participants. The Declaration of Rights and Code of Conduct for Patients ( THA-11 ) also states that every patient has the fundamental right to receive professional medical care and health care from health professionals without discrimination as provided for in the Constitution of the Kingdom of Thailand (B.E. 2560) . Per ClinImprtOrdr , clinical trials in Thailand must comply with THA-28 . ClinImprtOrdr , ClinSampleProd , G-ResEthics , THA-28 , the NatHlthAct , and G-CT-DIPApp , state that a participant’s rights must also be clearly addressed in the informed consent form (ICF) (also referred to as the Patient Information Sheet) and during the informed consent process. The Right to Participate, Abstain, or Withdraw As set forth in … Go to Thailand > Participant Rights

Overview In accordance with the MHCTR , the MHCTR2006 , the G-ConsentPIS , and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( GBR-113 ), the United Kingdom’s (UK’s) ethical standards promote respect for all human beings and safeguard the rights of research participants. The MHCTR states that a participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. The Right to Participate, Abstain, or Withdraw As set forth in the MHCTR , the G-ConsentPIS , and GBR-113 , the participant or legal representative/guardian should be informed that participation is voluntary, that they may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled. The Right to Information As delineated in the MHCTR , the G-ConsentPIS , and GBR-113 , a potential research participant or legal … Go to United Kingdom > Participant Rights

Overview In accordance with 21CFR50 , 21CFR312 , the Pre2018-ComRule , the RevComRule , and the US-ICH-GCP , the United States’ (US) ethical standards promote respect for all human beings and safeguard the rights of research participants. A participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. The Right to Participate, Abstain, or Withdraw As set forth in 21CFR50 , the Pre2018-ComRule , the RevComRule , and the US-ICH-GCP , a potential participant or legal representative/guardian must be informed that participation is voluntary, that the participant may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled. The Right to Information As delineated in 21CFR50 , the Pre2018-ComRule , the RevComRule , and the US-ICH-GCP , a potential research participant or legal representative/guardian has the … Go to United States > Participant Rights

As delineated in LawNo14.874 , the inclusion of a participant in research in an emergency situation and without their prior consent will follow the provisions of the approved protocol. The research participant or the legal representative/guardian must be notified at the first possible opportunity and the decision regarding their continued participation in the research must be collected. In addition, according to the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( BRA-28 ), which Brazil has adopted per ResNo945 , in emergency situations, when prior consent of the participant is not possible, the consent of the legal representative/guardian, if present, should be requested. When prior consent of the participant is not possible, and the legal representative/guardian is not available, enrolment of the participant should require measures described in the protocol and/or elsewhere, with documented approval/favorable opinion by the research … Go to Brazil > Emergencies

According to the G-EthicalEval , the principal investigator must agree to work in accordance with the Declaration of Helsinki ( DRC-11 ), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products ( DRC-10 ), and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( DRC-3 ). DRC-3 makes provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by emergencies. Per DRC-3 , in an emergency, if the signed informed consent form (ICF) has not been obtained from the research participant or legal representative/guardian, or if an effective treatment is lacking but the investigational product could address the participant’s emergency needs, the clinical trial may be conducted. However, the method used on the participant must be explained clearly in the trial protocol, and the ethics committee must approve the protocol in … Go to DRC > Emergencies

The Guinea-PHC makes provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by an emergency. As delineated in the Guinea-PHC , in an emergency, when the participant is unable to give informed consent, the consent of a family member should be obtained. According to GIN-17, Guinea is also required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( GIN-7 ). Per GIN-7 , in an emergency, if the signed informed consent form (ICF) has not been obtained from the research participant or legal representative/guardian, or if an effective treatment is lacking but the investigational product could address the participant’s emergency needs, the clinical trial may be conducted. However, the method used on the participant must be explained clearly in the trial protocol, and the ethics committee must approve the protocol in advance. The participant or legal … Go to Guinea > Emergencies

The G-KenyaCT , the G-ECBiomedRes , and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( KEN-14 ), make provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by emergencies. Per the G-KenyaCT , research must be conducted in accordance with KEN-14 . As delineated in the G-KenyaCT and the G-ECBiomedRes , in an emergency, if the signed informed consent form (ICF) cannot be obtained from the research participant, the consent of the legal representative/guardian should be obtained. If the prior consent of the participant or legal representative/guardian cannot be obtained, the participant’s enrollment should follow measures specified in the protocol, and/or elsewhere, to ensure compliance with ethics committee (EC) and the Pharmacy and Poisons Board (PPB) requirements. The G-ECBiomedRes requires that the principle of clinical equipoise be applied, which essentially means … Go to Kenya > Emergencies

LawNo09-059 makes provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by medical emergencies. According to MLI-17, Mali’s ethics committees (ECs) follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( MLI-7 ), which addresses consent in the case of medical emergencies. As per LawNo09-059 and MLI-7 , the EC may approve emergency medical research when informed consent cannot be obtained from the participant. The investigator must submit a protocol for the EC’s approval that requires only the consent of the participant’s legal representative/guardian, if they are present. The participant should be informed about the research as soon as possible, at which time consent will be … Go to Mali > Emergencies

Per the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( THA-28 ), research participants involved in clinical research under emergency circumstances are viewed as vulnerable and should be provided additional protections to ensure their safety and well-being. Per ClinImprtOrdr , clinical trials in Thailand must comply with THA-28 . In addition, per the Declaration of Rights and Code of Conduct for Patients ( THA-11 ), patients who are in a life-threatening condition are entitled to immediate, urgent assistance from a healthcare practitioner as required, regardless of whether the patient requests assistance. THA-28 explains that in an emergency, if the signed informed consent form (ICF) cannot be obtained from the research participant, the consent of the legal representative/guardian should be obtained. If prior consent cannot be obtained from the legal representative/guardian, the participant’s enrollment should follow measures specified in the … Go to Thailand > Emergencies

The MHCTR , the MHCTR2006-No2 , the MHCTR-BSQ , and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( GBR-113 ) make provisions to protect the rights of a research participant during the informed consent process when a clinical trial of an investigational product (IP) is complicated by medical emergencies. As delineated in the G-ConsentPIS and GBR-18 , in an emergency, if the signed informed consent form (ICF) cannot be obtained from the research participant, the consent of the legal representative/guardian should be obtained. If the prior consent of the participant or legal representative/guardian cannot be obtained, the participant’s enrollment should follow measures specified in the protocol, and the ethics committee (EC) must provide documented approval in order to protect the participant’s rights, safety, and well-being. The participant or legal representative/guardian should provide consent as soon as possible. The MHCTR-BSQ amends the … Go to United Kingdom > Emergencies

21CFR50 , 21CFR56 , the US-ICH-GCP , and the G-ICEmrgncyReqs make provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by life-threatening medical emergencies, public health emergencies, or military operations. Medical Emergencies The US-ICH-GCP states that in emergency situations, when prior consent of the research participant is not possible, the consent of the legal representative/guardian, if present, should be requested. When prior consent of the participant is not possible and the legal representative/guardian is not available, enrollment of the participant should require measures described in the protocol and/or elsewhere, with documented approval/favorable opinion by the institutional ethics committee (EC) (referred to as an institutional review board (IRB) in the United States (US)). The participant or the legal representative/guardian should be informed about the trial as soon as possible, and … Go to United States > Emergencies

… on medical care may be approved where: It is likely that the research will lead to increased understanding about, or improvements in, the care of this population The requirements of relevant jurisdictional laws are taken into account Either: 1) any risk or burden of the proposed research to this particular participant is justified by the potential benefits, or 2) where participants have capacity to consent, any risk or burden is acceptable to them and justified by the potential … Go to Australia > Vulnerable Populations

Overview As set forth in LawNo14.874 , in all Brazilian clinical trials, research participants from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. Vulnerability is defined as a condition in which a person or group of people has reduced capacity to make decisions and to oppose resistance in the research situation as a result of individual, psychological, economic, cultural, social, or political factors. ResNo466 also defines vulnerability as the state of individuals or groups who, for any reason or motive, have their capacity for self-determination reduced or impeded, or are in any way prevented from resisting, especially with regard to free and informed consent. According to the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( BRA-28 ), which Brazil has adopted per ResNo945 , vulnerable participants are characterized as those who may be unduly … Go to Brazil > Vulnerable Populations

Overview As per the Guinea-PHC , in all Guinean clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. Vulnerable populations include persons who cannot give a fully free and informed consent because of the person’s situation or mental state, and may include, but are not limited to, children/minors, prisoners, physically or mentally handicapped, persons whose condition requires emergency treatment or life support, and pregnant or lactating women. Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( GIN-7 ). GIN-7 includes the following as vulnerable populations: members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of … Go to Guinea > Vulnerable Populations

Overview As set forth in the 2019-CTRules and the G-ICMR , in all clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. The G-ICMR further describes vulnerable groups and individuals as those who may have an increased likelihood of incurring additional harm, as they may be relatively (or absolutely) incapable of protecting their own interests. According to the G-ICMR , vulnerable populations are characterized as individuals/communities with hierarchical relationships (e.g., prisoners, armed forces personnel, or staff and students at medical, nursing, or pharmacy academic institutions); economically and socially disadvantaged individuals (e.g., persons who are unemployed, abandoned, orphans, have language barriers, or cultural differences); persons below the poverty line; ethnic, religious, or sexual minority groups; tribal and marginalized … Go to India > Vulnerable Populations

… decisions regarding their participation in research. Such research must be conducted to ensure that: Participants are protected from gross violations of human rights There is strict adherence to ethical principles There is at least one (1) member of the ethics committee approving such research who is an enlisted and authoritative member of the armed forces Terminally Ill Per the G-ECBiomedRes , research involving participants who are terminally ill with an incurable medical … Go to Kenya > Vulnerable Populations

… and those incapable of giving consent. Persons with Diseases As indicated in the LibCTReg , in the case of a clinical trial on a person of legal age who is suffering from a disease for which the investigational product (IP) is to be used, one (1) of the following conditions should be applied along with the general clinical trial requirements delineated in the LibCTReg : The use of the IP is indicated according to the findings of medical science in order to save the person's life The IP … Go to Liberia > Vulnerable Populations

Overview In all Malian clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. LawNo09-059 states that biomedical research may only be carried out on persons incapable of giving consent or those who are unable to give consent due to restricted freedom, if consent is provided by their legal representative/guardian, and they will benefit individually or collectively from participating in the study. According to LawNo09-059 , these participants may include minors and adults incapable of giving their consent and under guardianship, pregnant women or women of childbearing age, persons deprived of their freedom, persons staying in a health or social institution, and patients in emergency situations. DecreeNo2017-0245 mentions the following as vulnerable persons: pregnant or breastfeeding women, persons deprived of liberty, persons unable to express … Go to Mali > Vulnerable Populations

Overview As delineated in G-RECs-Op-2018 , in all Mexican clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. G-RECs-Op-2018 characterizes vulnerable populations as individuals or groups experiencing diminished autonomy due to imposing social, political, and/or economic situations that prevent them from having control over their quality of life. Populations traditionally viewed as vulnerable include minors, women, persons with disabilities, the elderly, those suffering from mental illness, immigrants, those who are illiterate, those belonging to ethnic or racial minorities, the unemployed, the homeless, and reclusive individuals. As per COFEPRIS-GCP , the principal investigator (PI) is required to comply with the Guideline for Good Clinical Practice E6 (R1) ( MEX-32 ), which similarly characterizes vulnerable populations as those who may be unduly … Go to Mexico > Vulnerable Populations

… the consent of each individual research participant within the group. Persons in Dependent Groups Per Decree021-2017 , clinical trials involving participants in subordinate or dependent relationships must meet the following requirements: One (1) or more of the EC’s members must represent the population under study or work with someone who has expertise in addressing social, cultural, and other issues related to the group in question Refusal or withdrawal of consent during the trial … the informed consent form (ICF), but with the mental capacity to provide their consent, their legal representative(s) may grant their written consent by printing their fingerprint. This consent must be provided in the presence of at least one (1) witness designated by the participant that does not belong to the research team, and who in turn will sign the ICF. If the participant is unable to sign or provide a fingerprint, another means may be used that the participant approves. In this … Go to Peru > Vulnerable Populations

… of benefits associated with their participation, or fear of retaliation from interested senior members of the hierarchy in case of refusal to participate. Characteristics that constitute vulnerability with reference to communities include one (1) or more of the following: Limited economic empowerment Inadequate protection of human rights Discrimination on the basis of health status Inadequate understanding of scientific research Limited availability of health care and treatment options … Go to Tanzania > Vulnerable Populations

… include children/minors, prisoners, the homeless, substance abusers, mentally and physically handicapped, armed forces, terminally ill, and pregnant women. Characteristics that constitute vulnerability in such populations include one (1) or more of the following: Limited economic empowerment Conflict and post-conflict situations Inadequate protection of human rights Discrimination on the basis of health status Limited availability of health care and treatment options … Go to Uganda > Vulnerable Populations

Overview As per the MHCTR and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( GBR-113 ), in all United Kingdom (UK) clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. Per GBR-131 , vulnerability may be defined in different ways and may arise as a result of being in an abusive relationship, vulnerability due to age, potential marginalization, disability, and due to disadvantageous power relationships within personal and professional roles. Participants may not be conventionally vulnerable but may be in a dependent relationship that means they can feel coerced or pressured into taking part. As stated in GBR-131 , researchers must assess potential vulnerability within the context of the research, in terms of potential consequences from their participation (immediate and long-term) or lack of positive impact … Go to United Kingdom > Vulnerable Populations

Overview As per 21CFR56 , the Pre2018-ComRule , the RevComRule , and the US-ICH-GCP , in all United States (US) clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. Institutional ethics committees (ECs) (institutional review boards (IRBs) in the US) must pay special attention to protecting such participants. (See USA-18 and USA-65 for more information on Common Rule departments/agencies, and the Regulatory Authority section for additional guidance on when the Pre2018-ComRule and the RevComRule apply to research.) The US-ICH-GCP requires special considerations for vulnerable populations and characterize them as those whose willingness to volunteer in a trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response for refusing to participate. Examples of these … Go to United States > Vulnerable Populations

… the G-NatlStmt states that except in cases involving standing parental consent, specific consent must be obtained from the child or young person whenever the child or young person has the capacity to make this decision, and either one (1) parent, except when the EC decides that the risks require the consent of both parents, or the child or young person’s parent/guardian. Per the G-NatlStmt , researchers must respect the developing capacity of children and young people to be … Go to Australia > Children/Minors

