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Therapeutic Goods Administration As per the TGAct , the TGR , and the G-CTHandbook , the Therapeutic Goods Administration (TGA) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections in Australia at the national level. The TGA allows for the supply of unapproved therapeutic goods to be used in clinical trials for experimental purposes in humans in accordance with the provisions in the TGAct and the TGR . There are two (2) regulatory schemes for supplying unapproved therapeutic goods in clinical investigations, which are more fully examined in the Scope of Assessment section . As per AUS-28 , the TGA is part of the Health Products Regulation Group (HPRG) within the Australian Department of Health, Disability and Ageing . The TGA’s Pharmacovigilance Branch is responsible for evaluating and authorizing certain clinical trials for all types of therapeutic products. According to the G-TrialsSOP the TGA also regulates the supply, import, export, … 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 and the BGD-GCP , 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, selling, 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 safety and … Go to Bangladesh > Regulatory Authority

… and microbes). For more information, see BRA-81 . Contact Information Per BRA-132 , the following is ANVISA’s contact information: ANVISA Assessoria do Sistema Nacional de Vigilância Sanitária Setor de Indústria e Abastecimento (SIA) Trecho 5 – Guará Brasília – DF CEP: 71205-050 Phone: (61) 3462-4120 or (61) 3462-6921 E-mail: asnvs@anvisa.gov.br ANVISA’s Electronic Contact Form ( BRA-68 ) may be used to submit technical questions. Phone: 0 800 642 9782 (for general inquiries) ( … Go to Brazil > Regulatory Authority

… 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 ethics … Go to Canada > Regulatory Authority

… 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

… of the Directorate of Pharmacy and Medicine (Direction de la Pharmacie et du Médicament (DPM)) and the National Quality Control Laboratory (Laboratoire National de Contrôle Qualité (LAPHAKI)) became the assets of ACOREP as of March 5, 2020. ACOREP is comprised of a Board of Directors, the General Management, and the College of Auditors. ( Note: ClinRegs will continue to reference DPM documents when this name is still used in website and regulatory material. New ACOREP … ( 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 , ACOREP’s contact information is as follows: Ministry of Health Congolese Pharmaceutical Regulatory Authority (ACOREP) 66 Boulevard du 30 juin immeubles Building 5à sec 4 eme niveau Kinshasa, Democratic Republic of the Congo Phone: … Go to DRC > Regulatory Authority

Central Drugs Standard Control Organization As set forth in the 2019-CTRules and the Hdbk-ClinTrial , the Central Drugs Standard Control Organization (CDSCO) is the regulatory authority responsible for clinical trial oversight, approval, and inspections in India. In accordance with the provisions of the 2019-CTRules , the Drugs Controller General of India (DCGI) heads CDSCO, and is responsible for granting permission for clinical trials to be conducted and for regulating the sale and importation of drugs for use in clinical trials. (Note: The DCGI is commonly referred to as the Central Licensing Authority in the Indian regulations.) According to IND-80 , CDSCO functions under the Directorate General of Health Services (DGHS) , which is part of the Ministry of Health and Family Welfare (MOHFW) . Per IND-80 and IND-79 , under the 2019-CTRules , CDSCO is responsible for approving new drugs and clinical trials, establishing drug standards, overseeing the quality of imported drugs, … 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

… and microbes). For more information, see MWI-35 . Contact Information Pharmacy and Medicines Regulatory Authority As per MWI-46 , the PMRA contact information is as follows: Pharmacy and Medicines Regulatory Authority Off Paul Kagame Road, Area 5 P.O. Box 30241 Lilongwe 3, Malawi Phone: +265 212 755 165 or +265 212 750 108 Email: info@pmra.mw National Commission for Science and Technology Per MWI-57 , the NCST contact information is as follows: Mailing Address: National Commission for … 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

… Guideline for Good Clinical Practice E6 (R2) ( MEX-22 ). However, COFEPRIS-GCP complies with the Guideline for Good Clinical Practice E6 (R1) ( MEX-32 ). Please note: Mexico is party to the Nagoya Protocol on Access and Benefit-sharing ( MEX-5 ), 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 MEX-35 . Contact Information As per MEX-71 and MEX-15 , … Go to Mexico > Regulatory Authority

National Institute of Health (INS) As per Decree021-2017 , Res006-2023 , and the G-CTInspec , Peru’s INS is the regulatory authority responsible for clinical trial approvals, oversight, and inspections. The INS, through the Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS)) (formerly known as the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT))), grants permission for clinical trials to be conducted in Peru in accordance with Decree021-2017 , Res184-2023 , Decree028-2023 (amending Decree021-2017 ), Res006-2023 , the INS-CTManual , and Res252-2022 (amending the INS-CTManual ) . As indicated in Law27657 and Decree001-2003 , the INS, a decentralized public executive agency within the Ministry of Health of Peru (Ministerio de Salud del Perú (MINSA)) , was granted authority to approve clinical trials by the MINSA in 2003. Decree021-2017 , Res006-2023 , and the … 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

… the Drug Board (also referred to as the Drug Committee in the English translation of the DrugAct ). Per the DrugAct , the board must consist of MOPH departmental directors-general and representatives from related organizations, as well as five (5) to nine (9) drug experts. Every two (2) years, the Minister of Public Health appoints the Committee, which is chaired by the Permanent Secretary of the MOPH. The DrugAct also indicates that the board should appoint a subcommittee to study the … 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

… the ICH’s Guideline for Good Clinical Practice E6(R2) ( GBR-113 ) in 2016. See GBR-80 for the current ICH guidelines that have been implemented by MHRA. Please note: The UK is party to the Nagoya Protocol on Access and Benefit-sharing ( GBR-5 ), 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 GBR-48 . Contact Information Per GBR-58 , the following … Go to United Kingdom > Regulatory Authority

This profile covers the role of the Department of Health & Human Services (HHS) ’s Food & Drug Administration (FDA) in reviewing and authorizing investigational new drug applications (INDs) to conduct clinical trials using investigational drug or biological products in humans in accordance with the FDCAct , 21CFR50 , and 21CFR312 . Regulatory requirements for federally funded or sponsored human subjects research, known as the Common Rule ( Pre2018-ComRule and RevComRule ), which the HHS and its Office for Human Research Protections (OHRP) implements in subpart A of 45CFR46, are also examined. Lastly, additional HHS requirements included in subparts B through E of 45CFR46 are described in this profile, where applicable, using the acronym 45CFR46-B-E . (Please note: ClinRegs does not provide information on state-level requirements pertaining to clinical trials.) Food & Drug Administration As per the FDCAct , 21CFR50 , and 21CFR312 , the FDA is the regulatory authority that regulates … Go to United States > Regulatory Authority

… more information, see ZWE-92 . Contact Information Medicines Control Authority of Zimbabwe ZWE-66 provides the following MCAZ contact information: Medicines Control Authority of Zimbabwe 106 Baines Avenue Harare, Zimbabwe Phone: +263-4-736981/5; 708255; 792165; 0772 145 191/2/3 WhatsApp Number: +263 718 855 934 Toll Free Numbers: Econet – 08080641; TelOne – 08004507 Main Email: mcaz@mcaz.co.zw Customer Service Email: customerservice@mcaz.co.zw PVCT Email: pvct@mcaz.co.zw Imports and … Go to Zimbabwe > Regulatory Authority

… ANVISA inspectors, one (1) of whom will be the lead inspector and the focal point for communication with either the clinical trial center or the sponsor/CRO(s). The inspections for both entities will take place over a maximum period of five (5) working days unless the period is altered with due justification. See GuideNo35-2020 and GuideNo36-2020 for additional details. Priority Submissions In addition to the previously stated DDCM requirements, ResNo204 establishes a priority … Go to Brazil > Scope of Assessment

Overview In accordance with the CanadaFDA , Health Canada (HC) reviews, evaluates, and approves applications for clinical trials using authorized therapeutic products. HC also approves the sale or importation of drugs for use in clinical trials. (See the Manufacturing & Import section for additional information on importation.) As delineated in the CanadaFDR and the G-CanadaCTApps , institutional ethics committee (EC) review is required for each clinical trial site and may occur in parallel with HC’s clinical trial application (CTA) review and approval. For HC’s interpretation of the relevant provisions of the CanadaFDR , see the G-FDR-0100 . See CAN-23 and CAN-19 for background information on HC’s scope of assessment. Per the CanadaFDA , a “therapeutic product” is defined as a drug or device, or any combination of drugs and devices, but does not include natural health products; and “therapeutic product authorization” refers to a license that is approved for the import, sale, … Go to Canada > Scope of Assessment

… with the reference listed drug Class 4: Drugs manufactured by domestic applicants by imitating the original drugs that have been marketed in China; such drugs must have the quality and efficacy consistent with the reference formulations Class 5: Drugs that have been marketed overseas and are under application for being marketed in China As per NMPA-No21-2021 , the NMPA provides additional technical support to expedite the review and approval process of domestically unlisted drugs that have been listed overseas in the above Classes 3 and 5. Per the DRR , the registration of biological products is classified according to innovative biological products, new medicines of improved biological products, and already listed biological products (including biological similar drugs). As … CDE will notify the applicant through a professional inquiry letter, clearly informing the applicant of the problems and revision opinions in the current protocol. The applicant must submit a revised clinical trial protocol within five (5) days, following the guidance in the Prcdrs-Changes . For clinical trial protocols that are deemed unfeasible, have participant safety risks, or other serious defects, and the applicant cannot revise and improve them within the time limit … Go to China > Scope of Assessment

… Overview According to DecreeNoD218 , Guinea-PHC , and GIN-5 , the National 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, … Go to Guinea > Scope of Assessment

… 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 clinical trial do not correspond to the information contained in the authorization application The facts presented give reason to doubt the safety or the scientific basis of the clinical trial … 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

Overview As indicated in DecreeNo2011-753 and MLI-2 , the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) within the Ministry of Health and Social Development (Ministère de la Santé et du Développement Social (MSDS)) is 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 trial’s commencement, the DPM must review the clinical trial application research data submitted by the sponsor or principal investigator, as well as the opinions of the ethics committees (ECs) consulted. According to LawNo09-059 and the DPM-ClinTrialDocs , the DPM review and approval process takes place after the EC review and approval process. Per LawNo09-059 , the EC must communicate its opinion on a research project to the DPM. LawNo09-059 also indicates that the EC’s opinions of the … 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

… . Per Res252-2022 , the file is then forwarded to the Clinical Trial Processing Area ( Área de evaluación de Ensayos Clínicos (AEC)) for review. T he list of clinical trial supplies ( PER-42 ), along with the required documentation in Annex 5 of Decree021-2017 , is then forwarded to the Research Product Safety Surveillance Area ( Área de Vigilancia de la Seguridad del Producto en Investigación (AVISPI)). AVISPI, in turn, sends this documentation to the ANM to request a binding … Go to Peru > Scope of Assessment

… 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 SLESRC and … Go to Sierra Leone > Scope of Assessment

… 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 4: Not approved; for referral for specialist opinion Category 5: Not approved – technical/scientific deficiencies; applicant to resubmit for the next cycle Category 6: Rejected due to administrative and technical items outstanding; applicant to resubmit for the next cycle If an applicant would like to … Go to South Africa > Scope of Assessment

… may review, reject, or vary its own decision. Per the G-AppConductCT , the clinical trials certification will be valid up to the proposed duration of the study indicated in the application. However, the validity will not extend beyond five (5) years. If the trial will last more than five (5) years, the applicant must request an extension. Further, the TMDA must approve amendments to a previously authorized protocol for changes that affect participant selection and monitoring; changes that affect clinical efficacy and safety … Go to Tanzania > Scope of Assessment

Overview In accordance with the DrugAct and ClinImprtOrdr , the Thai Food and Drug Administration (Thai FDA) is responsible for overseeing the import or ordering of drugs for clinical research purposes, and 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 per G-ResEthics , the scope of the Thai FDA’s assessment includes Phases I through IV clinical trials for new drugs (also referred to as “modern drugs”), traditional drugs (drugs intended for use in the practice of traditional medicine or to cure animal disease), unregistered drugs, registered drugs being studied in new doses or for indications not previously approved, and locally produced drugs that require efficacy testing. As indicated in ClinImprtOrdr , ClinSampleProd , and ECRegProc , the Thai FDA’s … Go to Thailand > Scope of Assessment

… may resume. Before issuing a notice, the NDA must inform the sponsor or PI of the notice and the reasons for the notice, and then advise the sponsor or PI to make a written representation on the intended suspension or termination within five (5) days. The NDA must consider the written representation and inform the sponsor or PI of its decision within seven (7) working days. However, the NDA is not required to inform the sponsor or PI of the notice if it appears that there is an … President of Uganda to obtain security verification and clearance for the investigator. The investigator must pay a Research Administration and Clearance fee for the entire period of the research project, but such a period must not exceed five (5) years. Investigators interested in continuing a study using an approved protocol beyond the UNCST research permit expiration date should make a written request for an extension or renewal of the permit to the UNCST Executive Secretary. The … Go to Uganda > Scope of Assessment

Overview In accordance with the MHCTR and the MHCTR2006 , the Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for reviewing, evaluating, and approving applications for clinical trials using registered 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 committee (EC) leading to a single UK decision for clinical trials. Per the G-Biosimilars , MHRA also regulates the licensing of biosimilars (i.e., similar biological medicinal products). Clinical Trial Review Process Per GBR-72 , under combined review for clinical trials of … Go to United Kingdom > Scope of Assessment

… a clinical study two (2) years or more under an IND, or if all investigations under an IND remain on clinical hold for one (1) year or more, the IND may be placed by the FDA on inactive status. An IND that remains on inactive status for five (5) years or more may be terminated. See 21CFR312 for more information on inactive status. 21CFR312 indicates that the FDA may propose to terminate an IND based on deficiencies in the IND or in the conduct of an investigation under an IND. If the … Go to United States > Scope of Assessment

… or biologics with a new combination of marketed ingredients Newly developed vaccines that are manufactured and used for the first time in Vietnam Drugs, biologics, and vaccines which have been legally marketed for a period of less than five (5) years in the country of origin (or a country of reference if provided for under international treaties to which Vietnam is a signatory) Drugs, biologics, and vaccines for which a clinical trial has been conducted, but have not met the MOH’s or … will determine the inspection scale and frequency based on the objective, purpose, design, complexity, blinding technique, scale, and end date of the research. The MOH must send an inspection notice to the sponsor and institution at least five (5) days before the inspection, and the inspection report must be completed and sent to the sponsor and institution within 20 days of the inspection. Clinical Trial Exemptions The DrugRgstrtn indicates that the Minister of Health may exempt new … Go to Vietnam > Scope of Assessment

… period of the trial. The clinical trial authorization will be valid up to the proposed duration of the study as indicated in the CTA and the authorization form, or for a period deemed necessary by MCAZ, but must not be for more than five (5) years. For a trial proposed to be conducted for more than five (5) years, the applicant must request an extension. MCAZ will issue an updated authorization if the application is found to be satisfactory upon review. If MCAZ raises additional questions, the applicant will have 30 days to respond and then the … Go to Zimbabwe > Scope of Assessment

Therapeutic Goods Administration As per the TGR , the sponsor is responsible for paying a fee to the Therapeutic Goods Administration (TGA) to submit an application 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 – … 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

National Medical Products Administration In accordance with the DRR , the applicant is required to pay a fee after the drug registration is approved by the National Medical Products Administration (NMPA) . As per the NMPA-No75-2020 and CHN-14 , the NMPA charges the following drug registration fees to review and approve clinical trials as part of the drug registration process (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements): New drugs made in China: 192,000 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 … Go to China > Regulatory Fees

… III (confirmatory) clinical trials 2,00,000 Rupees for Phase IV clinical trials 50,000 Rupees for reconsideration of application for permission to conduct clinical trial According to the 2019-CTRules , the sponsor must also submit a fee of 5,000 Rupees per product with an application for permission to manufacture or import the investigational product (IP) to be used in a clinical trial. In addition, the 2019-CTRules states that no fee is required to be paid along with the clinical … See also IND-31 for additional information on CDSCO fee requirements. As delineated in the 2024-CTRulesAmdt and Notice4Mar25 , clinical research organizations are required to pay a fee to register with CDSCO. The registration application 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 … Go to India > Regulatory Fees

… – 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 Post-Doctoral: EAC Countries – 5,000 Kenya Shillings; Kenyan Citizens – 5,000 Kenya Shillings; Rest of Africa – 10,000 Kenya Shillings; Non-Africans - $500 USD Public Institutions: Kenyan Citizens – 10,000 Kenya Shillings Private Institutions, Commercial/Market Research, Companies: Kenyan Citizens – 20,000 Kenya … Go to Kenya > Regulatory Fees

Liberia Medicines and Health Products Regulatory Authority The LibCTReg and the G-LibClinTrial require proof of payment of the clinical trial application fee in the application dossier. Per LibCTReg and LBR-39 , the Liberia Medicines and Health Products Regulatory Authority (LMHRA) charges a non-refundable fee to submit a clinical trial application for authorization. As delineated below, authorization fees vary depending on the phase and institution conducting the study: Industry Funded (Phase I): $25,000 USD Industry Funded (Phase II): $20,000 USD Industry Funded (Phase III): $15,000 USD Clinical Research Organization (CRO) 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 … Go to Liberia > Regulatory Fees

… must apply to the Pharmacy and Medicines Regulatory Authority (PMRA) for a clinical trial certificate upon payment of the prescribed fee. Per the PMRAFeesRegs , the following fees apply to clinical trials: Application, review, and registration: 5% of total budget Annual renewal: $2,200 USD Amendments: $300 USD As delineated in the PMRAFeesRegs , a fee equaling 6% of the total invoice value must also be paid for the importation of unregistered medicines or allied substances from … Go to Malawi > Regulatory Fees

… 7,553 Mexican Pesos ( G-BioequivStud ) Authorization of research protocol without risk (observational) in humans: 7,553.00 Mexican Pesos ( G-ObsrvStdies ) Amendment or modification to the research protocol or inclusions to the protocol: 5,665 Mexican Pesos ( G-ResProtocolAmd and MEX-11 ) In addition, per G-UnregDrugImprts , the fee to request a health permit to import investigational products for research purposes is 6,727.65 Mexican Pesos. As indicated in MEX-10 , the fee for … 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

… clinical trials of therapeutics, 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 … Go to Sierra Leone > Regulatory Fees

South African Health Products Regulatory Authority Per the MRSA , the South African Health Products Regulatory Authority (SAHPRA) is authorized to make regulations to collect fees for its various medicine regulatory functions. As delineated in ZAF-37 , applicants are responsible for paying several fees to submit a clinical trial application. MRSA-Fees , per Fees-Info , delineates the following fees: For a clinical trial application for the authorization of the use of unregistered medicines: Clinical trial application (safety and efficacy): South African Rand (R)33 700 Clinical trial application (bioequivalence study): R31 700 Clinical trial application (postgraduate study) with pharmaceutical company involvement: R11 200 Phase 4 clinical trial application and any other clinical trial application, including university-involved postgraduate qualification and/or pre-consultation of clinical trials: R5 100 For amendments to clinical trials: Technical amendment applications: R7 200 … Go to South Africa > Regulatory Fees

Tanzania Medicines and Medical Devices Authority As per the G-AppConductCT and the TMMDAFees , applicants are responsible for paying a processing fee to submit a clinical trial application. The TMMDAFees indicates that the Tanzania Medicines and Medical Devices Authority (TMDA) levies the following processing fees: $3,000 USD for submitting a clinical trial application Double the cost of registration and analysis fee for fast-track clinical trial applications $500 USD for amendments for major changes in clinical trials $300 USD for amendments for minor changes in clinical trials See the TMMDAFees for a complete list of TMDA fees and charges. Payment Instructions The G-AppConductCT states that the fee must be paid to the order of the TMDA directly to the bank by draft electronic transfer through the following accounts: Foreign applicants: Account Numbers 100380013 Citibank (T) and 02J1021399100 CRDB Local applicants: Account Number 2041100069 NMB Applicants are responsible for all bank … Go to Tanzania > Regulatory Fees

Thai Food and Drug Administration In accordance with ClinDrugFees , the applicant is required to pay a fee to 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 technical evaluation of documents of any application request related … Go to Thailand > Regulatory Fees

… proposal. The UNCST will not register the protocol or issue a research permit until this fee has been paid. Permits are valid for the entire duration specified for a project. However, the fee covers a research period not to exceed five (5) years. Projects that extend beyond the initial five (5) year period are required to pay $300 USD for the extension. All applicants, excluding East African students, are responsible for paying this fee. East African students are only required to pay a fee of $50 USD. However, UGA-20 further indicates … Go to Uganda > Regulatory Fees

Medicines and Healthcare Products Regulatory Agency As per the MHCTR , the MHCTR2006 , and the G-CTApp , the sponsor or the designated representative is responsible for paying a fee to the Medicines and Healthcare Products Regulatory Agency (MHRA) to submit a clinical trial application for authorization. According to the G-MHRAPaymt , applicants will receive an invoice to make a payment for the outstanding amount after validation of the application. Applicants must pay invoices upon receipt or they will incur penalty fees. Non-payment may also result in suspension of any license or authorization, followed by legal proceedings 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 … Go to United Kingdom > Regulatory Fees

Food & Drug Administration The Food & Drug Administration (FDA) does not levy a fee to review investigational new drug submissions. However, per the FDCAct , the FDARA , and USA-45 , the FDA has the authority to collect user fees from persons that submit certain human drug applications for review or that are named in approved applications as the sponsor of certain prescription drug products. See USA-45 for more information. … Go to United States > Regulatory Fees

