Sierra Leone
Regulatory Authority
Regulatory Authority
Scope of Assessment
Regulatory Fees
Ethics Committee
Ethics Committee
Scope of Review
Ethics Committee Fees
Authorizing Body
Clinical Trial Lifecycle
Submission Process
Submission Content
Timeline of Review
Trial Initiation
Safety Reporting
Progress Reporting
Sponsorship
Definition of Sponsor
Trial Authorization
Insurance
Compensation
Quality, Data & Records Management
Site/Investigator Selection
Informed Consent
Documentation Requirements
Required Elements
Compensation Disclosure
Participant Rights
Special Circumstances/Emergencies
Vulnerable Populations
Children/Minors
Pregnant Women, Fetuses & Neonates
Prisoners
Mentally Impaired
Investigational Products
Definition of Investigational Product
Manufacturing & Import
IMP/IND Quality Requirements
Labeling & Packaging
Product Management
Specimens
Definition of Specimen
Specimen Import & Export
QUICK FACTS
Clinical trial application language English
Regulatory authority & ethics committee review may be conducted at the same time Yes
Clinical trial registration required Yes
In-country sponsor presence/representation required Unspecified
Age of minors Under 18
Specimens export allowed Yes
Regulatory Authority > Regulatory Authority
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1.0, 3.1, 3.2, and 3.5
(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1, 1.2, 1.5, and 1.6
(3) (Legislation) The Pharmacy and Drugs Act, 2001 (PDA2001) (December 13, 2001)
Parliament, Republic of Sierra Leone
Relevant Sections: Part II
Summary

Overview

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. Additional Resources (A) and (B) state 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 Additional Resource (B), 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. In addition to its role in authorizing clinical trials, Additional Resource (C) indicates that the PBSL oversees drug marketing authorization, registration and inspection, import control, licensing, market and quality control, advertising and promotion, and pharmacovigilance.

According to the PDA2001, the PBSL is composed of nine (9) members including:

  • The Director of Drugs and Medical Supplies as Chairman
  • One (1) legal practitioner appointed by the Attorney-General and the Minister of Justice
  • One (1) pharmacist representing the faculty of the Pharmaceutical Sciences College of Medicines and Allied Health Sciences
  • One (1) pharmacist nominated by the Pharmaceutical Society of Sierra Leone
  • Two (2) Ministry-appointed members of the public
  • The President of the Pharmaceutical Society of Sierra Leone
  • The Secretary General of the Pharmaceutical Society of Sierra Leone
  • One (1) pharmacy technician representing the Pharmacy Technician cadre of the Pharmaceutical Society of Sierra Leone

The PDA2001 states that the members are permitted to hold office for three (3) years. Five (5) board members are required to form a quorum, three (3) of whom must be pharmacists. The PBSL’s Registrar, who is a pharmacist appointed by the Public Service Commission, serves as the chief administrator and secretary to the Board.

Additional Resource (D) indicates that the Board’s Pharmacovigilance & Clinical Trials department is responsible for evaluating clinical data for the registration of new products and conducting pharmacovigilance inspections. The department also confirms receipt of adverse drug reaction reports and gives feedback to reporters, participating institutions, and other key stakeholders. See Additional Resource (D) for more information on other PBSL departments.

Contact Information

Pharmacy Board of Sierra Leone
Central Medical Stores Compound
New England Ville, Freetown
P.M.B. 322
Sierra Leone

Phone: (+232 22) 228497, 225983, 229346
Fax: (+232 22) 224526
Email: info@pharmacyboard.gov.sl

Additional Resources
(A) (Website) Pharmacy Board of Sierra Leone – Mandate (Current as of November 7, 2019)
Pharmacy Board of Sierra Leone
(B) (Website) Pharmacy Board of Sierra Leone – Vision and Mission (Current as of November 7, 2019)
Pharmacy Board of Sierra Leone
World Health Organization and The Global Fund, Geneva, Switzerland
Relevant Sections: 5.0 Medicines Regulation
(D) (Website) Pharmacy Board of Sierra Leone – Pharmacovigilance & Clinical Trials (Current as of November 7, 2019)
Pharmacy Board of Sierra Leone
(E) (Website) Pharmacy Board of Sierra Leone - Contact Us (Current as of November 7, 2019)
Pharmacy Board of Sierra Leone
Pharmacy Board of Sierra Leone
(G) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October 2014–July 2018)
Regulatory Authority > Scope of Assessment
Last content review/update: November 25, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1.0, 3.1, 3.2, 3.5, 3.12, and 7.0 – Appendix VI
(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1, 1.2, 1.5, and 1.6
Summary

Overview

In accordance with the G-SLAppClinTrial, the SL-GCPs, and Additional Resource (A), 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 G-SLAppClinTrial and the SL-GCPs specify that the scope of the PBSL’s assessment includes all clinical trials (Phases I-IV). Based on the G-SLAppClinTrial and Additional Resource (A), ethics committee (EC) approval must be obtained prior to applying for PBSL approval. However, as delineated in the G-SLAppClinTrial, the PBSL review process may be conducted in parallel with the EC review in case of a public health emergency or as deemed fit by the PBSL. According to Additional Resource (B), investigators are also required to notify their local institution prior to initiating a trial.