The G-BMRC defines a child as a person below the age of 18. Consideration should be taken before involving children as study participants. Children should not be involved as participants in research that might be equally carried out in adults, and they should only participate in research to obtain knowledge regarding their health needs. According to the G-BMRC , participation of children in a clinical evaluation of a new drug trial is permitted only after Phase III clinical trials in adults. If testing the therapeutic value of a drug in a primary disease of children, the study can be carried out earlier. Study design of interventions applied to a child participant for the benefit of diagnostic, preventive, or therapeutic purposes should be justified in relation to anticipated risks involved in the study and anticipated benefits to society. Such interventions should be at least as advantageous as any available alternative interventions. The benefit and risk to the child participant … Go to Bangladesh > Children/Minors

LawNo8.069 (also known as the Statute of Children and Adolescents) states that a child is a person up to 12 years of age, and a teenager is one between 12 and 18 years of age. As per ResNo466 and OMREC , when the research participant is a child, the child’s parent/legal guardian must sign the informed consent form. However, per OMREC , all pediatric participants should be informed to the fullest extent possible about the study in language and terms that they are easily able to understand. The child’s opinion must be considered, even though the child may not be deemed competent to give consent. ResNo466 further notes that in cases where clarification is necessary for research with child and adolescent participants, investigators must provide a clear justification for their choice, specified in the protocol and approved by the EC (CEP), and by the National Research Ethics Commission (Comissão Nacional de Ética em Pesquisa (CONEP)) , when applicable. In these cases, the stages of … Go to Brazil > Children/Minors

Per CAN-35 , because the G-TCPS2 does not specify an age of consent for children, the decision on whether to seek consent from children is based on whether they have the capacity to understand the research and the risks and benefits of their participation. Youth who have not reached the age of majority (either 18 or 19 depending on the province or territory) may still be old enough to provide their own consent. For children who are not sufficiently mature to provide consent but are able to understand the nature of study participation, researchers must obtain the child’s assent in addition to the consent of an authorized third party. The decision of a child not to assent must be respected regardless of whether third-party consent was obtained. CAN-35 provides the following criteria for determining whether participants can provide their own consent, or whether an authorized third party should be involved: The risk level associated with the research project The legal requirements for age … Go to Canada > Children/Minors

As per MPL , minors refer to citizens who are under the age of 18. In accordance with the NMPA-GCP-No57-2020 and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( CHN-37 ), when the research participant is a child, the informed consent form (ICF) must be signed by the child’s parent/legal guardian. If the child can decide whether to participate, the ICF should also be approved by the child. The age of consent for children and minors is not defined in the currently available regulatory resources. See CHN-26 for an analysis of clinical trial participants’ rights in China. Per NMPA-No11-2017 , clinical trials may be conducted on children depending on existing knowledge of and extrapolation by research results in adults. Drugs that are intended for use in children should be evaluated in the appropriate age group for children and start in the high-age group followed by the low-age group. The EC-Guide stipulates the following conditions when … Go to China > Children/Minors

According to the FamilyCodeMemo , the age of majority is 18 years old in the Democratic Republic of the Congo (DRC). The G-EthicalEval recommends that children be included in the decision to participate in research based on their physical, psychological, and social developmental abilities. In addition, the G-EthicalEval requires principal investigators to work in accordance with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( DRC-3 ), which states that when a clinical trial includes minors, the minors should be informed about the trial to the extent compatible with their understanding and, if capable, should sign and personally date the written informed consent. Assent Requirements As per the G-EthicalEval , a child's ability to give informed assent to participate in research is globally established at the minimum age of 13. The research team should consider the complexity of the research and other aspects to raise this age, but never go … Go to DRC > Children/Minors

Guinea’s definition of a child/minor and the age of consent for children/minors are not specified in the currently available regulatory resources. In accordance with the Guinea-PHC , when the research participant is a child, the informed consent form (ICF) must be signed by the child’s parent/legal guardian. In the case of disagreement between the wishes of the child and the parent/legal guardian, the child’s wishes should prevail. The child’s personal consent must be requested when the child’s age allows the child to understand the purpose of the research, the risk, and disadvantages of this research, and what is expected of the child’s participation. Research may only be conducted in children if it cannot be conducted in less vulnerable participants, such as for the purpose of researching childhood diseases or pathologies to which children are particularly susceptible. Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good … Go to Guinea > Children/Minors

As per the G-ICMR , children are individuals who have not obtained the legal age of consent, which is 18. As stated in the G-ICMR , the 2019-CTRules , and the G-Children , in the case of pediatric clinical trials, participants are legally unable to provide written informed consent, and are dependent on their parents/legal guardians to assume responsibility for their participation in a research study. However, as specified in the 2019-CTRules , all pediatric participants should be informed to the extent compatible with the child’s understanding, and if capable, the pediatric participant should sign and personally date the informed consent form (ICF). In these studies, the following requirements should be complied with: Written informed consent should be obtained from the parent/legal guardian; however, all pediatric participants should be informed to the fullest extent possible about the study in a language and in terms that they are able to understand Where appropriate, pediatric … Go to India > Children/Minors

According to the G-KenyaCT , a minor is someone under 18 years of age. As set forth in the G-KenyaCT , the G-ECBiomedRes , and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( KEN-14 ), when the research participant is a minor, informed consent should be obtained from the parent/guardian. Per the G-KenyaCT , research must be conducted in accordance with requirements set forth in KEN-14 . The informed consent forms, assent forms, and the patient information sheets should be in a language that the parent/guardian clearly understand. All pediatric participants should be fully informed about the trial and its risks and benefits in a language and terms that they are easily able to understand. Per the G-KenyaCT , a minor should take part in the informed consent procedure in a way tailored to their age and mental maturity. If capable, the participant should sign and personally date the written informed consent. In addition, consent given by … Go to Kenya > Children/Minors

… for the child to take part in a research study as well as their permission for the use and disclosure of the child’s protected health information. If a second parent’s signature is not obtained, the first parent or guardian needs to choose one (1) of the following options on the form to justify why this is not possible: The ethics committee (EC) has determined that the permission of one (1) parent is sufficient (this option is only listed on the form if it has been approved by the EC) Second parent is deceased Second parent is unknown Second parent is incompetent Second parent is not reasonably available Only one (1) parent has legal responsibility for the care and custody of the child In addition, an individual may provide permission as a guardian for a child only if that individual can provide a written document indicating that the individual is legally … Go to Liberia > Children/Minors

The G-NHSRC states that a minor is a person less than 18 years of age. When the research participant is a minor, assent must be obtained in tandem with permission from the parent/legal guardian. Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( MWI-22 ). MWI-22 states that when a clinical trial includes minors, the minors should be informed about the trial to the extent compatible with their understanding and, if capable, they should sign and personally date the written informed consent. Assent Requirements As per the G-NHSRC , assent must be obtained from a minor who is deemed capable of providing assent. The National Health Sciences Research Committee (NHSRC) bases its assessment of a minor’s ability to assent on the minor’s age, maturity, and psychological state. In certain cases, the NHSRC may regard assent by minors to represent informed consent without requiring the permission … Go to Malawi > Children/Minors

DecreeNo2017-0245 states that the rights of participants who are minors must be particularly protected. According to MLI-17, Mali’s definition of a child/minor and the age of consent refers to individuals up to 17 years of age. Per LawNo09-059 , minors may be solicited for biomedical research only if they can benefit individually or collectively. In accordance with LawNo09-059 , when the research participant is a minor with either direct individual benefit or without direct individual benefit, their parent/legal guardian most provide consent. In addition, the research must not present a serious foreseeable risk to participants who are minors. In addition, per LawNo09-059 , if a study is to be conducted without direct benefit to participant(s) who are minors, the research must comply with the following conditions: Present no serious and foreseeable health risks Be useful to people with the same age, illness, or disability characteristics Provide results that cannot be achieved … Go to Mali > Children/Minors

… for justified reasons The informed consent information provided is appropriate for the understanding of minors Per G-RECs-Op-2018 and HlthResRegs , when two (2) persons exercise the parental authority of a minor, only the consent of one (1) of them must be permitted if there is irrefutable or manifest proof that the other is unable to provide it, proof of the parental authority’s negligence, or imminent risk to the minor’s health or life. HlthResRegs indicates that investigations … Go to Mexico > Children/Minors

… Decree021-2017 , the consent of the legal guardian may only be dismissed in the case of death, loss of rights according to Decree requirements, or proven impossibility to obtain consent has been documented appropriately. In the event that one (1) parent is a minor, the consent of the direct ascendant relative is also required unless the parent is a minor of 16 years of age or more, the participant has gotten married, or has obtained an official professional or trade title as earlier … Go to Peru > Children/Minors

According to the SL-GCPs , a minor is someone under 18 years of age. As set forth in the SL-GCPs , when the participant is a minor, informed consent must be obtained from the participant’s parent/legal guardian. Assent from the minor must also be obtained where the minor is capable of understanding. A minor’s refusal to participate in research must be respected. The SL-GCPs indicates that the national ethics committee (EC), the Sierra Leone Ethics and Scientific Review Committee (SLESRC), must pay special attention to protecting the welfare of certain classes of participants, including minors. Research involving minors should be approved only if: The research interventions, including those in observational research, presents the participant with no greater than minimal risk; or The research interventions present more than minimal risk but hold out the prospect of direct benefit for the participant; or The research interventions, including those in observational research, present more … Go to Sierra Leone > Children/Minors

The SA-GCPs and G-EthicsHR-ZAF stipulate that minors are younger than 18 years old and are regarded as vulnerable persons due to their lack of legal capacity. The G-GPHlthCare-IC states that a person over the age of 18 years is an adult and is legally competent to decide on all forms of treatment and medical procedures. However, a minor who is 12 years of age and older is legally competent to consent to a proposed investigation if the minor is of sufficient maturity and is able to understand the benefits, risks, social, and other implications of the research. A minor's refusal to participate in research must be respected. Per the SA-GCPs , documented permission from the parent/legal guardian must be obtained in advance prior to approaching the minor to request participation. According to the NHA , the SA-GCPs , the G-GPHlthCare , and the G-GPHlthCare-IC , consent for minors to participate in research must be obtained from: The parent/legal guardian in all but exceptional circumstances … Go to South Africa > Children/Minors

The ChildAct states that a person less than 18 years of age should be known as a child. As per the G-AppConductCT and the G-EthicsHR-TZA , when the research participant is a child, the informed consent form (ICF) must be signed by the child’s parent/legal guardian. According to the G-EthicsHR-TZA , research involving greater than minimal risk, but presenting the prospect of direct benefit to a child, may be conducted only if: The risk is justified by the anticipated benefit to the child The relation of the anticipated benefit to the risk is at least as favorable to the research study participants (children) as that presented by available alternative approaches Adequate provisions have been made for the solicitation of the child’s assent and the informed consent of the child’s parent/legal guardian Further, per the G-EthicsHR-TZA , research that involves greater than minimal risk and entails no prospect of direct benefit to the individual child participant, but is likely to yield … Go to Tanzania > Children/Minors

According to the ThaiCode , a person ceases to be a minor and attains majority at 20 years of age, or if the person gets married before age 20. THA-13 and THA-92 indicate that the age suitable to give consent is 18 years or older. The Declaration of Rights and Code of Conduct for Patients ( THA-11 ) also indicates that a child is someone under 18 years of age. As set forth in G-ResEthics , when the research participant is a minor, informed consent should be obtained from the parents, guardians, or legal representatives. Additionally, precautions against possible physical and mental harms should be exercised. Furthermore, the rights of the minors should be respected for their voluntary decision to participate in a clinical study. THA-11 similarly indicates that parents or legal guardians may exercise their rights on behalf of a child patient who is not over 18 years of age. The International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( THA-28 ) states that … Go to Thailand > Children/Minors

The NGHRP and the G-CTChldrnWmn define a child as a person below the age of 18. According to the G-CTChldrnWmn , data supporting the conduct of a clinical trial involving children should demonstrate that the benefit to the population outweighs the risk. For interventions or procedures that have no potential individual benefits for children: The risks must be minimized and no more than minimal; The purpose of the research must be to obtain knowledge relevant to the particular health needs of the population; The social value of the research for the children is compelling, and the research cannot be conducted in any other population; and Any research-related risk is the least possible for achieving the objectives of the research While consent from the child’s parent or guardian is required in most cases, the NGHRP does allow for mature and emancipated minors, as described below, to provide consent. As per the NGHRP , mature minors are defined as individuals 14-17 years of age who have … Go to Uganda > Children/Minors

… Guideline for Good Clinical Practice E6(R2) ( GBR-113 ), when the research participant is a minor, informed consent should be obtained from a parent/legal guardian. As per GBR-4 , the researcher needs only to obtain consent from one (1) person with parental responsibility. GBR-130 further indicates that the parent/legal guardian must not be connected with the conduct of the trial, is suitable to act by virtue of their relationship with the child/young person, and is available … Go to United Kingdom > Children/Minors

… problem affecting the health or welfare of children, and, The Commissioner of Food and Drugs consults with an expert panel and has an opportunity for public review and comment to determine that the investigation satisfies the conditions of one (1) of the other earlier described research types, or the following conditions are met: the investigation will be conducted in accordance with sound ethical principles and adequate provisions are made for soliciting the assent of children and the … not be implemented without the waiver The children/minors will be given additional information after participation, whenever appropriate When parent/legal guardian permission is necessary, the EC must determine whether the permission of one (1) parent/legal guardian is sufficient, or if permission from both is required. If the EC determines assent is required, it must also determine whether and how assent must be documented. 21CFR50 and 45CFR46-B-E do specify, however, that the … to understand, prevent, or alleviate a serious problem affecting the health or welfare of children/minors, but is not otherwise approvable Exceptions to the consent requirement involving both parents/legal guardians include when one (1) parent/legal guardian is deceased, unknown, incompetent, or not reasonably available, or, when only one (1) parent/legal guardian has legal responsibility for the care and custody of the child. The G-InfrmdCnsnt indicates that when obtaining … Go to United States > Children/Minors

According to ChildLaw , a child is someone under 16 years of age. As set forth in the PharmLaw-VNM , when the participant is a minor, informed consent must be obtained from the legal representative/guardian. Assent Requirements No information is currently available regarding assent requirements. … Go to Vietnam > Children/Minors

ZWE-49 indicates that the age of majority in Zimbabwe is 18. Children under 18 years of age have not attained the legal age for consent to treatments or to participate in a clinical trial. Children who are seven (7) to 17 years of age can give assent through a written affirmative agreement to participate in a clinical trial. As per ZWE-50 , when the research participant is a child under seven (7) years of age, the informed consent form (ICF) must be signed by the child’s parent/legal guardian. For children who are seven (7) to 17 years of age, the consent and assent requirements vary and are provided below. In addition, the ICF must include signatures in the appropriate sections if the study involves specimen collection and/or recording the child with photographs, video, or audio. Assent Requirements Per ZWE-11 , assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. This means … Go to Zimbabwe > Children/Minors