… Expedited review: the regular fees outlined above plus 50% of the process-specific fee For an application to conduct a clinical 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 … manufacturer’s premises are as follows: Sterile pharmaceutical manufacturing unit: $6,000 USD Pharmaceutical manufacturer’s premises with more than three (3) dosage forms and not including sterile product manufacturing facilities: $5,000 USD Pharmaceutical manufacturer’s premises with up to three (3) dosage forms: $4,500 USD Restricted pharmaceutical manufacturing premises: $3,500 USD Per CT-Fees , the application fees to export or import an unregistered medicine is as … Go to Zimbabwe > Regulatory Fees

… consist of a reasonable 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, … 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 on EC composition … Go to Bangladesh > Ethics Committee

… information on CONEP and the CNS. Ethics Committee Composition National Research Ethics Commission (CONEP) As per OSNo001 and ResNo446 , CONEP is an independent and multidisciplinary organization consisting of 30 appointed members and five (5) alternate members. Per ResNo446 , CONEP also has an Executive Secretary appointed by the MOH’s Secretariat for Science, Technology and Strategic Inputs and an Assistant Secretary appointed by the CNS to coordinate CONEP’s work and to manage the … should not have the right to vote. Once duly accredited or certified, ECs (CEPs) have complete autonomy to issue their opinions, in compliance with GCP. The EC (CEP) will also keep all project related documents on file for a period of five (5) years after the end of the research, with digital archiving permitted. As stated in LawNo14.874 , the institution hosting the EC (CEP) will promote and support the training of its committee members, with an emphasis on ethical and … Go to Brazil > Ethics Committee

… ethical conduct of research involving human participants. The PRE develops, interprets, and implements the G-TCPS2 . Ethics Committee Composition As delineated in the CanadaFDR and the G-CanadaCTApps , institutional ECs must have at least five (5) members 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 … Go to Canada > Ethics Committee

… in detail. The RegEthics states that EC members should agree to disclose their names, occupations, and affiliations, and to sign the reviews, confidentiality agreements, and a conflict of interest declaration. Each EC member term is five (5) years, after which they can be reappointed. Each institution that establishes an EC should also provide financial compensation to its committee members. EC review and approval decisions must take place during formal meetings. The majority of … Procedures for promptly notifying researchers of review opinions Procedures for appealing ethics review opinions The RegEthics and the NMPA-GCP-No57-2020 state that written records of all meetings and resolutions should be preserved for five (5) years following the completion of a clinical trial. … Go to China > Ethics Committee

… 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 professional associations A delegate from the Health Administration Additionally, Order1250-ZKM043 states that CNES members are recruited on the basis of the following criteria: Proven moral and scientific reputation Professional experience of at least five (5) years Practical training in bioethics Great availability Community leadership Order1250-ZKM043 further indicates that CNES’ mandate is five (5) years, which is renewable once. The CNES is governed by an office composed of a president, a vice-president, a secretary-rapporteur, a deputy secretary-general, and a treasurer, all elected by and from among the members. The government’s Public … Go to DRC > Ethics Committee

… Overview According to DecreeNoD218 , Guinea-PHC , and GIN-5 , the principal investigator (PI) must obtain ethics committee (EC) 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. As per DecreeNoD218 , CNERS operates under the Ministry of Health and Public Hygiene (Ministère de la Santé et de l'Hygiène Publique (MSHP)) . According to the Guinea-PHC and GIN-5 , CNERS is responsible for reviewing and approving clinical research protocols for studies conducted in humans. Per GIN-13 , CNERS is also responsible for ensuring research is conducted in accordance with the provisions of the Code of Ethics for … been incorporated into Guinea-PHC , for proposing amendments, and for examining ethical issues related to health research submitted by institutions or individuals. In addition to conducting research in compliance with the Guinea-PHC , per GIN-5 , CNERS must also comply with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( GIN-7 ), the Declaration of Helsinki ( GIN-23 ), the Council for International Organizations of Medical Science (CIOMS)’ … Go to Guinea > Ethics Committee

… members independent of the trial and the trial sponsor (applicant) should vote/provide opinions in study related matters. In addition, all records must be safely maintained after the completion or termination of the study for at least five (5) years from the date of the trial’s completion or termination (both hard and soft copies). The G-ICMR specifies that all EC members should review all proposals. Members should be given at least one (1) week to review the proposal and related … to risk level: exemption from review, expedited review, or full committee review. An investigator cannot decide that a protocol falls in the exempted category without an EC review. Per the 2019-CTRules and the G-ICMR , a minimum of five (5) members is required for the quorum. For detailed EC procedures and information on other administrative processes, see the 2019-CTRules , the G-ICMR , and IND-5 . See also IND-27 and IND-28 for the Indian Council of Medical Research (ICMR) ’s research conduct policies. … 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 should consist of at least seven (7) members, or an odd number above seven (7). The G-ECBiomedRes states that these members should be multidisciplinary and multisectoral in composition, collectively 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 … Go to Kenya > Ethics Committee

Overview Per the G-ACRE-IRB and the G-NREB , all research involving human participants should be reviewed by an ethics committee (EC). According to the NatResHlthPlcy , Liberia has two (2) ethics committees (ECs): the National Research Ethics Board of Liberia (NREB) and the Atlantic Center for Research and Evaluation Institutional Review Board (ACRE IRB) (formerly known as the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE-IRB)). National Research Ethics Board of Liberia As explained in the G-NREB , the NREB is an advisory institution that reports to the Ministry of Health (MoH) , and its members are appointed by the Minister of Health. According to LBR-38, only the NREB has the sole responsibility to review all clinical trial protocols. The G-NREB states that the board ensures all research related protocols within and outside of Liberia are in compliance with internationally recognized ethical standards (including the Belmont … Go to Liberia > Ethics Committee

Overview Malawi has a centralized registration process for ethics committees (ECs) and EC review. As mandated by the SciTechAct , the National Commission for Science and Technology (NCST) is the governmental body responsible for EC oversight, and for the promotion and coordination of research in Malawi. As per the G-NHSRC , the G-COMREC , and MWI-50 , the National Health Sciences Research Committee (NHSRC) and the College of Medicine Research and Ethics Committee (COMREC) are the two (2) NCST-approved ECs responsible for monitoring and evaluating health research studies involving humans. Per the R-HlthResCoord , each EC has members representing the other committee in order to facilitate the transfer of information between the ECs. The NHSRC and COMREC report to and are centrally monitored by the NCST. National Health Sciences Research Committee The G-HlthResConduct and the R-HlthResCoord indicate that the NHSRC has the sole jurisdiction to review studies with a national interest and … Go to Malawi > Ethics Committee

Overview As stated in LawNo09-059 , Mali requires investigators to obtain approval from a scientific committee and an approved ethics committee (EC) for each clinical trial. The scientific committee evaluates the technical validity of the research protocol. The EC provides its opinion on the validity of the research methods, particularly as they relate to participant protection and consent. Per DecreeNo2017-0245 , all clinical research protocols must be submitted to the National Committee of Ethics for Health and Life Sciences (Comité National d’Éthique pour la Santé et les Sciences de la Vie (CNESS)) or to an accredited institutional EC. Furthermore, the EC assumes the moral responsibility of the state and is directed to follow the investigator’s implementation of the protocol at its own expense. According to MLI-17, Mali’s EC system consists of six (6) committees: CNESS Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University o f Sciences, Techniques … Go to Mali > Ethics Committee

… transferring the files and appoint the responsible person at the institution where the REC registration was granted. In addition, the REC will keep all the essential documents reviewed and related to each evaluated investigation, up to five (5) years following the end of the investigation or during the period established in the applicable provisions. See G-RECs-Op-2018 for additional REC recordkeeping requirements. Hospital Bioethics Committees As indicated in G-CHBs-Op , Hospital … Go to Mexico > Ethics Committee

… ECs.) See PER-126 for EC registration instructions. Ethics Committee Composition As delineated in Decree021-2017 , institutional ECs must be multidisciplinary, with the participation of civil society, and be composed of at least five (5) regular members, who must ensure independence in their decision-making process. Decree021-2017 lists the following membership requirements: Persons with scientific expertise in the health field, including those with expertise in behavioral or … accessible. Ethics Committees for Human Subjects Health Research Other than Clinical Trials As indicated in Res233-2020 , ECs are multidisciplinary, reflecting the country’s social and cultural diversity, and must be comprised of at least five (5) members. Res233-2020 lists the following membership requirements: Persons with knowledge in research methodology and knowledge in the health field as well as in behavioral or social sciences Persons with knowledge of legal and ethical matters … Go to Peru > Ethics Committee

… who collectively have 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 , … Go to Sierra Leone > Ethics Committee

… to institutional requirements, a chairperson could be appointed or elected at the first meeting of a newly constituted EC. Alternatively, the chairperson could be appointed by the institutional leadership for a period of three (3) to five (5) years, renewable once, if so specified in the terms of reference. The chairperson must have experience in research methodology and research ethics, should have at least two (2) years’ experience as an EC member and should have leadership … EC members, institutions should be mindful of the need for ECs to develop institutional memory among the membership as well as to ensure succession planning. Members of ECs should be appointed formally for periods of three (3) to five (5) years, renewable once, after which the member should step down for at least one (1) term. Appointments should overlap so that no more than half the committee membership is new at any one appointment time. ECs should have standard operating … Go to South Africa > Ethics Committee

… the G-TMRCC and TZA-50 , the national EC in Tanzania is the National Health Research Ethics Committee (NatHREC) , which focuses on the ethical issues surrounding submitted research proposals. As delineated in the G-TMRCC , NatHREC-Charter , TZA-5 , and TZA-18 , NatHREC is a subcommittee of the Medical Research Coordination Committee (MRCC), which serves as the national health research coordinating body, and is responsible for supervising, controlling, coordinating, evaluating, and … institutions 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 clinical trials; research dealing with vulnerable, special, or marginalized groups; and sensitive topics or indigenous communities. Protocols … Go to Tanzania > Ethics Committee

… for additional information on the CREC, and the Submission Process and Submission Content sections for detailed CREC submission requirements. Ethics Committee Composition As per G-ResEthics , institutional ECs should consist of at least five (5) members, both male and female, with the following qualifications: At least one (1) member with knowledge and experience in research fields regularly reviewed (e.g., medicine, public health, social science, etc.) At least one (1) member who is a … patient care, counseling, and treatment knowledge and experience At least one-third of the total EC should be knowledgeable or trained in human research ethics ECRegProc , by comparison, also requires institutional ECs to have at least five (5) members who are experts on science, medicine, and ethics. In addition, the committee must include members representing the following qualifications: At least three (3) members who are medical professionals At least one (1) member must be an … Go to Thailand > Ethics Committee

… (EC) (referred to as a research ethics committee (REC) in Uganda), which must be accredited by the Uganda National Council for Science and Technology (UNCST) . Ethics Committee Composition The NGHRP states that an EC must have at least five (5) members who collectively encompass the qualifications and experience required to review and evaluate the scientific, medical, and ethical aspects of a proposed clinical trial. Specifically, the composition should include: Individuals of varying … its discretion, invite individuals with competence in special areas to assist in the review of protocols which require expertise beyond, or in addition to, that available in the EC. These individuals do not vote at EC meetings. See Sections 4.5.1 and 4.9 of the NGHRP for additional EC review requirements. As per the NGHRP , an EC must also prepare and maintain the following: Detailed written procedures Copies of reviewed proposals and corresponding documentation (e.g., scientific evaluations, progress reports, correspondence with investigators) Meeting minutes Records of continuing review activities Documents relating to research projects must be retained for at least five (5) years after the research project has been completed. All documents must be accessible for inspection and use by authorized UNCST representatives. See Section 4.6 of the NGHRP for additional EC recordkeeping requirements. … Go to Uganda > Ethics Committee

… the quorum is a majority of the EC. See the ClinRegs United States page , Ethics Committee topic for more information on ethics review requirements in the US. As indicated in GAfREC , committee member appointments are valid for up to five (5) years. Appointments may be renewed; however, members should not normally serve more than two (2) consecutive terms of five (5) years on the same EC, and members may resign at any time. Members must maintain confidentiality regarding all ethical review related matters and refuse any projects in which they have a conflict of interest. See the MHCTR and GAfREC for … Go to United Kingdom > Ethics Committee

… can help an institution to determine if a research study can be classified as non-exempt. Ethics Committee Composition As stated in 21CFR56 , the Pre2018-ComRule , and the RevComRule , an EC must be composed of at least five (5) members with varying backgrounds to promote complete and adequate research proposal review. The EC must be sufficiently qualified through member experience, expertise, and diversity, in terms of race, gender, cultural backgrounds, and … Go to United States > Ethics Committee

… (NECBR). Ethics Committee Composition The ECReg details general EC requirements applicable to both the CEBRGLs and the NECBR, as well as specific requirements for each type of EC. Per the ECReg , EC membership should have at least five (5) members, ensuring gender principles, and include the following: Members with expertise in the health sector and independent from the organization/institution that established the EC Members that are clinicians Members with experience in … criteria and VNM-1 for the list of 2023-2028 NECBR term members. Additionally, see VNM-14 for a list of NECBR SOPs. Terms of Reference, Review Procedures, and Meeting Schedule According to the ECReg , both CEBRGLs and the NECBR have five (5) year terms. However, the CEBRGLReg indicates that CEBRGLs have three (3) to five (5) year terms, as specified in the EC’s establishment decision. The ECReg also stipulates that the EC for the next consecutive term must include at least 20% new members. As stated in the ECReg , EC activities are non-profit. When reviewing … Go to Vietnam > Ethics Committee

… states that only those members who are independent of the investigator/sponsor of the trial should make decisions. Medical Research Council of Zimbabwe ZWE-11 indicates that MRCZ has monthly meetings to review research proposals. When five (5) copies of a new research proposal are submitted for review to the MRCZ, one (1) copy becomes the MRCZ copy, and the other four (4) copies are sent to external reviewers depending on their area of specialty and the title of the proposal. The … Go to Zimbabwe > Ethics Committee

Overview According to the G-NatlStmt , the institutional ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia) is responsible for protecting the interests of research participants and for promoting good research by ensuring adherence to the values of research merit and integrity, beneficence, justice, and respect for persons throughout the conduct of the research project. The EC must review the recruitment and consent processes, weigh the benefits and risks of the research, and consider the impact of the research on certain groups of participants deemed to merit special consideration. Additionally, ECs may conduct both scientific and ethics review or may delegate scientific review to a sub-committee. Pursuant to the G-NatlStmt , the establishment and maintenance of ethics review processes and processes for assessing the risk level of the research are part of an institution’s overall governance responsibility. In addition to ethics approval, research must also be … Go to Australia > Scope of Review

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 … Go to Brazil > Scope of Review

Overview According to the CanadaFDR , the G-CanadaCTApps , the G-TCPS2 , and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ), the primary scope of information assessed by institutional ethics committees (ECs) (called Research Ethics Boards (REBs) in Canada) relates to maintaining and protecting the dignity and rights of human research participants and ensuring their safety throughout their participation in a clinical trial. ECs must also pay special attention to reviewing informed consent and protecting the welfare of certain classes of participants deemed vulnerable. (See the Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired sections for additional information about these populations.) Note that per CAN-50 , Health Canada (HC) -implemented ICH guidance takes precedence over other HC guidance when they are not consistent. CAN-52 , which Canada has implemented per … Go to Canada > Scope of Review

Overview According to the EC-Guide , the NMPA-GCP-No57-2020 , and the NMPA-No11-2017 , the primary scope of information assessed by the ethics committee (EC) relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial, in accordance with the requirements set forth in the Declaration of Helsinki ( CHN-84 ). Per the Measures-Ethics and the RegEthics , ethics reviews and relevant personnel must comply with the Constitution of the People's Republic of China and Chinese laws and regulations. The Measures-Ethics indicates that life science and medical research involving humans must respect research participants and follow the principles of beneficence, non-harm, and fairness, and protect privacy and personal information. Per the RegEthics and the EC-Guide , the EC must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants … Go to China > Scope of Review

… Overview According to DecreeNoD218 , the Guinea-PHC , and GIN-5 , the mission of the National Ethics Committee for Health Research (Comité National d’Ethique pour la Recherche en Santé (CNERS)) is to ensure the scientific quality and ethical conduct of health research in the Republic of Guinea. As per the Guinea-PHC and GIN-5 , the primary scope of information assessed by CNERS relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. GIN-6 requires the principal investigator (PI) to respect the fundamental ethical principles of research involving human beings. As per the Guinea-PHC and GIN-5 , CNERS must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable. DecreeNoD218 , the Guinea-PHC , and GIN-5 also state that CNERS is responsible for … Go to Guinea > Scope of Review

… communicate this decision to the investigator as well as to the DCGI. Per the 2019-CTRules , the EC must also maintain data, records, registers, and other documents related to the conduct and review of the clinical trial for a period of five (5) years after completion of the study. For detailed EC review procedures and information on other administrative processes, see the 2019-CTRules , the G-ICMR , IND-5 , and IND-27 . See also IND-36 for the EC clinical trial application form and IND-52 for other commonly used EC review forms. The G-ICMR further states that research during humanitarian emergencies and disasters can be reviewed by an EC through … secretary on a case-by-case basis depending on the urgency and need. If an expedited review is done, full ethical review should follow as soon as possible. The EC should also closely monitor the conduct and outcome of research. See Section 12.5 of the G-ICMR for additional information on EC review requirements during humanitarian emergencies. For specific guidelines regarding gene therapy and stem cell therapy clinical trials, see G-GeneThrpy and G-StemCellRes . Academic Clinical … Go to India > Scope of Review

… 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 … Face-to-face meetings with PIs are not mandatory and may be conducted electronically or virtually if necessary. Also, protocols will be sent to reviewers within 48 hours of submission. Reviewers should complete their reviews within five (5) days during an outbreak. The PI should receive consolidated reviews with suggestions or approval within 10 working days, and should respond to the review within 48 hours. The director of the NREB secretariat will be the primary contact for … Go to Liberia > Scope of Review

Overview According to the G-NHSRC and the G-COMREC , the primary scope of information assessed by 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)—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-HlthResConduct states that scientific design; recruitment of research participants; care and protection of research participants; ethical consideration; and community consideration are essential elements that the NHSRC and COMREC must review in a clinical trial application. Per the G-NHSRC , the NHSRC must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable (See the Vulnerable Populations; Children/Minors; … Go to Malawi > Scope of Review

Overview According to LawNo09-059 , the primary mission of Mali’s ethics committees (ECs) is to ensure the scientific quality and ethical conduct of health research in the country, specifically with regard to participant protection and consent. 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, and by verifying the adequacy of confidentiality and privacy safeguards. ECs must also confirm that the study’s goal is to increase scientific understanding of humans and to provide approaches likely to improve the health conditions under consideration. See LawNo09-059 for detailed ethical review guidelines. Per DecreeNo2017-0245 , the rights of vulnerable persons, must be particularly protected when they are participating in a study. See also MLI-4 for additional information related to the protection of personal data in biomedical research. Per MLI-17, all six (6) ECs in Mali … Go to Mali > Scope of Review

… in G-RECs-Op-2018 , the REC agenda and documents corresponding to each session should be delivered at least seven (7) days prior to the meeting. It is then recommended that the REC’s decision be sent within a period not exceeding 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 … Go to Mexico > Scope of Review

Overview According to Decree021-2017 and the G-EC-CTRev , the primary scope of information assessed by institutional ethics committees (ECs) (Comités Institucional de Ética en Investigación (CIEIs)) relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. The EC scope also aligns with the principles delineated in the PeruConstitution and Decree011-2011 , which assert that the defense of the human person and respect for their dignity are the supreme goal of society and the state. As per Decree021-2017 , Decree011-2011 , and the G-EC-CTRev , ECs must also pay special attention to reviewing informed consent and to protecting 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 … Go to Peru > Scope of Review

… should have a review standard operating procedure (SOP) that allows a combination of rapid but thorough review and reciprocal recognition of review (see above) by other registered ECs. The SOP might stipulate that a small group of reviewers (3-5 persons) with appropriate expertise reviews the protocol. The deliberations and outcome of the process must be documented in minutes and reported to the full EC at its next meeting. Joint Review The G-EthicsHR-ZAF allows joint reviews wherein … Go to South Africa > Scope of Review

… Prisoners ; and Mentally Impaired sections for additional information about these populations). The NatHREC is responsible for ensuring an independent, timely, and competent review of all ethical aspects of the clinical trial protocol. TZA-5 states that the NatHREC must function in accordance with national and international standards and guidelines on health research, and guided specifically by the ethical principles expressed in the Declaration of Helsinki ( TZA-30 ), international … cover letter, the institution’s commitment letter, and other supporting letters; review the abstract/summary; review the application form, protocol, and appendices; and synthesize and submit comments online through REIMS ( TZA-32 ). Per TZA-5 , following successful validation of an application to the REIMS, the system generates a unique protocol number/identifier; this unique identifier must be used in reference to all communications to the PI or applicant regarding the application. … appeal is based. The MRCC will respond to PIs in writing within 30 days or upon scrutiny of the appeal. The MRCC Chairperson may invite the PI to appear in person to the MRCC within 30 days of receiving the written appeal. Expedited Review TZA-5 delineates the categories of research that qualify for NatHREC expedited review: Research activities that present no more than minimal risk to human participants Minor changes (modification or amendment) to a previously approved research … Go to Tanzania > Scope of Review

… research protocol to the CREC three (3) weeks prior to the CREC meeting. As delineated in THA-98 and THA-100 , submissions to the CREC are received by the CREC Sorting Secretary, which reviews the research protocol for completeness within five (5) working days. The research protocol may undergo an expedited review (completed within 10 days) or a full board review (completed according to each panel’s schedule). Per THA-100 , exemption decisions are also made within 10 working days. THA-98 and THA-100 indicate that for both types of reviews, the PI or research coordinator will be informed of the CREC decision within five (5) working days. THA-98 notes that CREC review of amendments follows the same processes, except that an expedited review will be completed within five (5) days. Additionally, the PI, research coordinator, or site investigator must submit documents to the local EC in accordance with institutional requirements (within 30 days). THA-100 further states that if applicable, the PI must submit a revised … Go to Thailand > Scope of Review