Clinical Trial Review Process

As set forth in the G-SLAppClinTrial and the SL-GCPs, the PBSL coordinates the clinical trial application process. The G-SLAppClinTrial states that the PBSL must issue a Clinical Trial Certificate to authorize the trial to be conducted. (See the Clinical Trial Lifecycle topic, Submission Content subtopic for submission requirements).

Additional Resources
Pharmacy Board of Sierra Leone
Relevant Sections: Checklist
(B) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October 2014–July 2018)
World Health Organization and The Global Fund, Geneva, Switzerland
Relevant Sections: 5.0 Medicines Regulation
Regulatory Authority > Regulatory Fees
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.1 and 7.0 – Appendix VIII
Summary

Overview

As per the G-SLAppClinTrial and Additional Resource (A), 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 processing fees vary depending on the phase and institution conducting the study:

  • Industry Funded (Phase I): $15,000 USD

  • Industry Funded (Phase II): $12,000 USD

  • Industry Funded (Phase III): $10,000 USD

  • Investigator/Local Phases: $5,000 USD

  • Research Institution Funded: $5,000 USD

  • Protocol Amendment: $1,000 USD

  • Expedited Protocol Review: $1,000 USD

  • Renewal of Clinical Trial Certificate (yearly): 10% of Clinical Trial Application Fee

  • Good Clinical Practice Inspection Fees Overseas: $5,000-$7,500 USD

Instructions for Payment of Clinical Trial Application Fee

The G-SLAppClinTrial and Additional Resource (A) do not provide instructions for payment of the clinical trial application fee. For more information about the payment process, contact the PBSL at info@pharmacyboard.gov.sl / wcnjohnson@pharmacyboard.gov.sl (Additional Resource (A)).

Additional Resources
Pharmacy Board of Sierra Leone
Relevant Sections: Checklist
Ethics Committee > Ethics Committee
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Sierra Leone Ethics and Scientific Review Committee – Application Guidelines and Checklist (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Ministry of Health and Sanitation, Directorate of Policy, Planning & Information
(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1, 1.2, 1.5, 1.6, 3.2, and 3.3
(3) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 2.0 and 3.1
Summary

Overview

As per the G-SLEthics, the SL-GCPs, and Additional Resource (A), the principal investigator (PI) must obtain national level ethics approval for each clinical trial from the Sierra Leone Ethics and Scientific Review Committee (SLESRC).

The G-SLAppClinTrial further indicates that ethical clearance for all phases of clinical trials involving humans must be sought from an ethics committee (EC) (known as Independent Ethics Committee/Institutional Review Board (IEC/IRB) in Sierra Leone). In cases where there is no recognized EC at the study institution, ethics approval from a recognized independent EC must be submitted with an appropriate justification from the applicant. All ECs are responsible for ensuring the protection of the rights, safety, and well-being of trial participants, and to provide assurance of that protection by reviewing, approving, and providing comments on trial protocols.

Terms of Reference, Review Procedures, and Meeting Schedule

As set forth in the SL-GCPs, the EC performs its functions according to written standard operating procedures (SOPs), maintains written records of its activities and meeting minutes, and complies with good clinical practices (GCPs) and other applicable regulatory requirements. (Please note that Sierra Leone is in the process of updating the SL-GCPs; ClinRegs is monitoring these developments.) An EC makes its decisions at announced meetings where a quorum, as stipulated in the SOPs, is present. Only those members who participate in the EC review process and discussion vote and provide their opinion.

The SL-GCPs also states that the EC must retain all relevant records for at least three (3) years after the study’s conclusion, and make them available to the Pharmacy Board of Sierra Leone (PBSL), the sponsor, and the investigators upon request.

Additional Resources
(A) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October 2014–July 2018)
Council on Health Research for Development, West Africa Health Organization, and International Development Research Centre - Canada
Relevant Sections: 4.3.3 - Research Ethics Review Capacity
Ethics Committee > Scope of Review
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 2.0 and 3.1
(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1.2, 3.1, and 3.4
(3) (Guidance) Sierra Leone Ethics and Scientific Review Committee – Application Guidelines and Checklist (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Ministry of Health and Sanitation, Directorate of Policy, Planning & Information
Summary

Overview

According to the G-SLAppClinTrial and the SL-GCPs, the primary scope of information assessed by the ethics committee (EC) (known as the Independent Ethics Committee/Institutional Review Board (IEC/IRB) in Sierra Leone) 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 ECs must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable. (Please note that Sierra Leone is in the process of updating the SL-GCPs; ClinRegs is monitoring these developments.)

Role in Clinical Trial Approval Process

As indicated in the G-SLAppClinTrial and Additional Resource (A), the Pharmacy Board of Sierra Leone (PBSL)’s review and approval of a clinical trial application is dependent upon obtaining EC approval.

