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 risk of adverse events from authorized clinical trials. The PBSL also conducts on-site inspections of the clinical trial site, sponsor, or manufacturing facilities to ensure the safety of clinical trial participants, the quality and reliability of data obtained in a trial, and that the facilities used continue to be acceptable throughout the clinical investigation.

The G-SLAppClinTrial requires that the PBSL establish an Expert Committee on Pharmacovigilance and Clinical Trials to provide support in reviewing and authorizing clinical trial applications, and to give medical and scientific opinions on issues related to clinical trials and medicines safety. The PBSL acts as the Secretariat for the committee. For more information, see the G-SLAppClinTrial.

SLE-15 indicates that the PBSL’s Pharmacovigilance and Clinical Trials department is responsible for ensuring that the PBSL’s legal obligations in relation to drug safety are fulfilled in accordance with PDA2001.

Other Considerations

Please note: Sierra Leone is party to the Nagoya Protocol on Access and Benefit-sharing (SLE-2), 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 SLE-18.

Contact Information

According to the PBSL website, the contact information for the PBSL is as follows:

Pharmacy Board of Sierra Leone
Central Medical Stores Compound
New England Ville, Freetown
P.M.B. 322
Sierra Leone
Phone: +232 73994830 and +232 99117117
Email: info@pharmacyboard.gov.sl; registrar@pharmacyboard.gov.sl

SLE-4 provides the following details for the Pharmacovigilance and Clinical Trials Department:

Head of Department: Pharm. Onome Abiri Thomas
Phone: +232 78534757

Ministry of Health

As per the ClinDrugTrialGCP, PharmLaw-VNM, DecreeMOH, and ASTTReg, Vietnam’s Ministry of Health (MOH) is the regulatory authority responsible for clinical trial approvals, registration, oversight, and inspections. The MOH grants permission for clinical trials to be conducted in Vietnam.

As indicated in DecreeMOH, the MOH is a governmental agency whose mission is to oversee all aspects of public health care management and protection for the Vietnamese population. With regard to pharmaceuticals, the MOH’s activities include, but are not limited to, formulating and promulgating legal documents, regulations, and national standards; granting and withdrawing pharmaceutical practice certificates; and issuing certificates of eligibility, registration permits, medicine import/export permits, and certificates of good manufacturing practice (GMP).

The ClinDrugTrialGCP and ASTTReg specify that the MOH’s Administration of Science, Technology and Training (ASTT) is responsible for managing the clinical trial review process. As per the ClinTrialSup, the MOH’s ASTT is also responsible for registering contract research organizations (CROs) that support clinical studies and provide other research services. (See the ClinTrialSup for detailed information on clinical trial research support activities and the related registration forms.)

Pursuant to the DrugRgstrtn, an Advisory Council created by the MOH issues registration papers for drug and medicinal ingredient circulation. The Advisory Council consists of experts with appropriate professional qualifications and experience to ensure the ability to evaluate dossiers, critique experts' opinions and recommendations of the MOH’s Drug Administration of Vietnam (DAV), and advise the Minister of Health on issues related to pharmaceutical legislation, quality, safety, and efficacy records of drugs and medicinal ingredients. See the Scope of Assessment section for more information on the Advisory Council’s role in drug clinical trial phase exemptions.

Please note: Vietnam is party to the Nagoya Protocol on Access and Benefit-sharing (VNM-2), 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 VNM-6.

Contact Information

According to VNM-11, the contact information for the ASTT is as follows:

Ministry of Health
Administration of Science, Technology and Training
No. 138B Giang Vo
Ba Dinh District
Hanoi City, Vietnam

Phone: 04.33846688
Fax: 04.32373236
Email: cuck2dt@moh.gov.vn

Overview

In accordance with the G-SLAppClinTrial and the SL-GCPs, the Pharmacy Board of Sierra Leone (PBSL) is the regulatory authority responsible for reviewing, evaluating, and approving applications for clinical trials using registered and unregistered investigational products (IPs). The scope of the PBSL’s assessment includes all clinical trials (Phases I-IV). As delineated in the G-SLAppClinTrial, clinical trial application submissions to the PBSL and the national ethics committee (EC), the Sierra Leone Ethics and Scientific Review Committee (SLESRC), may be made in parallel in the case of a public health emergency or as deemed fit by the PBSL.

Clinical Trial Review Process

As set forth in the G-SLAppClinTrial and the SL-GCPs, the PBSL coordinates the clinical trial application process. The SL-GCPs states that the sponsor/principal investigator (PI) must apply to the PBSL for approval to conduct a trial for a non-registered drug or a registered drug for new indications. The PBSL is responsible for reviewing the study design, which involves reviewing all significant ethical questions. The PBSL does a thorough scientific review of all applications for clinical trials to be conducted in Sierra Leone. According to the G-SLAppClinTrial, the PBSL must issue a Clinical Trial Certificate to authorize the initiation and conduct of the clinical trial.

As delineated in the G-SLAppClinTrial, the PBSL will inform the applicant in writing about the receipt of a valid clinical trial application or the formal grounds for non-acceptance, and the applicant must address formal grounds for non-acceptance. If changes are required and the applicant fails to modify the application correspondingly within a maximum of 30 working days, following the reasoned objections, the application will be deemed rejected. During evaluation, additional documents or changes may be requested through a query letter. Once a query has been raised and issued to the applicant, the process stops until the PBSL receives a written response to the query. If the PBSL requires changes to the application and the applicant fails to modify the application correspondingly within a maximum of 90 days following the reasoned objections, the application will be deemed rejected. See Figure 1 in Section 5.17 of the G-SLAppClinTrial for more details on the PBSL’s clinical trial authorization process.

The G-SLAppClinTrial indicates that any proposed amendment to the trial application, trial arrangements, and IP must be submitted to the SLESRC and the PBSL for approval before such amendments are carried out. If the amendments are substantial and are likely to have an impact on the safety of the trial participants, or are likely to change the interpretation of the scientific documents in support of the conduct of the trial, the sponsor must notify PBSL of the reasons for, and the content of, the amendments. For more details on amendment requirements, see the G-SLAppClinTrial.

According to the G-SLAppClinTrial, the Clinical Trial Certificate must be renewed annually with an application for renewal to the PBSL. A Clinical Trial Certificate will be revoked if conditions for which the certificate was issued are violated.

The G-SLAppClinTrial further states that if a clinical trial application is rejected by the PBSL, any person or institution may appeal the decision in writing within 60 days after receipt of the decision, to request PBSL review or reconsideration of the initial decision. The applicant must give grounds for review for each reason given in the clinical trial rejection. The grounds for the request must be based on the information that was submitted in the application. Upon review of the appeal application, the PBSL must provide the appeal application decision in writing, including a statement of reasons (e.g., findings, references to evidence, and reasons for the decision). For more information on appeal contents and timelines, see the G-SLAppClinTrial.

The G-SLInspect indicates that clinical trial inspections through on-site visits form part of the PBSL’s monitoring activities. Periodic good clinical practice (GCP) inspections of trial sites are conducted to ensure that the facilities used continue to be acceptable throughout the clinical investigation. The inspections may be carried out randomly and/or for specific reasons and are either announced or unannounced. An inspection would consist of a comparison of the procedures and practices of the PI with the commitments set out in the protocol and reports submitted to the PBSL by the investigator or the sponsor. See the G-SLInspect for more information.

Expedited Review During a Public Health Emergency

According to the G-SLAppClinTrial, if expedited review of a clinical trial during a public health emergency is anticipated, the applicant should inform the PBSL in writing. This will allow for a review team to be assembled and plans to be made to manage the workload as well as interactions with other oversight bodies such as the SLESRC. To ensure a rapid start of the clinical study, the PBSL will conduct simultaneous review, rather than sequential review, of the application with the SLESRC. For more information on expedited review, see the G-SLAppClinTrial.

Other Considerations

The G-SLAppClinTrial indicates that the PBSL may accept the decisions or scientific opinions of other national regulatory authorities, regional bodies, and international bodies if the IP or trial has been authorized by:

• International Council for Harmonisation (ICH) founding regulatory members
• ICH standing regulatory members
• ICH regulatory members
• ICH legislative and administrative authorities
• The African Vaccine Regulatory Forum (AVAREF) at a joint review meeting facilitated by the World Health Organization (WHO) with the provision of a favorable scientific opinion
• Any other regulatory decision deemed appropriate by the PBSL

According to the G-SLAppClinTrial, the PBSL may also consider an application for joint or assisted review by multiple national regulatory authorities and ECs for certain medical products of high public health value to countries on the African continent. For more information, see the G-SLAppClinTrial.

For information on applications involving biosimilar products, see the G-SLBiosimilar.

Overview

In accordance with the ClinDrugTrialGCP, PharmLaw-VNM, and ASTTReg, Vietnam’s Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT) manages the clinical trial review process for registered and unregistered investigational products (IPs). The ASTT is responsible for reviewing all clinical study documents, and per the ClinDrugTrialGCP, PharmLaw-VNM, the ECReg, and the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), the MOH’s national level ethics committee (EC), the National Ethics Committee in Biomedical Research (NECBR), is responsible for approving the research protocol. The ECReg further indicates that for research involving humans, institutions with ECs are responsible for overseeing an initial ethical and scientific appraisal of the research before it is reviewed by the NECBR. (Note: institutional level ECs are known as Councils of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs) in Vietnam.) For institutions conducting research that do not have a CEBRGL, the review and evaluation of the research is performed by the NECBR or the CEBRGL of another institution with appropriate expertise.

According to the ClinDrugTrialGCP, the ASTT reviews a clinical trial registration dossier submitted by the sponsor, as well as a study approval dossier submitted by the institution. Evidence of institutional EC approval from a CEBRGL is a required element of the study approval dossier, so CEBRGL and ASTT approval cannot be conducted in parallel. Additionally, the NECBR’s review of the protocol is initiated by the MOH as part of the ASTT’s study approval dossier review procedures. Per the ClinDrugTrialGCP and PharmLaw-VNM, ASTT review is finalized once NECBR approval is obtained and the entire study approval dossier is sent to the Minister of Health for final approval. (Note: The ClinDrugTrialGCP and BioequivTrial also refer to the sponsor as “organizations and individuals with clinical reagents” or “donor”.)

As per the ClinDrugTrial and PharmLaw-VNM, the scope of the MOH’s assessment includes all clinical trials (Phases I-IV) for the following:

• Drugs that contain a new active ingredient, or products with a new combination of marketed ingredients
• Newly developed biologics 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 internationally recognized good clinical practice (GCP) requirements

In addition, per the TradMedicine, the MOH also reviews and approves traditional medicines to be used in clinical trials (Phases I-IV) unless deemed exempt by the agency. The category of traditional medicine includes drugs developed from a provincial-level scientific research project or higher, drugs that were granted a certificate, or drugs used for treatment at health establishments at a provincial level or higher for 10 years or more and for 200 or more patients. The drugs must also have been approved by a Science and Technology Council or an EC specialized in traditional medicine as effective and safe to treat traditional medical diseases. Traditional medicines also include ancient methods.

For information on bioequivalence trials and testing, see the BioequivTrial and the BioTestReq.

Clinical Trial Review Process

Registration Dossier Review

According to the ClinDrugTrialGCP, the ASTT requires the sponsor to submit a clinical trial registration dossier. Upon receipt of the appropriate files, the ASTT will check the validity of the dossier. If the dossier is incomplete, the ASTT will provide a written notice and specific instructions for the sponsor to supplement the dossier. The sponsor is responsible for coordinating with the ASTT to complete the dossier within a maximum of 60 days from the date of receipt of the written notice. Past this time limit, the submitted application is no longer valid. Following the review of a complete and valid dossier, the ASTT Director will either issue a written approval (see Form 13 in Appendix III of the ClinDrugTrialGCP) or clearly state the reason for disapproval in writing.

See the Submission Process, Submission Content, and Timeline of Review sections for more information on registration dossiers.

Approval Dossier Review

Per the ClinDrugTrialGCP, research institutions must submit dossiers requesting clinical drug trial approval to the ASTT. The ASTT checks the validity of the dossier, and if it is incomplete, the ASTT will provide a written notice and specific instructions for the institution to supplement the dossier. The institution is responsible for coordinating with the ASTT to complete the dossier within a maximum of 60 days from the date of receipt of the written notice. Past this time limit, the research approval procedure must be repeated from the beginning.

The ClinDrugTrialGCP states that following receipt of a complete and valid dossier, the MOH will organize a meeting of the NECBR. After receiving the NECBR’s evaluation report of the research protocol, the ASTT will synthesize and complete the dossier, then submit it to the Minister of Health for approval if the protocol meets the requirements. If the protocol is not approved or needs correction, the ASTT will notify the institution in writing and clearly state the reason. If the protocol needs to be modified, the institution is responsible for coordinating with the ASTT to complete the dossier in up to 90 days from the date of receipt of the written notice. Past this time limit, the protocol approval procedure must be repeated from the beginning.

Procedures for the approval of research protocol amendments follow the same procedure described above for clinical drug trial approval. For more information, see the ClinDrugTrialGCP.

See Submission Process, Submission Content, and Timeline of Review sections for more information on the approval dossier.

Inspection

The BioequivTrial indicates that the ASTT may conduct inspections to ensure the rights and health of participants in the trial, ensure the quality and integrity of the research data, ensure that the responsibilities of stakeholders in the research are implemented in accordance with applicable regulations, and promptly detect violations of the research protocol. The MOH 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 based on the opinion of the MOH’s Advisory Council, the Minister of Health may exempt certain new drugs, vaccines, and biological products from one (1) or more phases of a clinical trial (including clinical data exemption or reduction). Registration certificates may be issued with the clinical trial phase exemption in the following cases:

• Medicines that meet urgent needs for national defense and security, epidemic prevention and control, and overcoming the consequences of natural calamities and catastrophes in which other drugs are not yet available on the market
• The drug has been licensed for circulation by at least one (1) of the reference regulatory agencies specified in Article 2 of the DrugRgstrtn
• Medicines used to treat rare and fatal diseases
• Vaccines and biological products manufactured in Vietnam in the form of technology transfer in one (1), several, or all phases of the finished product manufacturing process, which have clinical data on the products prior to the technology transfer in compliance with the DrugRgstrtn

See the DrugRgstrtn and the PharmLaw-VNM for more information on drugs that are exempted from a trial or certain phases of a trial.

Pharmacy Board of Sierra Leone

As per the G-SLAppClinTrial, the applicant is responsible for paying a non-refundable fee to the Pharmacy Board of Sierra Leone (PBSL) to submit a clinical trial application for authorization. As delineated below, the authorization fees for foreign sponsored 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 follows:

• Investigator/Local Phases: $2,000 USD
• Protocol Amendment: $750 USD
• Expedited Protocol Review: $900 USD
• Renewal of Clinical Trial Certificate (yearly): $50 USD

Payment Instructions

No information is currently available regarding payment instructions for the clinical trial application fee to the PBSL.

No information is currently available regarding fees required to submit a clinical trial application for authorization to the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT).

Overview

The G-SLAppClinTrial states that in Sierra Leone, the Sierra Leone Ethics and Scientific Review Committee (SLESRC) fulfills the functions of the ethics committee (EC) (known as an Independent Ethics Committee (IEC) in Sierra Leone). Ethical clearance for all phases of clinical trials involving humans must be sought from the SLESRC. The SLESRC is responsible for ensuring the protection of the rights, safety, and well-being of trial participants, and providing assurance of that protection by reviewing, approving, and providing comments on trial protocols and the suitability of the investigator(s), facilities, and the methods and materials to be used in obtaining and documenting informed consent of the trial participants.

Ethics Committee Composition

As per the SL-GCPs, the EC (i.e., the SLESRC) should consist of members 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, the EC (i.e., the SLESRC) must perform its functions according to written standard operating procedures (SOPs), maintain written records of its activities and meeting minutes, and comply with good clinical practice (GCP) and other applicable regulatory requirements. An EC must make its decisions at announced meetings where a quorum, as stipulated in the SOPs, is present. Only those EC members who are independent of the trial’s principal investigator (PI) and sponsor should vote or provide an opinion on any trial-related matters. In addition, only members who participate in the EC review process and discussion should vote and provide their opinion.