As delineated in LawNo14.874 and ResNo466 , research with pregnant women will be preceded by similar research with women outside the gestational period, except when the pregnancy or the unborn child is the fundamental object of the research. Additionally, per LawNo14.874 , this research will only be permitted when the foreseeable risk to the health of the pregnant woman or the unborn child is minimal. ResNo466 also specifies that any Brazilian clinical studies involving women of childbearing age or who are pregnant, require additional safeguards to ensure that the participants are fully aware of the risks and that the research assesses the risks and benefits as well as any potential impact on fertility, pregnancy, the embryo or fetus, labor, lactation, and the newborn. Further, the investigator(s) should also ensure that female participants have the right to participate in the research without the use of compulsory contraceptives, if they have expressly indicated that they are free … Go to Brazil > Pregnant Women, Fetuses & Neonates

As per the G-TCPS2 , studies involving women of childbearing age, or who are pregnant, require additional safeguards to ensure that the research assesses the risks to the women and the fetuses. The following guidance applies to research involving materials related to human reproduction: Research using materials related to human reproduction in the context of an anticipated or ongoing pregnancy must not be undertaken if the information can reasonably be obtained by alternative methods Materials related to human reproduction for research use must not be obtained through commercial transaction, including exchange for services Per the G-TCPS2 , research on in vitro embryos already created and intended for implantation to achieve pregnancy is acceptable if: The research is intended to benefit the embryo Research interventions will not compromise the care of the woman, or the subsequent fetus Researchers closely monitor the safety and comfort of the woman and the safety of the embryo … Go to Canada > Pregnant Women, Fetuses & Neonates

While RegEthics lists pregnant women as a vulnerable population, there are no relevant provisions regarding any special consent procedures for pregnant women, fetuses, or neonates. Per NMPA-No11-2017 , any research studies of pregnant women should include a follow-up evaluation of these participants during pregnancy, as well as the fetuses and the children from that pregnancy. If a research study is intended for lactating women, the researchers should test the secretion of the drug or its metabolites in human milk, if feasible. If lactating women are recruited into a clinical trial, the effects of the drug on their infants should be monitored and, if necessary, followed. Pregnant women should be excluded from any research study if the investigational product is not intended for use during pregnancy. In this case, if a pregnancy occurs during the clinical trial, the study should be terminated and reported to the ethics committee for follow-up and evaluation of the pregnancy, fetus, and … Go to China > Pregnant Women, Fetuses & Neonates

… to ensure the research conforms to appropriate ethical standards. The informed consent of the pregnant woman or nursing mother is required for all proposed research studies. Studies to be conducted with this population should meet one (1) or more of the following conditions: The research should improve the health of the mother without harming the fetus or infant The research should increase the viability of the fetus The research should promote the proper development of the … Go to Guinea > Pregnant Women, Fetuses & Neonates

… possible benefits and ensure a competent person(s) conducts a proper scientific review of the protocol. In addition, when possible, older children should be studied before conducting studies in younger children and infants. The consent of one (1) parent is also required for neonate studies where research exposes them to no or minimal risk, or in studies that offer the prospect of direct benefit to the participant. However, for studies that do not offer the prospect of direct benefit or are high-risk, consent from both parents is required. Exceptions to this requirement include the following: Only one (1) parent has legal responsibility for the care and custody of the child One (1) parent is deceased, unknown, incompetent, or not available. In such cases, it is the duty of the investigators to provide adequate justification. A parent who is a minor should not provide consent. If both parents are minors, then enrollment of … Go to India > Pregnant Women, Fetuses & Neonates

Per the G-KenyaCT , research must be conducted in accordance with the requirements set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( KEN-14 ). In accordance with KEN-14 , informed consent requirements for conducting clinical trials with pregnant or nursing women or fetuses follow the general requirements listed in the Required Elements section . Specifically, the informed consent form should include a statement on the reasonably foreseeable risks or inconveniences to the participant, and when applicable, to an embryo, fetus, or nursing infant. As per the G-ECBiomedRes , research involving pregnant, lactating, and breastfeeding women may pose compromised long-term outcomes for the child. In addition, potential parent(s) can make decisions on behalf of the fetus(es), embryo(s), and zygote(s). For fetal, embryo, and zygote(s) cases, research should be limited as follows: Cases that present no harm or offer assistance to the life … Go to Kenya > Pregnant Women, Fetuses & Neonates

DecreeNo2017-0245 states that the rights of participants who are pregnant or breastfeeding must be particularly protected. As per LawNo09-059 , any Malian clinical studies involving a woman of childbearing age or one who is pregnant may only be conducted if the benefits of the research outweigh the risks to the woman and her embryo, her fetus, or her child. According to MLI-17, Mali’s ethics committees follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( MLI-7 ), which states that the informed consent form should include a statement on the reasonably foreseeable risks or inconveniences to the participant, and when applicable, to an embryo, fetus, or nursing … Go to Mali > Pregnant Women, Fetuses & Neonates

As per HlthResRegs , studies involving women of childbearing age; women who are in any stage of pregnancy or are postpartum; or studies involving treatments or procedures using embryos, fetuses, or newborns, are required to obtain an informed consent form (ICF) from the woman and her spouse or partner. In addition, HlthResRegs and G-RECs-Op-2018 note that consent from the spouse or partner may only be waived in the case of their incapacity (or irrefutable or manifest inability) to provide it, or when there is imminent risk to the health or life of the woman, embryo, fetus, or newborn. All studies must also comply with the general ethics requirements that must be fulfilled prior to research involving humans as delineated in HlthResRegs . HlthResRegs and G-RECs-Op-2018 further state that research in pregnant women will only be permitted if it is for therapeutic benefit, and represents an opportunity to understand, prevent, or alleviate any serious pathology. HlthResRegs and … Go to Mexico > Pregnant Women, Fetuses & Neonates

As per Decree021-2017 , studies involving women of childbearing age or who are pregnant require additional safeguards to ensure that the research assesses the risks and benefits as well as any potential impact on fertility, pregnancy, the embryo or fetus, labor, lactation, and the newborn. Clinical trials may only be conducted under the following conditions: The informed consent of the woman and her spouse or partner is obtained, and they are given information about any potential risks to the embryo, fetus, or newborn prior to the trial The spouse’s or partner’s consent may only be dismissed in the case of death; their inability to provide reliable consent; loss of rights; or when there is imminent risk to the health or life of the woman or the embryo, fetus, or newborn Informed consent may be withdrawn by the woman or spouse’s or partner’s request at any time, without detriment to them, provided the woman or fetus is not endangered The research must be preceded by trials in … Go to Peru > Pregnant Women, Fetuses & Neonates

… biomedical knowledge that cannot be achieved by other means According to the SL-GCPs , until it has been established whether a fetus ex utero is viable, a fetus ex utero may not be involved as a participant in any research study unless one (1) of the following conditions is met: The fetus faces no added risk from participation in the study, and the purpose of the study is to develop biomedical knowledge that cannot be obtained by other means The purpose of the study is to enhance the … Go to Sierra Leone > Pregnant Women, Fetuses & Neonates

The G-AppConductCT recommends that women of child-bearing potential be included at the earliest possible stages of clinical trial research so that potential sex-related differences are identified and taken into consideration when planning Phase III trials. The timing of including women of childbearing potential or pregnant women in clinical trials should comply with guidance in the International Council for Harmonisation's Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals ( TZA-15 ). Any research involving pregnant women should be individualized and based on a careful risk/benefit assessment, considering: The nature and severity of the disease The availability and results of previous nonclinical and clinical data The availability of alternative therapy and knowledge about their risks The stage of pregnancy in relation to the overall development of the fetus, especially regarding fetal brain development The … Go to Tanzania > Pregnant Women, Fetuses & Neonates

The G-ConsentPIS states that researchers must give a clear warning to potential participants when there is a risk of harm to an unborn child and/or risk when breastfeeding. The Participant Information Sheet (PIS) should provide specific advice to potential participants about the risks of becoming pregnant, of fathering a child, or of breastfeeding while taking part in the research including the need for pregnancy testing, contraceptive requirements, and how to report a pregnancy during the study. The PIS should also provide information about what will happen if a participant becomes pregnant, including whether and how the researcher will monitor the pregnancy. This would include access to the mother's and/or child's notes, and any possible follow up of the child including post-natal examinations. For men, researchers must provide clear warnings and advice if the research treatment could damage sperm and consequently pose a risk to possible pregnancies. Specific advice for pregnant … Go to United Kingdom > Pregnant Women, Fetuses & Neonates

… develop important biomedical knowledge that cannot be obtained otherwise, and there is no added risk resulting from the research Consent is obtained from both parents. If neither parent is able to provide consent, then informed consent of one (1) parent will suffice. Paternal consent is not required if pregnancy was a result of incest or rape. Consent of a legal representative or guardian of either or both parents will not suffice. Viable neonates may only be included in research to the … Go to United States > Pregnant Women, Fetuses & Neonates

Per the G-ECBiomedRes and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( KEN-14 ), prisoners are considered vulnerable because incarceration could affect their ability to make a voluntary decision regarding participation in research. Per the G-KenyaCT , research must be conducted in accordance with requirements set forth in KEN-14 . A research study involving prisoners should ensure that these prospective participants are informed and given the opportunity to make their own decisions without any interference or reprisals from a higher authority. The ethics committee must also ensure that the study will be independently monitored to assure the dignity and rights of the prisoners involved in the … Go to Kenya > Prisoners

… and approve clinical trial protocols. All clinical trial protocols submitted to the ACRE IRB are referred to the NREB.) Per the G-ACRE-IRB , the ACRE IRB may only approve research projects involving prisoners if the research falls under one (1) of the following categories: Study of possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk or inconvenience to the participant Study of prisons as … Go to Liberia > Prisoners

While there is no information available specifically regarding prisoner consent requirements, DecreeNo2017-0245 states that the rights of participants deprived of liberty must be particularly protected. According to LawNo09-059 , persons deprived of liberty may only be solicited for biomedical research if they are expected to receive a direct and major benefit for their health. … Go to Mali > Prisoners

… The SL-GCPs also states that when the EC reviews research involving prisoners, the following requirements must be met: The majority of the EC members, other than prison members, must have no association with the prison(s) involved At least one (1) member of the EC must be a prisoner, or a prisoners’ representative with appropriate background and experience to serve in that capacity. Where a research project is reviewed by more than one (1) EC, only one (1) EC need satisfy this requirement … Go to Sierra Leone > Prisoners

Per the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( GBR-113 ), prisoners are considered vulnerable because incarceration could affect their ability to make a voluntary decision regarding participation in research. A research study involving prisoners should ensure that these prospective participants are informed and are given the opportunity to make their own decisions without any interference from a higher authority. The ethics committee (EC) must also ensure that the study will be independently monitored to assure the dignity and rights of the prisoners involved in the research. GBR-9 indicates that research involving prisoners or conducted within the prison services of the United Kingdom are normally reviewed by a flagged EC in England and Wales if conducted in England and Wales, and any EC in Scotland or Northern Ireland if being conducted in Scotland and Northern Ireland. Per the UKwide-Rsrch , a prisoner or young offender is defined as … Go to United Kingdom > Prisoners

… on prisoner research. As per 45CFR46-B-E , ECs have additional approval responsibilities when reviewing research studies involving prisoners. An EC must only approve these studies if it determines that: The research under review represents one (1) of the permissible categories of research delineated in Subpart C The prisoner’s judgement will not be impaired by any possible advantages accruing to the prisoner through participation in the research, when compared to the general living … Go to United States > Prisoners

The CTEthics points to the involvement of prisoners as a situation that calls for careful scrutiny. The principle of respect for persons requires that prisoners not be deprived of the opportunity to volunteer for research. However, under prison conditions they may be subtly coerced or unduly influenced to engage in research activities for which they would not otherwise volunteer. Respect for persons would then dictate that prisoners be protected. Those involved in clinical research need to balance the competing considerations. Per ZWE-11 , if a participant involved in ongoing research that was approved by the Medical Research Council of Zimbabwe (MRCZ) becomes a prisoner during the study, the researcher must promptly notify the MRCZ for re-review of the protocol. All research interactions and interventions with, and obtaining identifiable private information about, the now-incarcerated participant must be suspended. In special circumstances in which the investigator asserts that it is … Go to Zimbabwe > Prisoners

According to ResNo466 , the research ethics committee (EC) (Comitê de Ética em Pesquisa (CEP)) must approve the participation of research participants who are mentally or physically incapable of giving consent, and sufficient justification must be provided for involving this population in a study. In cases where clarification is necessary to obtain adequate consent from participants with mental disorders or diminished decision-making capacity, investigators must provide a clear justification for their choice, specified in the protocol and approved by the EC (CEP), and by the National Research Ethics Commission (Comissão Nacional de Ética em Pesquisa (CONEP)) , when applicable. In these cases, the stages of clarification and free and informed consent must be followed, through the legal representatives/guardians of those invited to participate in the research, to preserve their right to information to the extent their capacity. In addition, the International Council for Harmonisation … Go to Brazil > Mentally Impaired

As stated in the Guinea-PHC , participants with a mental impairment are at risk in research studies as they are unable to fully comprehend the nature of the research and the informed consent process. Per the Guinea-PHC , mentally impaired participants should be fully informed about the study in which they have been asked to participate. Informed consent must be obtained from the legal representative/guardian who have been informed about the trial. The refusal of a mentally impaired participant should always be respected. Research may only be conducted in mentally impaired participants if it cannot be conducted in healthy participants. Per GIN-17, Guinea is also required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( GIN-7 ). GIN-7 states that when a clinical trial includes participants with mental impairment (e.g., those with severe dementia), the participant should be informed about the trial to the extent compatible with … Go to Guinea > Mentally Impaired

The G-ICMR states that, in the case of differently abled participants, such as those with physical, neurological, or mental disabilities, appropriate methods should be used to enhance the participants’ understanding. The G-ICMR also states that the presence of a mental disorder is not synonymous with incapacity of understanding or inability to provide informed consent. However, ethics committees (ECs) have special responsibilities when research is conducted on participants who are suffering from mental illness and/or cognitive impairment. ECs should exercise caution and require researchers to justify exceptions and their need to depart from the guidelines governing research. ECs should ensure that these exceptions are as minimal as possible and are clearly spelled out in the informed consent form. The G-ICMR also upholds the Declaration of Helsinki ( IND-63 ). As set forth in the MHA2017 , every person, including a person with mental illness, must be deemed to have the capacity to … Go to India > Mentally Impaired

As per the G-ECBiomedRes and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( KEN-14 ), an ethics committee (EC) within the relevant institution must approve the participation of adult research participants who are incapable by reason of physical and mental capacity to give consent. Per the G-KenyaCT , research must be conducted in accordance with requirements set forth in KEN-14 . In addition, as delineated in the G-ECBiomedRes , a research study may involve participants with mental incapacities or behavioral disorders under the following conditions: Such research could not be carried out equally well with individuals who are in possession of their full mental faculties The knowledge gained would be relevant to the health needs of persons with mental or behavioral disorders The participant’s consent has been obtained to the extent of the participant’s capabilities, and a prospective participant’s refusal to participate is always respected In … Go to Kenya > Mentally Impaired