However, as delineated in the G-SLAppClinTrial, the PBSL and the ECs may conduct their reviews in parallel in case of a public health emergency or as deemed fit by the PBSL. As per Additional Resource (B), investigators are also required to notify their local institution prior to initiating a trial.

The G-SLEthics, the SL-GCPs, and Additional Resource (B) further specify that the principal investigator (PI) must obtain national level EC approval for each clinical trial from the Sierra Leone Ethics and Scientific Review Committee (SLESRC). As per the G-SLEthics, 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.

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

(See the Clinical Trial Lifecycle topic, Submission Process and Timeline of Review subtopics for detailed submission process requirements).

Additional Resources
Pharmacy Board of Sierra Leone
Relevant Sections: Checklist
(B) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October 2014–July 2018)
Ethics Committee > Ethics Committee Fees
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Sierra Leone Ethics and Scientific Review Committee – Application Guidelines and Checklist (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Ministry of Health and Sanitation, Directorate of Policy, Planning & Information
Summary

Overview

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)
  • 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
Additional Resources
No additional resources
Ethics Committee > Authorizing Body
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Sierra Leone Ethics and Scientific Review Committee – Application Guidelines and Checklist (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Ministry of Health and Sanitation, Directorate of Policy, Planning & Information
(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.2
Summary

Overview

According to the G-SLEthics, the Sierra Leone Ethics and Scientific Review Committee (SLESRC) operates within the Ministry of Health and Sanitation (MoHS)’s Directorate of Training, Non-Communicable Diseases and Research.

EC Composition

As per the SL-GCPs, ethics committees (ECs) (known as Independent Ethics Committees/Institutional Review Boards (IECs/IRBs) in Sierra Leone) consist of members who collectively encompass the qualifications and experience required to review and evaluate the scientific, medical, and ethical aspects of a proposed clinical trial. (Please note that Sierra Leone is in the process of updating the SL-GCPs; ClinRegs is monitoring these developments.)

Specifically, EC composition 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 institutional trial site

In addition, only those EC members who are independent of the trial principal investigator (PI) and sponsor should vote or provide an opinion on any trial-related matters. The EC should maintain a list of its members and their qualifications.

Additional Resources
No additional resources
Clinical Trial Lifecycle > Submission Process
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.1 and 3.2
(2) (Guidance) Sierra Leone Ethics and Scientific Review Committee – Application Guidelines and Checklist (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Ministry of Health and Sanitation, Directorate of Policy, Planning & Information
Summary

Overview

In accordance with the G-SLAppClinTrial, 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. The G-SLAppClinTrial also states that both the sponsor and the PI are responsible for ensuring the protocol satisfies the protocol checklist requirements (see Additional Resource (A)). 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 and Additional Resource (A), the PBSL’s review and approval of a clinical trial application is dependent upon obtaining EC (known as Independent Ethics Committee/Institutional Review Board (IEC/IRB) in Sierra Leone) approval. However, the G-SLAppClinTrial also states that the PBSL and the ECs may conduct their reviews in parallel in case of a public health emergency or as deemed fit by the PBSL.

In addition, per Additional Resource (B), investigators are also required to notify their local institution prior to initiating a trial. (See Clinical Trial Lifecycle topic, Submission Content subtopic for detailed submission requirements).

Delivery Address for Clinical Trial Application

The Registrar
Pharmacy Board of Sierra Leone
Central Medical Stores
New England Ville, Freetown
P.M.B. 322
Sierra Leone

Assembly and Number of Copies

The G-SLAppClinTrial indicates applicants must submit two (2) copies of the application form signed by all of the authorized parties, as well as one (1) hard copy and one (1) soft copy of the entire application and related documents. The soft copy of the documents submitted should be in Microsoft Word, although Acrobat PDF files are also acceptable.

The G-SLEthics states that the SLESRC requires the PI to submit 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.

Clinical Trial Application Language Requirements

As per Additional Resource (B), the clinical trial application and accompanying material must be provided in English.

Additional Resources
Pharmacy Board of Sierra Leone
Relevant Sections: Checklist
(B) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October 2014–July 2018)
(C) (Website) Pharmacy Board of Sierra Leone - Contact Us (Current as of November 7, 2019)
Pharmacy Board of Sierra Leone
Clinical Trial Lifecycle > Submission Content
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.1 and 3.2
(2) (Guidance) Sierra Leone Ethics and Scientific Review Committee – Application Guidelines and Checklist (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Ministry of Health and Sanitation, Directorate of Policy, Planning & Information
Summary

Overview

As set forth in the G-SLAppClinTrial, 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. The G-SLAppClinTrial also states that both the sponsor and the PI are responsible for ensuring the protocol satisfies the protocol checklist requirements (see Additional Resource (A)).