The SL-GCPs also states that the EC must retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for at least three (3) years after the study’s conclusion, and make them available to the Pharmacy Board of Sierra Leone (PBSL) upon request. The EC may be asked by investigators, sponsors, or the PBSL to provide its written procedures and membership lists.

Overview

As per the ECReg, the ClinDrugTrialGCP, the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), and PharmLaw-VNM, Vietnam requires institutional and national level ethics committee (EC) approval for clinical trials. According to the ECReg and VNM-12, institutional level EC approval is provided by a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL). PharmLaw-VNM states that national level EC approval is conducted by the Ministry of Health (MOH)’s National Ethics Committee in Biomedical Research (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 include the following:

• Members with a professional degree in the health sector related to the common research areas assessed by the EC, including at least one (1) person independent from the organization that establishes the EC
• Clinical doctors
• Members with legal expertise or knowledge of ethical principles in biomedical research, with a university degree or higher
• Members with no expertise in the health sector
• Members under 40 years of age, members from 40 years old to under 50 years old, and members aged 50 or older
• Male and female members (neither gender may be less than 20% of the total membership)

The ECReg further indicates that EC members must have the necessary experience, knowledge, skills, and ability to perform their duties in order to validate the science and protect the interests of research participants. Members with expertise in the health sector must have at least five (5) years of experience working in the field of research assessed by the EC. All members must also have time to participate in and perform the duties of the EC, and keep confidential any information related to the research, opinions discussed during the meeting, commercial secrets of individuals and organizations participating in the study, and personal information about the research participant. Members must also receive training and certification from the MOH or MOH-accredited organizations in Good Clinical Practice (GCP) and the EC’s standard operating procedures (SOPs).

Council of Ethics in Biomedical Research at the Grass Root Level

As explained in the ECReg and the CEBRGLReg, institutional ECs, known as CEBRGLs, should consist of at least five (5) members. The ECReg states that a CEBRGL consists of one (1) chair, one (1) to two (2) vice-chairs, a standing division, and specialized subcommittees (if necessary).

The CEBRGLReg further indicates that CEBRGLs may have at most 11 members. All members must be honest, objective, and have biomedical research ethics knowledge and expertise. The chair and vice-chair should be prestigious scientists.

The ECReg requires that the chair and vice-chairs have at least 15 years of experience working in the field of research evaluated by the EC, a good reputation, and the capacity to independently manage and run the EC. The chair and vice-chairs must also be fair and impartial, and not be pressured by the research institution, investigators, and other agencies, organizations, and individuals. An individual cannot be appointed as the chair of the EC for more than two (2) consecutive terms.

According to the ECReg, a CEBRGL should have no more than two (2) professional secretaries and no more than two (2) administrative secretaries. Professional and administrative secretaries must be honest, objective, and university educated. Furthermore, professional secretaries must have knowledge about scientific and technological management, scientific research, and ethics in biomedical research, while administrative secretaries must have administrative, clerical, and archival skills.

According to the CEBRGLReg, a secretariat based in the host institution’s Science Research Management Office should assist the CEBRGL with application processing and other administrative tasks.

See the ECReg and the CEBRGLReg for additional CEBRGL membership criteria.

National Ethics Committee in Biomedical Research

The ECReg requires the NECBR to have at least nine (9) official members, including one (1) chair, three (3) vice-chairs, and other official members, including professional and administrative secretaries. The NECBR also includes data monitoring and other subcommittees as needed. The Administration of Science, Technology and Training (ASTT) and the MOH act as standing members of the office of the NECBR.

The ECReg requires that the chair and vice-chairs have at least 15 years of experience working in the field of research evaluated by the EC, a good reputation, and the capacity to independently manage and run the EC. The chair and vice-chairs must also be fair and impartial, and not be pressured by the research institution, investigators, and other agencies, organizations, and individuals. An individual cannot be appointed as the chair of the EC for more than two (2) consecutive terms.

According to the ECReg, the NECBR should have no more than three (3) professional secretaries, and two (2) administrative secretaries at most.

The ECReg states that professional and administrative secretaries must be honest, objective, and university-educated. Professional secretaries must have knowledge about scientific and technological management, scientific research, and ethics in biomedical research, while administrative secretaries must have administrative, clerical, and archival skills.

See the ECReg for additional NECBR membership criteria and VNM-1 for the list of 2023-2028 NECBR term members.

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 must be established or reorganized at the end of the term. The EC for the next consecutive term must include at least 25% new members.

As stated in the ECReg, EC activities are non-profit. The EC must fully apply the ethical principles prescribed in the ECReg and relevant legal documents, and comply with ethical guidelines of international organizations. The ethical guidelines used by the EC should be clearly stated and disseminated to investigators. In addition, ECs function on the principles of collectivity, democracy, and independence when evaluating research proposals and making decisions. If necessary, ECs may invite an independent consultant to provide a professional opinion to the EC. ECs should also facilitate the coordination of and/or reference the evaluation results of other domestic or foreign ECs.

According to the ECReg, the EC’s decision for a research proposal should be based on the consensus of the EC members and must be recorded in the EC’s meeting minutes. In case it is difficult to reach a consensus, the EC’s chair has the right to decide to immediately commence voting, or request that the principal investigator supplement the research dossier for the EC to consider and vote on during the next EC meeting. Research is approved only when there is no more than one (1) disapproval vote out of the total number of valid votes.

In addition, the ECReg states that ECs must conduct periodic assessments of ongoing studies within a time period that is consistent with the level of risk for study participants, but at least once a year on or before the date the EC approved the research protocol. The conclusion of the periodic assessment results should state that the EC’s previous decisions are still valid, or have been changed, suspended, or revoked.

The ECReg requires that EC members be trained prior to appointment and provided with updated and supplementary training in the ethical and scientific aspects of biomedical research. The head of the organization that establishes the EC is responsible for assigning a unit to manage scientific research activities to develop and deploy training plans for EC members. The updated and supplementary training must be conducted at least once every two (2) years. For more information on training requirements for EC members, see the ECReg.

As set forth in CEBRGLReg, the CEBRGLs should operate within written SOPs to conduct their reviews. The chair oversees the meetings, makes conclusions, and reports this information to the institutional head. Voting members must have no conflict of interest with the research. The CEBRGL members must review research documentation and prepare comments for the secretary prior to the meeting. Most CEBRGLs do not meet regularly but instead meet upon request for review and on the availability of the majority of its members. The CEBRGLs should also refer to the NECBR’s SOPs to develop their own SOPs. See CEBRGLReg for detailed CEBRGL review procedures.

Overview

According to the G-SLAppClinTrial and the SL-GCPs, the primary scope of information assessed by the national ethics committee (EC), the Sierra Leone Ethics and Scientific Review Committee (SLESRC), relates to protecting the well-being and rights of research participants and ensuring their safety throughout their participation in a clinical trial.

As per the SL-GCPs, the EC (i.e., the SLESRC) must also pay special attention to trials that may include vulnerable subjects.

Role in Clinical Trial Approval Process

As indicated in the G-SLAppClinTrial, clinical trial application submissions to the Pharmacy Board of Sierra Leone (PBSL) and the SLESRC may be made in parallel in the case of a public health emergency or as deemed fit by the PBSL. For parallel submissions, the PBSL requires proof of the application’s submission to the SLESRC, as well as any updated versions of documents or information as requested by the SLESRC.

The G-SLEthics further specifies that the principal investigator (PI) must obtain approval for a clinical trial from the SLESRC. The PI should submit a proposal along with other required documentation to the SLESRC Chair at least two (2) calendar months prior to the anticipated commencement of the proposed study.

The SL-GCPs requires that the EC review a proposed clinical trial within a reasonable time and document its views in writing, clearly identifying the trial, the documents reviewed, and the dates for the following: approval/favorable opinion; modifications required prior to its approval/favorable opinion; disapproval/negative opinion; and termination/suspension of any prior approval/favorable opinion. The EC must conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human participants, but at least once per year.

There is no stated expiration date for EC approval in the G-SLAppClinTrial, the SL-GCPs, or the G-SLEthics.

(See the Submission Process and Timeline of Review sections for detailed submission process requirements.)

Overview

According to the ECReg, the CEBRGLReg, the ClinDrugTrialGCP, and the PharmLaw-VNM, the primary scope of information assessed by ethics committees (ECs) relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. The ECs involved in clinical trial approval in Vietnam include institutional level ECs, called Councils of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs), and the Ministry of Health (MOH)’s National Ethics Committee in Biomedical Research (NECBR).

As per the ECReg, the CEBRGLReg, and the PharmLaw-VNM, ECs must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable or those with limited or no legal capacity. The ECReg further indicates that when considering research related to vulnerable groups, representatives of the research participants or experts with knowledge and experience working with the groups must participate in the EC meeting. (See the Vulnerable Populations; Children/Minors; and Pregnant Women, Fetuses & Neonates sections for additional information about these populations.)

The ECReg and the CEBRGLReg also state that CEBRGLs and the NECBR are responsible for ensuring independent, timely, and competent reviews of all ethical aspects of the clinical trial protocol. They must act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants; confirming the suitability of the investigator(s), facilities, and methods; and verifying the adequacy of confidentiality and privacy safeguards. See the ECReg and the CEBRGLReg for detailed ethical review guidelines.

The ECReg indicates that when ECs conduct research record evaluations, ongoing research supervision, and research results evaluations, they should evaluate the following:

• Research design and conduct
• Potential risks and benefits
• Selection of research populations and participant selection and protection
• Financial benefits and financial costs related to research participants
• Protecting the research participants’ privacy and confidentiality
• The process of providing information and obtaining participants’ written consent to participate in research
• Impact of research on the participants’ community
• Researcher capacity and research goal

Role in Clinical Trial Approval Process

As delineated in the ClinDrugTrialGCP, the MOH’s Administration of Science, Technology and Training (ASTT) is responsible for reviewing the clinical trial registration and study approval dossiers for completeness. Evidence of institutional EC approval from a CEBRGL is a required element of the study approval dossier, so CEBRGL and ASTT approval cannot be conducted in parallel. Additionally, the NECBR’s review of the protocol is initiated by the MOH as part of the ASTT’s study approval dossier review procedures. Per the ClinDrugTrialGCP and the PharmLaw-VNM, the ASTT’s review is finalized once NECBR approval is obtained and the entire study approval dossier is sent to the Minister of Health for final approval.

The ECReg indicates that for research involving humans, institutions with ECs are responsible for overseeing an initial ethical and scientific appraisal of the research before it is reviewed by the NECBR. For institutions conducting research that do not have a CEBRGL, the review and evaluation of the research is performed by the NECBR or the CEBRGL of another institution with appropriate expertise.

The ECReg indicates that ECs may assess a research dossier or application under an expedited process if:

• The research involves minimal risk
• The research documents have been previously reviewed by an EC
• The research documents have been reviewed and approved by an EC of the same level
• It is a periodic report on implementation of research that has already been approved
• It is an application for amendment and supplementation of a research protocol that has already been approved
• It is reporting adverse events occurring in research that has already been approved
• It is reporting violations of an approved research protocol

According to the ECReg, research dossiers are reviewed under the EC’s full process if they do not qualify for expedited review as stipulated above, or if the evaluator requests that the dossier be examined according to the full process. The EC’s decision under the full review process is legally valid when at least five (5) members (including at least one (1) member with appropriate expertise in the health sector, one (1) member with no expertise in the health sector, and one (1) independent member), including members of both sexes, are present at the EC’s meeting and vote in the decision. The meeting must also have been convened by the EC’s chair or vice-chair (if authorized), and record meeting minutes. The EC's expedited review process decision is legally valid when at least two (2) members of the EC have reviewed and evaluated the dossier. See the Timeline of Review section for more information on the expedited and full review processes.

According to the ECReg, the EC must send a written notification of its evaluation to the leading research institution and principal investigator (PI), and publish the evaluation results on a bulletin board or on the website of the EC or the organization that established the EC. The EC may approve, conditionally approve, or decide not to approve a research dossier, and the written notifications must be issued accordingly.

Per the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), for administrative changes to the clinical trial protocol, the research institution must report in writing to the ECs at all levels and the ASTT. Changes that do not affect the health and interests of trial participants, or the research designs, processes, and procedures, must be approved by the CEBRGL and the NECBR. The application and evaluation process are carried out in accordance with the provisions of the ECReg. Changes affecting the health and interests of trial participants, or the research designs, processes, and procedures, must be approved by competent regulatory agencies. The application for approval of changes and procedures must comply with the ClinDrugTrialGCP. See the ECReg and the ClinDrugTrialGCP for more information.

For internal NECBR forms and documents, see VNM-3.

According to the BioequivTrial, ECs may also conduct periodic or unscheduled inspections. The sponsor and EC should determine the scale and frequency of the inspections based on the objectives and design of the research. The purpose of the inspection should be to evaluate trial conduct and PI/study team compliance with the protocol, standard operating procedures (SOPs), good clinical practices (GCPs), 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 ECs must conduct periodic reviews of ongoing studies within a time period that is consistent with the level of risk for study participants, but at least once a year on or before the date the EC approved the research protocol. The conclusion of the periodic review results should state that the EC’s previous decisions are still valid, or have been changed, suspended, or revoked. Circumstances for unscheduled reviews include:

• Modification of the protocol that has the potential to affect the rights, safety, and/or interests of the research participants or investigators
• A serious adverse event related to the research or the research product
• Discovery of new facts or information that could affect a potential benefit or risk of harm related to the study
• A request to suspend all or a portion of the study by the sponsor or regulatory agency

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 institutions, donor agencies, and institutions not ordinarily based in Sierra Leone: $1,500 USD
• For exclusively government funded studies: 500,000 Leones (must be submitted with a cover letter from the Permanent Secretary of the relevant Ministry or the Chief Medical Officer in the case of the Ministry of Health and Sanitation (MoHS))
• For any amendment made to a previously approved application: 25% of the current fee for the first request, 50% for the second, and 100% for subsequent ones. Sierra Leonean students are exempt from this charge.
• For an application extension: 25% of the original fee
• For exclusively electronic applications: additional $50 USD

Payment Instructions

No information is currently available regarding payment instructions for the SLESRC.

As stated in the ECReg, ethics committees (ECs) should indicate the fee structure (if any) required to assess a proposed study. Fee requirements should be included in the written instructions provided to investigators for submitting research dossiers for evaluation. The head of the organization that establishes the EC is responsible for allocating sufficient resources for the EC to perform its duties effectively.

According to VNM-12, the Ministry of Health (MOH)’s National Ethics Committee in Biomedical Research (NECBR) and institutional level ECs (known as Councils of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs)) charge a fee to review clinical trial documentation. The current NECBR and CEBRGL fees are $1,000-$2,000 USD.

Overview

SLE-3 indicates that the national ethics committee (EC), the Sierra Leone Ethics and Scientific Review Committee (SLESRC), does not have a supervisory or oversight mandate over institutional ECs for health research. Few institutions have their own institutional ECs.

Registration, Auditing, and Accreditation

No applicable requirements.

Overview

According to the ECReg, the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT) is responsible for registering the institutional level ethics committees (ECs), known as Councils of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs) in Vietnam.

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 website. The ASTT may suspend, or propose suspension to a competent authority, of an EC’s operation in case it is found that the EC violates the provisions of the ECReg, affecting the protection of rights, safety, and health of research participants.

Overview

In accordance with the G-SLAppClinTrial and the SL-GCPs, Sierra Leone requires the sponsor and principal investigator (PI) to obtain clinical trial authorization from the Pharmacy Board of Sierra Leone (PBSL) before commencement of the clinical trial. Furthermore, per the G-SLEthics, the PI is required to obtain ethics approval from the national ethics committee (EC), the Sierra Leone Ethics and Scientific Review Committee (SLESRC).