Overview According to GAfREC , the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( GBR-113 ), and GBR-9 , the primary scope of information assessed by ethics committees (ECs) within the United Kingdom (UK) Health Departments’ Research Ethics Service (RES) ( GBR-62 ) relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. (Note: ECs are known as research ethics committees (RECs) in the UK). GAfREC specifies that ethical review is required for research proposals that involve investigational products (IPs), material consisting of human cells, and other situations that are described in GAfREC . As per GAfREC , the MHCTR , the MHCTR2006 , the MHCTR2006-No2 , and GBR-113 , ECs must pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable. (See the Vulnerable … Go to United Kingdom > Scope of Review

Overview 21CFR56 , 21CFR312 , the Pre2018-ComRule , the RevComRule , and the US-ICH-GCP state that the primary scope of information assessed by the institutional ethics committee (EC) (referred to as an institutional review board (IRB) in the United States (US)) relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. As delineated in 21CFR56 , the Pre2018-ComRule , and the RevComRule , the EC must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable. (See the Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses, & Neonates; Prisoners; and Mentally Impaired sections for additional information about these populations). The EC is also responsible for ensuring a competent review of the research protocol, evaluating the possible risks and expected benefits to participants, and … Go to United States > Scope of Review

… if the EC chair requests that the dossier be examined according to the full process. See the Ethics Committee and Timeline of Review sections for more information on the expedited and full review processes. The ECReg indicates that within five (5) working days of the results of its assessment, the EC must send a written notification of its evaluation to the leading research institution and principal investigator (PI). The EC may approve, conditionally approve, or decide not to approve a … team compliance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and other applicable regulatory requirements. The sponsor or the EC must send an inspection notice to the institution and PI at least five (5) days before the inspection, and the inspection report must be completed and sent to the institution and PI within 20 days of the inspection. The ECReg indicates that the EC must conduct periodic reviews, at least once a year, of ongoing … Go to Vietnam > 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

… National Ethics Committee for Health Research (CNERS) As per GIN-6 , the principal investigator is responsible for paying a fee of 5,000,000 Guinean Francs to the National Ethics Committee for Health Research (Comité National d’Ethique pour la Recherche en Santé (CNERS)) to review and approve the clinical trial protocol and related documents. For protocol amendments or … 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 be examined to the CNERS secretariat, an acknowledgement of receipt and a payment receipt will be sent to the investigator. … 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 NACOSTI-accredited institutional ECs. For an example of institutional fee requirements charged by the Scientific and Ethics Review Unit (SERU) at the Kenya Medical Research Institute (KEMRI) , see KEN-27 … Go to Kenya > Ethics Committee Fees

National Research Ethics Board of Liberia As described in the G-NREB , the National Research Ethics Board of Liberia (NREB) must charge a minimal fee for the review of each submission type. Submissions include research protocols, re-submissions, amendments, and continuing reviews. The fee structure is based on the following application types: research protocol, behavioral research, investigational product (IP) (clinical trial), non-clinical trial, or waiver/exemption. Fees specifically associated with conducting a clinical trial 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 … Go to Liberia > Ethics Committee Fees

National Health Sciences Research Committee According to MWI-4 and MWI-15 , non-Malawian researchers must pay $150 USD or its equivalent in Malawian Kwacha to the National Health Sciences Research Committee (NHSRC) upon submission of a research proposal. Malawian students (Masters and below) are required to pay 5000 Malawian Kwacha. The G-NHSRC indicates that following the protocol’s approval, the principal investigator must also pay the Ministry of Health (MOH) a fee of 10% of the total budget indicated in the proposal to cover NHSRC institutional capacity strengthening and administrative operating expenses. MWI-15 further specifies that the fee, referred to as a 10% NHSRC Human Subject Protection (HSP) fee, must be paid by PhD students and above. Payment Instructions Per MWI-15 , the application fee and the 10% HSP fee may be paid at the MOH Headquarters Cash Office or through the following bank details: Account Name: NHSRC NCST Review Fees Account Number: 1010759176 Bank Name: … Go to Malawi > 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

Sierra Leone Ethics and Scientific Review Committee The G-SLEthics indicates that the national ethics committee (EC), the Sierra Leone Ethics and Scientific Review Committee (SLESRC), requires the principal investigator (PI) to pay a nonrefundable administrative fee to submit a protocol for ethical review and approval. The fees are as follows: For self-funded, individual Sierra Leonean researchers based in Sierra Leone: 300,000 Leones For graduate students studying in Sierra Leone: 200,000 Leones For Sierra Leonean students studying abroad: $100 United States Dollars (USD) For Sierra Leonean academics abroad: $150 USD For all foreign students studying abroad: $200 USD For self-funded, international researchers: $400 USD For national/local non-governmental organizations (NGOs)/community-based organizations (CBOs): 2,000,000 Leones For international NGOs based in Sierra Leone and international universities conducting non-clinical research: 4,000,000 Leones For multinational … Go to Sierra Leone > Ethics Committee Fees

… 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 International researchers, amendment – $750 USD International researchers, extension – $300 USD International students, expedited review – $548 USD International students, ordinary … Go to Tanzania > Ethics Committee Fees

… and THA-50 delineates the following fees: New research project: 25,000 Baht Request for certification renewal of old research project: 10,000 Baht Amendments to the research project (research outline amendments/adding a research location): 5,000 Baht Report requesting amendments to the research outline: Amendment certified by the local EC of the joint research institute in the CREC-certified research project, followed by a report submitted for CREC consideration (site-specific … Go to Thailand > Ethics Committee Fees

Institutional Ethics Committees The CTEthics indicates that an institutional ethics committee (EC) should establish and record working procedures concerning review fees charged. Medical Research Council of Zimbabwe Pursuant to CTEthics , ZWE-41 , and ZWE-11 , the prescribed fees (posted in US dollars) for ethical review by the national EC, the Medical Research Council 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 … Go to Zimbabwe > Ethics Committee Fees

… with renewal required every 2 (two) years. Additionally, the DGDA will charge fees for the EC registration application and pay reasonable per diem to the members of the National Advisory Committee for attending evaluation meetings. See Annexure 5 of the BGD-GCP and BGD-17 for a list of documents required for EC registration approval. … 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 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

… the committee must also notify CDSCO via Form CT-02A, which will become part of the official record known as the guaranteed registration of the DCGI. Per the 2019-CTRules and IND-53 , the EC registration will remain valid for a period of five (5) years from the date of issue, unless suspended or cancelled sooner. The EC may apply for registration renewal via SUGAM ( IND-59 ) using Form CT-01 and should include all additional required documentation 90 days prior to the registration’s … for a period of two (2) years. Final registration will be granted to the EC on Form CT-03 when the DHR has completed its review of the application and the associated documentation. The final registration will remain valid for a period of five (5) years from the date of its issue, unless suspended or cancelled sooner. The 2019-CTRules further states that the EC may also apply to request registration renewal using Form CT-01 along with the specified documentation at least 90 days prior to … and further inquiry to confirm there have been no documentation changes, the DHR will renew the EC’s registration on Form CT-03 within 45 working days from the date of application receipt. The renewed registration will remain valid for five (5) years from the date of its issue, unless suspended or cancelled sooner. If the EC fails to comply with any of the registration conditions, the 2019-CTRules notes that the DHR may, after giving the EC an opportunity to show cause as to why such … Go to India > 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

Overview The National Bioethics Commission (Comisión Nacional de Bioética (CONBIOÉTICA)) was established as a decentralized entity of the Ministry of Health (Secretaría de Salud) in 2005, as specified in D-CONBIOETICA . According to D-CONBIOETICA and MEX-55 , the agency has technical and operational autonomy in defining and establishing national bioethics policies in medical care and health research. Per D-CONBIOETICA , GenHlthLaw , G-RECs-Op-2018 , and MEX-57 , CONBIOÉTICA is also responsible for promoting the organization and operation of Research Ethics Committees (RECs) ( Comités de Ética en Investigación (CEIs) ) and Hospital Bioethics Committees in public and private health institutions, for establishing and disseminating criteria to support development of REC activities, and for providing committee member training support. In addition, per D-CONBIOETICA , CONBIOÉTICA’s other roles include: Exercising the Commission’s legal authority and head Commission operations Presiding over … 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

… A critical part of the ongoing quality assurance review process is the EC annual report form ( ZAF-54 ). The G-EthicsHR-ZAF states that the NHREC conducts a comprehensive quality assurance assessment and administrative audit of ECs on a five (5)-year cycle to check compliance with the various administrative and record-keeping standards. When an EC persistently fails to comply with expected standards, the NHREC must enforce the standards, e.g., to suspend operations until compliance is … Go to South Africa > Oversight of Ethics Committees

… body responsible for oversight, and for the promotion and coordination of research in Tanzania. The NIMR is a semi-autonomous organization under the Ministry of Health (MoH) . The IERC-Accredit , the G-EthicsHR-TZA , the G-TMRCC , and TZA-5 state that the NIMR’s Medical Research Coordination Committee (MRCC) serves as the national health research coordinating body, and is responsible for supervising health research in Tanzania. The MRCC, as the NIMR’s clearance body, delegates the … in Tanzania are also reviewed by a specialized nine (9)-member Clinical Trials Sub-Committee, which meets monthly and reports to the NatHREC. For detailed information on NatHREC responsibilities, see the G-TMRCC , the G-EthicsHR-TZA , and TZA-5 . TZA-5 acknowledges that not all human subjects research requires review and approval at the national level—i.e., research that does not involve investigational products or collaboration with foreign institutions. For studies that may not need national … Go to Tanzania > Oversight of Ethics Committees

Overview As delineated in 21CFR56 and 45CFR46-B-E , the Department of Health & Human Services (HHS) and the HHS’ Food & Drug Administration (FDA) have mandatory registration programs for institutional ethics committee (ECs), referred to as institutional review boards (IRBs) in the United States (US). A single electronic registration system ( USA-28 ) for both agencies is maintained by HHS’ Office for Human Research Protections (OHRP) . Registration, Auditing, and Accreditation In accordance with the G-IRBReg-FAQs and USA-61 , EC registration with the HHS OHRP system ( USA-28 ) is not a form of accreditation or certification by either the FDA that the EC is in full compliance with 21CFR56 , or by the HHS that the EC is in full compliance with 45CFR46-B-E . Neither EC competence nor expertise is assessed during the registration review process by either agency. Food & Drug Administration According to 21CFR56 and the G-IRBReg-FAQs , the FDA requires each EC in the US, that either reviews … 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

Overview As per the BGD-GCP , the Ministry of Health and Family Welfare (MOHFW) ’s Directorate General of Drug Administration (DGDA) is responsible for reviewing, evaluating, and approving clinical trial applications for drugs in Bangladesh. The BGD-GCP and BGD-22 indicate that ethical clearance by an ethics committee (EC) (referred to as an independent ethics committee (IEC)/institutional review board (IRB) in Bangladesh) is a required element of a clinical trial application to the DGDA. Therefore, DGDA review and ethics review may not be conducted in parallel. (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.) In addition, as delineated in the G-BMRC and BGD-16 , any health research to be conducted in Bangladesh must be registered with the BMRC, and scientific validity should be approved by a valid Scientific … Go to Bangladesh > Submission Process

Overview As stated in ResNo945 and the G-DDCMManual , the sponsor, the designated contract research organization (CRO) (clinical research representative organization (CRPO) in Brazil), or the sponsor-investigator must apply to the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) to obtain approval for a clinical trial application (Clinical Drug Development Dossier (Dossier de Desenvolvimento Clínico de Medicamento (DDCM))) for a drug that will have all or part of its development in Brazil for registration purposes. (Note: Applications are also known as petitions in Brazil). According to LawNo14.874 and ResNo945 , research involving human beings must be subject to prior ethical analysis by research ethics committees (ECs) (Comitês de Ética em Pesquisa (CEPs)). ResNo945 explains that clinical trial applications can be submitted in parallel, however, a drug clinical trial may only be initiated after approval is obtained by both the EC (CEP) and … Go to Brazil > Submission Process

Overview In accordance with the CanadaFDR and the G-CanadaCTApps , Canada requires the sponsor to obtain clinical trial authorization from Health Canada (HC) prior to initiating the trial. The sponsor must file a clinical trial application (CTA) to the appropriate Directorate within HC’s Health Products and Food Branch (HPFB) . In addition, as delineated in the CanadaFDR and the G-CanadaCTApps , the sponsor may submit a CTA for clinical trial authorization to the HC in parallel with its submission to an institutional ethics committee (EC) (known as a Research Ethics Board (REB) in Canada) for a favorable ethical opinion. 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 ( CAN-6 )) for each participating trial site is submitted. The HCNotice-CTSIForm indicates that the CTSI form improves efficiencies … Go to Canada > Submission Process

… CHN-14 states that Chinese legal entities must submit application materials to the NMPA/CDE for a formal process review (including checking the electronic materials as described below). NMPA will process clinical trial applications within five (5) working days if the study falls within the scope of its authority; the application materials are complete and comply with the prescribed format; and if all required supplementary materials are submitted. If accepted, the CDE then organizes and … clinical trial database, if applicable) for verification at the same time. For clinical trial database data, the relevant materials must be prepared in a separate set of CD-ROMs. Additionally, the ElectronicApps-Rqts states that within five (5) working days after the acceptance of the drug registration application, the applicant must upload a Microsoft Word file of the application materials (e.g., pharmacy, non-clinical, and clinical reviews) through the CDE’s Applicant Window ( … Go to China > Submission Process

… approval is contingent upon EC approval. Regulatory Submission Per DRC-12, ACOREP’s delivery address is: Ministère de la Santé Publique, Hygiène et Prévention Autorité Congolaise de Réglementation Pharmaceutique (ACOREP) 4ème niveau, immeubles 5 à sec, boulevard du 30 juin Kinshasa I, B.P. 11998, République Démocratique du Congo Ethics Review Submission The G-EthicalEval indicates that the EC is responsible for establishing well-defined procedures for submitting an application for … as of March 2019, research protocols and relevant materials to be submitted to the national EC, the National Committee of Health Ethics (Comité National d'Éthique 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 … Go to DRC > Submission Process

… Overview In accordance with DecreeNoD218 , Guinea-PHC , and GIN-5 , the principal investigator (PI) must obtain 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 … 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

Overview In accordance with the LibCTReg and the G-LibClinTrial , the sponsor, the legal representative, the principal investigator (PI), or the sponsor-investigator is responsible for submitting a clinical trial application to the Liberia Medicines and Health Products Regulatory Authority (LMHRA) and obtain written permission from the National Research Ethics Board of Liberia (NREB) . However, per the G-NREB , the PI must obtain ethics committee (EC) approval. The LibCTReg and the G-LibClinTrial state that the NREB and LMHRA reviews may be conducted in parallel. Per the G-LibClinTrial and the G-NREB , the LMHRA will only issue final approval once NREB approval is obtained. Regulatory Submission As indicated in the LibCTReg and the G-LibClinTrial , the sponsor or the representative should submit the application form and associated documents along with the prescribed fee. Also, per the G-LibClinTrial , four (4) sets of the application should be submitted both electronically and as … Go to Liberia > Submission Process

Overview According to the G-CTARevVacBiol , the R-HlthResCoord , and MWI-50 , the Pharmacy and Medicines Regulatory Authority (PMRA) requires the applicant to obtain PMRA approval and ethics committee (EC) approval of a clinical trial application. 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 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. Regulatory Submission According to MWI-60 , an electronic or soft copy of the clinical trial application dossier must be sent to the PMRA at registration@pmra.mw and info@pmra.mw . As per the G-CTARevVacBiol and MWI-9 , applicants must submit three (3) copies of the … Go to Malawi > Submission Process

Overview In accordance with LawNo09-059 and DPM-ClinTrialDocs , Mali requires the sponsor (also referred to as the promoter in Mali) or the principal investigator (PI) to obtain clinical trial authorization from the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) within the Ministry of Health and Social Development (Ministère de la Santé et du Développement Social (MSDS)) . As delineated in LawNo09-059 , the investigator is required to obtain approval from a scientific committee and ethics committee (EC) prior to obtaining the DPM’s approval. According to MLI-17, 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 the primary EC for reviewing clinical research protocols in Mali. As per … 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

Overview In accordance with Decree021-2017 , Res655-2019 (amending Decree021-2017 ), the INS-CTManual , Res252-2022 (amending the INS-CTManual ), and Decree010-2025 , the sponsor or the contract research organization (CRO) is responsible for submitting a clinical trial application to the INS to obtain approval to conduct a clinical trial in Peru. Per Decree021-2017 , Res655-2019 , the INS-CTManual , Res252-2022 , and the G-EC-CTRev , the INS-accredited ethics committee (EC) (El Comité Institucional de Ética en Investigación (CIEI)) must first approve the research protocol and informed consent form (ICF), and the sponsor or the CRO must submit this information as part of the application dossier in order for the INS to conduct its review. Therefore, the INS and EC reviews may not be conducted in parallel. Decree021-2017 also states that sponsors not based in Peru are required to appoint a legal representative in the country who coordinates all communication with the INS’s Directorate of … Go to Peru > Submission Process

… England Ville, Freetown P.M.B. 322 Sierra Leone As per SLE-23, the clinical trial application and accompanying material must be provided in English. Ethics Review Submission The G-SLEthics states that the PI should submit to the SLESRC five (5) hard copies of the full research proposal (and all supporting documents) detailing the ethical issues in the study and how they will be addressed (only three (3) copies for extensions), each in a separate envelope. In addition, an electronic … 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 … 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 and … resolution 300 dpi (photographs up to 600 dpi), avoid grayscale or color where possible, use only lossless compression techniques. The file must be searchable (OCR scanned). In addition, the maximum size of documents allowed per e-mail is 5 MB. As per arrangement with CTU, in case of a big file of documents and documents that need to be couriered, the waybill should indicate the type of application, protocol number, and SAHPRA database tracking number. As delineated in the … Go to South Africa > Submission Process

… to the TMMDAct , the CT-Regs , and the G-AppConductCT , the Tanzania Medicines and Medical Devices Authority (TMDA) requires the sponsor, the designated contract research organization (CRO), or the investigator to obtain TMDA approval. Per TZA-5 , the principal investigator (PI) is required to submit an application for ethical review of a research study to the national ethics committee (EC), the National Health Research Ethics Committee (NatHREC) . All clinical trials must get ethics … . See the G-ResearchClearance and TZA-47 for additional information about applying for a research permit through the National Research Clearance Committee (NRCC). Ethics Review Submission National Health Research Ethics Committee The TZA-5 specifies that the NatHREC requires all applicants to complete the Application Form for Ethics Approval (see Form 03 in TZA-5 ) with the research protocol to obtain ethics approval. PIs or applicants must submit all required documents at least two (2) months prior to the commencement of the research study, and they must select either an expedited or ordinary review … Go to Tanzania > Submission Process

… , the following is contact information for submitting an application to the OSSC ( THA-35 ) in person or via email, and for requesting permission to access the Skynet E-Submission System ( THA-54 ): One Stop Service Center (OSSC) Building 6, 5 th Floor Food and Drug Administration Building Ministry of Public Health 88/24 Tiwanon Road Talat Khwan Subdistrict Mueang District, Nonthaburi Province 11000 Email (E-Consult): econsultcenter@fda.moph.go.th Phone: 02 590 7614 (Consultation … Go to Thailand > Submission Process

Overview According to the NDPA-CTReg , the G-CTConduct , the NGHRP , the G-UNCSTreg , and the G-TrialsGCP , institutional ethics committee (EC) (research ethics committee (REC) in Uganda) approval, National Drug Authority (NDA) approval, and Uganda National Council for Science and Technology (UNCST) registration are mandatory before a study may commence. Per the NDPA-CTReg , the NDA’s review and approval of a clinical trial application are dependent upon the applicant submitting proof in the application of institutional EC approval and a research permit from the 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 Submission National Drug Authority According to the NDPA-CTReg , an application … Go to Uganda > Submission Process

Overview In accordance with the MHCTR , the MHCTR2006 , the G-CTApp , and GBR-9 , the United Kingdom (UK) requires the sponsor or the designated legal representative to obtain clinical trial authorization from the Medicines and Healthcare Products Regulatory Agency (MHRA) prior to initiating the trial. Per G-CTApp and G-IRASCombRev , the UK’s combined review process offers a single application route and coordinated/parallel review from MHRA and the ethics committee (EC) leading to a single UK decision for clinical trials. Note: G-CTApprovedCountries and the MHCTR-EUExit list the countries where a clinical trial sponsor or their legal representative may be established; these countries are initially European Union (EU) and European Economic Area (EEA) countries. Combined Review Submission Per G-CTApp and G-IRASCombRev , all new applications for clinical trials of investigational medicinal products (CTIMPs) must be prepared, submitted, and reviewed via the combined review process using … 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

… Trslt-Ntc requires foreign researchers to use qualified translation institutions for translation of research materials. All translated research materials should be accompanied by a confirmation from a qualified translation institution. See ZWE-5 for a list of qualified language institutions. National Biotechnology Authority of Zimbabwe Per the NBA-Proc , vaccine clinical trial protocols must be submitted by the investigator to the institutional biosafety committee (IBC), followed by … Go to Zimbabwe > Submission Process