As indicated in the G-SLAppClinTrial and Additional Resource (A), the PBSL’s review and approval of a clinical trial application is dependent upon obtaining ethics committee (EC) (known as Independent Ethics Committee/Institutional Review Board (IEC/IRB) in Sierra Leone) approval. Further, per the G-SLEthics, the PI is required to obtain ethics approval from the national EC, the Sierra Leone Ethics and Scientific Review Committee (SLESRC).

In addition, as per Additional Resource (B), investigators are also required to notify their local institution prior to initiating a trial.

PBSL Requirements

As per the G-SLAppClinTrial and Additional Resource (A), the following documentation must be submitted to the PBSL:

  • Cover letter
  • Completed clinical trial application forms signed by authorized persons
  • Protocol (see below for detailed protocol requirements)
  • EC approval
  • Proof of registration with a PBSL-approved clinical trials registry
  • Informed Consent Form (ICF) and patient information
  • Investigator’s Brochure (IB)
  • Signed declarations by the investigator(s)
  • Investigator(s) curriculum vitae(s) (CVs)
  • Insurance certificate
  • Data Safety Monitoring Board (DSMB) membership, CVs, and signed charter
  • Financial declaration by the sponsor and the PI
  • Copy of recruitment advertisement
  • Investigational product (IP) dossier and certificate of analysis
  • Good Manufacturing Practice (GMP) certificate

  • Sponsor/PI contractual agreement

  • Statistical analysis plan (SAP)

  • Full, legible copies of key, peer-reviewed published articles supporting the application

  • Non-refundable application fee as specified in the PBSL’s Fee Schedule (see Appendix VIII of the G-SLAppClinTrial)

SLESRC Requirements

As per the G-SLEthics, the SLESRC requires the PIs 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 topic, Ethics Committee Fees subtopic for detailed fee information)

Clinical Protocol

According to the G-SLAppClinTrial, the clinical protocol should include, but is not limited to, the following elements:

  • Protocol title and code
  • Sponsor and monitor (if other than the sponsor) contact information
  • Investigator(s) contact information
  • IP description
  • Form, dosage, route, method, and frequency of administration; treatment period
  • Summary of potential risks and known benefits to research participants
  • Trial objectives and purpose
  • Trial design, random selection method, and blinding level
  • Participant selection/withdrawal criteria
  • Participant treatment
  • Safety and efficacy assessments
  • Adverse event reporting requirements (See Clinical Trial Lifecycle topic, Safety Reporting subtopic for additional information)
  • Statistics and methods to track trial data
  • Ethical considerations
  • Data management and recordkeeping
  • Publication policy

For complete protocol requirements, refer to the G-SLAppClinTrial.

Additional Resources
Pharmacy Board of Sierra Leone
(B) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October 2014–July 2018)
Clinical Trial Lifecycle > Timeline of Review
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.1, 3.2, 3.5, 7.0 – Appendix Ic
(2) (Guidance) Sierra Leone Ethics and Scientific Review Committee – Application Guidelines and Checklist (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Ministry of Health and Sanitation, Directorate of Policy, Planning & Information
(3) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 10
Summary

Overview

As indicated in the G-SLAppClinTrial and Additional Resources (A) and (B), the Pharmacy Board of Sierra Leone (PBSL) review and approval of a clinical trial application is dependent upon obtaining ethics committee (EC) (known as Independent Ethics Committee/Institutional Review Board (IEC/IRB) in Sierra Leone) approval. According to the G-SLEthics, the principal investigator (PI) is required to obtain ethics approval from the national EC, the Sierra Leone Ethics and Scientific Review Committee (SLESRC).

However, the G-SLAppClinTrial also states that the PBSL and the ECs may conduct their reviews in parallel in case of a public health emergency or as deemed fit by the PBSL.

In addition, as per Additional Resource (B), investigators are also required to notify their local institution prior to initiating a trial.

PBSL Approval

Clinical Trial Application Submission

As per the G-SLAppClinTrial, the PBSL’s review and approval process for clinical trial applications takes 180 working days.

The G-SLAppClinTrial and the SL-GCPs state that the PBSL must issue a Clinical Trial Certificate to authorize the trial to be conducted.

SLESRC Approval

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

Additional Resources
Pharmacy Board of Sierra Leone
(B) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October 2014–July 2018)
Clinical Trial Lifecycle > Trial Initiation
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 2.0, 3.1, 3.2, 3.5, and 3.8
(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1, 1.2, 2, 4.5, 5.5, and 10
(3) (Guidance) Sierra Leone Ethics and Scientific Review Committee – Application Guidelines and Checklist (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Ministry of Health and Sanitation, Directorate of Policy, Planning & Information
Summary

Overview

In accordance with the G-SLAppClinTrial and the SL-GCPs, 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, ethics approval must be obtained from an ethics committee (EC) (known as an Independent Ethics Committee/Institutional Review Board (IEC/IRB) in Sierra Leone) prior to initiating a study. The SL-GCPs and the G-SLEthics further indicate that the PI must obtain ethics approval from the national EC, the Sierra Leone Ethics and Scientific Review Committee (SLESRC). (Please note that Sierra Leone is in the process of updating the SL-GCPs; ClinRegs is monitoring these developments.)