As indicated in the G-SLAppClinTrial, a favorable opinion from the SLESRC is a required element of a clinical trial application to the PBSL. However, submissions to the PBSL and the SLESRC may be made in parallel in the case of a public health emergency or as deemed fit by the PBSL.

Regulatory Submission

The G-SLAppClinTrial indicates that applicants must submit 15 hard copies of all clinical trial application documents to the PBSL, as well as one (1) soft copy in Microsoft Word format (Acrobat PDF files are also acceptable).

As per the G-SLAppClinTrial, the delivery address for a clinical trial application is as follows:

The Registrar
Pharmacy Board of Sierra Leone
Central Medical Stores
New 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 copy of the application should be emailed to efoday@health.gov.sl. The G-SLEthics also indicates that the PI may submit an exclusively electronic application for an additional fee. See the Ethics Committee Fees section for more information.

The G-SLEthics states that PIs should submit their applications with a cover letter addressed to the Chair of the SLESRC at least two (2) calendar months before the anticipated commencement of the proposed study.

Per the G-SLEthics, the delivery information for the SLESRC is as follows:

Office of the Sierra Leone Ethics and Scientific Review Committee
Ministry of Health and Sanitation
Directorate of Policy, Planning & Information (DPPI)
Youyi Building, Fifth Floor, East Wing
Freetown
Sierra Leone
Phone: +23278 366493

Overview

In accordance with the ClinDrugTrialGCP, PharmLaw-VNM, and ASTTReg, Vietnam requires the applicant to obtain clinical trial authorization from the Ministry of Health (MOH). The Administration of Science, Technology and Training (ASTT) is the department within the MOH that manages the clinical trial review process. As delineated in the ClinDrugTrialGCP, the MOH’s national level ethics committee (EC), the National Ethics Committee in Biomedical Research (NECBR), must also approve the research protocol.

As per the ClinDrugTrialGCP, evidence of institutional EC approval from a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL) is a required element of the study approval dossier submitted to the ASTT, so CEBRGL and ASTT approval cannot be conducted in parallel. Additionally, the NECBR’s review of the protocol is initiated by the MOH as part of the ASTT’s study approval dossier review procedures. Per the ClinDrugTrialGCP and the PharmLaw-VNM, ASTT review is finalized once NECBR approval is obtained and the entire study approval dossier is sent to the Minister of Health for final approval.

Regulatory Submission

According to VNM-12, the registration dossier and the study approval dossier should be submitted to the MOH’s ASTT at the address found in VNM-11:

Ministry of Health
Administration of Science, Technology and Training
No. 138B Giang Vo
Ba Dinh District
Hanoi City, Vietnam

As per the ClinDrugTrialGCP, the sponsor must submit, directly or via post, one (1) copy of the clinical trial registration dossier signed by the sponsor’s representative(s) to the ASTT. Separately, research institution(s) must submit one (1) copy of the study approval dossier, signed by the principal investigator (PI) and the head of the testing facility, directly or via post to the ASTT. See Appendix III of the ClinDrugTrialGCP for the registration form and the forms that comprise the study approval dossier. (Note: The ClinDrugTrialGCP also refers to the sponsor as “organizations and individuals with clinical reagents” or “donor” throughout the document.)

As delineated in the ClinDrugTrialGCP, the clinical trial application and accompanying material must be provided in Vietnamese or English. If the document is not available in Vietnamese or English, a notarized translation of the document must be provided in Vietnamese or English. The ClinDrugTrialGCP also indicates that the Investigator’s Brochure (IB) summary (also referred to as the research product profile in Vietnam) submitted to the MOH with the registration application should be in Vietnamese or in English with a supplementary summary in Vietnamese. See the Submission Content section for detailed information on documentation to be submitted.

Ethics Review Submission

As per VNM-12, the application for NECBR approval should also be submitted at the address found in VNM-11:

Ministry of Health
Administration of Science, Technology and Training
No. 138B Giang Vo
Ba Dinh District
Hanoi City, Vietnam

VNM-12 indicates that for NECBR review, the applicant must submit four (4) copies of the relevant documents directly or via post to the ASTT. Except for the IB, the Certificate of Analysis, and the good manufacturing practices (GMP) certificate, which may be in English, all relevant documents must be submitted in Vietnamese.

According to the ECReg, ECs issue their own guidelines for research evaluation submissions, providing information and regulatory forms for investigators. See the Submission Content section for the minimum requirements of the EC evaluation guidelines.

Regulatory Authority Requirements

As per the G-SLAppClinTrial and SLE-9, the following documentation must be submitted to the Pharmacy Board of Sierra Leone (PBSL) (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

• Cover letter, including the list of documents submitted and their version number and date
• Non-refundable application fee as specified in the PBSL’s Fee Schedule (see Appendix I of the G-SLAppClinTrial)
• Protocol with all the relevant sections including site-specific addendums (see below for detailed protocol requirements)
• Two (2) copies of the completed clinical trial application forms signed by authorized persons, including cover page (see Appendix II of the G-SLAppClinTrial)
• Proof of registration with the Pan African Clinical Trial Registry (PACTR) (SLE-19) or an internationally recognized PBSL-approved online registry
• Investigator’s Brochure (IB)
• Synopsis of previous trial(s) with the investigational product(s) (IP(s)), if applicable
• Summary of product characteristics or other professional information for all registered medicines used in the trial, or the international equivalent if the medicines are not registered in Sierra Leone
• A list of the planned clinical trial sites and the planned number of trial participants at the sites
• The name and position of the principal investigator(s) (PI(s)) who will be responsible for the sites where the trial is to be conducted, who must be registered with the relevant statutory health council, where applicable, and a resident in Sierra Leone
• Signed curriculum vitae(s) (CVs) for all key staff participating in the conduct of the clinical trial, as well as other relevant documents (see Annex 8 of SLE-6 for the recommended CV format for staff conducting clinical trials)
• Proof of current training in good clinical practice (GCP) for investigator(s), pharmacist(s), and monitor(s)
• Proof of registration of the key investigators with a professional statutory body, if applicable
• Any previous training in the principles of GCP or experience obtained from work with clinical trials and patient care
• Any conditions, such as economic interests and institutional affiliations, that might influence the impartiality of the investigator(s)
• Proof of current, relevant, and appropriate study insurance for all participants undertaken by the sponsor
• Proof of sponsor indemnification for investigator(s) and trial site(s) (see Annex 7 of SLE-6 for suggested wording of the sponsor indemnification)
• Professional indemnity insurance for investigator(s) and other trial staff
• Details of the site(s) where the trial is to be conducted and a duly justified written statement on the suitability of the clinical trial sites adapted to the nature and use of the IP. This should include a description of the suitability of facilities, equipment, and human resources, and a description of expertise, issued by the head of the clinic/institution at the clinical trial site or other responsible party
• A favorable opinion from the Sierra Leone Ethics and Scientific Review Committee (SLESRC). In the case of a parallel submission, proof of clinical trial application submission to the SLESRC and the updated versions of documents or information as requested by the SLESRC are required
• Recruitment arrangements
• Signed joint financial declaration between the sponsor and the PI (see Appendix IIIc of the G-SLAppClinTrial and Annex 4 of SLE-6)
• Data Safety Monitoring Board (DSMB) membership, CVs, and signed charter
• IP dossier and label
• Product information if the IP is registered: summary of product characteristics, patient information leaflet/package insert, and labelling
• Current good manufacturing practice (GMP) certificate issued from the national regulatory authority of the country where the IP is manufactured
• Product information and certificate of analysis for the concomitant and rescue medications
• Certificate(s) of analysis of the IP
• Certificate(s) of accreditation for the central laboratories
• Participant information sheet, informed consent form (ICF), and informed consent procedure
• Signed declaration by the applicant (see Annex 2 of SLE-6)
• Sponsor/PI contractual agreement, including the study budget
• Signed declaration by the PI and the sponsor of the trial that they are familiar with and understand the protocol, and will comply with GCP as determined by the PBSL in the conduct of the trial (see Appendix IIIa of the G-SLAppClinTrial 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 applicable
• Electronic copies of key peer reviewed publications following International Committee of Medical Journal Editors (ICMJE) recommendations to support the application, if applicable
• Labelled CD-ROM (list of files submitted on CD-ROM)

See the G-SLAppClinTrial for more details, including the application submission checklist (Appendix IIa) and the application form (Appendix IIb). The application checklist and form are also available at SLE-9 and SLE-6, respectively.

Additionally, see Appendix V of the G-SLAppClinTrial for the Clinical Trial Amendment Form. See also SLE-8 for the amendment checklist.

Ethics Committee Requirements

As per the G-SLEthics, the SLESRC requires the PI to submit the following documentation for ethics approval:

• Cover letter to the Chair of the Committee
• ICF attached to each proposal (Committee does not accept verbal consent, except where it is supported by an independent witness)
• Completed checklist for the Essential Elements in the Application for Approval (see the G-SLEthics)
• Brief CV for the PI and associates clearly stating their roles (not more than four (4) pages each)
• Study proposals submitted for award of a degree must be accompanied by a letter of confirmation from the supervisor and approval by the institution’s review board
• Requests for amendment or extension of study should include a copy of the previous approval letter
• A non-refundable administrative fee for each proposal submitted (see the Ethics Committee Fees section for detailed fee information)

Clinical Protocol

The G-SLAppClinTrial indicates that the clinical trial protocol must comply with the International Council for Harmonisation's (ICH) Guideline for Good Clinical Practice E6(R2) (SLE-24) and the SL-GCPs. Accordingly, the protocol must include:

• General information (protocol title, identifying number, and date; contact information for the sponsor, medical expert, investigator(s), trial site(s), qualified physician(s), and laboratory and/or institutions involved in the study)
• Background information
• Objectives and purpose
• Trial design
• Selection, withdrawal, and treatment of participants
• Assessment of efficacy
• Assessment of safety
• A description of the statistical methods to be used in the trial
• Direct access to source data and documents
• Quality control and quality assurance
• Ethical considerations
• Data handling and recordkeeping
• Financing and insurance
• Publication policy

Regulatory Authority Requirements

As per the ClinDrugTrialGCP, the following documentation must be submitted to the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT) for clinical trial registration dossiers:

• Clinical trial registration application form signed by a representative of the sponsor (See Form No. 6 in Appendix III of the ClinDrugTrialGCP)
• Summary of the Investigator’s Brochure (IB) (also referred to as the research product profile in Vietnam) including general information about the clinical reagent (name, ingredients, indications, physical properties, chemistry, preparation, and other relevant information), pre-clinical research materials, and clinical trial study documents from previous phases

For clinical trial study approval dossiers, the ClinDrugTrialGCP indicates that the following documentation must be submitted to the MOH’s ASTT:

• Clinical trial approval application form signed by the principal investigator (PI) and the head of the research institution (See Form No. 7 in Appendix III of the ClinDrugTrialGCP)
• Full IB, including proof of compliance with Good Laboratory Practices (GLPs) for research institutions or proof of compliance with Good Manufacturing Practices (GMPs) (also referred to as good medicine production standards in Vietnam) for drug manufacturers, and proof of compliance with quality testing requirements from national inspection agencies or ex-warehousing certificates for vaccine or biological batches (Refer to the Quality Requirements section for detailed IB requirements)
• A copy of the written approval for clinical trial registration from the MOH’s ASTT
• For phase IV clinical trials, a certified or notarized copy of the written request for phase IV clinical drug testing from the respective regulatory authorities
• A certified or notarized copy of the research institution’s certificate of eligibility for pharmaceutical business
• Certification of participation by all study sites for multicenter research studies in Vietnam
• A certified or notarized copy of the approval from the People’s Provincial Committee (for community-based studies)
• Contract/agreement between the sponsor and the host institution; and contract/agreement between sponsor and the contract research organization (CRO), if applicable
• Explanation of study protocol (See Form No. 8 in Appendix III of the ClinDrugTrialGCP)
• Case report form (CRF)
• PI’s Curriculum Vitae (CV) and a copy of the Good Clinical Practice (GCP) certificate issued by the MOH or an institution recognized by the MOH
• Informed Consent Form (ICF) (See Form No. 9 in Appendix III of the ClinDrugTrialGCP) (See also the Required Elements section for additional information)
• Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL) evaluation report
• Investigational product (IP) labeling

See the ClinDrugTrialGCP for detailed requirements.

Ethics Committee Requirements

The ECReg indicates that both the institutional level ethics committees (ECs) (CEBRGLs) and the national EC (National Ethics Committee in Biomedical Research (NECBR)) issue guidelines for research evaluation submissions, providing information and regulatory forms for investigators. The guidelines include information on the following:

• Name and address of the secretary, employee, or member of the EC receiving the application file, or address of the website (if any)
• List of all written material in record
• Specifications of the documents
• Language of the document in the record
• Number of copies to be submitted
• Application deadline compared to evaluation date
• Recording and notification processes for invalid documents
• Estimated time for post-assessment decision announcement
• The timeframe that should be followed if the EC requires the applicant to provide additional information or documents
• Evaluation fee of research records (if any)
• Procedures for requesting EC approval of an amendment of the outline or related documents
• Specification of materials for selection, information, and consent to participate in the study

According to ECReg, the documents that ECs must review when evaluating a research proposal include:

• Signed and dated application, including signatures of co-applicant and representative of the relevant organization
• Research protocol (with version number and date), with documents and appendices (if any)
• A summary of the study in simple and understandable language
• Description of ethical considerations relevant to the study (may be included in the protocol); measures that will be taken to protect participant privacy and data confidentiality; protective care for participants; compensation to be provided to participants; and insurance package for participants (if applicable) (See the Required Elements and Participant Rights sections for detailed information)
• IB
• Study data collection forms (with version numbers and dates)
• Forms, documents, and advertisements used in the participant selection process
• ICF (with version number and date) for participants that are 18 years or older and have full civil capacity to give consent
• ICF (with version number and date) for participants and their parents and/or legal guardian(s), if the participant is 16 years old to under 18 years old
• ICF (with version number and date) for parents and/or legal guardian(s), if the participant is under 16 years old
• Assent form (with version number and date) for participants who do not have the capacity to give legal consent, including children from 12 years old to under 16 years old, a person with inadequate civil act capacity, or a patient in a limited cognitive condition
• Description of participant selection and ICF collection processes
• Procedures for monitoring, evaluating, and managing adverse events (AEs) (See the Safety Reporting section for additional AE/serious adverse event information)
• All previous decisions of other ECs or regulatory authorities regarding the proposed study (including decisions and reasons for objecting or proposing amendments to the previous protocol)
• Documents demonstrating that the research institution has agreed to allow the study after the regulatory authority’s approval (if the study is conducted outside the organization that established the EC)
• Investigators' commitment to agree to comply with the ethical guidelines
• The PI’s current scientific background and qualifications related to the relevant research

See the ECReg for additional information on documentation requirements for research protocol re-evaluation or amendments, as well as for evaluation applications for periodic reports, AE reports, protocol violation reports, and research result reports.

Clinical Protocol

As per the ClinDrugTrialGCP, the MOH requires the following elements to be included in a protocol submission:

• Title
• Protocol code
• Duration
• Management level (state/ministry/institution/province)
• PI/co-investigator(s) names and contact information
• Funding
• Phase requested
• Institution to conduct research
• Sponsor and contact information
• Situation of domestic and foreign research
• Objectives
• Methodology (including trial design, random selection method, and standard operating procedures (SOPs) for each research technique)
• Participant selection/withdrawal
• Participant treatment
• AE reporting requirements (See the Safety Reporting section for additional information)
• Laboratory test methods
• Ethical considerations
• Inspection and monitoring
• Post study medical care
• Study team training
• International cooperation
• Implementation progress
• Format of the expected results
• Activities of coordinating organizations

See Appendix III in the ClinDrugTrialGCP for a copy of the full form.