… in the ICF to take part in this research study, as well as their permission for the use and disclosure of the participant’s protected health information. The participant’s assent should also be attained unless this can be justified by one (1) of the following reasons: The EC determined that assent of the participant was not a requirement The capability of the participant is so limited that the participant cannot reasonably be consulted The previously listed options are only … Go to Liberia > Mentally Impaired

DecreeNo2017-0245 states that the rights of participants unable to express themselves with full cognizance must be particularly protected. According to MLI-17, Mali’s ethics committees follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( MLI-7 ), which states that when a clinical trial includes participants with mental impairment (e.g., those with severe dementia), the participant should be informed about the trial to the extent compatible with their understanding and, if capable, the participant should sign and personally date the written informed … Go to Mali > Mentally Impaired

Law30947 establishes a legal framework that guarantees access to services, promotion, prevention, treatment, and rehabilitation in mental health as conditions for the full exercise of the right to health and well-being of the person, the family, and the community. The law states that mental health care takes into account the model of community care as well as respect for human rights and the dignity of the individual, without discrimination and using the intercultural approach, which eliminates the stigmatization of people with mental health problems. Some of the principles addressed in Law30947 specifically applicable to ensuring consent in this vulnerable population include: Confidentiality – Mental health care guarantees the confidentiality of information obtained in the clinical context. The disclosure, examination, or release of medical records without the express consent of the individuals involved, or if applicable, the consent of their legal representative(s), is prohibited … Go to Peru > Mentally Impaired

… Consent cannot be given that is contrary to the interests of a participant with mental or intellectual impairment, and the person's refusal to participate in research must always be respected. Accordingly, consent must be obtained from one (1) of the following: The participant to the extent that the participant is competent to give informed consent The participant’s legal representative/guardian when the participant is deemed not competent to do so An authority, organization, or … Go to Sierra Leone > Mentally Impaired

Per G-ResEthics , informed consent should be obtained from the legal representatives or guardians of participants for studies involving psychiatric or mentally incapacitated patients. The Declaration of Rights and Code of Conduct for Patients ( THA-11 ) also states that parents or legal representatives may exercise their rights on behalf of a physically or mentally handicapped child patient who cannot exercise their rights on their own. As further explained in MentalHlthAct , any research to be conducted with patients who are mentally impaired have the right to: Receive treatment according to medical standards that protect human dignity Have information about their illness and treatment kept confidential other than what is required to be disclosed by law Sign an ethics committee (EC) approved consent form prior to participation Receive equal access to state health insurance and social security systems In addition, MentalHlthAct prohibits disclosure of health information of mentally … Go to Thailand > Mentally Impaired

… for example, through use of an independent, qualified professional Establishing a waiting period in the decision-making process to allow additional time for decision-making Using methods to enhance consent capacity, for example through (1) simplification and/or repetition of information, (2) involvement of a participant advocate or trusted family member/friend to assist when sharing information about the clinical investigation, and (3) refraining from discussions during periods … Go to United States > Mentally Impaired

As per LawNo14.874 , ResNo945 , the G-BioIProdManual , and the G-SynthDrugProdManual , an investigational product (IP) is defined as an experimental drug, placebo, active comparator, or any other product to be used in a clinical trial. (Note: Experimental drugs are a subset of IPs, however, the sources and the profile use the two (2) terms interchangeably.) In addition, the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( BRA-28 ), which Brazil has adopted per ResNo945 , states that an IP is a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved … Go to Brazil > Definition of Investigational Product

As delineated in the CanadaFDR , the G-GMP-Annex13 , and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ), an investigational product is defined as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form. Per CAN-50 , Canada has implemented CAN-52 . Note that per CAN-50 , Health Canada (HC) -implemented ICH guidance takes precedence over other HC guidance when they are not consistent. For HC’s interpretation of the relevant provisions of the CanadaFDR , see the G-FDR-0100 … Go to Canada > Definition of Investigational Product

Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( GIN-7 ). GIN-7 defines an investigational product as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved … Go to Guinea > Definition of Investigational Product

As delineated in the 2019-CTRules , an investigational product (IP) is defined as the pharmaceutical formulation of an active ingredient or a placebo (including the comparator product) being tested or used as a reference in a clinical trial. The 2019-CTRules further defines an investigational new drug as a new chemical or biological entity or a product having a therapeutic indication, but which has never been tested before on human participants. … Go to India > Definition of Investigational Product

According to MLI-17, Mali’s ethics committees follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( MLI-7 ), which defines an investigational product as a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial. This includes a product with a marketing authorization when it is used or assembled (formulated or packaged) in a different way from the approved form, when used for an unauthorized indication, or when used to gain further information about an approved … Go to Mali > Definition of Investigational Product

As delineated in COFEPRIS-GCP and the Guideline for Good Clinical Practice E6 (R1) ( MEX-32 ), an investigational product (IP) is defined as any pharmaceutical form containing an active ingredient or placebo, or a product of biological or biotechnological origin that is used or tested in a clinical trial, including a registered product when used or packaged in a different way with for which it was authorized, or when it is tested for indications that have not been authorized, or when it is used to obtain more information about its authorized use. COFEPRIS-GCP also notes this definition also applies to new chemical and biological entities, generics, new formulations, combination products, and biosimilars, and medical devices with or without the release of some active ingredient. NOM-012-SSA3-2012 similarly states that investigational medicines or devices are used or applied to humans for scientific research purposes, for which there is insufficient scientific evidence to demonstrate … Go to Mexico > Definition of Investigational Product

As delineated in Decree021-2017 and the G-SafeRpt , an investigational product (IP) is defined as a pharmaceutical form of an active substance or placebo, being tested or used as an active comparator in a clinical trial. This includes a product with a marketing authorization when it is used or assembled (formulated or packaged) in a different way from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use. Decree021-2017 also defines a placebo as a product with a pharmaceutical form, with no active ingredient, and therefore devoid of specific pharmacological action, which may be used as a control in the clinical trial or for maintaining … Go to Peru > Definition of Investigational Product

… indication, or when used to gain further information about an approved use. Per ClinImprtOrdr , clinical trials in Thailand must comply with THA-28 . G-ResEthics states that an investigational drug used in a clinical trial falls into one (1) of four (4) categories: New drugs Unregistered drugs in Thailand Drugs registered by the national drug authority, but being studied in new doses or indications not previously approved Locally produced drugs that require efficacy testing … Go to Thailand > Definition of Investigational Product

As delineated in the MHCTR , the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( GBR-113 ), and GBR-9 , an investigational product (IP), referred to as an investigational medicinal product (IMP) in the United Kingdom (UK), is defined as a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial. This includes a product with a marketing authorization when it is used or assembled (formulated or packaged) in a different way from the approved form; when used for an unapproved indication; or when used to gain further information about an approved … Go to United Kingdom > Definition of Investigational Product

As delineated in 21CFR312 , an investigational new drug is defined as a new drug or biological drug that is used in a clinical investigation. This includes a biological product that is used in vitro for diagnostic purposes. The terms ‘investigational drug’ and ‘investigational new drug’ are deemed to be synonymous for the purposes of this part. Additionally, the US-ICH-GCP defines an investigational product as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved … Go to United States > Definition of Investigational Product

… products (IPs) (i.e., therapeutic goods being used in a clinical trial) in Australia. As per AUS-88 and AUS-49 , the sponsor provides manufacturing and/or active ingredient information to the TGA in the clinical trial application under one (1) of the two (2) regulatory schemes—the Clinical Trial Notification (CTN) scheme or the Clinical Trial Approval (CTA) scheme. AUS-49 indicates that as part of a CTN scheme application involving a medicine or biological, the sponsor must provide … Go to Australia > Manufacturing & Import

… ), and must be made or countersigned by the head of the institution in which, or a director of the firm or company by which, the substance will be manufactured. A Form 17 license ( BGD-21 ) will, unless sooner cancelled, be in force for one (1) year from the date of issue, and may thereafter be renewed one (1) year at a time. According to the BGD-GCP , the IP(s) must be manufactured in good manufacturing practice (GMP)-compliant facilities. For investigational new drugs (INDs), the sponsor must submit the IND certificate from the national regulatory … from the DGDA. The DGDA has a legal responsibility to ensure that the IP has been manufactured in accordance with GMP and meets the conditions of the clinical trial authorization and the product specification file (PSF) (See Annexure 1 of the G-BGD-IP ). The DrugsCosAct indicates that as with the manufacture license, an import license may be temporarily suspended or canceled by the DGDA Director General if the manufacturer’s pharmacovigilance program is not conducted … Go to Bangladesh > Manufacturing & Import

… research is not to register or change the product registration. Also specified in ResNo208 (amending ResNo81 ) and ResNo613 (amending ResNo172 ), is the requirement that the investigator and institution submit the imported products through one (1) of the following methods: BRA-80 or Express Shipping. As indicated earlier in this section, the import petition must be submitted electronically and should comply with the documentation submission requirements discussed above and include the … Go to Brazil > Manufacturing & Import

… and is responsible for providing an attestation with respect to the CTA at the time of filing. Per the G-CanadaCTApps , the G-DrugApp , and CAN-4 , if clinical trial drugs are to be imported into Canada, the authorization template (Appendix 1) in CAN-4 should be completed and submitted for each importer in Canada. The G-DrugApp states that Canadian importer(s) must be located within Canada. As additional importers are identified, additional copies of the authorization template in … to send the clinical trial IP(s) directly to each trial site: Each party, including individual Canadian clinical trial sites, importing drugs directly (i.e., receiving drug shipments directly from outside of Canada) is identified on Appendix 1 of the Drug Submission Application Form (HC/SC 3011 form) ( CAN-4 ) for Phase I-III trials (submitted with the application if known at the time or prior to importation at the site). Appendix 1 may be replicated as many times as necessary to capture all importing parties. Clinical Trial Site Information (CTSI) forms ( CAN-6 ) for each Canadian site conducting the clinical trial are submitted to HC for Phase I-III trials, prior to the … Go to Canada > Manufacturing & Import

Manufacturing According to the DAL and the NMPA-No28-2020 , the National Medical Products Administration (NMPA) is responsible for authorizing the manufacture of investigational products (IPs) in China. See CHN-11 for an analysis of the authorization procedure for manufacturing drugs in China. Per the DAL and the NMPA-No28-2020 , the holder of the drug registration certificate must obtain a drug production license (found at NMPA-No72-2019 ) to produce a drug or entrust a pharmaceutical production enterprise to produce it. If an entrusted production enterprise is used, the drug registration certificate holder and the entrusted production enterprise must sign an entrustment agreement and a quality agreement. Blood products, narcotic drugs, psychotropic drugs, medical toxic drugs, and pharmaceutical precursor chemicals cannot be entrusted to a pharmaceutical production enterprise for production, unless otherwise stipulated by the NMPA. The DAL states that the drug production license must … Go to China > Manufacturing & Import

… is required for the shipment of the IP to be used in the trial. The sponsor may apply for IP import approval through ACOREP’s Digital Platform ( DRC-13 ). Please note: DRC is party to the Nagoya Protocol on Access and Benefit-sharing ( DRC-1 ), which may have implications for studies of IPs developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see DRC-7 . … Go to DRC > Manufacturing & Import

… for Good Clinical Practice E6(R2) ( GIN-7 ), which requires IPs to be manufactured, handled, and stored in accordance with applicable Good Manufacturing Practice (GMP) and used in accordance with the approved protocol. Import According to GIN-1, once the principal investigator (PI) obtains ethics committee approval from the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)) , the sponsor or the representative (typically the PI) must submit a written request along with additional documentation to the DNPM director to obtain approval to import IPs. (See the Submission Content section for detailed documentation requirements.) According to GIN-1, the DNPM’s approval of a drug import license application typically takes two (2) weeks. Additional information on the DNPM review and approval process is not available at this time. Please note: Guinea is party to the Nagoya Protocol on Access … Go to Guinea > Manufacturing & Import

… international non-proprietary name (INN) or generic name, drug category, dosage form, and data supporting IP stability in the intended container-closure system for the duration of the clinical trial. See the 2019-CTRules (Second Schedule, Table 1) for detailed data requirements. Additionally, for Phase III clinical trial batches, process validation data requirements may not be required; however, this requirement will vary depending on the IP’s complexity (biological, high tech, etc.). If … Go to India > Manufacturing & Import

Manufacturing According to the PPA and the G-KenyaCT , the Pharmacy and Poisons Board (PPB) is responsible for authorizing the manufacture of all drug products, including investigational products (IPs) in Kenya. Per the CTRules and the G-KenyaCT , an IP must be manufactured in accordance with the requirements of good manufacturing practice (GMP). The CTRules requires a sponsor to immediately notify the PPB in writing when a pharmaceutical or chemical alteration may affect the quality, safety, or efficacy of the IP product during an ongoing clinical trial. The G-KenyaCT states that the sponsor must submit the IP dossier directly to the PPB or may submit it through the principal investigator. The IP dossier must be prepared as per the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( KEN-14 ), which is required per G-KenyaCT . The manufacture of IPs may be subject to GMP inspection by the PPB in the same way as in the case of marketed drug products. … Go to Kenya > Manufacturing & Import

Manufacturing As set forth in the LMHRA-Act , the Liberia Medicines and Health Products Regulatory Authority (LMHRA) is responsible for issuing licenses or permits for premises and personnel to engage in the manufacture of medicinal products in Liberia. The LibCTReg also states that investigational products (IPs) for clinical trials must be manufactured according to internationally accepted good manufacturing practice (GMP) principles. Per the LibCTReg and the G-LibClinTrial , the LMHRA has also adopted the International Council for Harmonisation (ICH)'s Guideline for Good Clinical Practice E6(R2) ( LBR-8 ) for use along with the LMHRA guidelines. LBR-8 notes that the sponsor should ensure an IP including the active comparator(s) and placebo, if applicable, is characterized as appropriate to the IP’s stage of development and is manufactured in accordance with applicable GMP. Per LBR-29, the World Health Organization’s (WHO) GMP Guidelines for IPs ( LBR-26 ) and the International … Go to Liberia > Manufacturing & Import

… be conducted according to instructions given by or on behalf of the sponsor in the shipping order. A pre-clearance inspection should be carried out at the port of entry by the PMRA. The sponsor must complete the cover sheet contained in Annex 1 of the D-ImprtRelIMPs for the importation and release of IPs. Please note: Malawi is party to the Nagoya Protocol on Access and Benefit-sharing ( MWI-3 ), which may have implications for studies of IPs developed using certain non-human genetic … Go to Malawi > Manufacturing & Import