In addition, as per Additional Resource (A), investigators are also required to notify their local institution prior to initiating a trial. No waiting period is required following the applicant’s receipt of these approvals.

As per the G-SLAppClinTrial, an import permit from the PBSL is required for the shipment of an investigational product to be used in a trial (G-SLAppClinTrial states that approval is required from the National Medicines Regulatory Authority (NMRA)). Per the SL-GCPs, the NMRA is the same entity as the PBSL). (See the Investigational Products topic, Manufacturing & Import subtopic for additional information).

As stated in the G-SLAppClinTrial, the 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 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 practices (GCPs) for at least two (2) years. In addition, non-medically or pharmaceutically qualified scientists may participate as co-investigators or in other roles, but not as PIs. See the G-SLAppClinTrial for additional requirements.

Clinical Trial Agreement

While a signed clinical trial agreement is not an official requirement, the G-SLAppClinTrial and the SL-GCPs state that the clinical protocol submitted to the PBSL must include a contractual agreement between the sponsor and the PI.

EC Confirmation of Review and Approval

The G-SLAppClinTrial and Additional Resource (B) require the sponsor and the PI to obtain a copy of the EC approval and submit this documentation to the PBSL in the clinical trial application package prior to the trial’s commencement. (See Ethics Committee topic, Scope of Review subtopic and Clinical Trial Lifecycle topic, Submission Content subtopic for additional details on the EC review process).

Clinical Trials Registry

As per the G-SLAppClinTrial, proof of trial registration with a clinical trials registry must be submitted as part of a clinical trial application. The G-SLAppClinTrial and the SL-GCPs note that the PBSL-recommended registry is the Pan African Clinical Trial Registry (PACTR).

Data Safety Monitoring Board

As indicated in the G-SLAppClinTrial and the SL-GCPs, the sponsor may establish a Data Safety Monitoring Board (DSMB) to regularly assess the trial’s progress and analyze safety data. The G-SLAppClinTrial also requires the applicant to provide a copy of the DSMB’s membership, curriculum vitaes, and signed charter in the clinical trial application package submitted to the PBSL.

Additional Resources
(A) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October 2014–July 2018)
Pharmacy Board of Sierra Leone
Relevant Sections: Checklist
(C) (Website) Pan African Clinical Trials Registry (Current as of November 7, 2019)
Pan African Clinical Trials Registry
Clinical Trial Lifecycle > Safety Reporting
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 2.0, 3.1, 3.6, and 7.0 – Appendix Ia
(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1, 4.11, 5.5, 5.16, and 5.17
(3) (Guidance) Guideline for Detecting and Reporting Adverse Drug Reactions (G-ReportADR) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 10
Summary

Overview

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 medicinal product 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 in a subject to an investigational medicinal product 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

Reporting Requirements for AEs/ADRs

As stated in the G-SLAppClinTrial, the sponsor and the principal investigator(s) (PIs) are required to report all SAEs/SADRs that meet the Pharmacy Board of Sierra Leone (PBSL)’s reporting requirements immediately where possible, and in any event, within 48 hours of site awareness. 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 I Form (Additional Resource (A)), or must be previously approved by the PBSL.

The SL-GCPs further specifies 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.

According to the G-SLAppClinTrial, 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. All fatal cases must be followed-up with a formal autopsy report.

In addition, per the G-SLAppClinTrial, any SAE/SADR to the investigational product (IP) should receive immediate medical attention. Any frequent AEs/ADRs should be reported to the PBSL immediately where possible, and in any event, within seven (7) days of site awareness.

Investigator Responsibilities

As stated in the G-SLAppClinTrial, PIs are required to report all SAEs/SADRs that meet the PBSL’s reporting requirements immediately where possible, and in any event, within 48 hours of site awareness. 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.

As per the SL-GCPs, the PI should also comply with applicable regulatory requirements related to reporting unexpected SAEs/SADRs to the PBSL. For a reported death, the PI should supply the PBSL with any additional requested information (e.g., autopsy reports and terminal medical reports). The G-SLAppClinTrial also indicates that either the PI or the sponsor is required to provide information to the PBSL in all fatal cases, which must be accompanied by a formal autopsy report. In those cases where only a verbal autopsy report is practicable, the PI or the sponsor must obtain prior PBSL approval.

Sponsor Responsibilities

As stated in the G-SLAppClinTrial, the sponsor is required to report all SAEs/SADRs that meet the PBSL’s reporting requirements immediately where possible, and in any event, within 48 hours of site awareness. According to the G-SLAppClinTrial and the SL-GCPs, the sponsor is responsible for the ongoing safety evaluation of IPs, and is required to expedite the reporting of all AEs/ADRs that are both serious and unexpected to the PBSL, all concerned investigator(s)/institutions(s), and the ethics committee(s).

The SL-GCPs also states that the sponsor 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.