Overview

The G-SLAppClinTrial indicates that the Pharmacy Board of Sierra Leone (PBSL) and the Sierra Leone Ethics and Scientific Review Committee (SLESRC) reviews may be conducted in parallel in the case of a public health emergency or as deemed fit by the PBSL. For parallel submissions, the PBSL requires proof of the application’s submission to the SLESRC, as well as any updated versions of documents or information as requested by the SLESRC.

Regulatory Authority Approval

Per the G-SLAppClinTrial, the PBSL’s processing times of clinical trial applications for different investigational products (IPs) are as follows, unless otherwise specified by the PBSL on a case-by-case basis:

• Medical devices - 40 working days
• Pharmaceuticals - 50 working days
• Biological and biotechnology medical products - 60 working days
• Genetically modified organisms - 120 working days

As delineated in the G-SLAppClinTrial, the PBSL will inform the applicant in writing about the receipt of a valid clinical trial application or the formal grounds for non-acceptance within 10 working days from the receipt of the application. The applicant must address formal grounds for non-acceptance within 10 working days. If changes are required and the applicant fails to modify the application correspondingly within a maximum of 30 working days, following the reasoned objections, the application will be deemed rejected. If the PBSL requires changes to the application and the applicant fails to modify the application correspondingly within a maximum of 90 days following the reasoned objections, the application will be deemed rejected. See Figure 1 in Section 5.17 of the G-SLAppClinTrial for more details on the PBSL’s clinical trial authorization process.

According to the G-SLAppClinTrial, if expedited review of a clinical trial during a public health emergency is anticipated, the applicant should inform the PBSL in writing. The timeline for processing such applications is 10-20 working days. For more information on expedited review, see the Scope of Assessment section and the G-SLAppClinTrial.

The G-SLAppClinTrial further indicates that any proposed amendment to the trial application, trial arrangements, and IP must be submitted to the SLESRC and the PBSL for approval before such amendments are carried out. The PBSL’s processing time for protocol amendment applications is 30 working days. For more details on amendment requirements, see the G-SLAppClinTrial.

The G-SLAppClinTrial states that the PBSL must issue a Clinical Trial Certificate to authorize the trial to be conducted, which must be renewed annually. The PBSL’s processing time for a Clinical Trial Certificate renewal application is 15 working days.

The G-SLAppClinTrial further states that if a clinical trial application is rejected by the PBSL, any person or institution may appeal the decision in writing within 60 days after receipt of the decision, to request PBSL review or reconsideration of the initial decision. The PBSL’s response to the appeal application must be addressed to the affected person or institution within 90 days of the appeal’s submission. For more information on appeal contents and timelines, see the G-SLAppClinTrial.

According to the G-SLAppClinTrial, the PBSL’s processing time for IP import permits is 10 working days.

Ethics Committee Approval

No information is currently available on the SLESRC’s timeline of review.

Overview

As per the ClinDrugTrialGCP, evidence of institutional ethics committee (EC) approval from a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL) is a required element of the study approval dossier submitted to the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT), so CEBRGL and ASTT approval cannot be conducted in parallel. Additionally, the National Ethics Committee in Biomedical Research (NECBR)’s review of the protocol is initiated by the MOH as part of the ASTT’s study approval dossier review procedures. Per the ClinDrugTrialGCP and the PharmLaw-VNM, ASTT review is finalized once NECBR approval is obtained and the entire study approval dossier is sent to the Minister of Health for final approval.

Regulatory Authority Approval

Registration Dossier Review

As delineated in the ClinDrugTrialGCP, the ASTT initially checks the validity of the sponsor-submitted registration dossier (which includes the registration 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 time limit, the research approval procedure must be repeated from the beginning.

The ClinDrugTrialGCP states that within 25 days of receiving a complete and valid study approval dossier, the MOH will organize a meeting of the NECBR. Within five (5) working days after receiving the NECBR’s evaluation report, the ASTT gathers all materials related to the dossier and submits it to the Minister of Health for approval.

If the research protocol is not approved or needs to be corrected, the ASTT must notify the institution and state the reason, as per the ClinDrugTrialGCP. The institution must coordinate with the ASTT to complete the dossier within 90 days from the date of the notice. Past this time limit, the protocol approval procedure must be repeated from the beginning. Within five (5) working days after receiving the completed research protocol in accordance with the written notice, the ASTT gathers all materials related to the dossier and submits it to the Minister of Health for approval.

Ethics Committee Approval

The ECReg indicates that ECs issue their own guidelines for research evaluation submissions, providing information and regulatory forms for investigators. The guidelines include information regarding the application deadline in relation to the evaluation date, the expected timeframe for notification of a decision, and the timeframe to follow if the EC requires applicants to submit additional information or documents. See the Submission Content section for detailed information on minimum requirements for the EC guidelines.

According to VNM-12, the review and approval process for CEBRGLs takes 30 days. Meetings are scheduled upon request and are based on the availability of the majority of its members.

The ECReg indicates that under both the expedited and full review processes, within 30 days from the date of receipt of a complete and valid dossier, the EC must organize an examination of the dossier and notify the applicant of the EC’s decision. While both processes may take up to 30 days, the expedited review is streamlined with fewer reviewers.

According to the ECReg, within five (5) working days from the date that the research dossier evaluation results are available, the EC must send a written notification to the leading research institution and principal investigator, and publish the evaluation results on a bulletin board or on the website of the EC or the organization that established the EC.

See Scope of Review section for details on the EC’s role in the clinical trial approval process.

Overview

In accordance with the G-SLAppClinTrial, a clinical trial can only commence after the sponsor and the principal investigator (PI) receive authorization from Sierra Leone’s Pharmacy Board of Sierra Leone (PBSL) via a Clinical Trial Certificate. Additionally, per the G-SLAppClinTrial, the Sierra Leone Ethics and Scientific Review Committee (SLESRC) fulfills the functions of the ethics committee (EC) (known as an Independent Ethics Committee (IEC) in Sierra Leone) in the country. Ethics approval must be obtained from the SLESRC prior to initiating a study. The G-SLEthics indicates that the PI must obtain the SLESRC approval.

In addition, as per SLE-23, no waiting period is required following the applicant’s receipt of PBSL and SLESRC approval. According to the G-SLAppClinTrial, the PBSL must be informed of the trial’s initiation in writing on the exact date the study commences. If the trial does not begin or is delayed, then the PBSL must be informed of the new commencement date within 90 days of the Clinical Trial Certificate’s issuance. SLE-23 further indicates that investigators are required to notify their local institution prior to initiating a trial.

As per the G-SLAppClinTrial, a permit from the PBSL is required for the import of an investigational product (IP) to be used in a trial. (See the Manufacturing & Import section for additional information.)

Clinical Trial Agreement

The G-SLAppClinTrial and the SL-GCPs state that the clinical protocol submitted to the PBSL must include a signed contractual agreement between the sponsor and the PI.

As required by the G-SLAppClinTrial, the sponsor/PI contractual agreement must have sections indicating:

• Study title
• Protocol version and date
• Trial site
• IP information
• Definitions of all terms
• Effective date of agreement
• Outline of the sponsor’s responsibilities, which must include general management of the trial; provision of adequate funding, resources/logistics and IPs for the study; and insurance for the study participants
• Outline of the PI’s responsibilities, which must include retaining all trial related essential documents until the sponsor informs the PI these documents are no longer needed
• Term (period of study duration) and termination of agreement (conditions for this)
• Confidentiality

Per the SL-GCPs, the sponsor should obtain the investigator’s/institution’s agreement to:

• Conduct the trial in compliance with good clinical practice (GCP), with the applicable regulatory requirement(s), and with the PBSL-approved protocol
• Comply with procedures for data recording/reporting
• Permit monitoring, auditing, and inspection

The sponsor and the investigator/institution should sign the protocol, or an alternative document, to confirm this agreement.

Clinical Trial Registration

The G-SLAppClinTrial states that proof of trial registration with the Pan African Clinical Trial Registry (PACTR) (SLE-19), or an internationally recognized PBSL-approved online registry, must be submitted as part of a clinical trial application to the PBSL.

Overview

As delineated in the ClinDrugTrialGCP, the PharmLaw-VNM, and the ASTTReg, a clinical trial can only commence in Vietnam after authorization from the Ministry of Health (MOH) has been received. The MOH’s Administration of Science, Technology and Training (ASTT) manages the clinical trial review process. The ClinDrugTrialGCP indicates that the ASTT is responsible for reviewing the clinical trial registration and study approval dossiers. The MOH’s national level ethics committee (EC), the National Ethics Committee in Biomedical Research (NECBR), is responsible for approving the research protocol. Once the ASTT has completed its review and the NECBR has reviewed and approved the research protocol, the Minister of Health must give final approval to the entire study approval dossier. The ECReg further indicates that for research involving humans, institutions with ECs are responsible for overseeing an initial ethical and scientific appraisal of the research before it is reviewed by the NECBR. (Note: institutional level ECs are known as Councils of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs) in Vietnam.) For institutions conducting research that do not have a CEBRGL, the review and evaluation of the research is performed by the NECBR or the CEBRGL of another institution with appropriate expertise.

As per the ExprtImprtMeds, an import license must be obtained for the shipment of an investigational product (IP) to be used in the trial from the MOH’s Drug Administration of Vietnam (DAV). See the Manufacturing & Import section for additional information.

Clinical Trial Agreement

As per the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), the sponsor is required to enter an agreement with the participating principal investigator (PI)/host institution(s) before the trial begins to demonstrate the financial agreement between the parties. The PharmLaw-VNM also states that the sponsor is required to sign a clinical trial contract with the investigator(s).

Clinical Trial Registration

According to VNM-12, the ASTT encourages the sponsor and the PI to register their study with the United States National Institutes of Health’s ClinicalTrials.gov (VNM-13).

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 severity is inconsistent with the applicable product information

Safety Reporting Requirements

As stated in the G-SLAppClinTrial, the sponsor and the principal investigator(s) (PIs) are responsible for proper reporting of AEs and SAEs. The sponsor should expedite the reporting of all AEs that are both serious and unexpected. Any SAEs/SADRs must be reported to the Pharmacy Board of Sierra Leone (PBSL) immediately where possible. In any event, the SAEs/SADRs must be reported to the PBSL within 48 hours of site awareness, but no later than 15 calendar days.

The SL-GCPs indicates that all SAEs/SADRs should be reported immediately except for those incidents documented by the protocol or the investigator’s brochure that do not require immediate reporting. The immediate reports should be followed promptly by detailed, written reports. The reports should identify participants by unique code numbers. AEs and/or laboratory abnormalities identified in the protocol as critical to safety evaluations should be reported to the PBSL. Furthermore, per the G-SLAppClinTrial, any SAE/SADR related to the IP should receive immediate medical attention.

In addition, per the G-SLAppClinTrial, any frequent AEs/ADRs should be reported to the PBSL immediately where possible, and in any event, within seven (7) days of site awareness. Non-serious AEs must be reported to the PBSL on request and, where applicable, submitted as part of an application for registration.

The G-SLAppClinTrial indicates that non-serious AEs must be reported on request and where applicable, submitted as part of an application for registration.

Investigator Responsibilities

The G-SLAppClinTrial states that in the event of an SAE/SADR, the PI is required to submit follow-up information (e.g., copies of diagnostic test results, laboratory reports, medical record progress notes) as soon as it becomes available. This information should be clearly marked as updated information and include the protocol and participant numbers. Follow-up reports must be submitted immediately when there is a change in the severity of the SAE/SADR initially reported, whenever there is any new development on an initially reported SAE/SADR, and/or when the SAE/SADR is resolved. Follow-up reports must include an assessment of the importance and implication of any findings. All fatal cases must be accompanied by a formal autopsy report. In exceptional circumstances where a formal autopsy is not practicable, provision of a verbal autopsy report must be prior approved by the PBSL and be given with ample reasons. SLE-23 indicates that the investigator is responsible for submitting these follow-up reports, but the sponsor can also report through the contract research organization.

As per the SL-GCPs, the investigator should also comply with applicable regulatory requirements related to reporting unexpected SAEs/SADRs to the PBSL. For a reported death, the investigator should supply the PBSL with any additional requested information (e.g., autopsy reports and terminal medical reports).

Sponsor Responsibilities

According to the G-SLAppClinTrial and the SL-GCPs, the sponsor is required to expedite the reporting of all AEs/ADRs that are both serious and unexpected to the PBSL. The SL-GCPs further indicates that the sponsor must also expedite the reporting of all AEs/ADRs that are both serious and unexpected to all concerned investigator(s)/institutions(s) and the ethics committee(s).

Per the SL-GCPs, the sponsor is responsible for the ongoing safety evaluation of IPs, and should promptly notify the investigator(s)/institution(s) and the PBSL of findings that could adversely affect participant safety, impact the conduct of the trial, or alter the PBSL’s approval of the trial.

Other Safety Reports

The G-SLAppClinTrial indicates that notifications of changes in nature, severity, or frequency of risk factors must be submitted to the PBSL within 28 days, and new information that impacts the risk benefit profile of the product or conduct of the trial must be reported within seven (7) days.

Per the G-SLSftyMntrng and the G-SLAppClinTrial, a Development Safety Update Report (DSUR) must be submitted annually to the PBSL.

According to the G-SLSftyMntrng, the main objective of a DSUR is to present a comprehensive, thoughtful annual review and evaluation of pertinent safety information collected during the reporting period related to a drug under investigation, whether or not it is marketed, by:

• Examining whether the information obtained by the sponsor during the reporting period is in accord with previous knowledge of the IP’s safety
• Describing new safety issues that could have an impact on the protection of clinical trial participants
• Summarizing the current understanding and management of identified and potential risks, and
• Providing an update on the status of the clinical investigation/development program and study results

For more information on DSURs, see Section 12 of the G-SLSftyMntrng.

For safety reporting from foreign sites and other reporting requirements, see Appendicies VIa – VIc of the G-SLAppClinTrial.

Form Completion & Delivery Requirements

According to the G-SLAppClinTrial, the SAE/SADR report form must include detailed information to enable a causality assessment report to be prepared by the PBSL’s Expert Committee on Drug Safety. The SAE/SADR form must conform to the format of the Council for International Organizations of Medical Sciences’ (CIOMS) Form I (SLE-7), or must be previously approved by the PBSL. Furthermore, all SAEs/suspected unexpected serious adverse reactions (SUSARs) and AEs/ADRs must be reported using the SLE-7 form format and also electronically through the PBSL’s online reporting platform (SLE-14). Frequent AEs/ADRs should be reported to the PBSL in a line listing and through the PBSL’s online reporting platform. Electronic submissions must be E2B compliant. See SLE-12 for the International Council for Harmonisation (ICH)’s E2B Guidelines.

For non-serious AEs, the G-SLAppClinTrial indicates that individual reporting must be formatted in accordance with the data elements specified in the ICH Harmonised Tripartite Efficacy Guideline on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A) (see SLE-12).

Safety Reporting Definitions

As delineated in the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP) and the AERprtingD62, the following definitions provide a basis for a common understanding of Vietnam’s safety reporting requirements:

• Adverse Event (or Adverse Experience) (AE) – Any untoward medical occurrence (including any signs, symptoms, illnesses, or test results) in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product
• Serious Adverse Event (SAE) – Any untoward medical occurrence that may lead to death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or permanent incapacity, creates a congenital anomaly/birth defect, or requires appropriate medical intervention to prevent the aforementioned situations or medically important event
• Unexpected AE – AEs in which the essence, severity, specificity, or consequences are different or 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 AE/SAE information to ensure the timeliness of reporting and the safety of the research participants. The PI is required to report to the sponsor, the institutional ethics committee (EC), also known as a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL), the MOH’s National Ethics Committee in Biomedical Research (NECBR), the MOH’s Administration of Science, Technology and Training (ASTT), and the National Centre for Drug Information and Adverse Drug Reaction Monitoring (National DI and ADR Centre).

The ECReg further states that the NECBR is responsible for assessing the PI's recording, reporting, and handling of AEs occurring during the study.