Regulatory Authority Requirements Clinical Trial Notification (CTN) Scheme As delineated in AUS-49 , the following information must be submitted to the Therapeutic Goods Administration (TGA) through the online form on the TGA Business Services (TBS) webpage ( AUS-36 ): Sponsor name and address Sponsor declaration Notification fee (See Regulatory Fees section ) Organization-nominated contact’s name, phone number, and email An optional alternative contact, which may be chosen from the contacts for the agent or sponsor organization submitting the CTN. An Australian contact number is required to be listed with either the primary sponsor contact or the alternate sponsor contact Protocol number Expected trial start and completion dates Potential use of restricted goods Study title and description, which must be a minimum of 250 characters (spaces included) and up to a maximum of 2,500 characters “This Trial” check boxes indicating whether the trial involves the use of a medicine, a medical … 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) to conduct a clinical trial: Detailed description of Clinical Research Protocol Checklist (see BGD-22 ) Ethical clearance for conducting the clinical trial from the ethics committee (EC) (referred to as an independent ethics committee (IEC)/institutional review board (IRB) in Bangladesh) Investigator’s Brochure (IB) Informed consent form (ICF) Signed agreements between the sponsor, 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 … 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

Regulatory Authority Requirements As set forth in the CanadaFDR , the G-CanadaCTApps , and CAN-31 , Health Canada (HC) requires the sponsor to apply for clinical 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 CanadaFDR , the clinical trial application form ( CAN-4 ) and the following information and documents must be submitted: Protocol Summary of potential risks/benefits Clinical trial attestation that includes drug information (chemistry, names, classifications, dosage, therapeutic purpose, human-sourced excipient, drug identification number or notice … Go to Canada > Submission Content

Regulatory Authority Requirements National Medical Products Administration As delineated in the NMPA-No51-2023 , the applicant must submit the following materials to the National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) to have a communication meeting prior to submitting a clinical trial application for an exploratory clinical trial: The overall clinical development plan A complete first clinical trial protocol A risk management plan A subsequent clinical trial protocol, if applicable Non-clinical research review Pharmaceutical research review, etc. A clear statement of the issues to be communicated Next, the NMPA-No51-2023 states that prior to completing the exploratory clinical trial, the applicant must submit the following to CDE for another meeting to discuss conducting the confirmatory (or critical) clinical trial and the subsequent clinical trial protocol: A preliminary analysis of the results of the early clinical trials that have been conducted … 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

… and signed by the PI Completed ethics review application form, dated and signed by the PI (see GIN-6 ) Protocol ICF and/or assent form Data collection instruments IB Detailed project budget in Guinean francs Profile of investigators in five (5) lines CVs for all investigators (four (4) pages maximum per CV) Previous related decisions from CNERS and/or other countries Letters from associated partners Other documents In addition to the documents indicated by GIN-6 , GIN-5 also states that CNERS requires the following documents: Table of contents Acronyms and abbreviations Project summary in a maximum of 10 lines Research problem, objectives, and hypotheses Research sponsor(s) profile(s) and CV(s) Methodology … Go to Guinea > Submission Content

… of funding agency/sponsor and fund allocation, if applicable Investigators’ Curriculum Vitaes (CVs) Conflict of interest statement, if applicable Good clinical practice (GCP) training certificate for investigators (preferably within last five (5) years) Any other research ethics/other training evidence, if applicable as per EC standard operating procedures (SOPs) List of ongoing research studies undertaken by the principal investigator, if applicable Investigator’s undertaking statement … Go to India > Submission Content

… practice (GCP) training of the core study staff Data and Safety Monitoring Board (DSMB) information, including the charter, composition, and meeting schedule Detailed study budget Financial declaration by the sponsor and PI ( KEN-2 and Annex 5 of the G-KenyaCT ) 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 … 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

Regulatory Authority Requirements As per the G-CTAProcsVacBiol , the G-CTARevVacBiol , and MWI-60 , the following documentation must be submitted to the Pharmacy and Medicines Regulatory Authority (PMRA) in an application to conduct a clinical trial (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements): Comprehensive table of contents for the entire application, including a complete list of all documents provided in the application. The location of each document should be identified by tab identifiers. In general, the name for the tab identifier should be the name of the document Cover letter signed by the principal investigator (PI) or sponsor Proof of payment of the application and registration fees Signed and stamped Clinical Trial Application (Form CT 8) ( 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 … 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 necessarily be found in both sources, which provide overlapping and unique elements): Completed clinical trial authorization application signed by the sponsor Copy of the ethics committee (EC) approval of clinical trial protocol Copy of the clinical trial protocol signed by the sponsor in French Copy of investigator’s brochure (IB) in French Copy of insurance contract covering entire trial period Updated and valid certificate of clinical trial insurance Declaration forms completed and signed by the investigator(s) Copy of informed consent form (ICF) Participant information note/flyer Statement of commitment signed by the sponsor Copy of investigators’ curriculum … Go to Mali > Submission Content

… Efficacy and safety assessments Study schedule (document detailing activities to be carried out during the investigation) Bibliographic references and relevant trial data Names and signatures of PI and associate researchers (no more than five (5), classified according to their involvement in the research project) Other documents related to the research project or protocol Optional pre-assessment evaluation opinion (See Scope of Assessment and Submission Process sections for details on … Go to Mexico > Submission Content

Regulatory Authority Requirements As specified in Decree021-2017 , Res655-2019 (amending Decree021-2017 ), the INS-CTManual , Res252-2022 (amending the INS-CTManual ), Decree010-2025 , PER-71 , PER-83 , and PER-115 a clinical trial application submission must include the following documents (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping 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 Annex 3 in INS-CTManual and Annex 3 in Res252-2022 ) Research protocol in Spanish, and in the original language if … Go to Peru > Submission Content

… and Annex 4 on page 12 of SLE-6 ) Workload forms for investigator(s) Signed declaration(s) by the local PI, as well as each investigator and key staff participating in the clinical trial (see Appendix IIIb of the G-SLAppClinTrial and Annex 5 of SLE-6 ) Signed declaration(s) by the sub-investigators and key staff participating in the clinical trial CVs and signed declaration by regional monitor(s) (see Annex 6 of SLE-6 ) Copies of recruitment advertisement(s) and questionnaires, if … Go to Sierra Leone > Submission Content

… by sponsor and principal investigator (PI) or national PI (Annex 4 of ZAF-23 ) Signed declaration by applicant and national PI Signed declaration by national PI (See page 4 and Annex 3 ( ZAF-23 ) Signed declaration by sub-investigators (Annex 5 of ZAF-23 ) CV(s) and signed declaration by regional monitor(s) (Annexes 2 and 6 of ZAF-23 ) Proof of application to register the trial on the South African National Clinical Trials Register (SANCTR) ( ZAF-48 ) Active insurance certificate for … Go to South Africa > Submission Content

… Information Leaflet, informed consent forms (ICFs), and any other information to be given to participants Declarations by the principal investigator (PI) ( TZA-39 ), co/sub investigators ( TZA-41 ), and monitors ( TZA-40 ) (Also see Annexes 5-7 of the G-AppConductCT ) Joint declaration by sponsor and national PI in format prescribed in Annex 8 of the G-AppConductCT Investigator’s Brochure (IB), nonclinical overall summary (See Annex 10 of the G-AppConductCT ), and prescribing … of nonclinical, clinical, and quality data (See Module 2 of the G-AppConductCT ) Quality of the IP (See Module 3 of the G-AppConductCT ) Nonclinical study reports (See Module 4 of the G-AppConductCT ) Clinical study reports (See Module 5 of the G-AppConductCT ) As delineated in G-AppConductCT , an application must not cross reference the details or documentation between different clinical trials. The applicant must include a statement indicating that all the information in the … 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 Ethics Approval (see Form 3 in TZA-5 and the Research Ethics Information Management System (REIMS) ( TZA-32 )) Full protocol, including benefits sharing, placebo rationale, information on randomization/blinding, and a commitment to register the trial in a public registry Cover … 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 Consent Form in Thai Patient Information Sheet in Thai Research project summary in Thai Completed version of study protocol in Thai or English Chemistry, manufacturing, and control … 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 dossier following the Format for Investigational Medicinal Product Dossier ( See Schedule 2 of the NDPA-CTReg ) Phytochemical analysis report and microbiological contamination report, where the clinical trial is … Go to Uganda > 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

Regulatory Authority Requirements Medicines Control Authority of Zimbabwe As specified in the CT-AppAuth , a clinical trial submission package to the Medicines Control Authority of Zimbabwe (MCAZ) should contain the following documents: Cover letter Study protocol Investigator’s brochure Clinical trial pharmacy protocol/plan and MCAZ pharmacy license, where applicable (See the Pharm-IMPs for guidance on the pharmacy plan) Documentation of participant insurance for trial-related injuries Letter endorsing generic insurance certificate, if necessary Ethics approval or copy of letter applying for ethics committee (EC) approval and other relevant Zimbabwean regulatory approvals Proof of approval of study by the national regulatory authority in country of origin Proof of provision of Data Safety Monitoring Board (DSMB), Data Monitoring Committee, or Safety Monitoring Committee Monitoring plan Signed declarations: the declarations for good clinical practice (GCP) compliance by the principal … Go to Zimbabwe > Submission Content

… DGDA within 60 working days. However, the BGD-GCP further specifies that the 60 working day timeline only applies if there are no observations. BGD-22 indicates that DGDA Clinical Trial Cell members will screen protocol submissions within five (5) days. If a deficiency is found, the DGDA Clinical Trial Cell will issue a deficiency letter to the applicant within seven (7) days. After the Clinical Trial Advisory Committee decides to disapprove the protocol or recommend it for approval, the … Go to Bangladesh > Timeline of Review

Overview As stated in ResNo945 , clinical trial applications can be submitted in parallel, however, a drug clinical trial may only be initiated after approval is obtained by both the research ethics committee (EC) (Comitê de Ética em Pesquisa (CEP)) and the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) . Regulatory Authority Approval As set forth in LawNo14.874 , ANVISA’s analysis of the primary petitions for clinical trials with human beings (Clinical Drug Development Dossiers (Dossiês de Desenvolvimento de Medicamentos Clínicos (DDCMs))) must be completed within 90 business days. If no response is provided after regular receipt of the primary DDCM petition, clinical development may be initiated, provided that it contains the relevant ethical approvals. ResNo945 further specifies that upon receipt of the primary DDCM and the Specific Clinical Trial Dossier (Dossiê Específico de Ensaio Clínico (DEEC)) petitions, ANVISA has 90 business days, … 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

… have not been amended to show the transfer.) Regulatory Authority Approval National Medical Products Administration Per the DRR , upon application submittal, the NMPA will complete the administrative examination for completeness within five (5) days of receiving the application, and issue a notice of acceptance. If the application does not meet the technical requirements for review, the NMPA will notify the applicant, who must submit the additional information within five (5) days of the notice. According to CHN-14 , the NMPA will process clinical trial applications within five (5) working days if the study falls within the scope of its authority; the application materials are complete and comply with the legally-prescribed format; and the applicant submits all supplementary application materials in accordance with the … 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

… 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 project’s filing date. GIN-5 and GIN-12 indicate that the sponsor or principal investigator (PI) who submitted the protocol will be notified of the opinion of CNERS within 10 days of the committee meeting via email. GIN-5 specifies that the PI is required to submit a research protocol to CNERS at least 15 days prior to the committee meeting for the application to be reviewed during the current month. However, this period may be expedited for health emergency … required between the submission and its review by CNERS. GIN-6 further states that applications submitted during the first week of each month will be discussed at the regular monthly meeting which occurs on the last Thursday of each month. GIN-5 explains that the file must include all required documents for it to be admissible and evaluated by the committee (See the Submission Content section for the list of required documents.) Per GIN-6 , the CNERS Administrative Assistant will … Go to Guinea > Timeline of Review

Overview Based on the 2019-CTRules , the Hdbk-ClinTrial , the G-ICMR , and IND-31 , the review and approval of a clinical trial application by the Drugs Controller General of India (DCGI), head of the Central Drugs Standard Control Organization (CDSCO) , is dependent upon obtaining 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 at the same time as the EC review for each clinical trial site, except in the case of non-regulatory academic clinical trials that only require EC approval. 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 .) Regulatory Authority Approval As specified in the 2019-CTRules and IND-31 , upon receipt of a clinical … Go to India > Timeline of Review

… for details on the content of the request.) Per the G-KenyaCT , upon receipt of a clinical trial application, the PPB’s Clinical Trial Division of the Product Safety Department screens the application package for completeness, which takes five (5) days. If accepted, an automatic system-generated reference number will be issued for each application. If additional information is needed, the sponsor will have 10 days to respond. The PPB aims to respond to applications within 30 working … weeks prior to the expiration of the previous approval. Refer to the Checklist for Submitting a Request for Annual Approval ( KEN-35 ) for relevant documentation requirements. National Commission for Science, Technology and Innovation Per KEN-5 and KEN-31 , the timeline for NACOSTI’s license application process is 30 days. KEN-31 states that if a research license application does not meet the conditions required under the STI-Act , NACOSTI must reject the application and communicate … Go to Kenya > Timeline of Review

Overview According to the LibCTReg and the G-LibClinTrial , the National Research Ethics Board of Liberia (NREB) and the Liberia Medicines and Health Products Regulatory Authority (LMHRA) reviews may be conducted in parallel. However, per the G-LibClinTrial and the G-NREB , the LMHRA will only issue final approval once NREB approval is obtained. Regulatory Authority Approval The LibCTReg and the G-LibClinTrial indicate that upon receipt of a clinical trial application, the LMHRA screens the application package for completeness and must inform the applicant in writing about the validity of the application or the formal grounds for non-acceptance of the application within 10 working days of application receipt. If applicable, the applicant, in turn, must address formal grounds for non-acceptance within 10 working days. The LibCTReg and the G-LibClinTrial further explain that after validation of a complete clinical trial application, the LMHRA must inform the applicant in writing about … Go to Liberia > Timeline of Review

Overview Per LawNo09-059 and the DPM-ClinTrialDocs , the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) ’s review and approval of a clinical trial application is dependent upon obtaining written proof of the ethics committee (EC) approvals. Therefore, the DPM review and approval process may not be conducted in parallel with the EC review. Regulatory Authority Approval Per MLI-9 , the DPM Quality Assurance Division has set the timeline for evaluating applications at 15 days, but there are no guidelines stipulating specific timelines for review. The DPM secretary provides the clinical trial application to the DPM director once it is received. The approval decision is provided to the applicant as well as regional offices, health professional councils, health inspectors, and all Ministry of Health and Social Development (Ministère de la Santé et du Développement Social (MSDS)) departments. Ethics Committee Approval Institutional Ethics Committee … Go to Mali > Timeline of Review

… the request is deemed approved. G-UnregDrugImprts also notes that COFEPRIS has four (4) business days to send the applicant a prevention notification regarding missing or additional information required. The applicant, in turn, has five (5) business days to respond. Per HlthResRegs and G-RNECManual , once the applicant obtains an official authorization from COFEPRIS, the applicant has a maximum of five (5) working days to enter this information into the National Registry of Clinical Trials (Registro Nacional de Ensayos Clínicos (RNEC)) database ( MEX-68 ). The RNEC is in charge of the CAS’s Clinical Trials technical area and serves as the … in G-RECs-Op-2018 , the REC agenda and documents corresponding to each session should be delivered at least seven (7) days prior to the meeting. It is then recommended that the REC’s decision be sent within a period not exceeding five (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) … 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

… 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 applicant should … Go to Sierra Leone > Timeline of Review

Overview Based on ZAF-23 and the SA-GCPs , the review and approval of clinical trial applications by the South African Health Products Regulatory Authority (SAHPRA) and an accredited ethics committee (EC) may be conducted in parallel. The applicant must notify each regulatory body of the other’s approval once it has been received. However, note that the G-EthicsHR-ZAF recommends that scientific review be completed prior to ethics review and, in cases where scientific review capacity is not available, the EC approval should be delayed until SAHPRA scientific approval has been provided. Also, where site permissions are required, e.g., from Provincial Health Research Committees (PHRCs) or superintendents, to conduct research in health care facilities, ECs must delay granting full approval until these permissions are received to prevent research from beginning before the facility knows it will happen. Regulatory Authority Approval In general, per ZAF-36 , SAHPRA’s Clinical Trial Unit … Go to South Africa > Timeline of Review

… to authorize the trial to be conducted. Per the G-AppConductCT , the TMDA’s clinical trial authorization will be valid up to the proposed duration of the study indicated in the application. However, the validity will not extend beyond five (5) years. If the trial needs more than five (5) years, the applicant must request an extension. If granted, the TMDA will issue an updated certificate. Tanzania Commission for Science and Technology The G-ResearchClearance indicates that once COSTECH receives a new application, the Secretariat screens the application for completeness; registers the application; and sends an acknowledgement to the applicant within five (5) business days. If approved after COSTECH’s review, the principal investigator (PI) is then required to collect the research permit certificate from COSTECH. Per TZA-47 , COSTECH’s review committee meets every two (2) months, and applicants are … Go to Tanzania > Timeline of Review

… ( THA-35 ) sends the application package to an officer in the Thai FDA’s International Affairs and Investigational Drug Section. The officer then screens the package for completeness and informs the eligible sponsor of the results within five (5) working days from the date the application was received. If deemed complete, the officer sends the package to the assigned technical reviewer to proceed. If the officer finds the package to be incomplete, a “Screening Result Notification form” will be sent to the applicant or the applicant’s attorney for correction. If the applicant or the applicant’s attorney fails to fully correct the package within five (5) working days, then the Thai FDA will send a rejection letter and return all the documents to the applicant. However, the applicant may later correct or amend the application package and resubmit it to the OSSC. Once the correction is completed, … finds the technical information to be incomplete, then the applicant or the applicant’s attorney will be asked to clarify and/or submit additional documents/information. If the documentation or amended information is not submitted within five (5) working days, the Thai FDA will issue a rejection letter and return the package to the applicant. However, the applicant may resubmit a corrected package to the OSSC ( THA-35 ) (timeline not specified in G-CT-DIPApp ). If the applicant can … 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

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

… Dossier Review As delineated in the ClinDrugTrialGCP , the ASTT initially checks the validity of the sponsor-submitted registration dossier (which includes the registration application form and Investigator’s Brochure (IB) summary) within five (5) working days from the date of receipt of the application. If any issues are identified, the ASTT will issue a written notice to the sponsor, who must coordinate with the ASTT to complete the dossier within 60 days of receipt. Past this time limit, the submitted application is no longer valid. The ASTT Director will issue a written decision within five (5) working days of receiving a complete and valid dossier. Approval Dossier Review The ClinDrugTrialGCP indicates that research institutions must submit dossiers requesting clinical drug trial approval to the ASTT. The ASTT checks the validity of the study approval dossier within five (5) working days from the date of receipt of the application. If any issues are identified, the ASTT will issue a written notice to the institution, which must coordinate with the ASTT to complete the dossier within 60 days of receipt. Past this … Go to Vietnam > Timeline of Review

… (i.e., review period): Individual researcher/studies: four (4) to six (6) weeks Fast-track review for new studies: 10 working days Exemption review for new studies: 10 working days PhD students: four (4) to six (6) weeks Masters students: five (5) working days Undergraduate students: five (5) working days … 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 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

Overview In accordance with the CanadaFDR and the G-CanadaCTApps , a clinical trial can only commence after the sponsor receives authorization from both Health Canada (HC) and an institutional ethics committee (EC) (known as Research Ethics Board (REB) in Canada). No waiting period is required following the applicant’s receipt of these approvals. CAN-30 specifies that for purposes of the Clinical Trial Site Information (CTSI) Form ( CAN-6 ), the trial commencement date is the date when the clinical trial site is ready to enroll participants. The commencement date is a date after which the sponsor has both the HC authorization from the appropriate Directorate (date on the No Objection Letter (NOL)) and approval from the relevant EC. Further, the commencement date would be the date when the sponsor implements the protocol, which includes the screening period that occurs prior to the check-in date. See the Scope of Review section for detailed institutional EC requirements, and the … Go to Canada > Initiation, Agreements & Registration

Overview Per the DRR , clinical trials must be conducted in institutions conducting drug clinical trials that comply with relevant regulations, and abide by the NMPA-GCP-No57-2020 , including written approval from the ethics committee (EC) to the researcher before clinical trial implementation. Further, clinical trials of vaccines must be implemented or organized by China’s designated three-level medical institutions or disease prevention and control institutions at or above the provincial level that meet the prescribed conditions. Per the NHC-HGRmgt , the National Health 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 … Go to China > Initiation, Agreements & Registration

… Overview In accordance with DecreeNoD218 , Guinea-PHC , and GIN-5 , the principal investigator (PI) must obtain 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 … 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 LMHRA-Act , the LibCTReg , and the G-LibClinTrial , a clinical trial can only commence after the sponsor or the representative receives authorization from the Liberia Medicines and Health Products Regulatory Authority (LMHRA) . The LibCTReg and the G-LibClinTrial , in turn, state that the sponsor, the legal representative, the principal investigator (PI), or the sponsor-investigator must obtain written permission from the National Research Ethics Board of Liberia (NREB) . In addition, per the G-LibClinTrial , the appointed PI must provide proof of residency in Liberia in the clinical trial application submission package. As per the G-LibClinTrial , the sponsor or the representative is required to obtain LMHRA approval for the clinical trial before the import of an investigational product (IP) to be used in the trial is authorized. However, parallel submission for approval of the clinical trial and the permit to import the IP is possible if the import … Go to Liberia > Initiation, Agreements & Registration

Overview According to the G-CTARevVacBiol , the R-HlthResCoord , and MWI-50 , the Pharmacy and Medicines Regulatory Authority (PMRA) requires the applicant to obtain PMRA approval and ethics committee (EC) approval before initiating a clinical trial. 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 ECs—the National Health Sciences Research Committee (NHSRC) or the College of Medicine Research and Ethics Committee (COMREC). In addition, as per the D-ImprtRelIMPs , the sponsor should not supply the investigational product (IP) to be used in the clinical trial until the sponsor obtains all required documentation. As stated in the G-ImpExpMP , IP import permit applications should be made by the pharmacist of record for the trial. (See the Manufacturing & Import section for … Go to Malawi > Initiation, Agreements & Registration