Form Completion & Delivery Requirements

According to the G-SLAppClinTrial, SAE/SADR reporting forms must conform to the format of the CIOMS Form I (Additional Resource (A)), or must be previously approved by the PBSL.

As per the G-ReportADR, AEs/ADRs must be reported on a form provided by the PBSL’s National Pharmacovigilance Centre (NPC). The forms are available at all tertiary, secondary, and primary healthcare facilities at central and district levels, private hospitals, surgeries, clinics, pharmacies and drug stores nationwide. All health facilities should have an institutional contract person(s) (ICP) for pharmacovigilance. If the reporter is unable to send the completed form directly to the NPC at PBSL headquarters or to the PBSL’s regional offices, the form should be submitted to the ICP to forward to the PBSL.

The form is also available on the PBSL’s website (Additional Resources (B) and (C)), and should be submitted to the following address:

The Coordinator
Drug Safety Monitoring Programme
Pharmacovigilance and Clinical Trials Department
Pharmacy Board of Sierra Leone
Central Medical Stores Compound,
New England Ville, Freetown
Sierra Leone
P.M.B. 322

Tel: (+232 25) +282886
Email:
drugsafety@pharmacyboard.gov.sl

The G-ReportADR indicates that AEs/ADRs can also be reported online through the PBSL website (Additional Resource (D)).

According to Additional Resource (C), all questions relating to actual or suspected AEs/ADRs, medication errors, or product quality defects should be addressed to the NPC during working hours by phone at 099-117117 or email at drugsafety@pharmacyboard.gov.sl. See Additional Resources (B) and (C) for additional contact information.

The G-SLAppClinTrial further states that the sponsor and the investigator(s) may also submit SAE/SADR forms electronically, and must comply with the International Conference on Harmonisation (ICH) Harmonised Tripartite Efficacy Guidelines (E2A and E2B). See Appendix 7.0 (Ia) of the G-SLAppClinTrial for detailed requirements.

For additional safety reporting forms, see Additional Resource (F).

Data Safety Monitoring Board

As indicated in the G-SLAppClinTrial and the SL-GCPs, the sponsor may establish a Data Safety Monitoring Board (DSMB) to regularly assess the trial’s progress and analyze safety data. The G-SLAppClinTrial also requires the applicant to provide a copy of the DSMB’s membership, curriculum vitaes, and signed charter in the clinical trial application package submitted to the PBSL.

Additional Resources
(A) (Form) CIOMS Form I (Date Unavailable)
Council for International Organizations of Medical Sciences
Pharmacy Board of Sierra Leone
Pharmacy Board of Sierra Leone
(D) (Website) Pharmacy Board of Sierra Leone – Report Adverse Drug Reaction (Current as of November 7, 2019)
Pharmacy Board of Sierra Leone
International Conference on Harmonisation, Geneva, Switzerland
(F) (Website) Pharmacy Board of Sierra Leone - Forms (Current as of November 7, 2019)
Pharmacy Board of Sierra Leone
Clinical Trial Lifecycle > Progress Reporting
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.7, 7.0 – Appendices Ib, II, and III
(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 4.10 and 4.13
Summary

Overview

In accordance with the G-SLAppClinTrial and the SL-GCPs, the investigator or other authorized party must submit progress/quarterly reports on the status of the clinical trial and a final report upon the trial’s completion.

Interim/Progress Reports

As set forth in the G-SLAppClinTrial, the Pharmacy Board of Sierra Leone (PBSL) should be informed in writing of the exact date the study commences. Per the SL-GCPs, the investigator should submit written summaries of the trial status to the PBSL on a quarterly basis, or more frequently, if requested by the PBSL. According to G-SLAppClinTrial, the quarterly reports must be submitted starting from the date the Clinical Trial Certificate is issued. The Quarterly Progress Report Form provided in the G-SLAppClinTrial should be used (see 7.0 Appendix II). Per the SL-GCPs, the investigator should 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.

The G-SLAppClinTrial further states quarterly progress reports must be submitted to the PBSL within 21 days following the end of the previous quarter. In addition, 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. 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

The G-SLAppClinTrial states that 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 III.

According to the G-SLAppClinTrial and the SL-GCPs, 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. Per the G-SLAppClinTrial, the report should conform to the International Conference on Harmonisation (ICH) Harmonised Tripartite Efficacy Guidelines (E3) or the Consolidated Standards of Reporting Trials (CONSORT), unless otherwise specified in the conditions issued with the Clinical Trial Certificate. 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. With regard to publishing the study in a scientific journal or other medium, the PBSL recommends that the PI/sponsor wait 30 days from the time of the PBSL’s acknowledgement of receipt of the final report.

Additional Resources
International Conference on Harmonisation, Geneva, Switzerland
(B) (Website) Consolidated Standards of Reporting Trials (CONSORT) (Current as of November 7, 2019)
Ottawa, Canada
Sponsorship > Definition of Sponsor
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 2.0
(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1 and 5.2
Summary

Overview

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. An individual, company, institution, or organization that has been requested to fund a trial, but does not benefit in any way from the results of a trial, is excluded.