The BioequivTrial indicates that depending on the type of AE/SAE, the PI must comply with the following reporting requirements:

• Fatal or life-threatening SAEs in Vietnam: A report, in accordance with Form 4 in the Appendix of the BioequivTrial, must be submitted to the NECBR, the ASTT, and the National DI and ADR Centre within seven (7) working days from the date of receiving information about the SAE. Updates on the SAE must be provided in additional reports until the participant recovers or stabilizes.
• SAEs that are not fatal or life-threatening in Vietnam: A report, in accordance with Form 4 in the Appendix of the BioequivTrial, must be submitted to the NECBR, the ASTT, and the National DI and ADR Centre within 15 working days from the date of receiving information about the SAE.
• Non-serious AEs occurring in Vietnam: The AEs must be recorded and summarized in a periodical report, and reported in the full results of the trial research results to the NECBR and the ASTT.

The BioequivTrial indicates that in the event of fatal or life-threatening AEs/SAEs, the PI and the host institution are required to suspend the trial immediately, provide care and treatment to the participant(s), overcome and resolve the consequences, and document the events. According to the AERprtingD62, the PI must also document any deaths. The BioequivTrial and the AERprtingD62 further indicate that the PI and the host institution must report these events to the CEBRGL, the NECBR, the ASTT, and the National Center of DI and ADR.

For AEs that cause harm to the participant’s health, the BioequivTrial and the AERprtingD62 indicate that the PI is responsible for treating and following up on the participant’s health until the person is stable.

According to the BioequivTrial, the PI should provide periodic updates regarding AEs/SAEs to the sponsor, the CEBRGL, the NECBR, the ASTT, and the National Center of DI and ADR. If the extent and frequency of AEs/SAEs exceeds the allowable limit, investigators may propose to the sponsor, EC, and competent regulatory authority that the clinical trial be suspended.

The BioequivTrial and the AERprtingD62 indicate that all the following must be reported:

• SAEs occurring at study sites in Vietnam
• SAEs occurring at study sites outside of Vietnam in a multicenter Vietnamese study that lead to cessation/suspension of the study or a change in the protocol
• All other AEs occurring in clinical drug trials at study sites in Vietnam

Sponsor Responsibilities

Per the BioequivTrial and the AERprtingD62, the sponsor must coordinate with the PI to report AEs/SAEs occurring at study sites in Vietnam to the CEBRGL, the NECBR, the ASTT, and the National Center of DI and ADR. The sponsor must collect AE/SAE data.

For SAEs occurring at study sites outside of Vietnam in a multicenter Vietnamese study, the BioequivTrial states that the sponsor must report to the NECBR, the ASTT, and the National Center of DI and ADR within 10 working days from the date of a decision to stop/suspend the study, withdraw participants from the study, or change the research protocol.

In addition, the AERprtingD62 requires that the sponsor report findings from clinical studies, epidemiology studies, in vitro studies, and other information that may lead to an important risk of the investigational product.

Form Completion & Delivery Requirements

Per the BioequivTrial, SAEs in Vietnam should be reported using a Reporting Form for SAEs in Clinical Trials (Appendix, Form 4).

Interim and Annual Progress Reports

Per the SL-GCPs, the investigator should submit written summaries of the trial status to the Pharmacy Board of Sierra Leone (PBSL) as required in the G-SLAppClinTrial, or more frequently, if requested by the PBSL. The investigator should also promptly provide written reports to the PBSL on any changes that significantly affect the conduct of the trial and/or increase the risk to participants.

As set forth in the G-SLAppClinTrial, quarterly reports must be submitted starting from the date the Clinical Trial Certificate is issued using the Quarterly Progress Report Form provided in Appendix VIIb. The reports must be submitted to the PBSL within 21 days following the end of the previous quarter, and an interim report must be submitted within 21 days after the end of the first half of the trial period, and as stipulated in the protocol. If the trial is interrupted, the reason must be communicated in writing to the PBSL within 10 working days. See the G-SLAppClinTrial for additional details on preparing progress reports.

Final Report

According to the G-SLAppClinTrial, the principal investigator (PI) or the sponsor must notify the PBSL no later than 30 days following the trial’s completion and submit a preliminary report on the trial. This report, referred to as a close-out report in the G-SLAppClinTrial, must be submitted to PBSL after study completion in the recommended format as per Appendix VIII.

The G-SLAppClinTrial delineates that in addition to the close-out report, the PI or the sponsor must compile and submit a comprehensive formal report to the PBSL no later than 90 days following the trial’s completion. The report should conform to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Harmonised Tripartite Guideline - Structure and Content of Clinical Study Reports (E3) (SLE-11). The report must include a short but comprehensive summary of the essential findings of the trial, as well as its methodology and course, and be submitted in hard and soft copies. Publication(s) of the study in a scientific journal or other medium for the purpose of disseminating the information obtained to stakeholders may be done only after notification of the PBSL.

The SL-GCPs indicates that the investigator is responsible for submitting the final report summarizing the trial’s outcome to the PBSL.

Interim and Annual Progress Reports

The BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP) indicates that investigators are responsible for providing periodic and unscheduled reports.

According to the ECReg, progress reports submitted to ethics committees (EC) for evaluation must contain the following:

• Summary of research protocol
• Complete research protocol, including previously approved revisions, if applicable
• Reports on research progress
• Reports on the number of participants who were selected for the study, completed the study, and withdrew from the study
• Detailed report on adverse events (AEs) and issues causing risks to participants, if applicable
• Summary of relevant information, especially safety information
• Current informed consent form (ICF)
• Independent inspection report of investigator and sponsor
• Notice of principal investigator (PI) or sponsor regarding early suspension/termination or completion of the study, if applicable

Final Report

The BioequivTrial and the ClinDrugTrialGCP indicate that the PI, the sponsor, and the host institution are responsible for submitting a final report to the Ministry of Health (MOH) when a study is completed. The final report, which must include an analysis of the data and information on AEs/serious adverse events (SAEs), must be submitted in accordance with Form No. 12 in Appendix III of the ClinDrugTrialGCP. The BioequivTrial further states that the clinical trial results must be made public within three (3) years from the date of issuance of the competent authorities' decision approving the results, and should comply with applicable copyright regulations.

As per the G-SLAppClinTrial and the SL-GCPs, a sponsor is defined as an individual, company, institution, or organization that takes ultimate responsibility for the initiation, management, and financing of a trial.

In accordance with the G-SLAppClinTrial and the SL-GCPs, the sponsor may authorize a contract research organization (CRO) to perform one (1) or more of its trial-related duties and functions. However, the ultimate responsibility for the trial’s data quality and integrity always resides with the sponsor.

The SL-GCPs further requires that any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s). Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.

Additionally, as delineated in the SL-GCPs, a sponsor-investigator is defined as 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.

Per SLE-23, a foreign individual/organization may be the sponsor of a clinical trial, but a local representative in Sierra Leone is required.

As per the ECReg and the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), the sponsor is defined as an individual, entity, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. (Note: The ClinDrugTrialGCP and the BioequivTrial also refer to the sponsor as “organizations and individuals with clinical reagents” or “donor”.)

In addition, per the PharmLaw-VNM, the sponsor may select a qualified contract research organization (CRO) (also known as a research support organization in Vietnam) to run the clinical trial. The ClinTrialSup defines a CRO as an organization with the legal status to operate in the field of clinical trial research support and that is staffed with appropriately qualified personnel.

According to the ClinTrialSup, CROs may perform clinical research support activities such as implementing sponsors’ clinical research responsibilities, carrying out administrative support activities, and conducting clinical research monitoring. The ClinDrugTrialGCP indicates that a cooperative contract should exist between the sponsor and a CRO, if applicable. According to the PharmLaw-VNM, a sponsor and the CRO may be domestic or foreign.

In addition, as per the ClinTrialSup, CROs are also responsible for registering their organizations with the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT). Before implementing any activities in support of a clinical trial, a CRO must submit a registration dossier and the applicable forms for approval. The CRO is also required to report annually on its clinical research activities to the MOH’s ASTT. (See the ClinTrialSup for detailed information on clinical trial research support activities and the related registration forms.)

Overview

The SL-GCPs states that the sponsor is responsible for selecting the investigator(s) and the institution(s) for the clinical trial and for ensuring that the investigator(s) are qualified by training and experience. Additionally, the sponsor must define and allocate all trial-related duties and responsibilities to the relevant parties. 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.

As stated in the G-SLAppClinTrial, the principal investigator (PI) directly in charge of a trial, and at each site in a multi-center trial, must possess appropriate qualifications, training, and experience. The PI must be a scientist and domicile in Sierra Leone.

The G-SLAppClinTrial and the SL-GCPs further indicate that the PI must be responsible for the proper conduct of the trial(s), have previous experience as a co-investigator in at least two (2) trials in the relevant professional area, and have proof of formal training in good clinical practice (GCP) for at least two (2) years. See the G-SLAppClinTrial and the SL-GCPs for additional requirements.

Foreign Sponsor Responsibilities

Per SLE-23, a foreign individual/organization may be the sponsor of a clinical trial, but a local representative in Sierra Leone is required.

Data and Safety Monitoring Board

As indicated in the G-SLAppClinTrial, the sponsor must establish an independent data-monitoring committee, such as a Data and Safety Monitoring Board (DSMB), to regularly assess the trial’s progress and analyze safety data. The applicant must provide a copy of the DSMB’s membership, curriculum vitaes, and signed charter in the clinical trial application package submitted to the Pharmacy Board of Sierra Leone (PBSL). However, the SL-GCPs indicates that establishing a DSMB is optional.

The G-SLAppClinTrial further indicates that a duly signed and authenticated DSMB report(s) and/or minutes must be forwarded to the PBSL upon request. For more information on DSMB requirements, see the G-SLAppClinTrial.

Multicenter Studies

As delineated in the SL-GCPs, in the event of a multicenter clinical trial, the sponsor must ensure that:

• All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor, and the approvals of the PBSL and the ethics committee
• The case report forms (CRFs) are designed to capture the required data at all multicenter trial sites
• Investigator responsibilities are documented prior to the start of the trial
• All investigators are given instructions on following the protocol, complying with a uniform set of standards to assess clinical and laboratory findings, and completing the CRFs
• Communication between investigators is facilitated

In addition, the sponsor may organize a coordinating committee or select coordinating investigators.

Overview

As set forth in the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP) and PharmLaw-VNM, the sponsor is responsible for selecting the investigator(s), the principal investigator (PI), the consultant experts, and the research institutions, taking into account the appropriateness and availability of the study site and facilities.

As stated in the BioequivTrial, all investigators must possess appropriate qualifications, training, and experience. All investigators involved in the trial must obtain completion certificates for a good clinical practice (GCP) course and a safety reporting course, each to be updated every three (3) years, from the Ministry of Health (MOH) or an authorized training facility.

See the BioequivTrial for information on PI and investigator rights and responsibilities.

Foreign Sponsor Responsibilities

No information is currently available on foreign sponsor requirements.

Data and Safety Monitoring Board

According to VNM-12, there are no requirements for establishing a Data and Safety Monitoring Board (DSMB). However, the MOH’s National Ethics Committee in Biomedical Research (NECBR) may recommend the establishment of a DSMB.

Multicenter Studies

The BioequivTrial states that for multicenter studies, in addition to analyzing general research results, it is necessary to conduct a separate analysis of key safety and efficacy variables on Asian or Vietnamese research populations using drugs for which racial factors are considered to have an effect on efficiency and safety. Furthermore, per the ClinDrugTrialGCP, the clinical trial study approval dossier must include documentation certifying the participation of research institutions in multicenter studies in Vietnam.

Insurance

The G-SLAppClinTrial states that for all sponsor-initiated trials, a valid insurance certificate for the duration of the study must be provided before initiating the study, and a copy of this coverage must be included in the clinical trial application submission to the Pharmacy Board of Sierra Leone (PBSL). Sponsors and principal investigators (PIs) must ensure insurance cover for clinical trial participants and must submit a certificate of insurance cover for participants as evidence. The certificate must at least contain:

• Insurance company
• Policy number
• Initial date
• Expiry date
• Insured (Policy Holder/Sponsor)
• Description of activity (purpose of the policy)

The G-SLAppClinTrial and the SL-GCPs also state that the sponsor must provide insurance or indemnify the investigator(s)/institution(s) against claims arising from the trial, except for those claims arising from malpractice and/or negligence as stipulated in the G-SLAppClinTrial. See Annex 7 of SLE-6 for suggested wording of the sponsor indemnification.

Compensation

Injury or Death

The SL-GCPs indicate that 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 requirement(s). In addition, when trial participants receive compensation, the method and manner of compensation should comply with the PBSL's requirements.

Trial Participation

According to the SL-GCPs, the ethics committee (EC) (i.e., the Sierra Leone Ethics and Scientific Review Committee (SLESRC)) should review both the amount and method of payment to participants to assure that neither presents problems of coercion or undue influence. Payments to a participant should be prorated and not wholly contingent on the participant’s completion of the trial. The EC should also ensure that information regarding payment to participants, including the methods, amounts, and schedule of payment, is set forth in the written informed consent form and any other written information to be provided to participants. The way payment will be prorated should be specified.

Insurance

According to VNM-12, there is no specific Vietnamese guidance that addresses indemnity agreements between the sponsor and the contract research organization (CRO), investigator(s), or institution(s). However, the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP) lists an insurance contract as an essential document to be obtained by the principal investigator (PI), institution, and sponsor before conducting a clinical trial. The purpose of the insurance contract is to ensure that research participants will be compensated in the event of a trial-related injury.

Compensation

Injury or Death

As specified in the PharmLaw-VNM, the sponsor is responsible for providing compensation to research participants in the event of trial-related injuries. The BioequivTrial also states investigators are responsible for compensating participants when an adverse event that seriously impacts the participant’s health was caused by the investigator’s violation of the research protocol.

Trial Participation

According to the BioequivTrial, payment and compensation, if any, to clinical trial participants must be clearly indicated in the research protocol. Per the ECReg, ethics committees (ECs) must consider the amount and method of payment to ensure that there is no coercion or influence on the voluntariness of participants. Payments should be made according to each visit.

Quality Assurance/Quality Control

As stated in the SL-GCPs, the sponsor is responsible for implementing and maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data are generated, recorded, and reported in compliance with the protocol, good clinical practice (GCP), and the Pharmacy Board of Sierra Leone (PBSL)’s regulatory requirement(s). The sponsor is responsible for obtaining 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.

Monitoring Requirements

As part of its QA system, the SL-GCPs notes that the sponsor may choose to perform a clinical trial audit. The purpose of the audit should be to evaluate trial conduct and compliance with the protocol, SOPs, the PBSL, and other applicable regulatory requirements. The sponsor should ensure that the auditors are qualified by training and experience, and that their qualifications are documented. The sponsor must also ensure that the audit is conducted in accordance with the sponsor’s own written procedures on what to audit, how to audit, the frequency of audits, and the form and content of audit reports. The observations and findings of the auditor(s) should be documented. No specific timeframe is provided for the audit process. See the SL-GCPs for detailed audit requirements.

Premature Study Termination/Suspension

As per the SL-GCPs, if a trial is terminated or suspended prematurely, the sponsor should promptly inform the investigator(s)/institution(s) and the PBSL of the termination or suspension, and explain the reason(s) for the termination or suspension. The ethics committee (EC) (i.e., the Sierra Leone Ethics and Scientific Review Committee (SLESRC)) should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor or by the investigator/institution.

Quality Assurance/Quality Control

As stated in the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), the sponsor is responsible for assigning a monitor to assist in maintaining a quality assurance (QA) system with written standard operating procedures (SOPs) that ensure trials are conducted and data are generated, recorded, and reported in compliance with the protocol. In addition, the quality management system applied in clinical trials must meet International Organization for Standardization (ISO) 9001-equivalent standards or higher.