… in accordance with applicable good manufacturing practice (GMP) and used in accordance with the approved protocol. DecreeNo2017-0245 further mandates that clinical research must follow good clinical practices. In addition, as specified in MLI-1 , the sponsor (also known as the promoter in Mali) must provide the following documentation to the DPM in the clinical trial application submission package: Certificate(s) of GMPs for products issued by the pharmaceutical regulatory authority in … product, other products used in the clinical trial) Establishment opening certificates and/or authorization certificates of manufacturing laboratories issued by the pharmaceutical regulatory authority of the country of manufacture (see MLI-1 for application) Import According to MLI-17, the Ministry of Health and Social Development (Ministère de la Santé et du Développement Social (MSDS)) is responsible for authorizing the import of IPs in Mali. Once the DPM receives the EC approval … and approves the import license prior to product shipment. Per DPM-ClinTrialDocs , the import license is valid for six (6) months. (See the Scope of Assessment section for more details on the clinical trial application review process). Per MLI-1 , the sponsor must also provide copies of import and/or export requests for IPs to the DPM in the clinical trial application submission package (see MLI-1 for application). Please note: Mali is party to the Nagoya Protocol on Access and … Go to Mali > Manufacturing & Import

… national territory for an unlimited time Temporary import – authorizes the entry of products for a limited time and with a specific purpose, with the understanding that they must return to the country of origin in a period not exceeding one (1) year Import in transit – authorizes the entry of products for their transfer from one (1) national office to another, for their departure to leave the country, within a period not exceeding 30 days, and for sale or temporary distribution. The sale or distribution is authorized exclusively for medicines to be used for strategic … in all sources, which provide overlapping and unique elements): Authorizations, Certificates and Visits Form (see MEX-25 ) (Original) Proof of payment of fees (original and two (2) copies) Health License Notice of Operation (original and one (1) copy) Approval from the research protocol office authorized by COFEPRIS and its amendments, (only in the case of research on human beings) (original and one (1) copy) Technical and scientific information demonstrating the identity and purity of … Go to Mexico > Manufacturing & Import

… that the ANM will grant this authorization within three (3) business days of filing the application. See Scope of Assessment section for additional information on the ANM’s role in the clinical trial application approval process, and Annex 1 in Res252-2002 for a flowchart delineating the clinical trial authorization process. In addition, per Decree021-2017 , the INS-CTManual , and Res252-2022 , the sponsor or the CRO must apply to the DIIS using PER-117 to expand or modify the list … Go to Peru > Manufacturing & Import

Manufacturing As set forth in the PDA2001 , the Pharmacy Board of Sierra Leone (PBSL) is responsible for authorizing the manufacture of all drug products in Sierra Leone. According to the SL-GCPs , the sponsor must ensure that the investigational product (IP) is manufactured in accordance with applicable good manufacturing practice (GMP). The G-SLAppClinTrial states that a GMP certificate from the national competent authority of the country of origin is required when the IP has no marketing authorization in Sierra Leone, or has marketing authorization but its original indication is modified for the purpose of the trial. The GMP certificate should conform to the World Health Organization (WHO) format. Import The G-SLAppClinTrial states that the PBSL is responsible for authorizing the import of IPs. A request to import an IP may be submitted after the PBSL has approved the clinical trial application. The G-SLAppClinTrial indicates that the import application submission must include the … Go to Sierra Leone > Manufacturing & Import

Manufacturing According to the SA-GMPs and the GRMRSA , the South African Health Products Regulatory Authority (SAHPRA) is responsible for authorizing the manufacture of investigational products (IPs) in South Africa. As delineated in the G-ManuImpExp , a manufacturer’s license for IPs is required for both total and partial manufacture, and for the various processes of dividing up, packaging, or presentation, in accordance with the MRSA . To obtain a license, the application form ( ZAF-55 ) should be emailed to SAHPRA at gmplicensing@sahpra.org.za , accompanied by the following information: Proof of payment Existing SAHPRA license for renewal and amendment applications Cover letter Site Master File Signed declaration SAHPRA inspection resolution Intellectual property documentation Department of Health premises license Registration of responsible pharmacist South African Pharmacy Council (SAPC) Record of a Pharmacy SAPC Record of a Pharmacy Owner Municipal Approval/Zoning Certificate … Go to South Africa > Manufacturing & Import

… the supplier Name and address of the manufacturer of each product Trade or proprietary name of each product The international nonproprietary name (generic name) of the drug and its strength In the case of the product containing more than one (1) active ingredient, the name and strength of each product The pharmacopoeia specification of the ingredient of each product Product registration number issued by the authority for each product The quantity, pack size, unit value, and total value … a trader account. An online access registration form is available in Annex I of the G-ImpExp . As delineated in the TFDCA-ImptExpt and the G-ImpExp , the import permit is valid for six (6) months, not transferable, and issued to cover only one (1) shipment. Per the G-ImpExp , in the case of partial shipments, two (2) shipments may be allowed based on the initial import permit. See the TFDCA-ImptExpt and the G-ImpExp for detailed import application requirements. The TFDCA-ImptExpt and the … Go to Tanzania > Manufacturing & Import

… after the clinical trial application has been approved. As explained in ClinSampleProd , the Thai FDA’s approval of a request to manufacture drug samples for investigational purposes is obtained using the P.Y.8 form ( ClinSampleProd (Appendix 1) or THA-76 (Appendix 1)). ClinSampleProd specifies that the following information must be included with the P.Y.8 form (Appendix 1): Detailed list of manufactured drugs Appearance and color of medicine Number or quantity to be produced Quantity of drug ingredients (must be reported in metric units or in a percentage) Packaging size (packaging details) Specifying if drug … Go to Thailand > Manufacturing & Import

Manufacturing According to the NDPA-CTReg , the G-CTConduct , and the G-TrialsGCP , the National Drug Authority (NDA) is responsible for authorizing the manufacture of investigational products (IPs) in Uganda. The NDA will only approve the manufacture of an IP after approval of the clinical trial application. The NDPA-CTReg indicates that if the IP is to be manufactured in Uganda, the holder of the clinical trial certificate must apply to the NDA for a manufacturing license. Uganda follows the G-GMPMedicinal , the G-GMP-APIs , and the G-GMPAnnexes for good manufacturing practice (GMP), which were adopted from Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidance. Per the G-GMPMedicinal , the holder of the NDA’s manufacturing authorization must manufacture IPs to ensure that they are fit for their intended use; comply with the requirements of the clinical trial authorization; and do not place participants at risk due to inadequate safety, quality, or efficacy. The G-GMPAnnexes … Go to Uganda > Manufacturing & Import

… ( GBR-113 ), the MIA(IMP) holder must also comply with the GMP guidelines and provide an IMP Certificate of Analysis. In addition, the MHCTR and the MHCTR2006 specify that the holder of an MIA(IMP) must always have the services of at least one (1) QP at their disposal. The QP must satisfy the qualification and experience requirements delineated in the aforementioned sources. The QP’s primary legal responsibility is to certify batches of IPs prior to use in a clinical trial, or prior to … Go to United Kingdom > Manufacturing & Import

… in accordance with GMPs. Import As set forth in 21CFR312 , the FDA is also responsible for authorizing the import and export of IPs. An IP may be imported into the US if it is subject to an IND that is in effect for it and complies with one (1) of the following requirements: The IP consignee is the IND sponsor, or The consignee is a qualified investigator named in the IND, or The consignee is the domestic agent of a foreign sponsor, is responsible for the control and distribution of … Go to United States > Manufacturing & Import

… trials are categorized as finished drugs without registration numbers. Once the MOH approves the study approval dossier, an import permit application must be submitted to the MOH’s DAV for approval of the IP. The import permit is valid for one (1) year. The PharmLaw-VNM further indicates that a drug/medicinal ingredient that does not have a certificate of free sale must be licensed for import with a quantity not exceeding that which is written on the import license when it is to be used … Go to Vietnam > Manufacturing & Import

… certificate(s) (where applicable) for all batches to be imported Per ZWE-83, applications for importation of IPs should be emailed to mcaz@mcaz.co.zw and pvct@mcaz.co.zw using the Section 75 application tab on the Clinical Trials Registry ( ZWE-1 ) for the relevant clinical trial, or submitted as a hard copy to MCAZ. Note that to import registered medicines for a clinical trial, the requirements in the MSC-ImportExport must be followed. Per the CT-AppAuth and the Pharm-IMPs , the MCAZ … Go to Zimbabwe > Manufacturing & Import

… use and as required by the clinical trial authorization. A pharmaceutical quality system designed, set up, and verified by the manufacturer or importer should be described in written procedures, taking into account the guidance in Chapter 1 or Part I of the AU-PIC-S-GMP-Guide . Manufacturers should maintain documentation including specifications and instructions; the IP order; manufacturing formulae and processing instructions; packaging instructions; and batch records. The product … Go to Australia > Quality Requirements

… a repeated dose study, or a special study Results of clinical pharmacokinetic studies Information regarding safety, pharmacodynamics, efficacy, adverse events data, and dose responses obtained from prior clinical trials in humans For phase 1 clinical trials involving the use of a drug for the first time in humans (First-in-human, FIH), attach reports of toxicity and detailed pharmacokinetic and pharmacodynamic studies, as a complement to the IB as soon as they are available … Go to Brazil > Quality Requirements

Investigator’s Brochure In accordance with the CanadaFDR and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ), which Canada has implemented per CAN-50 , the sponsor is responsible for providing the investigators with an Investigator’s Brochure (IB). The CanadaFDR and CAN-52 specify that the IB must contain all of the relevant information on the investigational product(s) (IPs), including significant physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical information. The sponsor must ensure that an up-to-date IB is made available to the investigator(s), and the investigator(s) must provide an up-to-date IB to the ethics committee. Note that per CAN-50 , Health Canada (HC) -implemented ICH guidance takes precedence over other HC guidance when they are not consistent. For HC’s interpretation of the relevant provisions of the CanadaFDR , see the G-FDR-0100 . The CanadaFDR and … Go to Canada > Quality Requirements

Investigator’s Brochure Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( GIN-7 ). As specified in GIN-7 , the Investigator’s Brochure (IB) must include the following sections: Table of Contents Summary Introduction Physical, Chemical, and Pharmaceutical Properties and Formulation Nonclinical Studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles) Effects in Humans (pharmacology, pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; and regulatory and post-marketing experiences) Summary of Data and Guidance for the Investigator(s) The sponsor should also update the IB as significant new information becomes available. See GIN-7 for detailed content guidelines. Quality Management Per GIN-7 , the sponsor must maintain a Certificate of Analysis to document the identity, purity, and strength of the IP(s) to be used in the clinical … Go to Guinea > Quality Requirements

… to submit the international non-proprietary name (INN) or generic name, drug category, dosage form and data supporting IP stability in the intended container-closure system for the duration of the clinical trial (see the Second Schedule, Table 1 in the 2019-CTRules for detailed data requirements). Additionally, for Phase III clinical trial batches, process validation data requirements may not be required; however, this requirement will vary depending on the IP’s complexity (biological, … Go to India > Quality Requirements

Investigator’s Brochure In accordance with the CTRules and the G-KenyaCT , the sponsor must provide an up-to-date Investigator’s Brochure (IB). An updated IB and Drug Safety Update Report (DSUR) must be submitted whenever available but at least once a year as a notification to the Pharmacy and Poisons Board (PPB) or when there are substantial changes to the previous version. Per the G-KenyaCT , research must be conducted in accordance with the requirements set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( KEN-14 ). As specified in the G-KenyaCT and KEN-14 , the IB must provide coverage of the following areas: Physical, chemical, and pharmaceutical properties The pharmacological aspects including its metabolites in all animal species tested The pharmacokinetics and metabolism including its biological transformation in all animal species tested Toxicological effects in any animal species tested under a single dose study, a repeated … Go to Kenya > Quality Requirements

… and the results of physical and analytical tests. Per MWI-22 , the sponsor must maintain a CoA to document the identity, purity, and strength of the IP(s) to be used in the clinical trial. The sponsor should complete the cover sheet in Annex 1 of the D-ImprtRelIMPs , include it with each IP shipment, and use the checklist in Annex 2 to ensure the required documentation is attached. As delineated in the D-ImprtRelIMPs , the sponsor should also prepare IP shipping instructions, … Go to Malawi > Quality Requirements

Investigator’s Brochure According to MLI-17, Mali’s ethics committees (ECs) follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( MLI-7 ), which provides detailed Investigator’s Brochure (IB) requirements. MLI-7 specifies that the IB must contain all of the relevant information on the investigational products (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse event data. The sponsor should also update the IB as significant new information becomes available. As specified in MLI-7 , the IB must include the following sections: Table of Contents Summary Introduction Physical, Chemical, and Pharmaceutical Properties and Formulation Nonclinical Studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles) Effects in Humans (pharmacology, pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; and regulatory … Go to Mali > Quality Requirements

Investigator’s Brochure As indicated in MEX-2 , COFEPRIS is in the process of implementing the ICH Guideline for Good Clinical Practice E6 (R2) ( MEX-22 ). G-HumResProt , MEX-84 , and G-DIGIPRiS-ResProts are in compliance with the Guideline for Good Clinical Practice E6 (R2) ( MEX-22 ), regarding investigational product (IP) quality/manufacturing and investigator’s brochure (IB) requirements (also known as investigator’s manual in Mexico), while COFEPRIS-GCP complies with the Guideline for Good Clinical Practice E6 (R1) ( MEX-32 ). As set forth in GenHlthLaw , and G-HumResProt , MEX-84 , and G-DIGIPRiS-ResProts , which are in compliance with ( MEX-22 ), the applicant or sponsor is responsible for providing the investigators with an investigator’s brochure (IB). MEX-22 specifies that the sponsor is generally responsible for ensuring that an updated IB is made available to the investigator(s), and the investigators are responsible for providing the updated IB to the responsible ethics … Go to Mexico > Quality Requirements

Investigator’s Brochure In accordance with Decree021-2017 , Res655-2019 (amending Decree021-2017 ), and Res252-2022 (amending the INS-CTManual ), the sponsor or the contract research organization (CRO) is responsible for providing the investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events (AEs) data. As noted in Decree021-2017 , the IB must be validated and updated on a regular basis by the sponsor and at least once a year by the responsible team member (if not the sponsor), when new information on the IP—not yet included in the IB—becomes available. Decree021-2017 and the INS-CTManual indicate that the updated IB should be sent to the INS’s Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) , the ethics committees (ECs), and … Go to Peru > Quality Requirements

Investigator’s Brochure In accordance with the SA-GCPs , the sponsor is responsible for ensuring an up-to-date Investigator’s Brochure (IB) is available to the investigator; investigators must provide it to the responsible ethics committee (EC). In the case of an investigator-sponsored trial, the sponsor-investigator must determine whether an IB is available from the commercial manufacturer. The SA-GCPs states that the IB should contain the following sections, each with literature references where appropriate: Table of Contents Summary: A brief summary (preferably not exceeding two (2) pages) to highlight the significant physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical information available that is relevant to the stage of clinical development of the investigational product (IP) A brief introductory statement with the chemical name (and generic and trade name for an approved product) of the IP, all active ingredients in the … Go to South Africa > Quality Requirements