Overview According to LawNo09-059 and DPM-ClinTrialDocs , a clinical trial can only commence after the sponsor (also known as the promoter in Mali) or the principal investigator (PI) receives authorization from the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) within the Ministry of Health and Social Development (Ministère de la Santé et du Développement Social (MSDS)) . According to LawNo09-059 , the investigator is also required to obtain approval from a scientific committee and ethics committee (EC) prior to obtaining the DPM’s approval. Per DecreeNo2017-0245 , the research must also meet the following conditions: Benefit the country in general and the people concerned Be conducted by a person and/or team qualified with reference to their scientific skills proven in the field Meet the criteria of good clinical practice and internationally recognized laboratories Respect the habits and customs recognized locally Respect national and … Go to Mali > 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 GRMRSA , the SA-GCPs , the G-EthicsHR-ZAF , and the NHAParticipants , a clinical trial can only commence in South Africa once an applicant receives approval from the South African Health Products Regulatory Authority (SAHPRA) and from a registered ethics committee (EC). There is no waiting period required following the applicant’s receipt of these approvals. Note that the G-EthicsHR-ZAF recommends that scientific review be completed prior to ethics review and, in cases where scientific review capacity is not available, the EC approval should be delayed until SAHPRA scientific approval has been provided. Also, where site permissions are required, e.g., from Provincial Health Research Committees (PHRCs) or superintendents, to conduct research in health care facilities, ECs must delay granting full approval until these permissions are received to prevent research from beginning before the facility knows it will happen. The trial must be conducted in … Go to South Africa > Initiation, Agreements & Registration

Overview According to the NDPA-CTReg , the G-CTConduct , the NGHRP , the G-UNCSTreg , and the G-TrialsGCP , institutional ethics committee (EC) (research ethics committee (REC) in Uganda) approval, National Drug Authority (NDA) approval, and Uganda National Council for Science and Technology (UNCST) registration are mandatory before a study may commence. As per the NGHRP and the UNHRO-Act , the UNCST also works in collaboration with the Uganda National Health Research Organisation (UNHRO) to register all health research protocols. However, the registration is conducted centrally at the UNCST. The G-CTConduct and the NDPA-CTReg indicate that following the NDA’s approval of the clinical trial application, the applicant is also required to obtain a permit from the NDA to import investigational products (IPs) approved for the clinical trial. See the Manufacturing & Import section for more information on IP import permit requirements. As stated in the G-TrialsGCP , research intended to be … Go to Uganda > 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

Safety Reporting Definitions According to the G-SftyRpt , the following definitions provide a basis for a common understanding of Australia’s safety reporting requirements: Adverse Event (AE) – Any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and that does not necessarily have to have a causal relationship with this treatment Adverse Reaction (AR) – Any untoward and unintended response to an investigational medicinal product related to any dose administered Unexpected Adverse Reaction (UAR) – An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., investigator's brochure (IB) for an unapproved investigational medicinal product) Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR) – Any adverse event/adverse reaction that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or … 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

Safety Reporting Definitions In accordance with LawNo14.874 , the ResNo945 , the G-SUSARs , the AESafetyManual , and CLNo13 , the following definitions provide a basis for a common understanding of Brazil’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/Experience (AE) – Any adverse medical occurrence in a research participant to whom a drug product was administered, and which does not necessarily bear a causal relationship to the treatment Adverse Drug Reaction or Adverse Reaction (ADR) – A harmful and unintentional response attributed to a drug and which occurs at doses normally used for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (SADR) – Any adverse medical occurrence with an investigational product (IP) that at any dose results in death, … Go to Brazil > Safety Reporting

… outcome that can be identified as serious and unexpected and for which, in clinical investigation cases, there is a reasonable suspected causal relationship. The G-CanadaCTApps requires the sponsor to complete the expedited reporting form ( CAN-5 ) and the CIOMS Form I ( CAN-7 ) and fax them to the appropriate HC Directorate: BRDD Fax: 613-957-0364; PDD Fax: 613-941-2121. Additionally, the G-DSUR indicates that HC recommends that DSURs in electronic Common Technical Document (eCTD) … Go to Canada > Safety Reporting

Safety Reporting Definitions In accordance with the NMPA-GCP-No57-2020 , the following definitions provide a basis for a common understanding of China’s safety reporting requirements: Adverse Event (AE) – All adverse medical events that occur after participants receive the experimental drugs. They can be manifested as symptoms and signs, diseases, or abnormal laboratory tests, but they may not be causally related to the experimental drugs Serious Adverse Event (SAE) – Any untoward medical occurrence that at any dose: results in death, is life threatening, requires hospitalization, results in persistent or significant disability or incapacity, or causes a congenital anomaly/birth defect after the participant receives the experimental drug during a clinical trial Adverse Drug Reaction (ADR) – Any adverse or undesired reactions that may be related to the experimental drugs that occur during clinical trials. There is at least a reasonable possibility of the causal relationship between the … 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

… to report serious or unexpected AEs/ADRs within 24-48 hours, deaths are to be reported immediately, and non-serious AEs/ADRs should be reported as soon as possible, not to exceed seven (7) days. Investigator Responsibilities According to GIN-5 , the principal investigator (PI) must report serious and unexpected AEs to the National Ethics Committee for Health Research (Comité National d’Ethique pour la Recherche en Santé (CNERS)) for review. According to GIN-17, CNERS does have an AE/ADR database, however, an electronic link is not available nor is any other information regarding the database at this time. Ethics Committee Responsibilities As indicated in GIN-5 , the ethics committee should assess the AEs that have occurred, the measures taken for the participant’s safety, and the information from CNERS (pharmacovigilance file). Form Completion & Delivery Requirements Per GIN-17, since CNERS has not … Go to Guinea > Safety Reporting

… and IND-42 also indicate that the EC is also required to forward its report along with its opinion on financial compensation, if any, to be paid by the sponsor or the representative, to the DCGI within 30 days of the incident. See Table 5 of the 2019-CTRules for details on the data elements required for reporting SAEs/SADRs that occur during a clinical trial. See the Insurance & Compensation section for additional information on sponsor compensation requirements. Investigator … Go to India > Safety Reporting

Safety Reporting Definitions According to the CTRules and the G-KenyaCT , the following definitions provide a basis for a common understanding of Kenya’s safety reporting requirements: Adverse Event (or Adverse Experience) (AE) – Any untoward medical occurrence in a participant in a clinical investigation study or intervention product, and which does not necessarily have a causal relationship with the treatment Adverse Drug Reaction (ADR) – All noxious and unintended responses to a clinical trial study or interventional product related to any dose or all unintended noxious responses to a registered medicinal product which occurs at doses normally used in humans for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function 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 … Go to Kenya > Safety Reporting

… in 2022, the ACRE IRB does not review and approve clinical trial protocols. All clinical trial protocols submitted to the ACRE IRB are referred to the NREB.): Unanticipated problems that are SAEs must be reported to the ACRE IRB within five (5) business days of the investigator becoming aware of the event. The board strongly recommends that a preliminary report be submitted by the investigator within 48 hours of learning of the SAE with a formal follow-up report submitted within the … Any other unanticipated problem should be reported to the ACRE IRB within two (2) weeks of the investigator becoming aware of the problem. The board strongly recommends that a preliminary report be submitted by the investigator within five (5) business days of learning of the unanticipated problem with a formal follow-up report submitted within the above timeline In addition, per the G-ACRE-IRB , when making a report to the ACRE IRB, the investigator should include the following … Go to Liberia > Safety Reporting

Safety Reporting Definitions In accordance with the G-SAEs-PMRA , the following definitions provide a basis for a common understanding of Malawi’s safety reporting requirements: Adverse Event (AE) – Any AE associated with the use of a medicine in humans, and which does not necessarily bear a causal relationship to the treatment. This may include an AE occurring in the following circumstances: during use in professional practice; from an overdose, whether accidental or intentional; from drug abuse; from drug withdrawal; and as a result of any failure of expected pharmacological action. Adverse Drug Reaction (ADR) – A reaction characterized by the suspicion of a causal relationship between the drug and the occurrence. Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (SADR) – An adverse experience occurring at any dose that results in death, is life-threatening, requires or extends patient hospitalization, results in persistent or significant disability, is a birth defect or … Go to Malawi > Safety Reporting

Safety Reporting Definitions In accordance with NOM-220-SSA1-2016 , NOM-012-SSA3-2012 , G-ClinResPV , and G-PharmPerSafRpt , the following definitions provide a basis for a common understanding of Mexico’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/Experience (AE) – Any undesirable medical event that may occur in a research participant during the clinical investigation stage of a drug/vaccine, but does not necessarily have a causal relationship to it Adverse Drug Reaction or Adverse Reaction (ADR) – An unwanted response to a drug, in which the causal relationship with it is, at least, reasonably attributable Unexpected Adverse Drug Reaction – One whose nature or severity is inconsistent with the applicable product information, or in the documentation presented for its sanitary registration Suspected Adverse Drug Reaction (SRAM) – Any clinical or … Go to Mexico > Safety Reporting

Safety Reporting Definitions According to Decree021-2017 , Decree021-2017-Correct , the G-SafeRpt , and the G-CTSafety , the following definitions provide a basis for a common understanding of Peru’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 event or situation harmful to the health of the research participant to whom an investigational product (IP) has been administered, which does not necessarily have a causal relationship with its administration Adverse Reaction (AR) – Any AE in which there is a clearly defined causal relationship with an IP or there is at least a reasonable possibility of causation, which occurs regardless of any dose administered to that participant Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR) – Any AE/AR that results in death, is life threatening, requires or extends … 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

Safety Reporting Definitions In accordance with the SA-GCPs and the G-SafetyRpt , the following definitions provide a basis for a common understanding of South Africa’s safety reporting requirements: Adverse Event/Experience (AE) – Any untoward medical occurrence that may present during treatment with a medicine, but which does not necessarily have a causal relationship with this treatment Adverse Drug Reaction or Adverse Reaction (ADR) – A noxious and unintended response to a medicine in humans or animals, including lack of efficacy, and which occurs at any dosage and can also result from overdose, misuse, or abuse of a medicine 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 patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect Unexpected Adverse … Go to South Africa > Safety Reporting

… SUSARs to the sponsor using the case report form (CRF)/reporting form and the SAE/SADR Reporting Form approved in the protocol, or CIOMS Form I ( TZA-7 ). See section 3.0 of the G-ReptSafetyData for key data elements to include on the form. TZA-5 requires the principal investigator (PI) to ensure that the protocol includes all required elements for safety monitoring, including assessment and reporting of any anticipated or unanticipated AEs and SAEs. Ethics committees (ECs) (both the … (7) days of becoming aware of the event. Thereafter, a detailed report of the SAE should be submitted within eight (8) days. All other reportable AEs should be reported to the EC as soon as possible and in any case not later than 15 days. TZA-5 requires the investigator to submit an initial report on an SAE to NatHREC within 24 hours of its occurrence and a final or followup report on the SAE within 14 days of its occurrence. Further the G-EthicsHR-TZA requires the investigator to … Go to Tanzania > Safety Reporting

Safety Reporting Definitions In accordance with ClinImprtOrdr , ClinSampleProd , G-AEReptReqs , and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( THA-28 ), the following definitions provide a basis for a common understanding of Thailand’s safety reporting requirements: Adverse Event (AE) – Any untoward or unfavorable medical occurrence in a research participant to whom a drug product was administered, and which does not necessarily bear a causal relationship to the treatment Adverse Drug Reaction (ADR) – All dangerous and adverse reactions resulting from any dose of an investigational drug, for which it is at least reasonably likely that the adverse reaction is attributable to the drug being studied, that is, a relationship cannot be ruled out 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 … 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

… all relevant clinical trial numbers of trials covered by the DSUR (including all the IRAS IDs and the EudraCT and CTIS numbers ( GBR-87 and GBR-39 )), an email address for correspondence, and the payment reference number in the format: ‘DSUR-[5 digit MHRA company number]-[IMP name]-[Payment date DD/MM/YYYY] An analysis of the participant’s safety in the concerned clinical trial(s) with an appraisal of its ongoing risk/benefit A listing of all suspected serious adverse reactions … Go to United Kingdom > Safety Reporting

… the sponsor, to submit three (3) tables of adverse event information. The tables should consist of the following summarized data: All serious 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 … Go to United States > Safety Reporting

… have not been recorded or considered in the study protocol or relevant study documents Also, according to VNM-12, the Ministry of Health (MOH) uses the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( VNM-5 ) to define its safety reporting terminology. Safety Reporting Requirements Investigator Responsibilities As per the BioequivTrial and the AERprtingD62 , the principal investigator (PI) is responsible for detecting and settling SAEs and updating … 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 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

Interim and Annual Progress Reports Pursuant to the CanadaFDR , the G-CanadaCTApps , CAN-22 , and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ), investigators and sponsors share responsibility for submitting interim and annual reports on the status of a clinical trial. The investigator is required to provide annual progress reports to the institutional ethics committee (EC) and submit interim progress reports to the EC and Health Canada (HC) if there are any significant changes affecting the trial or risk to participants. The sponsor is required to submit annual reports (in the form of an updated Investigator’s Brochure (IB)) to HC. Note that per CAN-50 , 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 CAN-52 , which Canada has implemented per CAN-50 , the investigator should … 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 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 … 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 CNERS. … Go to Guinea > Progress Reporting

Interim and Annual Progress Reports As described in the 2019-CTRules and IND-31 , the Drugs Controller General of India (DCGI), who heads the Central Drugs Standard Control Organization (CDSCO) , requires the sponsor (applicant) to submit a six (6)-month status report for each clinical trial electronically via the CDSCO’s SUGAM portal ( IND-59 ). The report should clarify whether the trial is ongoing, completed, or terminated. In the case of termination, detailed reasons for such termination must be communicated to the DCGI within 30 working days of the termination. In addition, per the 2019-CTRules , an ethics committee (EC) may periodically request study progress reports from the investigators. As delineated in the 2019-CTRules , sponsors are also required to submit an annual status report for the clinical trial to the DCGI. The 2019-CTRules further specifies that in cases where trials have been prematurely discontinued for any reason, including a lack of commercial interest in … Go to India > Progress Reporting

Interim and Annual Progress Reports As stated in the G-KenyaCT , the sponsor and/or the principal investigator (PI) is required to send progress reports to the Pharmacy and Poisons Board (PPB) on an annual basis, or as may be required, from the date of the trial’s initiation. The progress report should contain the following: Current status of the study Summary of the participants screened (e.g., failed screenings, participants enrolled, withdrawn, or lost to follow-up, and other challenges) Summary of protocol deviations and violations Updated investigational product Investigator’s Brochure Drug Safety Update Report Copy of the latest Data Safety Management Board report Copy of favorable opinion from the ethics committee (EC) on record Copy of annual practice license for the investigators and pharmacists Suspected, Unexpected, Serious Adverse Event (SUSAR) and Serious Adverse Event (SAE) Log For multisite trials, per the G-KenyaCT , the sponsor or the representative must submit a … Go to Kenya > Progress Reporting

… that the applicant must submit a closeout report with a copy of the LMHRA-issued disposal certificate to the LMHRA. The G-LibClinTrial specifies this report should be submitted within 90 days from completion of the clinical trial. (See Annex 5 of the G-LibClinTrial for closeout 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) ( … Go to Liberia > Progress Reporting

Interim and Annual Progress Reports 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 notes that the investigator should promptly provide written reports to the sponsor and the institutional ethics committee (EC) on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants. According to the G-NHSRC , the National Health Sciences Research Committee (NHSRC) requires an initial submission of a progress report within three (3) months of approval of the study, and an annual report for medium to long-term studies. The G-COMREC requires that the College of Medicine Research and Ethics Committee (COMREC) follow the progress of studies for which a positive decision has been reached and establish a subcommittee responsible for monitoring ongoing studies. As part of the monitoring process, every approved study must submit annual … Go to Malawi > Progress Reporting

Interim and Annual Progress Reports 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) ( MLI-7 ), which also explains that the investigator should 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. In addition, as delineated in the FMPOS-USTTB-ECProcs , the principal investigator (PI) must submit an annual progress report to the Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, … Go to Mali > 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

… 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 investigator must submit written progress reports every six (6) months to the National Health Research Ethics Committee (NatHREC) for all ongoing approved health research activities in Tanzania. In addition, per the G-ResearchClearance , … the trial’s completion. This report should be followed by a final study report within six (6) months after trial closure unless otherwise justified. The structure and content of the final report should comply with TZA-11 . In addition, per TZA-5 , the PI is required to submit a final report to the NatHREC once the last participant has completed all visits and all adverse experiences have been brought to appropriate resolution. Final reports must be submitted to the NatHREC on a Close-out Form (Form 08 in TZA-5 ) and processed as an expedited review. The Secretariat will review the Close-out Form. The expedited reviewer will request additional information from the researcher, as needed. Written documentation acknowledging the closeout will be provided … Go to Tanzania > Progress Reporting

Interim and Annual Progress Reports As delineated in G-ResEthics , the investigator(s) must submit progress reports on the status of the trial to the ethics committee (EC) at the designated interval (not specified). For high-risk research protocols, investigator(s) should report the progress more frequently than for a low-risk protocol. The investigator should also provide a proposed schedule to submit a progress report to the EC from the date of protocol submission for ethical review, which should be at least once a year. The International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( THA-28 ) further notes that investigator(s) should submit a research summary report in writing to the EC once a year, or more often, as required by the EC. Investigator(s) should send a written report to the EC and the institution, if applicable, regarding any changes that may impact the research process and/or cause increased risk to the research participants. Per … Go to Thailand > Progress Reporting

Interim and Annual Progress Reports In accordance with the G-CTAuth-GBR , GBR-32 and GBR-65 , it is no longer a requirement to submit annual progress reports to the ethics committee (EC) for all studies receiving a final EC opinion in England, Wales, Scotland, and Northern Ireland. Alternatively, the G-CTAuth-GBR indicates that annual safety reports (Development Safety Update Reports (DSURs)) must be submitted, completing relevant sections of the report that are applicable to the trial. (See Safety Reporting section for information on DSURs). However, note that GBR-65 states that depending on the type of approval, a progress report may be requested to track progress. See the Regulatory Fees section for information on fees for annual progress reports. Final Report As per the MHCTR and the G-CTAuth-GBR , the sponsor must notify the Medicines and Healthcare Products Regulatory Agency (MHRA) and the EC in writing that a clinical trial has ended within 90 days of the conclusion of the … Go to United Kingdom > Progress Reporting

Interim and Annual Progress Reports As per the US-ICH-GCP , the investigator should promptly provide written reports to the sponsor and the institutional ethics committee (EC) (institutional review board (IRB) in the United States (US)) on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants. As specified in 21CFR312 , the investigator must furnish all reports to the sponsor who is responsible for collecting and evaluating the results obtained. In addition, per 21CFR56 and the US-ICH-GCP , the investigator should submit written summaries of the trial status to the institutional EC annually, or more frequently, if requested by the institutional EC. 21CFR312 states that the sponsor must submit a brief annual progress report on the investigation to the Food & Drug Administration (FDA) within 60 days of the anniversary date that the investigational new drug went into effect. The report must contain the following information for each … Go to United States > Progress Reporting

As per LawNo14.874 and ResNo945 , a sponsor is defined as a natural or legal person, under public or private law, that supports research through financing, infrastructure, human resources, or institutional support. ResNo466 defines a sponsor as an individual, company, institution, or organization that supports research through 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 Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) , the sponsor's responsibilities. Any trial-related functions that are transferred to a CRO must also be … 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 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 D-ImprtRelIMPs and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( MWI-22 ), a sponsor is defined as an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. Per MWI-25, clinical trials in Malawi are required to follow MWI-22 . MWI-22 goes on to specify 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. In accordance with MWI-22 , a sponsor may transfer any or all of its trial-related duties and functions to a contract research … Go to Malawi > 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

In accordance with G-ResEthics , and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( THA-28 ), a sponsor is defined as an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or 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 CRO should be specified in a written agreement or contract. A sponsor may be domestic or foreign. Per THA-65 and THA-77 , although applicants residing outside Thailand cannot register directly with Digital ID ( THA-89 ), they … Go to Thailand > 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

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

Overview Per the DRR , drug clinical trials must be conducted in institutions conducting drug clinical trials that comply with relevant regulations and abide by the clinical trial quality management standards. As set forth in the NMPA-GCP-No57-2020 and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( CHN-37 ), the sponsor is responsible for selecting the investigator(s) and 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. 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 (IB). Additionally, the sponsor must define and allocate all study related duties and responsibilities to the relevant parties participating in the … Go to China > 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-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 International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( MWI-22 ). MWI-22 provides the following guidance to sponsors on investigator and site selection: 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 … Go to Malawi > Site/Investigator Selection

Overview As set forth in LawNo09-059 , the sponsor 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 properly trained on the needs of the research as well as in research ethics. The sponsoring institution must do the following: Ensure the training of staff who participate in the conduct of biomedical research Require researchers to disclose their conflicts of interest in advance Have the conflict-of-interest declarations reviewed by an ethics committee (EC) and, where appropriate, make adjustments In addition, DecreeNo2017-0245 mandates that clinical … Go to Mali > Site/Investigator Selection

… sponsor or the CRO and the PI (per Annex 4 in INS-CTManual , Annex 4 in Res252-2022 , and form FOR-DIIS-063 ( PER-34 )) Affidavit signed by the PI and sponsor on preparation of research institution for trial (per Annex 4 in INS-CTManual , Annex 5 in Res252-2022 , and form FOR-DIIS-064 ( PER-35 )) Updated undocumented curriculum vitaes (CVs) of all research center team members with attached copies of documents demonstrating training in GCP within the past three (3) years (per the … Go to Peru > Site/Investigator Selection