Per the BioequivTrial, the principal investigator (PI) is responsible for ensuring the accuracy, truthfulness, confidentiality, integrity, and verifiability of the research data. Correction of data must be in accordance with applicable regulations: without deleting the original data, the assigned researcher must name, sign for confirmation, and specify the date of correction. The lead investigator must submit an encrypted list of trial participants to the regulatory agency after the clinical trial ends. The retention and submission of the list of participants after decryption must be kept secret.

The trials should be conducted in compliance 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 (VNM-10)).

Monitoring Requirements

As part of its QA system, the BioequivTrial states that the sponsor should assign a monitor to inspect the trial. The sponsor should appoint individuals who are independent from the trial and are qualified by training and experience to conduct inspections, in accordance with the ClinTrialSup. The ClinDrugTrialGCP further indicates that SOPs, the monitoring/inspection plan, and procedures must also be submitted to the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT).

For information on ASTT and ethics committee (EC) monitoring responsibilities, see the Scope of Assessment and Scope of Review sections.

Premature Study Termination/Suspension

According to the BioequivTrial, the sponsor may terminate a trial early if the sponsor learns of any serious protocol violations that seriously affect the health of trial participants, or, the accuracy and truthfulness of the data during an inspection. The sponsor should send notices to the Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL), the MOH’s National Ethics Committee in Biomedical Research (NECBR), and the relevant authority, in addition to notifying the institution and PI.

Electronic Data Processing System

As delineated in the SL-GCPs, when using electronic trial data handling and/or remote electronic data systems, the sponsor must ensure and document that the electronic data processing system(s) conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance, and that the sponsor maintains standard operating procedures (SOPs) for using these systems. The responsibilities of the sponsor, investigator, and other parties with respect to the use of these computerized systems should be clear, and the users should be provided with training in their use. Refer to the SL-GCPs for detailed information on electronic trial data systems.

Records Management

As set forth in the SL-GCPs, the sponsor, or other data owners, should retain all sponsor-specific essential documents pertaining to the trial for at least two (2) years after formal discontinuation of the trial or in conformance with the applicable regulatory requirement(s) 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 conduct of a clinical trial.

Electronic Data Processing System

According to the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), when using electronic trial data processing systems, the sponsor should use appropriate data handling programs and have adequate standard operating procedures (SOPs) for these systems. In addition, per the ClinDrugTrialGCP, the research institution’s general documentation must include a brief description of any electronic document system in its technical and professional standards, if applicable.

Records Management

As per the BioequivTrial, all information on clinical trials must be recorded, handled, managed, and kept in accordance with applicable regulations in order to accurately report, interpret, monitor, and check the accuracy and reliability of clinical trial information and data. Research institution facilities for storing clinical trial records and documents must ensure confidentiality; restricted access; fire and explosion prevention and control; and avoidance of adverse effects of light, temperature, humidity, and penetration of insects and other animals. In addition, research dossiers and documents should be archived and preserved according to the contract between the sponsor and the institution. For research and development of new products, documentation needs to be kept for at least 10 years.

No information is currently available regarding personal data protection requirements.

Responsible Parties

Per Decree13, the personal data controller is an organization or individual that decides the purposes and means of processing personal data. The personal data processor is an organization or individual that performs data processing on behalf of the data controller, through a contract or agreement with the data controller. An organization or individual that both decides the purposes and means for, and directly processes, personal data is referred to as a personal data controller and processor.

Decree13 states that the personal data controller must:

• Implement organizational and technical measures, as well as appropriate safety and security measures, to prove that data processing activities have been carried out in accordance with Decree13, reviewing and updating these measures as necessary
• Record and store a system log of personal data processing
• Notify the Ministry of Public Security (MPS) of violations of regulations on protection of personal data as prescribed in Decree13
• Select a personal data processor in accordance with a clear mandate and work only with a personal data processor that has appropriate safeguards in place
• Ensure the rights of data subjects as prescribed in Decree13

Additionally, Decree13 indicates that the personal data processor must:

• Only receive personal data after having a contract or agreement on data processing with the personal data controller, and process personal data in accordance with the contract or agreement
• Fully implement measures to protect personal data specified in Decree13 and other relevant legal documents
• Delete and/or return all personal data to the personal data controller after finishing data processing

According to Decree13, both the personal data controller and processor are also responsible to the data subject for damages caused by the processing of personal data. In addition, they must cooperate with the MPS and competent state agencies in protecting personal data by providing information for investigation and handling of violations of Decree13.

Per VNM-8, the MPS is responsible for protecting the rights of data subjects against violations of Decree13, and for maintaining the National Information Portal on Personal Data Protection (VNM-7). See VNM-7 for additional personal data protection resources.

Data Protection

Per Decree13, organizations and individuals involved in personal data processing must apply personal data protection measures to prevent unauthorized collection of personal data from translation systems and equipment. It is illegal to set up software systems, enact technical measures, or organize activities of collecting, transferring, buying, and selling personal data without the consent of data subjects.

According to Decree13, personal data protection measures must be applied from the beginning and throughout the processing of personal data, including management, technical, investigational, and procedural measures. Network security for the data processing system, as well as the means and equipment, must be checked before processing data, irrecoverably deleting data, or destroying devices containing personal data.

Decree13 states that in the case of sensitive personal data, a department with the function of protecting personal data must be designated, personnel in charge of personal data protection must be appointed, and information about the department and individual in charge of personal data protection must be exchanged with the agency specializing in personal data protection (e.g., MPS). Additionally, data subjects must be notified that their sensitive personal data is being processed.

Decree13 states that if a violation of Decree13 has been detected, the personal data controller/personal data controller and processor must notify the MPS’s Department of Cybersecurity and Prevention within 72 hours after the violation occurs using Form No. 03 (see Appendix of Decree13 or VNM-9). If the notification is submitted after 72 hours, the reason for the late notice must be attached. Additionally, the personal data processor must notify the personal data controller of the violation as quickly as possible. See Decree13 and VNM-9 for more information on notification requirements for violations of personal data protection regulations.

Consent for Processing Personal Data

Decree13 delineates that a data subject’s consent is only valid when the data subject voluntarily and clearly knows the type of personal data to be processed; the purpose of processing personal data; that organizations and individuals are allowed to process the personal data; and the rights and obligations of data subjects. The data subject’s consent must be expressed clearly, specifically in writing, by voice, by ticking the consent box, in the syntax of consent via text message, by selecting consent technical settings, or through another action that demonstrates consent. When there are multiple purposes for the data collection, the personal data controller/personal data controller and processor must list the purposes for the data subject to agree to one (1) or more of the stated purposes, and consent must be given for each purpose. The data subject’s consent must be expressed in a format that can be printed or reproduced in writing, including in electronic or verifiable formats. Silence or non-response of the data subject is not considered as consent, and the data subject may give partial or conditional consent. The data subject’s consent is valid until the data subject decides otherwise or when the competent state agency requests in writing.

Per Decree13, data subjects also have a right to: be aware of data processing activities; access their data; delete data; restrict data processing; provision of data; object to data processing; complain, denounce, and initiate lawsuits; claim damages; and self-defense. For the processing of sensitive personal data, the data subject must be informed that the data to be processed is sensitive personal data.

Decree13 states that in certain cases, the data subject’s consent is not required for the processing of personal data. This includes urgent cases where it is necessary to immediately process relevant personal data to protect the life and health of the data subject or others, and in the event of a state of emergency on national defense, security, social order and safety, major disasters, or dangerous epidemics.

See Decree13 for more details on obtaining consent from data subjects; the rights of data subjects; and situations where consent is not required for the processing of personal data.

Withdrawal of Consent

According to Decree13, withdrawal of consent must be in a format that can be printed or reproduced in writing, including in electronic or verifiable format. Upon receiving a request from a data subject to withdraw consent, the personal data controller/personal data controller and processor must notify the data subject of possible consequences and damages that may occur when consent is withdrawn. The personal data controller, personal data processor, personal data controller and processor, and any third parties must stop, and request any relevant organizations and individuals to stop, processing the data of the data subject that has withdrawn consent. Withdrawal of consent does not affect the legality of the data processing that was agreed to prior to the withdrawal.

Children

Per Decree13, children’s personal data must be processed in accordance with the principle of protecting the rights and ensuring the best interests of the children. The processing of children’s personal data must have the consent of the child if the child is seven (7) years of age or older, as well as the consent of the parent(s) or legal guardian(s). The personal data controller, personal data processor, personal data controller and processor, and any third parties must verify the age of the children before processing the children's personal data. The relevant parties must stop processing the children’s personal data and/or irreversibly delete or destroy the children’s personal data in the following cases:

• The data was processed for improper purposes, or the purpose of processing personal data with the consent of the data subject has been fulfilled, unless otherwise provided for by law
• The child’s parent(s) or legal guardian(s) withdraws consent for the processing of the child’s personal data, unless otherwise provided for by law
• At the request of a competent authority when there are sufficient grounds to prove that the processing of personal data affects the children’s legitimate rights and interests, unless otherwise provided for by law

Obtaining Consent

In all Sierra Leone clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in the SL-GCPs. In obtaining and documenting 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 with the clinical trial application. The G-SLEthics further indicates that the PI must also submit the ICF to the national ethics committee (EC), the Sierra Leone Ethics and Scientific Review Committee (SLESRC), for review. (See the Required Elements section for details on what should be included in the form.)

The SL-GCPs states that the investigator, or the investigator’s designated representative, must provide detailed research study information to the participant or legal representative/guardian. In addition, 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 participant or legal representative/guardian should also be given adequate time to consider whether to participate.

As per the SL-GCPs, none of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant or legal representative/guardian to waive or appear to waive their legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representatives from their liabilities for any negligence.

Re-Consent

According to the SL-GCPs, the participant or legal representative/guardian should be informed in a timely manner if new information becomes available that may be relevant to the participant’s willingness to continue participation in the trial. The communication of this information should be documented, and the participant or legal representative/guardian should receive a copy of the signed and dated ICF updates, including a copy of any amendments to the written information provided to the participants.

Language Requirements

As per SLE-23, the clinical trial application and accompanying material must be provided to the PBSL in English.

Documenting Consent

The SL-GCPs states that the participant or legal representative/guardian, as well as the investigator(s), must sign and date the ICF.

Where the participant is illiterate or the legal representative/guardian is illiterate, an impartial witness should be present during the entire informed consent discussion. The witness should sign and date the ICF after:

• The written ICF and any other written information is read and explained to the participant or legal representative/guardian;
• The participant or legal representative/guardian has orally consented to the participant’s involvement in the trial; and
• The participant or legal representative/guardian has signed and dated the ICF, if capable of doing so.

According to the G-SLEthics, the SLESRC does not accept verbal consent, except when supported by an independent witness.

Per the SL-GCPs, before participating in the study, the participant or legal representative/guardian should receive a copy of the signed and dated ICF.

Waiver of Consent

The SL-GCPs delineates that where the protocol indicates that prior consent of the participant or legal representative/guardian is not possible, the EC (i.e., the SLESRC) should determine whether the proposed protocol and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials. See the Emergencies and Mentally Impaired sections for more information.

Obtaining Consent

In all Vietnamese clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in the ClinDrugTrialGCP, the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), and the PharmLaw-VNM. As per the ClinDrugTrialGCP, the BioequivTrial, and the ECReg, the informed consent form (ICF) is viewed as an essential document that must be sent to the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT) as part of the clinical trial study approval dossier, for which the Minister must issue final approval.

The ECReg indicates that a research proposal involving humans, including the ICF, must undergo ethical and scientific review by the MOH’s National Ethics Committee in Biomedical Research (NECBR) and an institutional level ethics committee (EC) (known as a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs)).

The BioequivTrial states that the principal investigator (PI) or the clinical testing facility is responsible for obtaining written consent from trial participants before carrying out any study procedures.

As per the ECReg, the ICF should be provided in easy-to-understand language, suitable for potential research participants to support their ability to give fully informed consent. For participants with limited education, the ICF should be provided and explained verbally. According to the BioequivTrial and the ECReg, the information should also be presented without coercion or unduly influencing a potential participant to enroll in the clinical trial. The ClinDrugTrialGCP further states that the participant or legal representative/guardian should also be given the opportunity to ask questions about the research, and given adequate time to consider whether to participate.

Re-Consent

No information is currently available on re-consent.

Language Requirements

As delineated in the ClinDrugTrialGCP, the clinical trial application and accompanying material must be provided in Vietnamese or English. If the document is not available in Vietnamese or English, a notarized translation of the document must be provided in Vietnamese or English.

VNM-12 indicates that the ICF content should be presented in Vietnamese and English for global clinical studies, but for studies with domestic sponsors, only Vietnamese is required. The English copy serves as a reference to the NECBR. The study information sheet should be in Vietnamese.

Documenting Consent

As per the ClinDrugTrialGCP, the BioequivTrial, the ECReg, and the PharmLaw-VNM, the participant or the legal representative/guardian must sign and date the ICF. No information is provided in these sources concerning copies to be issued to the participant or legal representative/guardian.

Waiver of Consent

The ECReg indicates an EC may waive the requirement for written voluntary consent from research participants if the study requires absolute confidentiality. The EC’s decision to waive the voluntary written consent requirement must consider the benefits and risks of the study to the participants, as well as measures to protect the rights and safety of the participants.

Based on the SL-GCPs, the informed consent form (ICF) should include the following statements or descriptions, as applicable:

• The study involves research and an explanation of its nature and purpose

• Trial procedures to be followed, including all invasive procedures

• Expected duration of participation

• Participant’s responsibilities in the trial

• Experimental aspects of the study

• Approximate number of participants involved in the trial

• The trial treatment(s) and the probability for random assignment to each treatment

• Any foreseeable risks or discomforts, and when applicable, to an embryo, fetus, or nursing infant

• Any expected benefits or prorated payment; if no benefit is expected, the participant should also be made aware of this

• Alternative procedures or treatment that may be available

• Compensation and/or medical treatment available to the participant in the event of a trial-related injury

• Person(s) to contact for further information regarding the trial and the rights of trial participants, and whom to contact in the event of trial-related injury

• Any additional costs that may result from participation in the research

• That the monitor(s), the auditor(s), the ethics committee (EC) (i.e., the Sierra Leone Ethics and Scientific Review Committee (SLESRC)), and the Pharmacy Board of Sierra Leone (PBSL) will be granted direct access to the participant’s original medical records to verify clinical trial procedures and/or data without violating the participant’s confidentiality

• That records identifying the participant will be kept confidential and, to the extent permitted by applicable laws and/or regulations, will not be made publicly available. If the results are published, the participant’s identity will remain confidential

• Foreseeable circumstances under which the investigator(s) may remove the participant without the participant’s consent

• That participation is voluntary, the participant may withdraw at any time, and refusal to participate will not involve any penalty or loss of benefits, or reduction in the level of care to which the participant is otherwise entitled

• The participant or legal representative/guardian will be notified in a timely manner if significant new findings develop during the course of the study which may affect the participant's willingness to continue

Additionally, see Annex 1 of SLE-6 for standardized wording for the ICF.

Based on the ClinDrugTrialGCP, the informed consent form (ICF) should include the following statements or descriptions, as applicable:

• Description of research with an explanation of its purpose and objectives
• Expected duration of study
• Research methods to be followed
• Inclusion and exclusion criteria for research participants
• Identification of investigator(s) who will be responsible for assessing confidential medical information to select study participants
• Number of participants involved in the study
• Description of any foreseeable risks to the participant
• Any expected benefits to the participant and/or the community, and any study-related payment to the participant
• Alternative procedures or treatment that may be available to the participant
• The extent to which confidentiality of records identifying the participant will be maintained
• Selection of those parties who will be able to access, inspect, supervise and monitor the participant’s records
• Compensation and/or medical treatment available in the event of a trial-related injury
• Person(s) to contact for further information regarding the trial and the rights of trial participants and whom to contact in the event of trial-related injury
• Statement that participation is voluntary and the participant may withdraw at any time for any reason

See Form No. 9 in Appendix III of the ClinDrugTrialGCP for a copy of the ICF.