Investigator’s Brochure In accordance with the CT-Regs and the G-AppConductCT , the Tanzanian government follows the International Council for Harmonisation's (ICH) Guideline for Good Clinical Practice E6(R2) ( TZA-13 ), and requires the sponsor or the designated contract research organization (CRO) to provide investigators with an Investigator’s Brochure (IB). The G-AppConductCT states that the IB should be presented in a concise, simple, objective, balanced, and non-promotional form that enables a clinician, or potential investigator, to understand it and make an unbiased risk-benefit assessment of the appropriateness of the proposed trial. The contents of the IB should be approved by the disciplines that generated the described data and a medically qualified person should generally participate in the editing of an IB. If the investigational product (IP) is locally marketed and its pharmacology is well established and widely understood by medical practitioners, an extensive IB may … Go to Tanzania > Quality Requirements

Investigator's Brochure In accordance with ClinImprtOrdr , ClinSampleProd , G-ResEthics , G-CT-DIPApp , and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( THA-28 ), the sponsor or the designated contract research organization (CRO) is responsible for providing the investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. The sponsor should also update the IB as significant new information becomes available. Per ClinImprtOrdr , clinical trials in Thailand must comply with THA-28 . ClinImprtOrdr and ClinSampleProd further state that the IB should comply with the current version of THA-28 . Per ClinImprtOrdr , the sponsor is also referred to as the applicant or importer. As specified in G-ResEthics , ClinImprtOrdr , and ClinSampleProd … Go to Thailand > Quality Requirements

Investigator’s Brochure In accordance with the MHCTR , the MHCTR2006 , and GBR-92 , the sponsor or the designated representative is responsible for providing investigators with an Investigator’s Brochure (IB), which must contain all of the relevant information on the investigational product(s) (IPs) (known as investigational medicinal products (IMPs) in the United Kingdom (UK)) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. The sponsor or the designated representative should also update the IB as significant new information becomes available. As specified in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( GBR-113 ), the IB must provide coverage of the following areas: Physical, chemical, and pharmaceutical properties and formulation parameters Non-clinical studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles) Effects of IPs in humans … Go to United Kingdom > Quality Requirements

Investigator's Brochure In accordance with 21CFR312 and the US-ICH-GCP , the sponsor is responsible for providing investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational new drug(s)/investigational product(s) (IPs) obtained through the earlier research phases. The sponsor must also update the IB as significant new information becomes available. As specified in 21CFR312 and the US-ICH-GCP , the IB must provide coverage of the following areas (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements): A brief description of the drug substance and the formulation, including the structural formula, if known A summary of the pharmacological and toxicological effects of the drug in animals and, to the extent known, in humans A summary of the pharmacokinetics and biological disposition of the drug in animals and, if known, in humans A summary of … Go to United States > Quality Requirements

Investigational product (IP) labeling must comply with the requirements set forth in the G-CTHandbook , the AU-ICH-GCP , and the AU-PIC-S-GMP-Guide . (Note: In Australia, therapeutic goods being used in a clinical trial are IPs.) Per the AU-PIC-S-GMP-Guide , as annotated by the G-CTHandbook , the following information must be included on the IP label: Sponsor’s name, address, and phone number. The main contact details for information on the product, clinical trial, and emergency unblinding must be an Australian contact Pharmaceutical dosage form, route of administration, and quantity of dosage units. For closed blinded trials, the labeling should include a statement indicating “placebo or [name/identifier] + [strength/potency]” The batch and/or code number to identify the contents and packaging operation A trial reference code, which should identify the particular trial site, unless provided elsewhere or its absence can be justified. The trial reference code used should also identify … Go to Australia > Labeling

Investigational product (IP) labeling in Brazil must comply with the requirements set forth in ResNo945 , the G-DDCMManual , RegNo136 , the G-BiolProdManual , and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( BRA-28 ), which Brazil has adopted per ResNo945 . As described in the RegNo136 and the G-BiolProdManual , the following labeling information must be included on the primary package label (or any intermediate packaging), and the outer packaging (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements): Name, address, and telephone number of sponsor, contract research organization (CRO) (clinical research representative organization (CRPO) in Brazil), or investigator (the main contact for information about the product, clinical trial and emergencies) Presentation, pharmaceutical form, route of administration, quantity of dosage units, and the drug … Go to Brazil > Labeling

Investigational product (IP) labeling in Canada must comply with the requirements set forth in the CanadaFDR , the G-CanadaCTApps , the G-GMP-Annex13 , and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ). The CanadaFDR and the G-CanadaCTApps state that for an IP to be used in a clinical trial, it must be properly labeled in both official languages: English and French. The CanadaFDR requires that IPs be packaged and labelled under the supervision of personnel who have had satisfactory technical, academic, and other training. The packager and/or labeler must have written procedures and ensure that the IP is packaged, labelled, and tested in compliance with those procedures. For Health Canada (HC) ’s interpretation of the relevant provisions of the CanadaFDR , see the G-FDR-0100 . Per CAN-50 , Canada has implemented CAN-52 . As delineated in the CanadaFDR and the G-GMP-Annex13 , the following information must be included on the … Go to Canada > Labeling

… overlapping and unique elements.) Adopted name in China Instructions Generic name License holder and their address Indications or functions Strength, dosage, and usage Production date and batch number Expiration (Should be marked as one (1) day or one (1) month earlier than the actual expiration date, depending on whether the date is labeled to a specific day or month) Manufacturer and their address Ingredients Adverse reactions Contraindications and precautions Storage information Approval … Go to China > Labeling

The G-EthicalEval requires that the principal investigator agree to work in accordance with the Declaration of Helsinki ( DRC-11 ), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products ( DRC-10 ), and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( DRC-3 ). DRC-3 provides guidance on labeling of investigational products, stating that they should be coded and labeled in a manner that protects the blinding, if applicable. Per DRC-12, labeling materials must be included in the clinical trial application to the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) of the Ministry of Public Health, Hygiene and Prevention (Ministère de la Santé Publique, Hygiène et Prévention) … Go to DRC > Labeling

Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( GIN-7 ), which states that the investigational product (IP) must be coded and labeled in a manner that protects the blinding, if applicable. The IPs must also be suitably packaged in a manner that will prevent contamination and unacceptable deterioration during transport and storage. … Go to Guinea > Labeling

Per the 2019-CTRules and IND-31 , the labeling of any new drug or investigational new drug product manufactured or imported for the purpose of conducting a clinical trial or for testing and analysis should include the following items: The drug name or code number Batch number or lot number Manufacture date Use before date Storage conditions Name of institution/organization/center where the clinical trial or testing and analysis is proposed to be conducted Manufacturer name and address Purpose for which the investigational product is being … Go to India > Labeling

Per the G-KenyaCT , investigational products (IPs) used in Kenyan clinical trials must be properly labelled. A final copy/version of the labelling must be submitted to the Pharmacy and Poisons Board (PPB) for approval and should contain the following minimum information: Statement indicating that the product is for “clinical trial purpose only” Recommended storage conditions Protocol code or identification Name, address, and telephone number of the sponsor, contract research organization, or investigator (the main contact for information on the product, clinical trial, and emergency unblinding) Pharmaceutical dosage form, route of administration, quantity of dosage units, and in the case of open trials, the name/identifier and strength/potency The batch and/or code number to identify the contents and packaging operation A trial reference code allowing identification of the trial, site, investigator, and sponsor, if not given elsewhere The trial participant identification … Go to Kenya > Labeling

According to MLI-17, Mali’s ethics committees follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( MLI-7 ), which states that the investigational product be coded and labeled in a manner that protects the blinding, if applicable. … Go to Mali > Labeling

Investigational product (IP) labeling in Mexico must comply with the requirements set forth in COFEPRIS-GCP , NOM-164-SSA1-2015 , NOM-059-SSA1-2015 , and the Guideline for Good Clinical Practice E6 (R1) ( MEX-32 ). As delineated in COFEPRIS-GCP and NOM-059-SSA1-2015 , the IP label must be written in Spanish and contain, at a minimum, the following information (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements): Name, address, and telephone number of the sponsor or main contact Protocol identification number Pharmaceutical form and route of administration Manufacturer name and address Lot number, identification code, and dosage form Statements: “For clinical studies only” or "Permitted use only investigation ", "Forbidden marketing", and "Keep away from the reach of children" Symbol or pictograms warning, if applicable Expiration date Storage conditions NOM-164-SSA1-2015 also states that the IP label must … Go to Mexico > Labeling

Investigational product (IP) labeling in Peru must comply with the requirements set forth in Decree021-2017 . Labels for IPs used in a clinical trial must be written in Spanish or English language and printed in indelible ink. In addition, the following information must be included as a minimum on the product label: Name, address, and telephone number of the sponsor or contract research organization (CRO) Trial number and/or trial title IP name or unique code Date of IP’s expiration or reanalysis Manufacturing lot number Number of units and pharmaceutical form Route of administration Special storage and conservation requirements “For research use only”, “no sale”, or similar wording indicating the IP is clinical trial material The inner labeling of the IP should contain: IP name Active ingredient concentration Route of administration Manufacturer's name or logo Batch number and expiration date In double-blind trials where the IP character, lot number, and manufacturer’s name are not … Go to Peru > Labeling

… forth in the SA-GCPs , the GRMRSA , MRSA , and the PIC-S-GMP-Guide (which South Africa adopted pursuant to the SA-GMPs ). The GRMRSA states that for an IP to be used in a clinical trial, it must be properly labeled in English and at least one (1) other official language, and should appear in clearly legible and indelible letters. As set forth in the PIC-S-GMP-Guide , the following labeling information must be included on both the outer packaging and the immediate container: The name, … Go to South Africa > Labeling

Investigational product (IP) labeling in Thailand must comply with the requirements set forth in ClinImprtOrdr , ClinSampleProd , G-ResEthics , G-CT-DIPApp , and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( THA-28 ). Per ClinImprtOrdr , clinical trials in Thailand must comply with THA-28 . G-ResEthics and THA-28 state that the IP must be coded and labeled in a manner that protects blinding, if applicable. In addition, per G-CT-DIPApp , if a drug product is registered in Thailand, a certified copy of a certificate(s) of drug registration by the Thai Food and Drug Administration (Thai FDA) must be submitted. ClinImprtOrdr , ClinSampleProd , and G-CT-DIPApp specify that in general, primary and secondary labels must contain (at least) the following requirements (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements): All containers and packaging of all sizes are to use … Go to Thailand > Labeling

Labeling for investigational products (IPs) (known as investigational medicinal products (IMPs) in the United Kingdom (UK)) must comply with the requirements set forth in the MHCTR , the MHCTR2006 , GBR-15 , and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( GBR-113 ). As specified in GBR-15 , for an IP to be used in a clinical trial, it must be properly labeled in the official language of the country where the trial is being conducted. As set forth in GBR-15 , the following labeling information must be included on the primary package label (or any intermediate packaging), and the outer packaging: Name, address, and telephone number of the sponsor, contract research organization (CRO), or investigator Pharmaceutical dosage form, route of administration, quantity of dosage units, and in the case of open trials, the name/identifier and strength/concentration Batch and/or code number to identify the contents and packaging operation Trial … Go to United Kingdom > Labeling

Investigational new drug/investigational product (IP) labeling in the United States (US) must comply with the requirements set forth in Section 312.6 of 21CFR312 , which include the following: The immediate package of an IP intended for human use must bear a label with the following statement: “Caution: New Drug-Limited by Federal (or US) law to investigational use” The label or labeling of an IP must not bear any false or misleading statements and must not represent that the IP is safe or effective for the purposes for which it is being investigated The appropriate Food & Drug Administration (FDA) Center Director may grant an exception or alternative to the requirements above for specific lots, batches, or other units of a human drug or biological product that is or will be included in the Strategic National Stockpile. In addition, the US-ICH-GCP states that the IP must be coded and labeled in a manner that protects the blinding, if … Go to United States > Labeling

Investigational product (IP) labeling in Vietnam must comply with the requirements set forth in PharmLaw-VNM . Per VNM-12, the requirements in Articles 7 and 8 of the MedLabel should also be applied to IP labeling. According to the MedLabel , the outer packaging label of the drug must show the following: Drug name Dosage form Ingredients, content, and volume or concentration of pharmaceutical ingredients and medicinal materials in the drug formula Packaging specifications Indications, usage, and contraindications of the drug Circulation registration number or import license number (if any) Production batch number, date of manufacture, expiry date of the drug, quality standards, and drug storage conditions Signs to note and recommendations when using the drug Name and address of the drug manufacturing facility Name and address of the import facility (for imported drugs) Origin of the drug Additionally, as stated in the MedLabel , the intermediate packaging label of the drug must … Go to Vietnam > Labeling

Supply, Storage, and Handling Requirements As stated in the AU-ICH-GCP , the sponsor must supply the investigator(s) with the investigational product(s) (IP(s)) (i.e., therapeutic good(s) being used in a clinical trial). The G-CTHandbook indicates that Therapeutic Goods Administration (TGA) approval through the Clinical Trial Approval (CTA) scheme or notification through the Clinical Trial Notification (CTN) scheme must occur prior to supplying the IP(s) to the trial site(s). The AU-ICH-GCP specifies that the sponsor must ensure the following: Timely delivery of the IP(s) Records maintained for IP document shipment, receipt, disposition, return, and destruction A system for retrieving or disposing of IP(s) and documenting this retrieval or disposal Written procedures including instructions for IP handling and storage, adequate and safe receipt of the IP(s), dispensing of the IP(s), retrieval of unused IP(s), return of unused IP(s) to the sponsor, and disposal of unused IP(s) by the … Go to Australia > Product Management

Supply, Storage, and Handling Requirements As delineated in LawNo14.874 , medicines should be packaged, stored, and disposed of in accordance with the applicable regulations. As specified in ResNo945 and the G-DDCMManual , the investigational products (IPs) must be stored in a protected area, under the sponsor’s control, and may only be distributed to the locations where they will be used following the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) ’s approval of the clinical trial applications (Clinical Drug Development Dossier (Dossiê de Desenvolvimento Clínico de Medicamento (DDCM))) and Specific Clinical Trial Dossier (Dossiê Específico de Ensaio Clínico (DEEC)) petitions published in the Official Gazette of the Union (Diário Oficial da União (DOU)) . If a company is interested in importing IP(s) prior to DDCM approval, along with the DDCM documentation, the sponsor must submit a declaration of commitment to distribute to clinical trial … Go to Brazil > Product Management