… complete the trial, and that other commitments or trials do not divert essential subjects, resources, or facilities away from the trial in hand The maximum number of clinical trials that a PI is allowed to supervise at the same time is five (5) All investigators in a clinical trial, as well as the trial monitor, must have had formal training in Good Clinical Practices (GCPs) within the last three (3) years. Evidence of attending the GCP course should be submitted. Per the … endpoints and to recommend to the sponsor whether to continue, modify, or terminate a trial. See the G-EthicsHR-TZA for details on the DSMB composition, qualifications, affiliation, terms of reference, and reporting. As delineated in TZA-5 , NatHREC considers DSMBs to be relevant in the following kind of studies: Controlled studies with mortality and/or severe morbidity as a primary or secondary endpoint Randomized controlled studies focused on evaluating the clinical efficacy and … with a long duration Studies carried out in emergency situations The CT-Regs states that the DSMB requirement may depend on trial design and scientific background, risk and benefit assessment, or any other reasons determined by the NatHREC. TZA-5 states that for clinical trials conducted only in Tanzania, the DSMB must include representation from Tanzania. For multi-country clinical trials, the DSMB must include regional representation, and a Tanzanian must be among the members. Where … Go to Tanzania > Site/Investigator Selection

… representative for the UK study. Similarly, no amendment will need to be submitted in the UK if a sponsor remains in the UK and a legal representative is added to cover EU/EEA sites. Additional foreign sponsor requirements are listed in Section 5.2 of GBR-113 . Data Safety and Monitoring Board Per GBR-18 , the chief investigator should ensure that arrangements are made for a data safety and monitoring board (known as a data monitoring committee (DMC) in the UK). GBR-113 recommends … 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

… benefits The impossibility of obtaining or manufacturing the IP for technical or safety reasons, duly justified, and provided that the sponsor provides an equivalent or superior therapeutic alternative available on the market A lapse of five (5) years, counted from the commercial availability of the experimental drug in the country The availability of the IP in the public health network LawNo14.874 further notes that in the case of reactions arising from the study itself, the sponsor … research participants diagnosed with ultra-rare diseases, the sponsor must ensure free access to the best prophylactic, diagnostic, and therapeutic methods that have proven to be effective at the end of the study, for a period of five (5) years after obtaining ANVISA registration. ResNo311 , which amends ResNo38 , also indicates that the sponsor or the contract research organization (CRO) (clinical research representative organization (CRPO) in Brazil) should guarantee access to … Go to Brazil > Insurance & Compensation

Insurance The CanadaFDR does not require the sponsor to provide insurance coverage to investigators, institutions, or trial participants. However, the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ), which Canada has implemented per CAN-50 , guides sponsors on providing insurance. Note that per CAN-50 , Health Canada (HC) -implemented ICH guidance takes precedence over other HC guidance when they are not consistent. Compensation Injury or Death The Canadian regulations do not require compensation for trial participants in the event of trial-related injuries or death. However, CAN-52 indicates that the sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries. Trial Participation The Canadian regulations do not require compensation for trial participation. However, as per the G-TCPS2 and CAN-52 , the informed consent form (ICF) should contain a statement with a … Go to Canada > 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

… 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, or death must … Go to Malawi > Insurance & Compensation

Insurance According to LawNo09-059 , DecreeNo2017-0245 , and DPM-ClinTrialDocs , the sponsor is required to carry a valid insurance policy for the expected duration of the study for any unforeseen injury to research participants. The LawNo09-059 specifically states that in the case of biomedical research on human beings, the sponsor (also referred to as a promoter in Mali) must take out an insurance policy guaranteeing the civil liability of the 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 … Go to Mali > 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

Insurance As set forth in the G-Insurance and the SA-GCPs , all clinical trial sponsors and investigators must obtain adequate insurance and indemnity to cover any liability claims during the conduct of a clinical trial, in accordance with the responsibilities described in the SA-GCPs . As delineated in the SA-GCPs and G-Insurance , a sponsor must follow the principles set forth in the Association of the British Pharmaceutical Industry’s (ABPI) guidelines ( ZAF-26 and ZAF-25 ) to comply with South Africa’s clinical trial insurance requirements. Per the SA-GCPs , research participants should not bear any financial cost to rectify harms that occur as a result of trial participation. The insurer pays the medical costs of necessary treatment to restore the previous position of the participant, if possible, when bodily or other injury is attributable to trial participation. Only bodily injuries of an enduring and disabling character (including exacerbation of an existing condition) and/or … Go to South Africa > Insurance & Compensation

… Insurance As set forth in the CT-Regs , the G-AppConductCT , the G-CTInsurance-TZA , and TZA-5 , the sponsor or the designated contract research organization (CRO) is responsible for providing insurance coverage for any unforeseen injury to research participants. Before a clinical trial begins, the sponsor should also provide insurance … must not be asked to waive the right to compensation and must retain the legal rights to seek monetary compensation for research-related injuries including settlements out of court, in accordance with applicable laws in Tanzania. Per TZA-5 , investigator(s) must ensure participants (or their dependents in case of participant death) are equitably compensated should they sustain unexpected serious injuries (physical, psychological, or social harm) that are judged to be related to … Go to Tanzania > 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

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

Quality Assurance/Quality Control Per the DRR , the management of drugs used in clinical trials must comply with the clinical trial quality management regulations specified in NMPA-GCP-No57-2020 . As stated in the NMPA-GCP-No57-2020 and the NMPA-No65-2021 , the sponsor must establish quality control (QC) and quality assurance (QA) systems for the clinical trial. The NMPA-GCP-No57-2020 and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( CHN-37 ) specify that the quality management system for clinical trials should cover the entire process of clinical trials, including the design, implementation, recording, evaluation, result reports, and filing of clinical trials. NMPA-No65-2021 reiterates that sponsors must establish a quality management and pharmacovigilance system for investigational products (IPs). This system must collect safety information, monitor risk, identify and control safety problems in a timely manner, proactively take necessary … Go to China > 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 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 guides sponsors on quality, data, and records management. Per MWI-22 , 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, identification of processes and data that are critical to ensure participant protection and the reliability of trial results Identification of risks to critical trial processes and data Evaluation of the identified risks against existing risk controls Decisions on which risks to reduce and/or which risks to accept Documentation of quality management activities and communication to those involved in or … 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

… initiated, the DIIS’s Clinical Trials Subdirectorate (Subdirección de Ensayos Clínicos) notifies the participant(s) responsible for conducting the trial of the possible sanction(s) and the charges being made. The participant(s) then has five (5) business days from the date of notification to dispute the charges. The Clinical Trials Subdirectorate may subsequently carry out an examination to determine the existence of the liability(ies) subject to sanction within a maximum period of 30 … Go to Peru > Risk & Quality Management

… study, the investigator must inform, in writing, the appropriate EC, the National Institute for Medical Research (NIMR) , the TMDA, and the research sponsor of the early termination and the underlying reason for such termination. Per TZA-5 , the National Health Research Ethics Committee (NatHREC) should be notified if the investigator chooses to suspend the study. To resume a suspended study regardless of who initiated the suspension, the PI must submit a request to the Medical … Go to Tanzania > Risk & Quality Management

… Premature Study Termination/Suspension Per the NDPA-CTReg , in the case of a sponsor-initiated clinical trial termination, the sponsor must notify the NDA within 15 days using the format specified in Schedule 2 of the NDPA-CTReg or UGA-5 . The notification must give reasons for the termination, indicate the disposal process for the unused investigational product, and give the effective date of the termination. The G-CTConduct further requires that the sponsor provide evidence of … Go to Uganda > Risk & Quality Management

Quality Assurance/Quality Control As stated in the MHCTR , the MHCTR2006 , and GBR-92 , 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 and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( GBR-113 ). 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. QC should be applied to each stage of data handling to ensure that all data are reliable and have been correctly processed. The sponsor must also obtain the investigator(s) and the institution(s) agreement to: Conduct the trial in compliance with GBR-113 and the protocol agreed to by … Go to United Kingdom > Risk & Quality Management

… As delineated in 21CFR312 and the US-ICH-GCP , if the sponsor determines the study presents an unreasonable and significant risk to the participants, the sponsor must discontinue the study as soon as possible, and no later than five (5) working days after making the determination. The sponsor must also notify the FDA, all ECs, and all investigators who have participated in the study about the termination. Additionally, the sponsor must ensure the disposition of all remaining … Go to United States > Risk & Quality Management

… with good clinical practice (GCP) principles and standards outlined in the ClinDrugTrialGCP and the BioequivTrial Appendix, which are based on the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( VNM-5 ) and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products (Please refer to Annex 3 of The Use of Essential Drugs: Sixth Report of the WHO Expert Committee for these guidelines ( … Go to Vietnam > 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 According to the BGD-GCP , the sponsor should utilize appropriately qualified individuals to supervise the overall conduct of the trial, handle the data, verify the data, conduct the statistical analyses, and prepare the trial reports. When using electronic trial data handling 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 (SOPs) for using these systems Ensure that the systems are designed to permit data changes in such a way that the data changes are documented and that there is no deletion of entered data Maintain a security system that prevents unauthorized access to the data, and a list of the individuals who are authorized to make data changes Maintain adequate backup of the data Safeguard the … Go to Bangladesh > Data & Records Management

… be clear, and the system users should be provided with training. Refer to BRA-28 for additional information. Records Management As delineated in ResNo945 , the sponsor must be responsible for storing clinical trial data for a period of five (5) years after the last approval of a registration request for registration in Brazil. ResNo945 and BRA-28 also state that the sponsor should retain clinical trial data in physical or digital format for at least two (2) years in case of the … in writing when trial-related records are no longer needed. Additionally, per LawNo14.874 , investigators are responsible for storing under their custody, in physical or digital media, essential research data and documents for a period of five (5) years after a project’s formal end or discontinuation, and for a period of 10 years in the case of advanced therapy products. … 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

… confirm the necessary documents of the investigator, clinical trial institution, and sponsor, and these documents must be properly kept in their respective clinical trial archives. Clinical trial documents must be retained for at least five (5) years after the trial drug is approved for marketing or after the termination of the clinical trial. In addition, the NMPA-GCP-No57-2020 emphasizes that clinical trial essential documents are important to the National Medical Products … Go to China > Data & Records Management

… 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 dated, filed, and preserved safely for a period of five (5) years after the study’s completion, or for at least two (2) years after the expiration date of the new drug or investigational new drug batch studies, whichever is later. See the 2024-CTRulesAmdt for more details. See the Scope of Review … Go to India > Data & Records Management

… as terminated files and records must be retained for three (3) years after the denial of the research The G-ACRE-IRB further explains the research records from a study must be retained by the investigator(s) for a period of no more than five (5) years following the closure date. If other regulations and policies apply to a particular protocol, then the duration of protocol retention is in accordance with the applicable regulations/policies. For detailed ACRE IRB recordkeeping … Go to Liberia > 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

… needed. In addition, as delineated in COFEPRIS-GCP , the principal investigator (PI) is responsible for preparing, integrating, using, filing, and ensuring the safekeeping of the research participant’s clinical file for a minimum of five (5) years in accordance with NOM-004-SSA3-2012 , MEX-32 , and Good Documentation Practices per NOM-164-SSA1-2015 . Per NOM-004-SSA3-2012 , clinical records are the property of the institution or the medical services provider that generates them. … rights over this information to protect their health and the confidentiality of their data. Consequently, because the documents are prepared in the interest and benefit of the patient/participant, they must be kept for a minimum period of five (5) years, which is calculated from the date of the last medical procedure/visit. … 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

… of the country(ies) where the product is approved, and/or where the sponsor intends to apply for approval(s). In addition, all clinical and experimental data (electronic or paper) must be kept in a secure place for a period of five (5) years, or 20 years for a new drug application, after a trial’s completion. The data must also be readily available for review upon request by the Pharmacy Board of Sierra Leone (PBSL) . See the SL-GCPs for a list of essential documents for the … Go to Sierra Leone > Data & Records Management

… have unrestricted access rights to data sets collected through a collaborative research project. Lastly, investigators must ensure that research records from which the data has been obtained are available at the research site for at least five (5) years after completion of the research project. Electronic records are acceptable. … Go to Uganda > Data & Records Management

… the institution(s) in writing when trial-related records are no longer needed. However, per the MHCTR2006 , the sponsor and the Chief Investigator must ensure that the documents contained in the trial master file are retained for at least five (5) years following the trial’s completion. The documents must be readily available to the Medicines and Healthcare Products Regulatory Agency (MHRA) upon request and be complete and legible. The sponsor should ensure that trial participant medical files are also retained for at least five (5) years after the trial’s conclusion. In addition, GBR-113 states that the sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system … Go to United Kingdom > Data & Records Management

Responsible Parties Per AUS-70 , the PrivacyAct regulates how certain health service providing organizations collect and handle personal information, including health information. It also includes provisions that 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 not identifying themselves or of using a pseudonym, and an APP entity must not collect sensitive information about an individual unless the individual consents to the collection of the information. The APP outline further requirements for the consideration of personal information privacy; the … Go to Australia > Personal Data Protection

… , the controller must communicate the incident to the ANPD and to the personal data holder within three (3) working days from the date of first awareness. The controller must also keep a record of the security incident for a minimum of five (5) years, counting from the date of registration, unless additional obligations are established that require a longer period of record maintenance. See CD-ANPD-No15 for detailed reporting requirements. See also BRA-61 and BRA-62 for additional … Go to Brazil > 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 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

Responsible Parties The PDPA defines the “data controller” as the person or juristic person having the power and duties to make decisions regarding the collection, use, or disclosure of the personal data. Data Protection Per the PDPA , the data controller must ensure that collected personal data remains 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 and requires the data subject’s explicit consent. Permissible personal data collection includes data collected in the interest of public health, such as protecting against cross-border dangerous contagious … Go to Thailand > 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

Responsible Parties As stated in USA-86 , the HIPAA Privacy Rule establishes the conditions under which protected health information (PHI) may be used or disclosed by covered entities for research purposes (Per USA-87 , the Privacy Rule is located at 45CFR160 and Subparts A and E of 45CFR164 ; see USA-87 for more information). The Privacy Rule builds upon protections, described in Department of Health & Human Services (HHS) (the Pre2018-ComRule and the RevComRule ) and Food & Drug Administration (FDA) ( 21CFR50 and 21CFR56 ) regulations, that help ensure the privacy of participants and the confidentiality of information. (Please note: ClinRegs does not provide information on state-level personal data protection requirements.) Per the Privacy Rule, a covered entity means: a health plan; a healthcare clearinghouse; or a healthcare provider who transmits any health information in electronic form in connection with a transaction covered by the Privacy Rule. Data Protection According to … Go to United States > Personal Data Protection

Obtaining Consent In all Australian clinical trials, valid consent is required from each participant in accordance with the requirements set forth in the AU-ICH-GCP and the G-NatlStmt . According to the AU-ICH-GCP , if requirements specified in the G-NatlStmt appear to differ from those specified in the AU-ICH-GCP , the Therapeutic Goods Administration (TGA) recommends compliance with the G-NatlStmt . As per the AU-ICH-GCP , the informed consent form (ICF) (also referred to as a participant information sheet and consent form (PICF) in Australia) is viewed as an essential document that must be reviewed and approved by an institutional ethics committee (EC) (known as a Human Research Ethics Committee in Australia) and kept on file before the trial commences. (See the Required Elements section for details on what should be included in the form.) According to the G-TrialsSOP , the principal investigator (PI) for any research project retains overall responsibility for ensuring a … Go to Australia > Documentation Requirements

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-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 documenting … 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

Obtaining Consent In all Chinese clinical trials, a freely given informed consent is required to be obtained from each participant in accordance with the requirements set forth in the NMPA-GCP-No57-2020 , the Measures-Ethics , the RegEthics , and the EC-Guide . In addition, China is implementing the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( CHN-37 ) as a guidance document. As per the NMPA-GCP-No57-2020 , the DAL , the EC-Guide , and CHN-37 , the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by an ethics committee (EC) and provided to the National Medical Products Administration (NMPA) with the clinical trial application. Per the MgmtHumanGen , the ICF must also be provided to the Ministry of Science and Technology (MOST) (now National Health Commission (NHC) ) as part of its application procedures for human genetic resource (HGR) licenses. In addition, per the VaccineLaw , in carrying out … Go to China > 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 … Go to Guinea > Documentation Requirements

… the participant may not be in a position to give consent. An attempt should be made to obtain the participant’s consent as soon as possible Refer to the Children/Minors section for information on waivers involving children. See the G-ICMR , IND-5 , and IND-27 for additional information on informed consent requirements. … Go to India > Documentation Requirements

Obtaining Consent In all Malawian clinical trials, a freely given informed consent is required to be obtained from each participant in accordance with the requirements set forth in the G-NHSRC , the G-COMREC , and MWI-40 . The G-BioSampCompense also confirms that a participant’s voluntary informed consent is required. Also, 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 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 the Pharmacy and Medicines Regulatory Authority (PMRA) with … 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 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

… informed consent, the investigator should comply with Pharmacy Board of Sierra Leone (PBSL) requirements and should adhere to good clinical practice (GCP) and to the ethical principles that have their origin in the Declaration of Helsinki ( SLE-5 ), which is available in Appendix 3 of the SL-GCPs . As per the SL-GCPs and the G-SLAppClinTrial , the informed consent form (ICF) is viewed as an essential document. The sponsor and principal investigator (PI) must submit the ICF to the PBSL … Go to Sierra Leone > Documentation Requirements

… and the G-EthicsHR-TZA state that the investigator, or the designated representative, must provide detailed research study information to the participant or the legal representative/guardian. The G-AppConductCT , the G-EthicsHR-TZA , and TZA-5 also specify that the oral and written information concerning the trial, including the ICF, should be easy to understand and presented without coercion or unduly influencing a potential participant to enroll in the clinical trial. The … Go to Tanzania > Documentation Requirements

Obtaining Consent In all United States (US) clinical trials, a freely given informed consent is required to be obtained from each participant in accordance with the requirements set forth in 21CFR50 for Food & Drug Administration (FDA) regulated clinical trials, and the Pre2018-ComRule or the RevComRule for federally funded or sponsored clinical trials. (See USA-18 and USA-65 for more information on Common Rule departments/agencies, and the Regulatory Authority section for additional guidance on agency-specific compliance.) Department of Health & Human Services (HHS) -funded or sponsored clinical trials must also comply with 45CFR46-B-E . The FDA has also adopted the US-ICH-GCP as guidance. As per 21CFR50 , the Pre2018-ComRule , the RevComRule , and the US-ICH-GCP , the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by an institutional ethics committee (EC) (institutional review board (IRB) in the US) and provided to the FDA with the … Go to United States > Documentation Requirements

… Trslt-Ntc requires foreign researchers to use qualified translation institutions for translation of research materials. All translated research materials should be accompanied by a confirmation from a qualified translation institution. See ZWE-5 for a list of qualified language institutions. Documenting Consent Per the ZWE-GCP and the CT-AppAuth , prior to participation in a clinical trial, the written ICF should be signed and personally dated by the participant. Informed consent is … Go to Zimbabwe > Documentation Requirements

According to the BGD-GCP , the G-BMRC , BGD-15 , and BGD-16 , the informed consent discussion, the written informed consent form (ICF), and any other written information to be provided to participants should include statements or descriptions of the following (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements): The interviewer’s details That the trial involves research The research method and 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 measures to be taken to minimize risks 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 … Go to Bangladesh > Required Elements

Based on ResNo466 , OMREC , and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( BRA-28 ), which Brazil has adopted per ResNo945 , 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 and duration of the trial The trial procedures to be followed, including all invasive procedures The participant’s responsibilities Experimental aspects of the study The approximate number of participants in the study Any expected risks or discomforts to the participant, and when applicable, to an embryo, fetus, or nursing infant Any expected benefits to the participant; if no benefit is expected, the participant should be informed of this point Treatments available to participants, how they are administered, and the probability of receiving every treatment … Go to Brazil > Required Elements

Based on the G-TCPS2 , the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ), and CAN-35 , the informed consent form (ICF) should include the following statements or descriptions in plain language, 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 purpose and duration The trial treatment(s) and the probability for random assignment to each treatment The procedures to be followed, including all invasive procedures The participant’s responsibilities Those aspects of the trial that are experimental Any reasonably foreseeable risks or inconveniences to the participant and, when applicable, to an embryo, fetus, or nursing infant Any reasonably expected benefits; if no benefit is expected, the participant should be made aware of this The disclosure of specific alternative procedure(s) or … Go to Canada > Required Elements

Based on the NMPA-GCP-No57-2020 , the Measures-Ethics , the EC-Guide , the RegEthics , and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( CHN-37 ), 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 of the trial Any expected risks or discomforts to the participant Any expected benefits to the participant; if no benefit is expected, the participant should be informed of this point The participant’s responsibilities The approximate number of participants involved in the trial Those aspects of the trial that are experimental Treatment available to the participant as well as important potential risks and benefits associated with this treatment The alternative procedure(s) or course(s) of treatment that may be available … Go to China > 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

… and the participant pool, the researcher may offer other pertinent information to ensure that participants are fully informed about the study and any risks or benefits from participating in it Compensation Disclosure Regarding compensation, TZA-5 states that investigator(s) must ensure participants are aware of the compensation guidelines and that their rights regarding compensation are protected. Participants must not be asked to waive their rights to free treatment or compensation for … Go to Tanzania > 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

Per the ZWE-GCP and the CTEthics , 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): The clinical trial involves research and its purpose 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 alternative procedure(s) or course(s) of treatment that may be available to the participant, and their important potential benefits and risks The compensation … Go to Zimbabwe > Required Elements

Overview In accordance with the AU-ICH-GCP and the G-NatlStmt , Australia’s ethical standards protect participants’ rights and promote respect for human beings, research merit and integrity, justice, and beneficence. The G-NatlStmt further recognizes that state or territory authorities may have additional statutes regarding the use of human tissues, guardianship, and illegal and unprofessional conduct. Furthermore, a participant’s rights must be clearly addressed in the informed consent form (ICF) (also referred to as a participant information sheet and consent form (PICF) in Australia). The Right to Participate, Abstain, or Withdraw As stated in the AU-ICH-GCP and the G-NatlStmt , 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 the participant is otherwise entitled. The … Go to Australia > Participant Rights