Compensation Disclosure

Per the ECReg, ethics committees (ECs) must ensure that information relating to payment for study participants, including the method, amount, and payment schedule, is included in the ICF and other documents given to participants.

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 clearly addressed in the informed consent form (ICF) and during the informed consent process.

The Right to Participate, Abstain, or Withdraw

As stated in the SL-GCPs, 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.

The Right to Information

As per the SL-GCPs, a potential research participant or legal representative/guardian has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation or treatment in the case of injury, and any significant new information regarding the research study.

The Right to Privacy and Confidentiality

According to the SL-GCPs and the G-SLAppClinTrial, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right.

The Right of Inquiry/Appeal

The SL-GCPs states that the research participant or legal representative/guardian should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries and/or the participant’s rights.

The Right to Safety and Welfare

As set forth in the SL-GCPs and the G-SLAppClinTrial, the research participant’s dignity, safety, and welfare must take precedence over the interests of science and society.

See the Required Elements and Vulnerable Populations sections for additional information regarding requirements for participant rights.

Overview

In accordance with the ClinDrugTrialGCP, Vietnam’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.

The Right to Participate, Abstain, or Withdraw

As stated in the ClinDrugTrialGCP and the PharmLaw-VNM, the participant or the legal representative/guardian should be informed that participation is voluntary and that the participant may withdraw from the research study at any time for any reason without being held liable.

Additionally, the PharmLaw-VNM states that participants have the responsibility to comply with investigators’ instructions according to approved clinical trial documents.

The Right to Information

As per the ClinDrugTrialGCP and the PharmLaw-VNM, a potential research participant or legal representative/guardian has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, and any compensation or treatment in the case of injury.

The Right to Privacy and Confidentiality

According to the ClinDrugTrialGCP and the PharmLaw-VNM, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right.

The Right of Inquiry/Appeal

The ClinDrugTrialGCP states that the research participant or legal representative/guardian should be provided with contact information for a person to contact regarding trial-related inquiries.

Furthermore, the PharmLaw-VNM states that the participant has the right to file a complaint or lawsuit against any illegal acts committed by the sponsor or investigator.

The Right to Safety and Welfare

As set forth in the ECReg, the risks to the research participant must take precedence over any anticipated benefits to the participant and the interests of society.

See the Required Elements and Vulnerable Populations sections for additional information regarding requirements for participant rights.

The SL-GCPs make provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by emergency situations.

As delineated in the SL-GCPs, if the signed informed consent form (ICF) cannot be obtained from the research participant in an emergency, then the consent of the legal representative/guardian, if present, should be obtained. If prior consent of the participant or legal representative/guardian cannot be obtained, then the participant’s enrollment should follow measures specified in the protocol, and/or elsewhere, with documented approval/favorable opinion by the ethics committee (EC) (i.e., the Sierra Leone Ethics and Scientific Review Committee (SLESRC)) and the Pharmacy Board of Sierra Leone (PBSL) to protect the rights, safety, and well-being of the participant and ensure compliance with EC and PBSL requirements. The participant or legal representative/guardian should be informed about the trial and provide consent as soon as possible.

In addition, per the SL-GCPs, because the participants who are experiencing medical emergencies are usually extremely vulnerable, these individuals should be excluded from all but minimally invasive observational research. ECs must also take great care when assessing emergency care research. Once the researcher has presented clear reasons to justify the initiation of emergency care research without consent to the EC, the EC may approve the research provided it is satisfied that:

• Reasonable steps are being taken to ascertain the religious and cultural sensitivities of participants experiencing medical emergencies
• The condition of the participant precludes the giving of consent
• Inclusion in the trial is not contrary to the interests of the participant
• The research is intended to be therapeutic and poses no more risk than is inherent to the patient’s condition or would be caused by alternative methods of treatment
• The participant and the legal representative/guardian will be informed as soon as is reasonably possible of the patient’s inclusion in the study and of the option to withdraw from the research project at any time
• The participant will be informed, and consent obtained, once the participant who has undergone the necessary emergency procedures has regained consciousness
• The research is based on valid scientific hypotheses and offers a realistic possibility of benefit over standard care

The ECReg indicates an ethics committee (EC) may waive the requirement for written voluntary consent from research participants for research in emergency situations where the participant or the legal representative/guardian cannot voluntarily agree to participate in the study. The EC’s decision to waive the voluntary written consent requirement must consider the benefits and risks of the study to the participants, as well as measures to protect the rights and safety of the participants.

Overview

As per the SL-GCPs, in all Sierra Leonean clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process.

According to the SL-GCPs and the G-SLAppClinTrial, vulnerable populations include individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with the participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. The SL-GCPs states that other participants representing vulnerable populations include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. Additionally, types of research that need additional attention include research involving collectivities, indigenous medical systems, innovative therapy or interventions, HIV and AIDS clinical and epidemiological research, and emergency care research.

The SL-GCPs indicates that the national ethics committee (EC), the Sierra Leone Ethics and Scientific Review Committee (SLESRC), must pay special attention to protecting the welfare of certain classes of participants, including minors, women, persons with mental disabilities or substance abuse related disorders, persons in dependent relationships or comparable situations, prisoners, and persons highly dependent on medical care.

Persons Highly Dependent on Medical Care

According to the SL-GCPs, participants who are highly dependent on medical care must be given special attention to protect the welfare of this vulnerable study population. Researchers need to acknowledge that the participant’s medical condition may compromise the participant’s informed consent and affect the participant’s ability to form an opinion or to communicate. There may also be a perception of coercion if a participant is reluctant to refuse consent for fear that it may compromise the participant’s medical treatment.

As delineated in the SL-GCPs, the following research areas require investigators to pay special attention to these participants to safeguard their welfare and ensure proper consent:

• Intensive care research – Characteristic features are the difficulties in communicating with participants receiving ventilatory assistance and the impairment of cognition in heavily sedated participants. Whenever possible, information should be obtained from potential participants prior to their admission to intensive care. These participants should be excluded from all but minimally invasive observational research due to their extreme vulnerability.
• Neonatal intensive care research – Research involving infants should be conducted in strict accordance with the principles discussed in the Children/Minors section. These principles do not permit research that is contrary to the child’s best interests.
• Terminal care research – Research in terminal care is distinguished by the short remaining life expectancy of participants and potential vulnerability to unrealistic expectations of benefits. Researchers must ensure that the prospect of benefit from research participation is neither exaggerated nor used to justify a higher risk than that involved in the participant’s current treatment.
• Research involving persons with impaired capacity to communicate or unconscious persons – Refer to the Mentally Impaired section.

Persons in Dependent Groups

As set forth in the SL-GCPs, for participants whose proposed involvement in research arises from dependent or comparable relationships, the EC must be satisfied that the participants’ consent is both adequately informed and voluntary. The following list provides some examples of hierarchically structured groups and the junior or subordinate relationships that may exist in these groups:

• Older persons and their caregivers
• Persons with chronic conditions or disabilities and their caregivers
• Wards of the state and guardians
• Patients and healthcare professionals
• Students and teachers
• Prisoners and prison authorities
• Persons with life-threatening illnesses
• Employees and employers (e.g., farm workers and their employers, members of the uniformed services and hospital staff and their employers)

See the Children/Minors; Pregnant Women, Fetuses & Neonates; and Mentally Impaired sections for additional information about these vulnerable populations.

Overview

As per the ECReg and VNM-4, in all Vietnamese clinical trials, research participants selected from vulnerable populations must be provided additional protections by the ethics committee and the investigator(s) to safeguard their health and welfare during the informed consent process. VNM-4 characterizes vulnerable populations as those incapable of giving consent, which may include children, pregnant women, people with mental disabilities, people living with HIV/AIDS, people who are illiterate, prisoners, detainees, sex workers, and other special populations.

See the Children/Minors and Pregnant Women, Fetuses & Neonates sections for additional information about these vulnerable populations.

According to the SL-GCPs, a minor is someone under 18 years of age.

As set forth in the SL-GCPs, when the participant is a minor, informed consent must be obtained from the participant’s parent/legal guardian. Assent from the minor must also be obtained where the minor is capable of understanding. A minor’s refusal to participate in research must be respected.

The SL-GCPs indicates that the national ethics committee (EC), the Sierra Leone Ethics and Scientific Review Committee (SLESRC), must pay special attention to protecting the welfare of certain classes of participants, including minors. Research involving minors should be approved only if:

• The research interventions, including those in observational research, presents the participant with no greater than minimal risk; or
• The research interventions present more than minimal risk but hold out the prospect of direct benefit for the participant; or
• The research interventions, including those in observational research, present more than minimal risk and do not hold out the prospect of direct benefit to the participant, but have a high probability of yielding generalizable knowledge.

In all cases, the protocol must provide sufficient information to justify clearly why minors should be included as participants.

Assent Requirements

The G-SLAppClinTrial also states that in trials involving minors, the parent/legal guardian of a minor is required to sign an informed consent form (ICF). In addition, an assent form similar to the ICF must also be signed and dated by a minor who is capable of understanding as a confirmation of the minor’s willingness to participate in a trial, after having been informed of all aspects of the trial that are relevant to the minor’s decision to participate.

As delineated in the SL-GCPs, assent refers to a minor’s affirmative agreement to participate in research. If a minor fails to object, this should not be construed as assent. The EC (i.e., the SLESRC) must ensure that adequate steps are specified in the protocol to obtain the minor’s assent when, in the EC’s judgment, the minor is capable of providing such assent. Additionally, when the EC determines that assent is required, it must also indicate whether and how such assent must be documented.

According to ChildLaw, a child is someone under 16 years of age.

As set forth in the PharmLaw-VNM, when the participant is a minor, informed consent must be obtained from the legal representative/guardian.

Per the ECReg, signed informed consent forms (ICFs) are required for:

• The parent/legal guardian, if the participant is under 16 years old
• The participant and the parent/legal guardian, if the participant is 16 years old to under 18 years old
• Participants that are 18 years or older and have full civil capacity to give consent

Assent Requirements

The ECReg further specifies that a signed assent form is required for participants who do not have the capacity to give legal consent, including children from 12 years old to under 16 years old. The assent form should contain information similar to an ICF, but be simpler, shorter, and easier to understand. For participants from seven (7) years old to under 12 years old, the assent form content should be provided and explained verbally.

The SL-GCPs requires that the national ethics committee (EC), the Sierra Leone Ethics and Scientific Review Committee (SLESRC), pay special attention to protecting the welfare of certain classes of participants, including women who are or may become pregnant.

The SL-GCPs states that the following conditions must be met for research conducted with pregnant women and fetuses:

• Applicable studies on animals and non-pregnant individuals have been completed
• The purpose of the study is to meet the health needs of the mother of the particular fetus, the risk to the fetus is minimal and, in all cases, presents the least possible risk for achieving the study’s objectives
• Individuals engaged in the study will have no part in any decision as to the timing, method, and procedures used to terminate the pregnancy, and determining the viability of the fetus at the termination of the pregnancy
• No procedural changes that could cause greater than minimal risk to the fetus or the pregnant woman will be introduced into the procedure for terminating the pregnancy solely in the interest of the activity

Per the SL-GCPs, for any study to be conducted that is associated with either the fetus in utero or ex utero, the parents should be legally competent and have given their informed consent.

The SL-GCPs also specifies that the father’s informed consent does not need to be obtained if any of the following applies:

• The study purpose is to meet the mother’s health needs
• The father’s identity or whereabouts cannot be reasonably established
• The father is not reasonably available
• The pregnancy is the result of rape

Further, per the SL-GCPs, no fetus in utero may be involved as a research participant unless:

• The purpose of the study is to meet the health needs of the particular fetus, and the fetus will be placed at risk only to the minimum extent necessary to meet these needs
• The risk to the fetus in the proposed study is minimal, and the study’s objective is to obtain biomedical knowledge that cannot be achieved by other means

According to the SL-GCPs, until it has been established whether a fetus ex utero is viable, a fetus ex utero may not be involved as a participant in any research study unless one (1) of the following conditions is met:

• The fetus faces no added risk from participation in the study, and the purpose of the study is to develop biomedical knowledge that cannot be obtained by other means
• The purpose of the study is to enhance the possibility of survival of the particular fetus to the point of viability

The SL-GCPs states that nonviable fetuses may not be involved as participants in any research activity unless both of these conditions are met:

• The vital functions of the fetus will not be artificially maintained; experimental activities that would terminate the heartbeat or respiration of the fetus will not be employed
• The purpose of the study is to acquire biomedical knowledge not otherwise obtainable

Participants engaged in the study will have no part in any decision as to timing, method, and procedures used to terminate the pregnancy, and/or determining the viability of the fetus at the pregnancy’s termination.

The PharmLaw-VNM states that for studies involving women who are pregnant or breastfeeding, the rationale for participant selection and appropriate protection measures for these participants must be clearly stated in the study approval dossier.

The SL-GCPs indicates that the national ethics committee (EC), the Sierra Leone Ethics and Scientific Review Committee (SLESRC), must pay special attention to protecting the welfare of certain classes of participants, including prisoners. Prisoners are considered vulnerable because incarceration could affect their ability to make a voluntary decision regarding participation in research. A research study may only involve prisoners as participants when the EC (i.e., the SLESRC) has ensured that the clinical trial involves:

• The study of the possible causes, effects, and processes of incarceration and of criminal behavior with no more than minimal risk and inconvenience to the participants
• The study of prisons as institutional structures or of prisoners as incarcerated persons
• Research on conditions particularly affecting prisoners as a class (e.g., vaccine trials and other research on diseases that may be more prevalent in prisons, and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults) only after appropriate experts have been consulted
• Research on practices, both innovative and accepted, that have the intent and probability of improving the health or wellbeing of prisoners

In addition, per the SL-GCPs, in a study where some prisoners may be assigned to control groups that may not benefit from the research, the study may proceed only after appropriate experts have been consulted. Research that could be conducted on a population other than prisoners should not be permitted unless the EC is presented with a valid case and is convinced that the study does not represent exploitative research.

The SL-GCPs also states that when the EC reviews research involving prisoners, the following requirements must be met:

• The majority of the EC members, other than prison members, must have no association with the prison(s) involved
• At least one (1) member of the EC must be a prisoner, or a prisoners’ representative with appropriate background and experience to serve in that capacity. Where a research project is reviewed by more than one (1) EC, only one (1) EC need satisfy this requirement

No information is currently available.

According to the SL-GCPs, the national ethics committee (EC), the Sierra Leone Ethics and Scientific Review Committee (SLESRC), must pay special attention to research participants with mental disabilities, including those with psychiatric, cognitive, or developmental disorders, or participants with substance abuse related disorders. Individuals who have been institutionalized may be further compromised in terms of their capacity to make a truly voluntary decision to participate in a study.

Per the SL-GCPs, research involving people with mental disabilities or with substance abuse related disorders must therefore:

• Be relevant to mental disabilities or substance abuse related disorders so that it is necessary to involve people who have a mental disability and/or a substance abuse related disorder(s)
• Justify the involvement, as the study population, of institutionalized people with mental disabilities
• Ensure appropriate evaluation procedures for ascertaining the participants’ ability to provide informed consent. If participants are deemed unable to understand and make a choice, then consent should be obtained from the participant’s legal representative/guardian
• Ensure that consent is free from coercion and risk to participants
• Ensure that only minimal risk is involved, and that the risk is outweighed by the anticipated benefits for the participants and by the importance of the knowledge that will be derived from the research

In addition, the SL-GCPs notes that persons with intellectual or mental impairment should not participate in research that might be conducted equally well with individuals without those impairments. Consent cannot be given that is contrary to the interests of a participant with mental or intellectual impairment, and the person's refusal to participate in research must always be respected. Accordingly, consent must be obtained from one (1) of the following:

• The participant to the extent that the participant is competent to give informed consent
• The participant’s legal representative/guardian when the participant is deemed not competent to do so
• An authority, organization, or individual legally authorized to do so

The SL-GCPs further states that research involving participants with impaired capacity to communicate also requires special attention. The distinguishing features of research involving participants with impaired capacity to communicate include acute impairment states requiring medical care, as well as non-acute states. In acute impairment states, the condition and medical care may mask the participant’s degree of cognition and require different means of expression. In non-acute impairment states, the condition may prevent the participant from expressing wishes at all.