Supply, Storage, and Handling Requirements Per CanadaFDR , drugs must be manufactured, handled, and stored in accordance with good manufacturing practice (GMP). As defined in the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ), which Canada has implemented per CAN-50 , the sponsor must supply the investigator(s) with the investigational products (IP(s)), including the comparator and placebo, if applicable. The sponsor should not supply the IP(s) until approvals from Health Canada (HC) and the institutional ethics committee (EC) are obtained. CAN-52 specifies that the sponsor must ensure the following: Timely delivery of the IP(s) Records maintained for IP document shipment, receipt, disposition, return, and destruction Written procedures including instructions for IP handling and storage, adequate and safe receipt of the IP(s), dispensing of the IP(s), retrieval of unused IP(s), return of unused IP(s) to the sponsor, and disposal … Go to Canada > Product Management

Supply, Storage, and Handling Requirements The G-EthicalEval requires that the principal investigator agree to work in accordance with the Declaration of Helsinki ( DRC-11 ), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products ( DRC-10 ), and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( DRC-3 ). Per DRC-3 , the sponsor must supply the investigator(s)/institution(s) with the investigational product(s) (IP(s)). The sponsor should not supply either party with the IP(s) until the sponsor obtains all required documentation. The IPs must also be suitably packaged in a manner that will prevent contamination and unacceptable deterioration during transport and storage. The sponsor must ensure the following: IP product quality and stability over the period of use IP manufactured according to any applicable Good Manufacturing Practice (GMP) Proper coding, packaging, and labeling of … Go to DRC > Product Management

Supply, Storage, and Handling Requirements According to the 2019-CTRules and IND-31 , in the event that a new drug or investigational new drug manufactured for clinical trial or testing and analysis purposes is left over, remains unused, incurs damage, has an expired shelf life date, or has been found to be of sub-standard quality, the drug must be destroyed and the action taken should be recorded. Per the 2019-CTRules , the investigational product (IP) section of the protocol submitted as part of the clinical trial application must include the following: IP description and packaging (i.e., IP ingredients and formulation, and placebos used, if applicable) Dosing required during study Packaging, labeling, and blinding method Method of assigning treatments to participants and identification code numbering system to be used Storage conditions Accountability (e.g., instructions for receipt, storage, dispensation, and return of IPs) Policy and procedure for handling unused IPs Record … Go to India > Product Management

Supply, Storage, and Handling Requirements Per the PPA , the Pharmacy and Poisons Board (PPB) is responsible for the regulation of investigational products (IPs), including all matters relating to the safety, packaging, and distribution of medicines. The PPB must ensure that all medicinal products manufactured in, imported into, or exported from the country conform to prescribed standards of quality, safety, and efficacy. Further, the PPB must ensure that the personnel, premises, and practices employed in the manufacture and storage of IPs complies with prescribed requirements. Per the G-KenyaCT , research must be conducted in accordance with requirements set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( KEN-14 ). As defined in the G-KenyaCT and KEN-14 , the sponsor must ensure the following (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements): Timely … Go to Kenya > Product Management

Supply, Storage, and Handling Requirements According to MLI-17, Mali’s ethics committees (ECs) follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( MLI-7 ), which provides guidance on investigational product (IP) management. Per MLI-7 , the sponsor must supply the investigator(s)/institution(s) with the IP(s), but not until approval is obtained from the Ministry of Health and Social Development (Ministère de la Santé et du Développement Social (MSDS)) and an EC. The sponsor must ensure the following: IP product quality and stability over the period of use IP manufactured according to any applicable Good Manufacturing Practice (GMP) Proper coding, packaging and labeling of the IP(s) Records maintained for document shipment, receipt, disposition, return, and destruction of the IP(s) Acceptable storage temperatures, conditions, and times for the IP Timely delivery of the IP(s) Written procedures … Go to Mali > Product Management

Supply, Storage, and Handling Requirements COFEPRIS-GCP and the Guideline for Good Clinical Practice E6 (R2) ( MEX-22 ) state the sponsor is responsible for supplying investigators with the investigational products (IP(s)) while ensuring that only the quantity of products necessary to carry out the study is provided, and that none of the products will be marketed or used for purposes unrelated to the investigation. MEX-22 further specifies that the sponsor is responsible for supplying the investigator(s)/institution(s) with the IP(s) and for ensuring the timely delivery of the IPs. However, the sponsor should not supply an investigator/institution with the IP(s)) until all the required documentation is obtained, such as the favorable opinion of the ethics committee (EC) and approval from the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) . The sponsor should ensure written procedures include … Go to Mexico > Product Management

Supply, Storage, and Handling Requirements Per PER-53 , the sponsor or the contract research organization (CRO) should supply the investigator(s)/institution(s) with the investigational products (IPs). Decree021-2017 indicates that the IPs will be dispensed through a Clinical Trials Dispensing Unit under the Pharmacy Service or Department of the research institution where the trial will be conducted. The dispensation process must comply with the G-GSPs and G-GDPs , and study specifications delineated by the sponsor. The Clinical Trial Dispensing unit is responsible for: Conducting an inventory of the IPs Controlling overused, used, and unused IPs for final disposal as established in the protocol See also Res833-2024 for regulatory requirements and technical criteria related to the implementation and operation of Clinical Trials Dispensing Units. Decree021-2017 further indicates that the sponsor or the CRO is responsible for the destruction of the unused and/or returned IPs. The IPs … Go to Peru > Product Management

Supply, Storage, and Handling Requirements As defined in the SA-GCPs , the sponsor is responsible for supplying a sufficient quantity of the investigational product (IP) after the sponsor obtains study approvals from the South African Health Products Regulatory Authority (SAHPRA) and the ethics committee (EC). The sponsor must ensure that written procedures include instructions and relevant documents for the investigator to follow for handling and storage of the IP for the trial. The procedures must address adequate and safe receipt, handling, storage, dispensing, retrieval of unused product from participants, and return of unused IP to the sponsor (or alternative disposition if authorized by the sponsor and in compliance with the SAHPRA-approved protocol). In addition, the sponsor must: Ensure timely delivery of the IP to the investigator Maintain records that document shipment, receipt, disposition, return, and destruction of the IP Maintain a system for retrieving the IP and then … Go to South Africa > Product Management

… reports file; procedures for handling complaints; and registers for unfit medicines, controlled drugs, recalls, and customers. Further, an importer should maintain the following documents on the premises for a period of not less than one (1) year after the expiration date of the pharmaceutical product: final invoices with corresponding import permits; copies of delivery notes; and sales invoices. Per the G-EthicsHR-TZA , the sponsor must: Provide to the ethics committee (EC) and … and maintained as required Documents must be readily available and retrievable for inspection by the TMDA The nature, content, and retention of documentation related to distribution and investigations should be retained for at least one (1) year after the expiry date of the product of concern Documents must be stored in facilities that safeguard against unauthorized access, modification, damage, deterioration, or loss Written procedures must exist for the preparation, review, … Go to Tanzania > Product Management

… or importer should be maintained and include the addressees’ identification. Refer to the MHCTR and GBR-113 for detailed, sponsor-related IP requirements. To help ensure the continuity of supply of medicines for clinical trials from January 1, 2021, the BrexitLtr-IPs indicates that the UK will unilaterally recognize certain European Union (EU) regulatory processes for a time-limited period. This recognition is known as “standstill.” Record Requirements As per GBR-113 , the sponsor … Go to United Kingdom > Product Management

Supply, Storage, and Handling Requirements As defined in the US-ICH-GCP , the sponsor must supply the investigator(s)/institution(s) with the investigational new drug(s)/investigational product(s) (IP(s)), including the comparator(s) and placebo, if applicable. The IPs must also be suitably packaged in a manner that will prevent contamination and unacceptable deterioration during transport and storage. Per 21CFR312 , the US-ICH-GCP , the G-CGMP-Phase1 , the G-CMC-Phase2-3 , and the G-INDPrep , the sponsor must ensure the following (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements): IP product quality and stability over the period of use IP manufactured according to any applicable good manufacturing practices (GMPs) Proper coding, packaging, and labeling of the IP(s) Acceptable storage temperatures, conditions, and times for the IP Timely delivery of the IP(s) Refer to the US-ICH-GCP , the G-CGMP-Phase1 , … Go to United States > Product Management

As per OrdNo2201 , ResNo504 , ResNo441 , and the G-BiolMatTransprt , a specimen is defined as any human biological material such as organs, tissues, cells, body fluids, excreta, and other fluids of human origin obtained from a single participant at a particular time. ResNo836 adds that these biological samples are intended to be used for laboratory or quality control tests. Additionally, per ResNo504 , human biological material is classified as Category A or B infectious biological material, or Category Risk Minimum. Category A includes materials where exposure can cause permanent disability or fatal disease to humans and animals. Category B includes those materials not listed in Category A such as samples suspected or known to contain infectious agents causing diseases in humans. Category Risk Minimum or “exempt human specimens” include biological materials from healthy individuals. Human biological materials must also be classified according to the World Health Organization (WHO) ’s … Go to Brazil > Definition of Specimen

In Mexico, a specimen is referred to as a “product of human beings.” According to GenHlthLaw and Reg-HumSpecDisp , products of human beings include any tissues or substances, excreted or expelled by the human body as a result of normal physiological processes. GenHlthLaw and Reg-HumSpecDisp also provide more specific definitions for specimens including germ cells, stem cells, blood and derivatives, plasma, tissue, cellular concentrates, and organs. Please refer to these sources for more detailed information. Additionally, G-RECs-Op-2018 states that human biological material includes organs, tissues, tissue components, cells, and products and cadavers of human … Go to Mexico > Definition of Specimen

No relevant provisions are currently available that define specimens. However, as noted in Decree021-2017 , standards relating to biological samples to be used in clinical trials will be approved in a forthcoming National Institute of Health (Instituto Nacional de Salud (INS)) resolution. … Go to Peru > Definition of Specimen

… sample. As delineated in the G-SLAppClinTrial , a biological specimen or a biological sample is defined as material derived from various animal and human sources (e.g., blood, tissues, and cells) used to treat and prevent diseases. SLE-1 further defines biological material as original material, progeny, and unmodified derivatives, but not new intellectual property. The terms referenced in this definition are explained as follows: Progeny refers to an unmodified descendant from … Go to Sierra Leone > Definition of Specimen

Per the G-EthicsHR-TZA , human biological materials include any substance obtained from a human research participant including, but not limited to, blood, urine, stool, saliva, hair, nail clippings, skin, and microorganisms and other associated bio-products. In Tanzania, specimens are biological materials transferred between researchers/organizations for medical research use only (see TZA-10 ). … Go to Tanzania > Definition of Specimen

A specimen, referred to as patient specimen in 49CFR173 , is defined as human or animal material collected directly from humans or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention. Patient specimen includes excreta, secreta, blood and its components, tissue and tissue swabs, body parts, and specimens in transport media (e.g., transwabs, culture media, and blood culture bottles). In addition, 42CFR73 defines specimen as samples of material from humans, animals, plants, or the environment or isolates or cultures from such samples for diagnosis, verification, or proficiency testing. The RevComRule defines an identifiable biospecimen as one for which the identity of the participant is or may readily be ascertained by the investigator or associated with the biospecimen. (See USA-18 and USA-65 for more information on Common Rule departments/agencies, and the Regulatory Authority section for additional guidance on when the … Go to United States > Definition of Specimen

Import/Export As set forth in ResNo208 (amending ResNo81 ) and ResNo172 , the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) is responsible for authorizing the import of human biological materials for clinical research purposes. ResNo208 (amending ResNo81 ) and ResNo613 (amending ResNo172 ) state that the import license will be carried out through the Integrated Foreign Trade System (SISCOMEX) ’s Single Foreign Trade Portal ( BRA-80 ) and express shipping. The following documentation is required to be submitted by the investigator and institution: Declaration from the importer with information on the Notice number (Special Notice (Comunicado Especial (CE)), Specific Special Notice (Comunicado Especial Específico (CEE)), Document for Import of Product(s) under investigation in the Clinical Drug Development Dossier (Dossiê de Desenvolvimento Clínico de Medicamento (DDCM)), or Dossier of Medical Device Clinical Investigation (DICD) issued by … Go to Brazil > Specimen Import & Export

… obtain a license. Per CAN-2 , because all human biological materials are potential carriers of human pathogens, the PHAC has categorized these materials by risk group based on risk to the individual/animal and risk to the community. Risk Group 1 consists of microorganisms, nucleic acids, or proteins that are unable or unlikely to cause human or animal disease so they are generally not considered to be pathogens, and are therefore exempt from the HPTA and the HPTR licensing requirements. … Go to Canada > Specimen Import & Export

… Commission (NHC) is responsible for China’s management of human genetic resources (HGR). (Note that per SC-Order777 and NHC-HGRmgt , management of HGR was transferred from the Ministry of Science and Technology (MOST) to NHC, effective May 1, 2024. The SC-Order777 amends the MgmtHumanGen to reflect the transfer of HGR management from MOST to the NHC, but the Bioscrty-Law has not yet been amended to reflect the transfer). The MgmtHumanGen and the Bioscrty-Law prohibit foreign … Go to China > Specimen Import & Export

… as well as for individual cases of diagnosis or therapeutic purposes, may not require permission. However, Indian participating center(s) must have appropriate regulatory approval and registration to receive foreign funds for research. See IND-1 for the application form to request a no objection certificate (NOC) to export biological samples. Refer to the G-XBiolMat , the G-ICMR , IND-74 , and IND-27 for additional information. Commercial Purposes According to the HumBiol-ImprtExprt , … Go to India > Specimen Import & Export

Import/Export Per the G-ECBiomedRes , biological material must not be imported nor exported without proper justification and authorization, which includes a signed material transfer agreement (MTA) approved by the relevant institutions and deposited with the National Commission for Science, Technology and Innovation (NACOSTI) . For exports, a Kenyan investigator must be included in the team that is conducting the research in the recipient country. All biological samples and data collected during research belong to the local participating institutions and country. In addition, KEN-37 has indicated that Kenya’s Pharmacy and Poisons Board (PPB) will approve of an export for overseas research if the following requirements are met: PPB initial approval letter or annual approval letter Ethics committee (EC) approval letter MTA Study protocol with a summary justification for the participants' sample exportation Informed consent form that highlights the areas where study participants are … Go to Kenya > Specimen Import & Export

… documents), and for ensuring that the samples collected from research participants are sent through the appropriate carrier to their destination. The sponsor may delegate these functions to the principal investigator (PI). Refer to Annex 1 of the G-StorExptSpecimens for a checklist to be completed by the PI for the proper storage and export of clinical trial samples. As per the G-StorExptSpecimens , the transport of specimens is subject to regulation by the International Air … Go to Malawi > Specimen Import & Export