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.

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.

Additional Resources
No additional resources
Sponsorship > Trial Authorization
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.1 and 3.2
(2) (Guidance) Sierra Leone Ethics and Scientific Review Committee – Application Guidelines and Checklist (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Ministry of Health and Sanitation, Directorate of Policy, Planning & Information
(3) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 9.0
Summary

Overview

In accordance with the G-SLAppClinTrial, Sierra Leone requires the sponsor and the principal investigator (PI) to obtain clinical trial authorization from the Pharmacy Board of Sierra Leone (PBSL). Additionally, per the G-SLAppClinTrial and Additional Resource (A), ethics approval must be obtained from an ethics committee (EC) (known as Independent Ethics Committee/Institutional Review Board (IEC/IRB) in Sierra Leone) prior to initiating a study.

The G-SLEthics and the SL-GCPs further indicate that the PI must obtain ethics approval from the national EC, the Sierra Leone Ethics and Scientific Review Committee (SLESRC).

The G-SLAppClinTrial states that both the sponsor and the PI are responsible for ensuring the protocol satisfies the protocol checklist requirements (see Additional Resource (A)).

The G-SLAppClinTrial states that the PBSL and the ECs may conduct their reviews in parallel in case of a public health emergency or as deemed fit by the PBSL. In cases where there is no recognized EC at the study facility(ies), ethics approval from a recognized IEC must be submitted with an appropriate justification from the applicant.

In addition to the completed application, per the G-SLAppClinTrial, the SL-GCPs, and Additional Resource (A), the sponsor or his/her authorized representative must also provide the EC approval letter, clinical protocol, patient information sheet, informed consent form, a certificate of analysis, and other documentation covered in the Clinical Trial Lifecycle topic, Submission Content subtopic.

Additional Resources
Pharmacy Board of Sierra Leone
Sponsorship > Insurance
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 5.8
(2) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.1
Summary

Overview

As set forth in the SL-GCPs, it is a legal requirement for the sponsor to carry a valid insurance policy for any trial-related injuries to research participants.

The G-SLAppClinTrial states that for all sponsor-initiated trials, an 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 (PI(s)) 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 SL-GCPs also states that the sponsor should 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.

Additional Resources
No additional resources
Sponsorship > Compensation
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.1
(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 4.8 and 5.8
Summary

Overview

As specified in the G-SLAppClinTrial, the clinical trial protocol must include a clear statement on any compensation and benefits package.

In addition, the SL-GCPs indicate that it is a legal requirement for the sponsor to carry a valid insurance policy for any trial-related injuries to research participants. When trial participants receive compensation, the method and manner of compensation should comply with the Pharmacy Board of Sierra Leone (PBSL)’s regulatory requirements.

According to the SL-GCPs, participants may receive prorated payment for participating in the trial. No additional information is provided regarding payment for participation in research.

(See Informed Consent topic, Compensation Disclosure subtopic for more information on participant compensation rights).

Additional Resources
No additional resources
Sponsorship > Quality, Data & Records Management
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1, 4.12, 5.0, 5.1, 5.5, 5.6, 5.14, 5.19, 5.21, 5.23, 6.11, and 6.13
Summary

Overview

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, the SL-GCPs, and the Pharmacy Board of Sierra Leone (PBSL) regulatory requirements. 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.

Per the SL-GCPs, the sponsor must also obtain agreement from the investigator(s) and the institution(s) to:

  • conduct the trial in compliance with the SL-GCPs, the PBSL and ethics committee (EC) (known as Independent Ethics Committee/Institutional Review Board (IEC/IRB) in Sierra Leone) requirements, and any other applicable regulatory requirement(s)
  • comply with data recording and reporting procedures
  • permit monitoring, auditing, and inspection
  • retain sponsor-specific essential documents in conformance with applicable regulatory requirements of the country(ies) where the product is approved, and/or where the sponsor intends to apply for approval(s)

See the SL-GCPs for detailed information on sponsor trial management requirements.

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 he/she maintains SOPs for using these systems. Refer to the SL-GCPs for detailed information on electronic trial data systems.

Record Management

As set forth in the SL-GCPs, the sponsor, or other owners of the data, should retain all sponsor-specific essential documents pertaining to the trial. The sponsor should retain all essential documents 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) 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.

Audit 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 his/her own SOPs and that the auditor observations are 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 or his/her representative should promptly inform the investigator(s)/institution(s) and the PBSL of the termination or suspensions, and explain the reason(s) for the termination or suspension. The EC should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor or by the investigator/institution.

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 PBSL and the EC
  • 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.

Additional Resources
No additional resources
Sponsorship > Site/Investigator Selection
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1, 5.6, and 5.7
(2) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 2.0 and 3.1
Summary

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 study related duties and responsibilities to the relevant parties participating in the study. As delineated in the SL-GCPs, 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.

Additionally, per the SL-GCPs, in the event of a multicenter clinical trial, the sponsor may organize a coordinating committee or select coordinating investigators.