As indicated in the SL-GCPs, research involving unconscious persons requires consent to be provided by the participant’s legal representative/guardian, including any relevant statutory authorities, on that person’s behalf. Because of their extreme vulnerability, unconscious persons should be excluded from all but minimally invasive observational research. When neither the prospective participant nor the legal representative/guardian is able to give consent in advance, the EC (i.e., the SLESRC) may approve a research project without prior consent if it is satisfied that:

• Inclusion in the trial is not contrary to the interests of the participant
• The research is intended to be therapeutic and poses no more risk than is inherent to the participant’s condition or would be caused by alternative methods of treatment
• The participant and the legal representative/guardian will be informed as soon as is reasonably possible of the participant’s inclusion in the study and of the option to withdraw from the research project at any time
• The research is based on valid scientific hypotheses and offers a realistic possibility of benefit over standard care

The ECReg states that a signed assent form is required for participants who do not have the capacity to give legal consent, including people with inadequate civil act capacity or in a limited cognitive condition. The assent form should contain information similar to an informed consent form (ICF), but be simpler, shorter, and easier to understand.

As delineated in the G-SLAppClinTrial and the SL-GCPs, an investigational product (IP) is defined 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 use.

The ClinDrugTrial defines an investigational product (IP) as a pharmaceutical product, biomedical product, vaccine, traditional medicine, or herbal medicine that contains a new active ingredient or substance, or a product with a new combination of already marketed pharmaceutical substances.

Manufacturing

As set forth in the PDA2001, the Pharmacy Board of Sierra Leone (PBSL) is responsible for authorizing the manufacture of all drug products in Sierra Leone. According to the SL-GCPs, the sponsor must ensure that the investigational product (IP) is manufactured in accordance with applicable good manufacturing practice (GMP).

The G-SLAppClinTrial states that a GMP certificate from the national competent authority of the country of origin is required when the IP has no marketing authorization in Sierra Leone, or has marketing authorization but its original indication is modified for the purpose of the trial. The GMP certificate should conform to the World Health Organization (WHO) format.

Import

The G-SLAppClinTrial states that the PBSL is responsible for authorizing the import of IPs. A request to import an IP may be submitted after the PBSL has approved the clinical trial application.

The G-SLAppClinTrial indicates that the import application submission must include the following documentation:

• Letter stating the name/description and quantities of each IP, placebo, and trial related product to be imported as well as the details of the location where the product is coming from and details of the recipient in Sierra Leone
• Certificate of analysis of IP and placebo for all batches to be imported
• Lot release certificate (where applicable) for all batches to be imported
• Investigator, sponsor, and recognized clinical research entity’s name and address

According to the G-SLAppClinTrial, the PBSL’s processing time for IP import permits is 10 working days. Imported IPs may be inspected by PBSL officials at the port of entry before they are released to the recognized clinical research entity. The PBSL may order for destruction or re-exportation of the IPs if it has any reason to believe that there is a protocol violation resulting in the termination of the study. See the G-SLAppClinTrial for detailed IP import requirements.

As per the G-FastReg, if a product being registered in Sierra Leone is going to be used in a clinical trial, the registration application may be expedited. If the conditions for expedited registration are fulfilled, the PBSL will process the application and communicate its decision within 21 calendar days.

Please note: Sierra Leone is party to the Nagoya Protocol on Access and Benefit-sharing (SLE-2), 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 SLE-18.

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 registration numbers. Once the MOH approves the study approval dossier, an import permit application must be submitted to the MOH’s DAV for approval of the IP. The import permit is valid for one (1) year.

The PharmLaw-VNM further indicates that a drug/medicinal ingredient that does not have a certificate of free sale must be licensed for import with a quantity not exceeding that which is written on the import license when it is to be used in a clinical trial, a bioequivalence study, a bioavailability assessment, or as a sample for registration, testing, scientific research, or display at a fair or exhibition.

The ExprtImprtMeds and Decree54 require the following documents to be included in an import permit dossier (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

• Import order form (three (3) copies)
• Copy of study protocol approved by the MOH
• A Certificate of Pharmaceutical Product (CPP) (may be substituted with a Free Sale Certificate (FSC) or Good Manufacturing Practice (GMP) certificate)
• The importer’s document bearing the importer’s seal, specifying the purposes and quantity of imported drugs and commitment to use the drugs for its intended purposes
• Quality standards and testing methods
• Drug label(s) and instruction manual(s) with importer seal (See the Labeling section for detailed labeling requirements)
• Preclinical and clinical records for drug(s) containing new pharmaceutical substances, or drug(s) with new combinations of circulating pharmaceutical substances, and an information sheet on placebo’s composition, if applicable

According to the ExprtImprtMeds, dossiers and documents attached to the order form must be prepared on size A4 paper and bound into a solid set. The records must be arranged in the order of the table of contents, with separation between the sections. The separators must be numbered for easy reference and must be affixed for certification by the importing enterprise on the first page of each section of the entire dossier and must have a cover page clearly stating: the name of the importer, order number, date of order, and type of order. The application for foreign drug import must be written in Vietnamese or English. If the application is written in English, the information in the package insert must be written in Vietnamese, except for the following information that may be written in other languages with Latin origin:

• Brand name, generic name, or international generic name of the drug
• International generic or scientific name of ingredient or ingredient quantity of the drug in case it cannot be translated into Vietnamese
• Name and address of the foreign enterprise that manufactures or franchises the drug

The MOH’s DAV will review and approve the import permit application within 15 working days from the date of receipt. According to VNM-12, however, the DAV review and approval process may take two (2) to eight (8) weeks if the DAV requires further clarification on the application. See the ExprtImprtMeds for applicable forms.

Please note: Vietnam is party to the Nagoya Protocol on Access and Benefit-sharing (VNM-2), 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 VNM-6.

Investigator’s Brochure

In accordance with the G-SLAppClinTrial and the SL-GCPs, the Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) (IP(s)) which is relevant to the study of the IP(s) in human participants.

As per the SL-GCPs, the sponsor is responsible for providing the investigators with an IB, and the sponsor should update the IB as significant new information becomes available. The G-SLAppClinTrial further specifies that an updated IB should be submitted at least once a year, or whenever it is updated within this period. Additional information and any changes that have been incorporated in the updated IB should be highlighted for ease of review and evaluation.

According to the G-SLAppClinTrial, the content and structure of the IB must comply with the SL-GCPs and the International Council for Harmonisation’s (ICH) Guideline for Good Clinical Practice E6(R2) (SLE-24). Accordingly, the IB must provide coverage of the following areas:

• Physical, chemical, and pharmaceutical properties and formulation parameters
• Non-clinical studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
• Effects of IP in humans (pharmacology, pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; and regulatory and post-marketing experiences)
• Summary of data and guidance for the investigator(s)
• Toxicological effects in any animal species tested under a single dose study, a repeated dose study, or a special study

See the SL-GCPs and SLE-24 for detailed content guidelines.

Quality Management

According to the G-SLAppClinTrial, a good manufacturing practice (GMP) certificate from the national competent authority of the country of origin is required when the IP has no marketing authorization in Sierra Leone, or has marketing authorization but its original indication is modified for the purpose of the trial. The GMP certificate should conform to the World Health Organization (WHO) format.

Investigator's Brochure

According to the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), the Investigator’s Brochure (IB) is considered an essential document to submit before a clinical trial may be conducted. Vietnam requires the sponsor to submit a summary of the IB to the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT) in the clinical trial registration dossier. Research institutions are required to submit the full IB to the ASTT in the study approval dossier. (Note: The ClinDrugTrialGCP and the BioequivTrial also refer to the sponsor as “organizations and individuals with clinical reagents” or “donor”.)

As per the ClinDrugTrialGCP and the BioequivTrial, the IB contains information and data about preclinical research and clinical trials on the investigational product(s) (IPs). The IB also demonstrates that clinical information related to the IP has been provided to the principal investigator (PI).

As specified in the ClinDrugTrialGCP, the IB must provide coverage of the following areas:

• Information about the IP, including the ingredients, production processes, and quality standards
• For pharmaco-chemical drugs, pharmaceutical drugs, traditional medicines: proof of compliance with Good Laboratory Practices (GLPs) for research institutions or proof of compliance with Good Manufacturing Practices (GMPs) (also referred to as good medicine production standards in Vietnam) for drug manufacturers
• For vaccines: proof of compliance with quality testing requirements from national inspection agencies or ex-warehousing certificates for vaccine or biological batches
• Preclinical research documents for the IP: research reports on pharmacological effects, toxicity, safety, recommendations on dosage, route of administration, and usage
• Clinical research papers from the previous phases (if clinical trials are recommended in the next phase and the IP is not subject to exemption from previous phases)

Quality Management

The ClinDrugTrialGCP specifies that the IPs must be manufactured in a GMP-certified facility. The research institutions must also include a copy of the GMP certificate in the study approval dossier that is submitted to the ASTT.

(See the Product Management section for additional information on IP supply, storage, and handling requirements).

Investigational product (IP) labeling in Sierra Leone must comply with the requirements set forth in the G-SLAppClinTrial and the SL-GCPs. As stated in the G-SLAppClinTrial, all label information should be in English and the print should be clear, legible, and indelible.

As set forth in the G-SLAppClinTrial, the Pharmacy Board of Sierra Leone (PBSL) requires the following information be included on the labels:

• Sponsor details
• Pharmaceutical dosage form, route of administration, quantity of dosage units, and in the case of open trials, the name/identifier and strength/potency
• Batch number
• Trial reference number
• Trial subject identification number
• Name and address of the clinical trial site and the principal investigator
• Directions for use and any warnings or precautions that may be necessary
• Statement indicating “For clinical trial/research use only”
• Storage conditions
• Period of use (use-by date, expiry date, or re-test date as applicable), in month/year format and in a manner that avoids any ambiguity as well as date of dispensing, if applicable
• Statement indicating “Keep out of reach of children” except when the product is for use in trials where the product is not taken home by participants

The SL-GCPs further states that in blinded trials, the coding system for the IP(s) should include a mechanism that permits rapid identification of the product(s) in case of a medical emergency, but does not permit undetectable breaks of the blinding.

Investigational product (IP) labeling in Vietnam must comply with the requirements set forth in PharmLaw-VNM. Per VNM-12, the requirements in Articles 7 and 8 of the MedLabel should also be applied to IP labeling.

According to the MedLabel, the outer packaging label of the drug must show the following:

• Drug name
• Dosage form
• Ingredients, content, and volume or concentration of pharmaceutical ingredients and medicinal materials in the drug formula
• Packaging specifications
• Indications, usage, and contraindications of the drug
• Circulation registration number or import license number (if any)
• Production batch number, date of manufacture, expiry date of the drug, quality standards, and drug storage conditions
• Signs to note and recommendations when using the drug
• Name and address of the drug manufacturing facility
• Name and address of the import facility (for imported drugs)
• Origin of the drug

Additionally, as stated in the MedLabel, the intermediate packaging label of the drug must contain at least the following information:

• Drug name
• Production batch number
• Expiry date

As set forth in PharmLaw-VNM, the IP must also be clearly labeled with the wording: “Products used for clinical trials. Use for other purposes is prohibited.” While there is no specified language requirement for IP labeling in the regulatory resources, according to VNM-12, this wording should be in Vietnamese. A sample IP with the label in the smallest packed unit must also be included in the study approval dossier.

(See the Product Management section for additional information on IP supply, storage, and handling requirements).

Supply, Storage, and Handling Requirements

As delineated in the SL-GCPs, the sponsor must supply the investigator(s)/institution(s) with the investigational product(s) (IP(s)). The sponsor should not supply either party with the IP(s) until obtaining approval from the Pharmacy Board of Sierra Leone (PBSL).

The SL-GCPs specifies that the sponsor must:

• Ensure timely delivery of the IP(s) to the investigator(s)

• Maintain records that document shipment, receipt, disposition, return, and destruction of the IP(s)

• Maintain a system for retrieving IPs and documenting this retrieval
• Maintain a system for the disposition of unused IP(s) and documenting this disposition

• Take steps to ensure IP stability over the period of use
• Maintain sufficient quantities of the IP(s) to reconfirm specifications, if needed, and maintain records of batch sample analyses and characteristics

• Ensure the IP is manufactured according to any applicable good manufacturing practice (GMP)

• Ensure proper coding, packaging, and labeling of the IP(s)

Refer to the SL-GCPs for detailed sponsor-related IP requirements.

Per the SL-GCPs, the IP(s) should be packaged to prevent contamination and unacceptable deterioration during transport and storage. Additionally, per the G-SLAppClinTrial, the PBSL requires the IP packaging to comply with the following requirements:

• The container in which the product is contained should be of good quality
• The container and closure should be properly sealed in order to protect the product from the impact of outside environmental factors
• Each sample should contain an insert

According to the G-SLAppClinTrial, the principal investigator (PI) must notify the PBSL of each consignment of IP batches received on site. The notification must include the product name(s), quantities received, and batches received. The PBSL must approve destruction of IPs, which should be carried out in such a manner that all operations may be accounted for. These documents should clearly identify, or allow traceability to, the batches and/or participant numbers involved, and the actual quantities destroyed. A destruction certificate will be issued by the PBSL.

Record Requirements

The G-SLAppClinTrial indicates that for IPs purchased locally, the PI must document the source, proof of purchase, quantities purchased, and the Certificate of Analysis for each batch of IPs. Copies of all documents on the IP(s), whether purchased locally or imported, must be kept on site for verification and accountability during good clinical practice (GCP) inspections.

As per the SL-GCPs, the sponsor should retain all sponsor-specific essential documents in conformance with the applicable regulatory requirement(s) of the country(ies) where the product is approved, and/or where the sponsor intends to apply for approval(s). All sponsor-specific essential documents should be retained for at least 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.

Supply, Storage, and Handling Requirements

The BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP) indicates that at the end of a clinical trial, the principal investigator (PI) must inventory the investigational product (IP). The sponsor is responsible for storing the IP and for working with the host institution to withdraw and destroy the unused or remaining products, in accordance with applicable regulations.

Record Requirements

As stated in the BioequivTrial, the sponsor and the PI are responsible for filing the following essential documents before the trial begins and during the conduct of the trial:

• Sample(s) labels attached to IP container(s) (only the sponsor is required to file this information)
• Instructions for handling IPs and trial-related materials (if not included in protocol or Investigator’s Brochure (IB))
• Shipping records for IP- and trial-related materials

In addition, the sponsor and the PI are responsible for maintaining records of handling instructions and shipping records for IPs and trial-related materials.

According to the G-SLAppClinTrial and SLE-23, the Pharmacy Board of Sierra Leone (PBSL) is responsible for authorizing the import and export of all biological specimens in Sierra Leone. However, the G-SLAppClinTrial does not have any additional information regarding specimens import.

Export

As set forth in the G-SLAppClinTrial, all institutions or individuals that wish to export any clinical information, medical records, and/or biological samples from Sierra Leone to an institution outside of the country must complete the PBSL’s requirements for material transfer authorization. The sponsor must provide annual updates on the use of, and results obtained from, biological samples exported out of Sierra Leone.

Per the G-SLAppClinTrial and the G-MTA, the local principal investigator or study lead must submit an application for an export permit submitted through the Ministry of Health and Sanitation (MoHS) to the PBSL. All applications must be accompanied by the following documents:

• Evidence of informed consent for use of medical records, clinical information, and biological samples from living participants
• MoHS authorization for deceased patients
• Memorandum of understanding (MOU) between MoHS and the applicant
• Signed and dated Material Transfer Agreement (MTA)
• Payment of PBSL prescribed export permit fee

Please refer to SLE-1 for the materials transfer template.

No information is currently available.