… (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements): Import or Export of Products of Human Beings form (original) (see MEX-24 ) Proof of payment of rights (one (1) original; G-ImprtPermit also specifies that in terms of the Federal Rights Law , proof of payment of rights is applicable only to the application for a permit for the hospitalization of blood units, their components, and hematopoietic … to COFEPRIS to export umbilical cord blood or hematopoietic progenitor cells, for cryopreservation, research, or therapeutic purposes: Import or Export of Products of Human Beings form (original) (see MEX-24 ) Proof of payment of fees (one (1) original and two (2) legible copies (per G-ExprtPermit ); G-ExprtPermit also specifies that in terms of the Federal Rights Law , proof of payment of rights is applicable only to the application for a permit for the hospitalization of blood … Go to Mexico > Specimen Import & Export

No relevant provisions are currently available regarding the import or export of specimens. However, as noted in Decree021-2017 , standards relating to biological samples to be used in clinical trials will be approved in a forthcoming National Institute of Health (Instituto Nacional de Salud (INS)) resolution. … Go to Peru > Specimen Import & Export

… living participants MoHS authorization for deceased patients Memorandum of understanding (MOU) between MoHS and the applicant Signed and dated Material Transfer Agreement (MTA) Payment of PBSL prescribed export permit fee Please refer to SLE-1 for the materials transfer template. … Go to Sierra Leone > Specimen Import & Export

… by an institution or hospital. These requests must be submitted in writing using the application forms that may be obtained by contacting the NDOH Permit Programme at importexportpermit@health.gov.za . The forms also appear as Annexures 1-6 in the NHABloodCells and Form 1 in the NHARegMicroLabs . Upon review of the application, the Director-General will issue a permit or certificate authorizing the import or export request if the Director-General is satisfied that the submission meets the NHA , the NHABloodCells … may tailor the content to suit their individual contexts. Although some MTAs may include clauses governing sharing of data, it is advisable, as part of data management, to enter into separate data sharing agreements to regulate sharing of one (1) or more data sets from the custodian/provider to a third party. … Go to South Africa > Specimen Import & Export

Import/Export As delineated in the G-EthicsHR-TZA , investigators, sponsors, and collaborators must ascertain that in-country capacity to perform the required investigations/testing is not sufficient for the investigations before considering import of human biological materials outside the country. The only exception to this is when samples are being transferred for external quality assurance purposes. Investigators, sponsors, and collaborators are encouraged to build, develop, or strengthen local capacity for any investigative testing to fulfill the objectives of the proposed research study. All exchanges and transfers (including importation) of biological materials for research purposes requires approval from the National Health Research Ethics Committee (NatHREC) . The G-ResearchClearance requires foreign researchers to identify and affiliate with a locally-recognized institution. The local institution should support foreign partners in permit acquisition, communicating with … Go to Tanzania > Specimen Import & Export

Import/Export No information is currently available regarding the Thai Food and Drug Administration (Thai FDA) ’s role in approving the import and export of biological specimens. Material Transfer Agreement G-ResEthics states that in the case of the transfer of biological materials, the sponsor must complete the Material Transfer Agreement (MTA) form (Annex 8) to obtain or transfer biological materials for research purposes. An MTA form must also be used to transfer human tissue samples to other institutions. See also THA-13 for the Material Transfer Agreement and Material Transfer Record forms provided by the Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (ECMOPH) . Per THA-34 , the Central Research Ethics Committee (CREC) requires investigators to include a (draft) MTA in the initial protocol submission package in cases where specimens are sent to an outside research institution, according to each institution’s form. This document will be used by … Go to Thailand > Specimen Import & Export

… the transfer, export, or exchange of the research specimen. Material Transfer Agreement As set forth in the NGHRP and the G-UNCSTreg , the UNCST application for permission to transfer, export, or exchange samples for research purposes from one (1) organization to another, within the country and abroad, must be accompanied by an MTA between the provider organization and the recipient organization. Per the NGHRP , the MTA should include the following details: A list of the parties and … Go to Uganda > Specimen Import & Export

Import/Export As specified in the UK-HTA , the Human Tissue Authority (HTA) has jurisdiction regarding the import and export of specimens (known as “relevant materials” or “human tissue” in the United Kingdom (UK)) and complies with the Code of Practice on import and export set forth in Code-E . According to the UK-HTA , Code-E , GBR-56 , GBR-73 , and GBR-52 , the import and export of relevant material/human tissue is not in itself a licensable activity under the UK-HTA . However, once the material is imported, storage of this material may be licensable unless it is for a specific research project with ethical approval from an ethics committee (EC). GBR-73 explains that it is preferable for imported human tissue to be stored in a licensed establishment where possible, and if so, there is no requirement for EC approval to undertake research. However, if the premises where the human tissue will be held are not covered by an HTA license, each research project using the human tissue will … Go to United Kingdom > Specimen Import & Export

… Air ( USA-10 ) published biannually by the United Nations (UN) ’ International Civil Aviation Organization (ICAO) . Additionally, 28CFR202 prohibits certain data transactions that involve giving a country of concern or covered person access to: 1) bulk US sensitive personal data that involves bulk human ‘omic data; or 2) to human biospecimens from which bulk human ‘omic data could be derived. See the Personal Data Protection section and 28CFR202 for more information. Infectious Specimens … Go to United States > Specimen Import & Export

Import As set forth in the MgmtInfctSpcmn , the Ministry of Health (MOH) ’s General Department of Preventive Medicine (DPM) is responsible for regulating the transportation of infectious specimens. According to Decree89 , samples of medical microorganisms, biological products, tissues, and organs transported across the Vietnamese border must be medically declared (See Form No. 13 in the Decree89 ). VNM-12 further states that an import license from the DPM is required only if the specimens are infectious. Decree155Amend requires that application dossiers for the import of infectious specimens include: A written request for the grant of an import license A copy of the competent agency’s approval permitting the implementation of a valid research project, a copy of the approved project proposal or project document, or a copy of the valid written agreement between domestic and foreign establishments regarding the import of specimens A declaration regarding compliance with applicable … Go to Vietnam > Specimen Import & Export

… ZWE-89 , the MRCZ will forward the application for registration of a foreign researcher to the RCZ. The applicant must prepare 10 flat files, with each document in all 10 files clearly labeled. Of the 10 copies, eight (8) are for the RCZ, one (1) is for the MRCZ, and one (1) is for the applicant. Both the MRCZ and the RCZ must sign ZWE-89 and receive a copy of it. Per ZWE-89 , the following documents must be included: Ten copies of the principal investigator (PI) application letter Ten copies of the MRCZ cover … Go to Zimbabwe > Specimen Import & Export

… the possibility of using the participant’s stored genetic materials in a new research project in the ICF. In this case, the participant will be contacted for further authorization or their waiver. If it is impossible to obtain either one (1) of these documents, this fact shall be justified to the EC (CEP). The investigator(s) is also required to explain to the participant that the material will only be used upon approval of a new project by the EC (CEP) and when necessary, CONEP. … Go to Brazil > Consent for Specimen

… Commission (NHC) is responsible for China’s management of human genetic resources (HGR). (Note that per SC-Order777 and NHC-HGRmgt , management of HGR was transferred from the Ministry of Science and Technology (MOST) to NHC, effective May 1, 2024). As delineated in the MgmtHumanGen and the Rules-MgmtHGR , MOST (now the NHC), through its experts, is responsible for reviewing and approving license applications to collect HGR and conduct international collaborative projects using … Go to China > Consent for Specimen

In accordance with the G-ICMR , prior to collecting, storing, or using a research participant’s human biological material, consent must be obtained from the participant or the legal representative in writing. Additionally, per the G-ICMR , it is necessary for all health research involving human participants and their biological material and data to be reviewed and approved by an appropriately constituted ethics committee (EC). In addition to the informed consent form (ICF) required elements listed in the Informed Consent topic , the G-ICMR requires investigator(s) to communicate the following information to participants in the ICF regarding the use of their biological samples: The participant’s right to prevent the use of their biological sample (e.g., DNA, cell-line, etc.) and related data at any time during the conduct of the research The risk of discovery of biologically sensitive information and provisions to safeguard confidentiality The GCLP further indicates that prior to … Go to India > Consent for Specimen

Detailed information is currently unavailable regarding Kenya’s Pharmacy and Poisons Board (PPB) ’s requirements for obtaining informed consent from participants prior to collecting, storing, or using their biological sample(s). However, the G-KenyaCT states that for research involving children, the sponsor or the representative or the principal investigator should provide examples of patient information leaflets and informed consent forms (ICF) to the ethics committee (EC) for any proposed archiving of biological specimens for later research, or for genetics research. The G-ECBiomedRes requires that participants are made aware of the use of personal data through informed consent, including secondary data and biological material in biobanks. The secondary use of data requires approval by an accredited EC. The investigator must obtain consent from the participants for the new study. For situations where this is not practicable, the relevant accredited EC can approve a waiver of … Go to Kenya > Consent for Specimen

… the research results will be made available to the research participants and the concerned communities Pursuant to the G-ACRE-IRB , for research that involves the collection of identifiable private information or identifiable biospecimens, one (1) of the following must be included in the informed consent: A statement that identifiers will be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could … Go to Liberia > Consent for Specimen

Per DecreeNo2017-0245 , during the informed consent process, the participant must be informed that withdrawal is possible at any time, and that the withdrawal of the participant’s data and biological material may also be requested. … Go to Mali > Consent for Specimen

In accordance with GenHlthLaw , Reg-HumSpecDisp , and G-RECs-Op-2018 , prior to collecting, storing, or using a research participant’s human biological material, consent must be obtained from the participant or the legal representative. GenHlthLaw specifically states that the consent must be obtained in writing. From an ethical perspective, G-RECs-Op-2018 indicates it is important to consider including the following aspects in the informed consent for human biological materials use and storage: The document should clarify that samples may not be used for any purpose other than the one initially requested, and in accordance with the protocol approved by the Research Ethics Committee (REC) ( Comité de Ética en Investigación (CEI) ) The collection, use, and storage of biological material must guarantee the confidentiality and privacy of the donor The commercialization of biological material is prohibited The investigator may not exercise undue influence by offering financial compensation … Go to Mexico > Consent for Specimen

In accordance with Decree021-2017 , if a clinical trial team is considering the collection and storage of biological samples for future use, this point should be delineated explicitly in a separate informed consent form (ICF). Annex 4 of Decree021-2017 and the G-EC-CTRev also state that the ICF must list the following biological sample study procedures: Sample collection details: type, quantity, and number of times to be extracted; explaining how many times and how much is needed, in measures that the research participant understands Final destination of remaining samples: stating explicitly that the samples obtained will be used only for ongoing research, and will be destroyed when the trial is completed, unless storage is contemplated for future use Sample storage or their remainders for future studies: if stock samples are to be stored beyond the end of the trial and/or biological samples are to be taken for storage and future studies, it should be incorporated into a specific ICF … Go to Peru > Consent for Specimen

… to request that their specimens or records be destroyed or personal identifiers removed for those parts of the records that they might consider to be particularly sensitive, such as photographs, videotapes, or audiotapes In addition, per SLE-1 , the Pharmacy Board of Sierra Leone (PBSL) requires the recipient of the transferred original materials to agree to treat the material and provider information as confidential except when the material or information falls under the following … any knowledge or use of the information disclosed by the provider under the MTA It was approved in writing by the provider for disclosure, provided that such disclosure was made by the recipient in accordance with the terms of such approval SLE-1 further states that during the period of use and for five (5) years after, the recipient will use reasonable effort to maintain the confidentiality of the material and provider information covered by the MTA. To this end, the recipient will not, … Go to Sierra Leone > Consent for Specimen

In accordance with the NHA , the NHASpecAmend , the NHABiol , and the MTA-Human , prior to removing or withdrawing any human biological material (HBM) from the body of a living person for research purposes, consent must be obtained from that person in writing, before a competent witness. If the person is a minor, the parent/guardian of that person must provide consent. Furthermore, when withdrawing blood, the NHASpecAmend requires written consent from persons older than 16 years. Per the MTA-Human , the sponsor must obtain the completed informed consent form (ICF) from the donors of HBM and data, and submit it with the project protocol to the ethics committee (EC) for approval. Further, the sponsor must submit the ICF for secondary uses of the material to the EC should the need arise. Secondary use is defined as the use of the materials for health research purposes other than the uses determined in the approved protocol. Per the G-EthicsHR-ZAF , collection of HBM specifically for … Go to South Africa > Consent for Specimen

… consent form (ICF) templates provided by the Forum for Ethical Review Committees in Thailand (FERCIT) , including a broad ICF for the storage and use of data and biospecimens for future research (see THA-46 for document links). The CREC is one (1) of the ECs approved by the Thai Food and Drug Administration (Thai FDA) to review and approve clinical trial protocols. … Go to Thailand > Consent for Specimen

… “appropriate consent” must be obtained from the child’s parent/legal guardian. If the child has died, the written consent must have been obtained from the child’s parent/legal guardian prior to the child’s death in the presence of at least one (1) witness, or it must be signed at the direction of the child concerned by the parent/legal guardian, in the child’s presence, and in the presence of at least one (1) witness. As indicated in the UK-HTA and Code-A , in the case of an adult donor 18 years or older, consent must be obtained prior to removing any bodily materials. If the adult has died, the written consent is only valid when it is signed by the person prior to death in the presence of at least one (1) witness at their direction, or it is contained in the person’s will. An adult donor may also appoint one (1) or more people (“nominated representative(s)”) to consent on their behalf in the event of death. This consent may be obtained orally or … Go to United Kingdom > Consent for Specimen

… RevComRule further defines an identifiable biospecimen as one for which the identity of the participant is or may readily be ascertained by the investigator. See the Pre2018-ComRule , RevComRule , the G-SpecimensResrch , USA-2 , USA-9 , and USA-1 for additional information. See also the G-SpecimensResrch for exemptions to this definition. Additionally, as defined by the HHS’ National Institutes of Health (NIH) in USA-24 , research with specimens, cells, cell lines, or data involves human … information on Common Rule departments/agencies, and the Regulatory Authority section for additional guidance on when the Pre2018-ComRule and the RevComRule apply to research. The RevComRule requires the informed consent form to provide one (1) of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens: A statement that identifiers might be removed from the identifiable private information or … Go to United States > Consent for Specimen

In accordance with ZWE-57 , investigators must obtain informed consent from clinical trial participants for the long-term storage and future use of specimens. The informed consent form (ICF) ( ZWE-57 ) indicates participants must be informed that specimens will be collected for the laboratory tests described in the ICF that was signed to join the clinical trial. The following elements should be included in the specimens ICF: Information about the collection, storage, and future use of leftover samples Written permission to have leftover samples stored after the study has ended and used for future studies Participation is voluntary and participants may choose to not have any samples stored other than what is needed to complete the study and still be in this research study or any future study How the samples will be used in future research (e.g., DNA analysis or developing new diagnostic tests) Study researchers will not contact the participant or the participant’s regular doctor with … Go to Zimbabwe > Consent for Specimen