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 In accordance with the Declaration of Helsinki ( CHN-84 ), principles set forth in the NMPA-GCP-No57-2020 , and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( CHN-37 ), China’s ethics standards safeguard the rights of research participants. Participants also have the right to receive the nationally available standard of health care, and the right to report any trial-related injuries or issues to the investigator(s) and the ethics committee (EC). The RegEthics states that the EC must protect the legitimate rights and interests of the participants, safeguarding their dignity, and promoting the development of biomedical research norms. As indicated in the NMPA-GCP-No57-2020 , the EC-Guide , and the RegEthics , a participant’s rights must 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 & … Go to China > Participant Rights

Overview Per the G-NHSRC , Malawi’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 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 ), which addresses participant rights. (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-NHSRC and MWI-22 , the 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 otherwise entitled. … Go to Malawi > 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 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 In accordance with the SL-GCPs , which is guided by the International Council for Harmonsation’s Guideline for Good Clinical Practice E6(R2) ( SLE-24 ), the Declaration of Helsinki ( SLE-5 ), and other international guidelines, Sierra Leone’s ethical standards promote respect for all human beings and safeguard the rights of research participants. The SL-GCPs and the G-SLAppClinTrial state that a participant’s rights must also be … Go to Sierra Leone > 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 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

The G-TCPS2 and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ), which Canada has implemented per CAN-50 , make provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by medical emergencies. Note that per CAN-50 , Health Canada (HC) -implemented ICH guidance takes precedence over other HC guidance when they are not consistent. As per CAN-52 , 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 (EC) (known as Research Ethics Board (REB) in Canada) must approve the protocol in advance. The … Go to Canada > Emergencies

The EC-Guide states that during an emergency, clinical studies on human participants must not be conducted without prior review and approval by the ethics committee (EC). Per the NMPA-GCP-No57-2020 and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( CHN-37 ), in an emergency, if the signed informed consent form (ICF) has not been obtained from the research participant or the legal representative/guardian, or if an effective treatment is lacking, but the investigational product could save the participant’s life, recover health, or alleviate pain, the clinical trial may be conducted. However, the method used on the participant must be explained clearly in the trial protocol as well as the relevant trial documentation, and the EC must approve the protocol in advance. The participant or the legal representative/guardian should be informed about the trial as soon as possible, and consent to continue and other consent should be requested, as … Go to China > Emergencies

… due to the situation, informed consent must be administered to the participant or the legal representative/guardian at a later stage, when the situation allows. However, this should be done only with the prior approval of the EC. See IND-5 for additional information on consent requirements during medical emergencies. … Go to India > Emergencies

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 makes provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by medical emergencies. Per MWI-22 , 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 (EC) must approve the protocol in advance. The participant or legal representative/guardian should be informed about the trial as soon as possible, and consent to continue and other consent should be requested, as appropriate. As per … Go to Malawi > 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

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

… opinion, required to preserve the participant’s life and time is not sufficient to obtain an independent physician’s determination prior to using the IP, the investigator’s determinations should be carried out. However, within five (5) working days following the use of the IP, the investigator’s decision must be reviewed and evaluated in writing by a physician not participating in the investigation. According to 21CFR50 , 21CFR56 , and the G-EmrgncyUse , the investigator must also notify the EC within five (5) working days. 21CFR56 , the G-EmrgncyUse , and the G-IRBFAQs further state that following emergency use of the IP, EC review and approval is required for any subsequent use of the IP. Emergency Research The G-ICEmrgncyReqs defines emergency … Go to United States > Emergencies

As indicated in the CTEthics , written and verbal informed consent must be obtained, unless there are good reasons to the contrary, such as an emergency. Per CT-AppAuth , if Zimbabwe has been declared to be in a public health emergency disaster by the President or Minister of Health, the World Health Organization (WHO) , or any other designated person, an expedited regulatory review pathway for clinical trials will be implemented in line with ZWE-75 . The emergency procedures implemented by the Medicines Control Authority of Zimbabwe (MCAZ) and the national ethics committee (EC), the Medical Research Council of Zimbabwe (MRCZ) , in coordination with the African Vaccine Regulatory Forum (AVAREF) involves accelerated procedures, including EC review of consent. (See the Submission Process and Timeline of Review sections for additional … Go to Zimbabwe > Emergencies

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 G-TCPS2 , in all Canadian 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 International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ) characterizes vulnerable populations as those who may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from not participating. Examples are 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 the armed forces; and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, … Go to Canada > Vulnerable Populations

Overview As per the EC-Guide , the NMPA-GCP-No57-2020 , and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( CHN-37 ), in all Chinese 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 EC-Guide and the NMPA-GCP-No57-2020 define vulnerable persons as those who are relatively (or absolutely) incapable of safeguarding their interests, and consequently, are usually incapable of giving consent or refusing to give consent due to the restriction on their capacities or freedoms. These populations include people with low socioeconomic status and low education levels. The EC-Guide also defines vulnerability to include the following areas: economic, institutional fragility, cognitive, social, medical treatment, and compliance. The NMPA-GCP-No57-2020 and CHN-37 also include members of a group with a hierarchical … Go to China > Vulnerable Populations

… those participants from underrepresented and vulnerable populations. See the Children/Minors; Pregnant Women, Fetuses & Neonates ; and Mentally Impaired sections for additional information about these vulnerable populations. See also IND-5 for additional information on consent requirements for vulnerable populations. For specific guidelines regarding gene therapy and stem cell therapy clinical trials, see the G-GeneThrpy and the G-StemCellRes . Terminally Ill Patients Per the … Go to India > Vulnerable Populations

Overview As per the G-KenyaCT , the G-ECBiomedRes , and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( KEN-14 ), in all Kenyan 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 those participants with diminished autonomy whose decision to participate in a clinical trial may be unduly influenced by the expectation of benefits associated with participation or by coercion. This may include, but is not limited to, children/minors, pregnant women, neonates, fetuses, medical students, members of the uniformed forces, prisoners, orphans, homeless populations, unemployed, internally displaced persons, economically or educationally disadvantaged persons, marginalized social groups, individuals with terminal illnesses, and the mentally challenged. KEN-14 also includes members of a … Go to Kenya > Vulnerable Populations

Overview As per the G-NHSRC , in all Malawian 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-NHSRC characterizes vulnerable populations as those who are relatively or absolutely incapable of protecting their own interests due to illiteracy, a lack of education, autonomy, resources, or other necessary attributes. These participants may include children, pregnant women, prisoners, refugees, orphans, sex workers, people living with HIV and AIDS, persons with mental disabilities, and persons in dependent relationships (e.g., some women who culturally must ask their husbands before consenting to participate in a research study). 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 includes the following as vulnerable … Go to Malawi > 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 per Decree021-2017 , in all Peruvian clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. Additionally, the G-EC-CTRev specifies that the ethics committee (EC) (El Comité Institucional de Ética en Investigación (CIEI)) should identify the vulnerabilities of the research participants to determine the additional protections required and to protect their welfare and rights. Decree021-2017 defines vulnerable populations as those who are relatively (or absolutely) incapable of protecting their own interests due to a lack of autonomy, intelligence, education, resources, strength, or other necessary attributes. This may include those in subordinate groups, indigenous or native peoples, and those who cannot give their consent. In addition, per Decree011-2011 , in the case of individuals who do not have the capacity to exercise their autonomy, … Go to Peru > Vulnerable Populations

… in the research and should provide informed consent Special attention should be paid to the content, language of the consent document, procedures for obtaining informed consent, monitoring of the process, and testing comprehension TZA-5 requires the investigator to specify in the clinical trial application if a research protocol involves a vulnerable population or special group, provide adequate justification for their involvement, and provide information on how the … Go to Tanzania > 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

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 LibCTReg and the G-NREB , Liberia defines children and minors as those persons under 18 years of age. The G-NREB also defines adolescents as those between the ages of 15 and 17. The LibCTReg also states that the definition of legal guardian or the “legal representative of a minor” is based on the premise that a minor cannot grant consent or enter into an agreement. According to LibCTReg , the interest of a minor must be firstly protected by the parents (the father if the parents are married or the child is legitimized) or the mother of the child if the parents are not married. Where there is no parent alive, especially the mother if the child is not born out of wedlock or legitimized, any next of kin, preferably the grandparents first, the siblings second, or any person with interest in the welfare of the child, may petition the Probate Court for Decree of Guardianship. A guardian must be authorized to give consent for the minor child. No institution can serve as … 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

Pursuant to Law27337 , Law295 , Law1384 , and the G-EC-CTRev , the age of majority is 18 years of age. Per Law295 and the G-EC-CTRev , children under 16 are considered to be absolutely incapable of providing consent, except for those acts determined by law. Individuals who are over 16 and under 18 are considered to be relatively incapable of providing consent. However, individuals older than 16, who are married, or have obtained an official title authorizing them to practice a profession or trade, are exempt from this regulation. Per Law295 and Law1384 , females over 14 who are married are also exempt from this regulation. If a marriage is terminated, individuals who acquire this capacity by marriage do not lose this right. Law1384 further clarifies that individuals over 14 and under 18 who marry, or who become parents are considered fully capable of providing consent. Per Decree021-2017 , for studies involving minors, an ethics committee (EC) (El Comité Institucional de Ética en … Go to Peru > Children/Minors

… process; however, if the young person objects, researchers should respect their privacy. As per GBR-4 , for clinical trials of investigational products (IPs), it is usually inappropriate to ask very young children (e.g., under five (5) years old) to sign an assent form; however, their views should be considered. Researchers must make an informed judgment to determine when seeking assent is appropriate; the age of a child can only be taken as a guide. The child's developmental … Go to United Kingdom > Children/Minors

As set forth in 21CFR50 and 45CFR46-B-E , children are defined as persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the study will be conducted. USA-25 further states that the age of majority in most states is 18 and therefore for legal purposes, children are those individuals who have not reached the age of 18. See USA-25 for a table delineating the legal age of majority by state in the United States (US). Per the Pre2018-ComRule and the RevComRule , children require additional safeguards to be included in any research study in order to protect their rights and welfare. (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.) As delineated in the US-ICH-GCP , when the research participant is a minor, informed consent … Go to United States > 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 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

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 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. … Go to Malawi > 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

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

As per 21CFR50 and 45CFR46-B-E , for studies involving women of childbearing age or who are pregnant, a statement should be provided in the informed consent form (ICF) indicating that the treatment or procedure may involve risks to the participant, embryo, or fetus, which are currently unforeseeable. According to the US-ICH-GCP , the ICF should include a statement on the reasonably foreseeable risks or inconveniences to the participant, and when applicable, to an embryo, fetus, or nursing infant. Per the Pre2018-ComRule , pregnant women require additional safeguards to be included in any research study in order to protect their rights and welfare. Furthermore, according to the RevComRule , all of the available exemptions of the RevComRule for observational research may be applied to research involving pregnant women, fetuses, and neonates. See the RevComRule for details. (See USA-18 and USA-65 for more information on Common Rule departments/agencies, and the Regulatory Authority … Go to United States > Pregnant Women, Fetuses & Neonates

According to the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( BRA-28 ), which Brazil has adopted per ResNo945 , prisoners are included as an example of a vulnerable population that may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. ResNo466 also states that freedom of consent must be guaranteed to those research participants, including prisoners, who are fully competent but are exposed to specific constraints or have restricted autonomy. These participants must have the freedom to decide whether to participate without any fear of … Go to Brazil > Prisoners

According to the G-TCPS2 and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ), which Canada has implemented per CAN-50 , 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. Note that per CAN-50 , Health Canada (HC) -implemented ICH guidance takes precedence over other HC guidance when they are not … Go to Canada > Prisoners

The NMPA-GCP-No57-2020 and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( CHN-37 ) list prisoners as a vulnerable population. Per CHN-37 , 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 must also ensure that the study will be independently monitored to assure the dignity and rights of the prisoners involved in the research. In accordance with the NMPA-GCP-No57-2020 and CHN-37 , informed consent requirements for conducting clinical trials with prisoners should follow the general requirements listed in the Required Elements section … Go to China > 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

21CFR56 , 45CFR46-B-E , and the US-ICH-GCP include prisoners in their description of vulnerable populations. As set forth in 45CFR46-B-E , a prisoner is defined as any individual involuntarily confined or detained in a penal institution. Prisoners are considered vulnerable because incarceration could affect their ability to make a voluntary decision regarding participation in research. Per the Pre2018-ComRule and the RevComRule , prisoners require additional safeguards to be included in any research study in order to protect their rights and welfare. As delineated in the RevComRule , none of its observational research exemptions may be applied to research involving prisoners, except for research aimed at involving a broader subject population that only incidentally includes prisoners. (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 … Go to United States > Prisoners

Cognitive Impairment, Intellectual Disability, or Mental Illness The G-NatlStmt discusses the requirements for research involving participants with cognitive impairment, intellectual disability, and mental illness together, noting that many of the ethical issues they raise about research participation are similar. An ethics committee (EC) (known as Human Research Ethics Committee in Australia) must review and approve research involving such participants, except where the research uses collections of non-identifiable data and involves negligible risk. Per the G-NatlStmt , the research design should take into account factors that may affect the capacity to receive information, to consent to the research, or to participate in it. Additionally, care should be taken to determine whether the participant’s cognitive impairment, intellectual disability, or mental illness increases the susceptibility to some forms of discomfort or distress. Ways of minimizing effects of this susceptibility … Go to Australia > Mentally Impaired

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

According to the G-TCPS2 and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ), the ethics committee (EC) (known as Research Ethics Board in Canada) must approve the participation of research participants who are mentally or physically incapable of giving consent. Per CAN-50 , Canada has implemented CAN-52 . Per CAN-35 , adults with diminished decision-making capacity include: Individuals whose decision-making capacity remains only partially developed, such as those living with permanent cognitive impairment, and Individuals who once were capable of making an autonomous decision regarding consent but whose decision-making capacity is diminishing or fluctuating (e.g., due to cognitive impairment resulting from an injury or disease). Per CAN-35 , as is the case for any vulnerable population, care must be taken to ensure that adults with diminished decision-making capacity are not inappropriately included in research because of … Go to Canada > Mentally Impaired

While the RegEthics lists mentally impaired people as a vulnerable population, there are no relevant provisions regarding any special consent procedures for them. The NMPA-GCP-No57-2020 and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( CHN-37 ) allow the ethics committee to approve the participation of research participants who are incompetent, or mentally or physically incapable of giving consent under certain conditions. The informed consent form must be signed and dated by the participant’s legal representative/guardian. Per DctrlzCTs-Rare , for decentralized clinical trials of rare diseases, electronic informed consent may be used with mentally impaired people. For some rare disease patients with cognitive impairment (such as neurodevelopmental dyslexia) or writing disorders (such as primary hereditary dystonia), the legal representative/guardian can help introduce the material to better protect the rights and interests of … Go to China > Mentally Impaired

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 participants with mental impairment (e.g., those with severe dementia), the participants 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. The G-NHSRC states that consent for those who are not mentally able should be sought from their legal representative/guardian in the form of a signature or … Go to Malawi > 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

In accordance with 21CFR56 , the Pre2018-ComRule , and the US-ICH-GCP , an institutional ethics committee (EC) (institutional review board (IRB) in the United States (US)) must approve the participation of research participants who are mentally incapable of giving consent. According to the G-InfrmdCnsnt , which is the Food & Drug Administration (FDA) ’s discussion of the regulations in 21CFR50 , impaired consent capacity may involve partial impairment, impairment that fluctuates over time, or complete impairment. Consent capacity can be affected by a wide range of disorders and conditions, such as dementia, stroke, traumatic brain injury, intellectual and developmental disabilities, serious mental illness, intoxication, and delirium. Per the Pre2018-ComRule and the RevComRule , this population requires additional safeguards to be included in any research study to protect the rights and welfare of participants likely to be vulnerable to coercion or undue influence. (See USA-18 and … 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

As delineated in the NMPA-GCP-No57-2020 , investigational products (IPs) are defined as experimental and reference drugs used in a clinical trial. The International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( CHN-37 ) define an IP as a pharmaceutical form of an active ingredient 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 China > Definition of Investigational Product

As delineated in the D-ImprtRelIMPs and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( MWI-22 ), an investigational product (IP) (also referred to as an investigational medicinal product (IMP) in Malawi) 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 unauthorized indication, or when used to gain further information about an approved use. Per MWI-25, clinical trials in Malawi are required to follow MWI-22 … Go to Malawi > 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

Manufacturing As specified in the TGAct and the G-CTHandbook , the Therapeutic Goods Administration (TGA) authorizes the manufacture of investigational 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 either the TGA-issued good manufacturing practice (GMP) license, the GMP certification (for overseas manufacturers), or a relevant exemption. Pursuant to TGManuf , Australia adopted the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products, PE 009-17 ( AU-PIC-S-GMP-Guide ) regarding the manufacture … Go to Australia > Manufacturing & Import

… within 48 hours after arriving in Brazil and after compliance with relevant legal requirements. Additionally, imports intended for clinical trials whose objective is to register or alter product registration will be analyzed within five (5) days after protocol approval and compliance with legal requirements. Refer to ResNo208 (amending ResNo81 ) and ResNo613 (amending ResNo172 ) for detailed import procedures. As described in ResNo74 and BRA-108 , the import petition must be … Go to Brazil > Manufacturing & Import

Manufacturing As specified in the CanadaFDR , the G-CanadaCTApps , and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) ( CAN-52 ), Health Canada (HC) authorizes the manufacture of investigational products (IPs) in Canada. HC approves the manufacture of IPs as part of the clinical trial application (CTA) approval. Per CAN-50 , Canada has implemented CAN-52 . Note that per CAN-50 , HC-implemented ICH guidance takes precedence over other HC guidance when they are not consistent. The G-QCM-PharmCTAs provides guidance and templates to assist sponsors in completing the quality portion of the CTA, which in turn, enables HC to assess IP characteristics adequately. The G-GMP-Annex13 requires the sponsor to ensure that IPs for clinical trials are manufactured and imported in accordance with its provisions and with CanadaFDR requirements. Per the G-CanadaCTApps , sponsors must file amendments or notifications to a previously authorized CTA when … Go to Canada > Manufacturing & Import

… by the NMPA. The DAL states that the drug production license must indicate the validity period and production scope, and must be reviewed and reissued upon expiration. Per the NMPA-No28-2020 , a drug production license is valid for five (5) years; an application for a new drug production license must be submitted to the original issuing authority six (6) months before the expiration. As delineated in the DAL and the NMPA-No28-2020 , the following conditions must be met for drug … Go to China > Manufacturing & Import

As per D-ACOREP and DRC-15 , 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) , in collaboration with the relevant foreign trade ministry, is responsible for authorizing and controlling drug manufacture and imports in the Democratic Republic of the Congo (DRC). 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 requires investigational products (IPs) to be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP) and used in accordance with the approved … Go to DRC > Manufacturing & Import

Manufacturing As specified in the 2019-CTRules and IND-31 , the Central Drugs Standard Control Organization (CDSCO) ’s Drugs Controller General of India (DCGI) is responsible for authorizing the manufacture of investigational products (IPs) in India. The DCGI approves the manufacture of IPs as part of the clinical trial application review and approval process. To obtain permission to manufacture an IP for clinical trial purposes, the 2019-CTRules explains that applicants must apply to the DCGI using the Application for Grant of Permission to Manufacture New Drug or Investigational New Drug for Clinical Trial or Bioavailability or Bioequivalence Study or for Examination, Test and Analysis (CT-10). Per Notice16Jan24 , applicants may access this form via the National Single Window System (NSWS) portal ( IND-3 ). Per IND-73 , once users have completed the NSWS portal ( IND-3 ) registration process, they can search for their required approval applications/registrations using the NSWS … 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

… in clinical trials. Per LBR-30 , the Clinical Trials Unit within the LMHRA’s Pharmacovigilance & Clinical Trials Department is responsible for reviewing importation permits for IPs that are required for the conduct of clinical trials. Per LBR-5 , the department is also responsible for receiving IP application submissions in Liberia and coordinating with the LMHRA’s Clinical Trial Team to ensure the safety and efficacy of the IPs to be used in clinical trials. According to LBR-5 , the IP dossier documentation requirements for the LMHRA’s approval are as follows: Submit typewritten application as per G-LibClinTrial Pay the required fee into the LMHRA bank account Submit payment slip to the Finance Department to obtain an … Go to Liberia > Manufacturing & Import

Manufacturing According to the PMRAAct , the D-ImprtRelIMPs , and the G-CTARevVacBiol , the Pharmacy and Medicines Regulatory Authority (PMRA) is responsible for authorizing the manufacture of investigational products (IPs) (also referred to as an investigational medicinal products (IMPs)) in Malawi. 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 requires IPs to be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP) and used in accordance with the approved protocol. See MWI-11 for the PMRA’s GMP inspection application form. Import As stated in the PMRAAct , the D-ImprtRelIMPs , and the G-ImpExpMP , the PMRA is also responsible for authorizing the import of IPs. Per the PMRAAct and the G-ImpExpMP , the PMRA’s authorization is issued as an import permit. The G-ImpExpMP designates the principal investigator of a … Go to Malawi > Manufacturing & Import

Manufacturing According to DPM-ClinTrialDocs , the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) is responsible for authorizing the manufacture of investigational products (IPs) in Mali. The DPM reviews the manufacture of an IP as part of its review and approval of the clinical trial application. (See the Submission Process section for detailed application requirements). According to MLI-17, Mali’s ethics committees (ECs) also follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( MLI-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. 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 … Go to Mali > Manufacturing & Import

… registration prior to initiating any drug manufacturing activities. Reg-HlthProd states that COFEPRIS must complete its review in 60 days, or the application will be deemed approved. Per GenHlthLaw , the sanitary registration is valid for five (5) years. The sanitary registration may be extended for an additional five (5) years if the extension is requested prior to the expiration of the current authorization, or the registration will be cancelled or revoked. See also GenHlthLaw and Reg-HlthProd , for detailed drug manufacturer registration submission … the request is deemed approved. G-UnregDrugImprts also notes that COFEPRIS has four (4) business days to send the applicant a prevention notification regarding missing or additional information required. The applicant, in turn, has five (5) business days to respond. Reg-HlthProd and G-UnregDrugImprts further states that the maximum validity of import authorizations is 180 days, which may be extended for an equal period, provided the conditions in which they have been granted have … Go to Mexico > Manufacturing & Import

Manufacturing According to Decree021-2017 , Decree016-2011 , the INS-CTManual , and Res252-2022 (amending the INS-CTManual ), the sponsor or the contract research organization (CRO) must 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 investigational products (IPs) exclusively for research purposes in Peru. Decree021-2017 states that the manufacture of IPs in the country will be subject to Good Manufacturing Practice (GMP) and other regulations issued by the Ministry of Health of Peru (Ministerio de Salud del Perú (MINSA)) . Decree016-2011 further specifies that the national manufacture of pharmaceutical products for research purposes involving human beings must be carried out in pharmaceutical establishments that have a sanitary authorization and a GMP certificate, as appropriate. Refer to Decree016-2011 for … Go to Peru > Manufacturing & Import

… 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 Per ZAF-55 , the license is valid for five (5) years and the application to renew the license must be submitted at least 180 days before the expiration of the current license. In addition, per ZAF-23 , a clinical trial application to SAHPRA must include a certificate of good manufacturing … Go to South Africa > Manufacturing & Import

Manufacturing According to the DrugAct , ClinSampleProd , and ClinImprtOrdr , the Thai Food and Drug Administration (Thai FDA) is responsible for authorizing the manufacture of investigational products (IPs) in Thailand. The Thai FDA will approve the manufacture of an IP 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 samples are for human research studies or cases other than human research studies Drug label (two (2) copies) … Go to Thailand > Manufacturing & Import

… for the ongoing UK trial but includes an additional EU/EEA site for trials in the EU/EEA only, then no substantial amendment to the MHRA will be required. Please note: The UK is party to the Nagoya Protocol on Access and Benefit-sharing ( GBR-5 ), 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 GBR-48 . … Go to United Kingdom > Manufacturing & Import

Manufacturing As set forth in the PharmLaw-VNM , Decree54 , and the ClinDrugTrialGCP , the Ministry of Health (MOH) ’s Administration of Science, Technology and Training (ASTT) has overall responsibility for authorizing the manufacture of all drug products. According to VNM-4 , once the ASTT reviews and the Minister of Health approves the study approval dossier, the Drug Administration of Vietnam (DAV) coordinates with the ASTT to review and approve the investigational product (IP) for manufacture or import. In addition, the ClinDrugTrialGCP states that IPs which are under review for phase IV clinical trials require a certified or notarized copy of the written request for phase IV clinical drug testing from the respective regulatory authorities. Import As delineated in the ExprtImprtMeds , the MOH’s DAV is responsible for authorizing the import and export of drugs in Vietnam. According to ExprtImprtMeds , IPs for use in clinical trials are categorized as finished drugs without … Go to Vietnam > Manufacturing & Import

… a hard copy to MCAZ at 106 Baines Avenue, Harare. Note that to import registered medicines for a clinical trial, the requirements in the MSC-ImportExport must be followed. The MCAZ will process an application for an import permit within five (5) working days. Incomplete applications will be rejected and the applicant will be required to resubmit a complete new application for authorization to import the IPs, including proof of payment of the appropriate fee. Please note: Zimbabwe is … Go to Zimbabwe > Manufacturing & Import

Investigator's Brochure In accordance with ResNo945 , the G-DDCMManual , 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 providing investigators with an Investigator’s Brochure (IB). The IB must provide coverage for the following areas (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements): Physical, chemical, and pharmaceutical properties Pharmaceutical aspects Pharmacokinetics and metabolism Toxicological effects in any animal species tested under a single dose study, 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 … 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 In accordance with the NMPA-GCP-No57-2020 and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( CHN-37 ), the sponsor 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) including chemical, pharmaceutical, toxicological, pharmacological, and clinical information and data on the IP, including trials already completed or being conducted in other places. As specified in the NMPA-GCP-No57-2020 and CHN-37 , the IB must provide coverage of the following areas: Physical, chemical, and pharmaceutical properties and formulation parameters Pharmaceutical aspects Pharmacokinetics and metabolism Toxicological effects in any animal species tested under a single dose study, a repeated dose study, or a special study Results of clinical pharmacokinetic studies Information regarding safety, pharmacodynamics, … Go to China > Quality Requirements

Investigator's Brochure In accordance with the G-CTAProcsVacBiol and the G-CTARevVacBiol , the Malawi government requires the sponsor to provide investigators with an Investigator’s Brochure (IB). 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 specifies that the IB must contain all of the relevant information on the investigational product(s) (IPs) (also referred to as investigational medicinal products (IMPs) in Malawi) 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 MWI-22 , the IB must include the following sections: Table of Contents Summary Introduction Physical, Chemical, and Pharmaceutical Properties and Formulation Nonclinical Studies (pharmacology, pharmacokinetics, … Go to Malawi > 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

… ( PER-109 )). Additionally, to obtain trial authorization, per Decree021-2017 , the INS-CTManual , and Res252-2022 , the sponsor or the CRO is required to provide quality information regarding the IP in compliance with the requirements in Annex 5 of Decree021-2017 . As specified in Annex 5, the following documents relating to the IP must be submitted: Labeling information Certificate of batch release analysis or documents that include technical specifications of the batch/series result of the finished product Accelerated or … of the IP manufacturer, issued by the competent authority of the country of origin or document that guarantees its compliance For detailed information on submission requirements for comparator IPs and complementary products, refer to Annex 5 of Decree021-2017 . … Go to Peru > Quality Requirements

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

Investigational product (IP) labeling in China must comply with the requirements set forth in the NMPA-GCP-No57-2020 , the ProvLabel , the DAL , and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( CHN-37 ). The name, insert sheet, and label of any drug for which registration is applied must comply with the National Medical Products Administration (NMPA) ’s requirements as mandated in the preceding regulations. As per the NMPA-GCP-No57-2020 , the sponsor is responsible for ensuring the proper packaging and labeling of the IPs. The IPs, comparator, and placebo products must be labeled in conformity with the clinical protocol, and be easily recognizable, correctly coded, and marked with special labels indicating that the product is to be used for clinical trial purposes. For international multicenter clinical trials, NMPA-No2-2015 states that the label content of drugs should be complete and meet the requirements of the country or region where … Go to China > Labeling

Investigational product (IP) labeling in Malawi must comply with the requirements set forth in the D-ImprtRelIMPs . The D-ImprtRelIMPs states that 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 the D-ImprtRelIMPs , the following labeling information must be included on the outer packaging or on the immediate packaging when there is no outer packaging: Wording that clearly indicates the IP is clinical trial material Product name or unique code Storage temperature and conditions Expiration date Sponsor contact details Additionally, the G-ImpExpMP provides the following minimum labeling requirements for all imported medicines and/or active pharmaceutical ingredient (API): The information printed on labels must be indelible, engraved, or embossed on a primary and secondary container The immediate outer packaging of the medicine or API should be clearly labeled in English The … Go to Malawi > 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

… be checked by a second person. The labeling should be strictly controlled, and operations must be consistent with modern drug production manufacturing guidelines and procedures. See Appendix 6 of ClinImprtOrdr , Appendix 6 of THA-18 , Appendix 5 of ClinSampleProd , or Appendix 5 of THA-76 for the Application Form for Exemption from Drug Labeling Requirements on a Case-by-Case Basis. ClinImprtOrdr and ClinSampleProd state that recommendations for drugs used as specified in the research protocol, for use in accordance … 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

… and institution(s) in writing when record retention is needed and when the trial-related records are no longer needed. Per the AU-PIC-S-GMP-Guide , documents which are part of the product specification file must be retained for at least five (5) years. If the sponsor and the manufacturer are not the same entity, the sponsor must make appropriate arrangements with the manufacturer to fulfil the sponsor’s requirement to retain the clinical trial master file. Arrangement for retention of … Go to Australia > Product Management

… only after the written instruction from the sponsor/study monitor has been obtained. After finishing the trial, the sponsor/principal investigator must inform the DGDA about the remaining and used amount of IPs using the form in Annexure 5 of the G-BGD-IP . For more information on the destruction of IPs or the return of IPs to the sponsor, see the G-BGD-IP . Record Requirements Per the BGD-GCP , the sponsor should: Maintain records that document shipment, receipt, disposition, … Go to Bangladesh > 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

… of the clinical trial or the time limit required by relevant laws and regulations, whichever time period is longer. If the two (2) are inconsistent, the longer period must be used. The sponsor must keep clinical trial records for at least five (5) years after the IP is approved for marketing. In addition, as indicated in NMPA-GCP-No57-2020 , there must be clear documentation of the IP’s quality evaluation, such as approval for release, non-release or other decisions, and must be signed … Go to China > Product Management

… analyses of the trial data are complete or as required by the applicable regulatory requirement(s), whichever represents the longer retention period. G-GMP-MWI requires that for IPs, the batch documentation must be retained for at least five (5) years after the completion or formal discontinuation of the last clinical trial in which the batch was used. Additionally, the G-ImpExpMP indicates that upon issuance of import authorization by the PMRA, the importer is expected to retain such records for five (5) years from the date of importation, either as hard or electronic copies. Stored import records should be easily accessible and availed for review to the PMRA’s inspector/officers for any post-import audit or investigations. … Go to Malawi > Product Management

… were provided the doses specified by the protocol and reconcile all IP(s) received from the sponsor. Per NOM-059-SSA1-2015 , the sponsor is also responsible for storing files related to the manufacture and control of the IP for at least five (5) years after product registration has been granted. Additionally, the sponsor must ensure that this documentation is safeguarded, and that the files are stored at the sponsor’s facilities or in specific facilities contracted for this purpose. … 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

… two (2) years after formal discontinuation of the trial or in conformance with applicable regulatory requirements. In addition, all clinical and experimental data (electronic or paper) should be kept in a secure place for a period of five (5) years, and 20 years for a new drug application after a trial’s completion, and be readily available for review upon request by the PBSL. … Go to Sierra Leone > Product Management

… sufficient space should be provided Any alterations to documents must be signed and dated, ensuring the original information remains visible; if applicable, reasons for changes must be recorded Documents should be retained for at least five (5) years or as required by regulatory guidelines Electronic and physical records must be stored securely, ensuring confidentiality and restricted access Electronic storage and signatures may be employed, but access must be restricted, and … Go to Tanzania > Product Management

… also maintain shipping records for the IP(s) and trial related material, as well as for receipt date(s) of product delivery and quantity. According to the G-GMPAnnexes , product specification file documents must be retained for at least five (5) years, and the sponsor should retain the clinical trial master file for at least 25 years after the end of the trial, unless otherwise specified in relevant national laws. If the sponsor and the manufacturer are not the same entity, the sponsor … of documents to be retained should be defined in an agreement between the sponsor and manufacturer. Per the G-GMPMedicinal and the G-GMPAnnexes , batch documentation/manufacturing records must be retained by the manufacturer for at least five (5) years after the completion or formal discontinuation of the last clinical trial in which the batch was used. … Go to Uganda > Product Management

… the institution(s) in writing when trial-related records are no longer needed. However, per the MHCTR2006 , the sponsor and the chief investigator must ensure that the documents contained in the trial master file are retained for at least five (5) years following the trial’s completion. The documents must be readily available to the MHRA upon request and be complete and legible. The sponsor should ensure that trial participant medical files are also retained for at least five (5) years after the trial’s conclusion. … Go to United Kingdom > Product Management

Supply, Storage, and Handling Requirements Per the ZWE-GCP , the sponsor should provide an up-to-date investigator’s brochure (IB) to the investigator. The sponsor is also responsible for determining the acceptable storage temperatures and conditions, storage times, reconstitution fluids, and procedures for product infusion for the investigational products (IPs), if applicable. The investigator should be thoroughly familiar with the characteristics and appropriate use of the IP as described in the protocol, the current IB, the product information, and other information sources. Investigators in the trial should provide information on restrictions on the uses of the IP in any country. In addition, the Pharm-IMPs states that the principal investigator (PI) and/or investigator has the overall responsibility for all the medical products and IPs for the study. The pharmacist at each site participating in a clinical trial, who is designated as the pharmacist of record, is the primary … Go to Zimbabwe > 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

… The Guinea-PHC and GIN-5 refer to specimens as biological materials. … Go to Guinea > 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 Per the G-NatlStmt , if a human biospecimen will be, or has been, imported for research, researchers must establish whether the human biospecimen was obtained in a manner consistent with the requirements of the G-NatlStmt and relevant Australian legislation. If this cannot be established, then the human biospecimen should not be used for research in Australia. Per the G-CTHandbook , other legislation and requirements may impose restrictions on the import of therapeutic goods for clinical trials involving materials of biological origin (human, animal, plant, or microbial), genetically modified organisms, and other substances. See the G-CTHandbook for a non-exhaustive list. Export The G-NatlStmt states that a human biospecimen obtained in Australia may be sent overseas for research if its exportation is consistent with the original consent, and if ethics committee (EC) (known as a Human Research Ethics Committee in Australia) approval is obtained. Per the G-SpecExport , a permit … Go to Australia > Specimen Import & Export

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

Import Per the QuarantineLaw , the AQSIQ-No160 , and CHN-54 , imports of human tissue, biological products, blood, and hemoproducts are subject to health and quarantine inspection. The importer is required to declare the items for inspection with local offices governed by the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ). As described in CHN-46 , AQSIQ operates 35 Entry-Exit Inspection and Quarantine Bureaus (CIQ) in China’s 31 provinces. Per the AQSIQ-No160 , the management of special articles is subject to risk control, which includes quarantine approval, inspection, and supervision as per risk levels upon assessment. Importers of special articles must apply for the quarantine approval by submitting the following documents to the local CIQ: A completed Application for Quarantine of Inbound/Outbound Special Articles ( CHN-54 ) Specific descriptions of the special articles, including Chinese and English names, classification, composition, origin, … Go to China > Specimen Import & Export

… Import No information is available regarding specimen imports. Export GIN-5 states that the applicant must provide the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)) with information on the methods used to export biological materials from Guinea. CNERS must … Go to Guinea > Specimen Import & Export

Import/Export As specified in the G-XBiolMat , the HumBiol-ImprtExprt , and IND-55 , the applicable import/export guidelines for human biological materials/specimens in India are determined by whether the materials are to be used for biomedical research or for commercial purposes. According to IND-55 , the G-XBiolMat should be followed to import/export human biological material for biomedical research purposes, and the HumBiol-ImprtExprt is to be used to import/export human biological samples for commercial purposes. Biomedical Research According to the G-XBiolMat , the following guidelines should be considered for requests to transfer biological material abroad for research/diagnostic purposes, and for requests to transfer biological material from abroad to Indian institutions for research purposes: Exchange of material for diagnostic or therapeutic purposes for individual cases may be done without restriction, if this exchange is considered necessary by the doctor(s) in charge of … Go to India > Specimen Import & Export

… the approval of an ethics committee (EC) for the transfer of samples for analysis outside of Malawi. Other Considerations According to the G-GenResReqs and MWI-6 , COMREC and NHSRC-approved samples can be stored for a maximum of five (5) years during which time all tests/analyses approved for that particular study should be concluded. MWI-6 further states that if the sample is to be used beyond five (5) years, an updated authorization must be provided, which will last another five (5) years before it can be renewed. Per G-BioSampCompense , while samples are primarily allowed to be stored as long as they are needed for the initial study, leftover samples are also permitted to be stored as long as needed for a research … Go to Malawi > Specimen Import & Export

… G-ImprtPermit further notes that COFEPRIS has 45 business days to respond to the import request, and 15 business day to notify the applicant of missing or additional information required in a prevention letter. The applicant, in turn, has five (5) business days to respond COFEPRIS’s prevention letter. The import permit approval is valid for 180 business days. Refer to G-ImprtPermit for detailed information necessary to obtain import permits for teaching, diagnosis, and therapeutic … further notes that COFEPRIS has 45 business days to respond to the export request, and 15 business days to notify the applicant of missing or additional information required in a prevention letter. The applicant, in turn, has five (5) business days to respond to COFEPRIS’s prevention letter. The permit approval is valid for 180 business days. In addition, G-ExprtPermit outlines the following required documentation to be submitted to COFEPRIS to export umbilical cord blood or … Go to Mexico > Specimen Import & Export

… information on stock levels for this substance along with the export application. Applicants to whom a permit has been issued must keep a record of the import or export and submit this information using the register forms listed in Annexures 4, 5, and 6 of the NHABloodCells . The forms must be submitted to the Director-General annually before the end of February, for the preceding calendar year. Import/Export Requirements for Specific HBM Categories The NHABloodCells provides details on … Go to South Africa > Specimen Import & Export

… The local institution should support foreign partners in permit acquisition, communicating with relevant government offices, and facilitating the material transfer arrangements and access benefit sharing arrangements. As indicated in TZA-5 , when sharing or transferring material and/or data into or outside Tanzania, materials and/or data may be subject to government regulation and import/export control laws that define the conditions under which certain information, technologies, … Agreement (DTA) ( TZA-8 ) between the Tanzanian institution and its foreign counterpart. The MTA and DTA will specify the terms for collecting, storing, managing, transporting, and disposing or returning the materials and data to Tanzania. TZA-5 also requires submittal of the MTA and DTA to the NatHREC during the ethics review. Investigators who wish to share or transfer materials and/or data should complete an MTA or a DTA before any research samples/materials or data are transferred … Go to Tanzania > 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

Import/Export The import and export of human specimens, also known as patient/diagnostic specimens/substances or human biological materials in the United States (US), is governed by several federal agencies working cooperatively to ensure the safe transport of these materials. These agencies include, but are not limited to, the Department of Transportation (DOT) ’s Pipeline and Hazardous Materials Safety Administration (PHMSA) , the Centers for Disease Control and Prevention (CDC) ’s Import Permit Program (IPP) , the Department of Health & Human Services (HHS) , the United States Postal Service (USPS) , and the International Air Transport Association (IATA) . The IATA has also adopted all of the hazardous materials requirements set forth in the Technical Instructions for the Safe Transport of Dangerous Goods by Air ( USA-10 ) published biannually by the United Nations (UN) ’ International Civil Aviation Organization (ICAO) . Additionally, 28CFR202 prohibits certain data transactions … 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

In accordance with the G-TCPS2 , prior to collecting, storing, or using a research participant’s biological specimen(s), consent from the participant and/or the legal representative(s) and review/approval from the institutional ethics committee (EC) (known as Research Ethics Board (REB) in Canada) must be obtained. Specifically, consent is required from the following: The participant who will be donating biological materials, or an authorized third party on behalf of a participant who lacks capacity, taking into account any research directive that applies to the participant, or A deceased participant through a donation decision made prior to death, or by an authorized third party In addition, the G-TCPS2 states that in order to seek participant consent to use the participant’s biological materials in research, the investigator(s) must provide the prospective participant or authorized third party with the following information: The type and amount of biological materials to be taken … Go to Canada > Consent for Specimen

… Elements and Participant Rights sections for additional information on informed consent). For specific guidelines regarding gene therapy and stem cell therapy clinical trials, see the G-GeneThrpy and G-StemCellRes . See the G-ICMR , IND-5 , and IND-27 for additional information on genetic research informed consent requirements. … Go to India > 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

… 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, directly or indirectly, deal with, use, exploit, or disclose … Go to Sierra Leone > Consent for Specimen

… using stored human tissue samples, the institution and the EC should establish the rules and regulations to decide when the investigator can waive a donor’s informed consent in order to use stored tissue samples for research. Refer to Section 7.5 of G-ResEthics for detailed information. G-ResEthics states that the investigator or institution must obtain consent for human genetic research. Investigators and institutions must comply with numerous requirements to ensure participant consent, … Go to Thailand > Consent for Specimen

In accordance with the UK-HTA , Code-A , GBR-59 , and GBR-9 , prior to collecting, storing, or using a research participant’s specimens (known as relevant material/human tissue in the United Kingdom (UK)), consent from the participant or legal representative and ethics committee (EC) approval must be obtained. The scope of the UK-HTA provisions specifically cover England, Northern Ireland, and Wales. The UK-HTA licensing requirements do not apply in Scotland, with the exception of those provisions relating to the use of DNA. Scotland complies with the Scotland-AnatAct and the Scotland-HTA for the removal, retention, use, licensing, and import of human organs, tissue, and tissue samples specifically removed post mortem, and subsequently used for research. Per G-ConsentPIS , the Participant Information Sheet (PIS) supports the consent process to help ensure participants have been adequately informed. In addition, the PIS forms part of the transparency information that must be provided … Go to United Kingdom > Consent for Specimen

As delineated in the G-IC-IVDs , the Food & Drug Administration (FDA) only provides informed consent guidance with respect to its regulations governing the informed consent requirement when human specimens are used for FDA-regulated in vitro diagnostic device investigations. Informed consent requirements guiding Department of Health & Human Services (HHS) -conducted or -supported research on human research participants is regulated by the Pre2018-ComRule and 45CFR46-B-E . Per the Pre2018-ComRule and the G-SpecimensResrch , the HHS views research involving human subject specimens as research involving human participants and subject to informed consent requirements if the specimens obtained may be classified as identifiable private information. Identifiable private information or identifiable specimens are those that can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems. The RevComRule further defines an identifiable … 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 not to 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