Data Safety Monitoring Board (DSMB)

As indicated in the G-SLAppClinTrial and the SL-GCPs, the sponsor may establish a Data Safety Monitoring Board (DSMB) to regularly assess the trial’s progress and analyze safety data. The G-SLAppClinTrial also requires the applicant to provide a copy of the DSMB’s membership, curriculum vitaes, and signed charter in the clinical trial application package to be submitted to the Pharmacy Board of Sierra Leone (PBSL).

Additional Resources
No additional resources
Informed Consent > Documentation Requirements
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1.2, 4.8 and 9.0
(2) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 2.0, 3.1, and 3.2
(3) (Guidance) Sierra Leone Ethics and Scientific Review Committee – Application Guidelines and Checklist (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Ministry of Health and Sanitation, Directorate of Policy, Planning & Information
Summary

Overview

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.

As per the SL-GCPs and the G-SLAppClinTrial, the informed consent form (ICF) is viewed as an essential document. An ethics committee (EC) (known as Independent Ethics Committee/Institutional Review Board (IEC/IRB) in Sierra Leone) must review and approve the ICF, and the sponsor and principal investigator (PI) must submit it to the Pharmacy Board of Sierra Leone (PBSL) with the clinical trial application. The G-SLEthics further indicates that the PI must submit the ICF to the national EC, the Sierra Leone Ethics and Scientific Review Committee (SLESRC), for review. (See the Informed Consent topic, Required Elements subtopic for details on what should be included in the form.)

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

Re-Consent

According to the SL-GCPs, the participant and/or his/her legal representative(s) and/or guardian(s) 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 and/or his/her legal representative(s) and/or guardian(s) 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 Additional Resource (A), the clinical trial application and accompanying material must be provided in English.

Documentation Copies

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

Where the participant is illiterate and/or his/her legal representative(s) and/or guardian(s) 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 and his/her legal representative(s) and/or guardian(s);

  • The participant and his/her legal representative(s) and/or guardian(s) have orally consented to the participant’s involvement in the trial; and

  • The participant and his/her legal representative(s) and/or guardian(s) have 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 his/her legal representative(s) and/or guardian(s) should receive a copy of the signed and dated ICF.

Additional Resources
(A) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October 2014–July 2018)
Informed Consent > Required Elements
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 4.8 and 9.0
(2) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 2.0 and 3.1
(3) (Guidance) Sierra Leone Ethics and Scientific Review Committee – Application Guidelines and Checklist (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Ministry of Health and Sanitation, Directorate of Policy, Planning & Information
Summary

Overview

As delineated in the SL-GCPs and the G-SLAppClinTrial, prior to beginning a clinical trial, an ethics committee (EC) (known as Independent Ethics Committee/Institutional Review Board (IEC/IRB) in Sierra Leone) must approve the written informed consent form (ICF) and any other information being provided to the research participant and/or his/her legal representative(s) or guardian(s). The G-SLEthics further indicates that the principal investigator (PI) must submit the ICF to the national EC, the Sierra Leone Ethics and Scientific Review Committee (SLESRC), for review.

No Coercion

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 and/or his/her legal representative(s) and/or guardian(s) to waive or appear to waive his/her 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.

ICF Required Elements

Based on the SL-GCPs, the ICF should include the following statements or descriptions, as applicable:

  • That 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 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 or his/her family or dependents in the event of a trial-related injury
  • The 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 records identifying the participant will be maintained, and if the results of the trial are published, the participant’s identity will remain confidential
  • That the monitor(s), the auditor(s), the EC, 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
  • The extent to which confidentiality of records identifying the participant will be maintained, and will not be made publicly available to the extent permitted by applicable laws and/or regulations. If the results are published, the participant’s identity will remain confidential
  • Foreseeable circumstances under which the investigator(s) may remove the participant without his/her 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
  • That the participant and/or his/her legal representative(s) or guardian(s) 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
Additional Resources
No additional resources
Informed Consent > Compensation Disclosure
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 4.8
Summary

Overview

In accordance with the SL-GCPs, the informed consent form (ICF) should contain statements describing compensation related to participation in the trial and trial-related injury.

Compensation for Participation in Research

According to the SL-GCPs, the ICF should include a statement describing the anticipated prorated payment, if any, to the participant for participating in the trial. No additional information is provided regarding payment for participation in research.

Compensation for Injury

As per the SL-GCPs, the ICF should include a statement advising the participant that compensation and medical treatment is available in the event of any trial-related injury.

(See the Informed Consent topic, Required Elements subtopic for additional details on what should be included in the ICF.)

Additional Resources
No additional resources
Informed Consent > Participant Rights
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1, 1.2, 4.8, and Appendix 3 (Section I, 5 and 6)
(2) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.1 and 3.2
Summary

Overview

In accordance with the SL-GCPs, 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 his/her legal representative(s) or guardian(s) should be informed that participation is voluntary, that he/she 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 and/or his/her legal representative(s) or guardian(s) 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 and/or his/her legal representative(s) or guardian(s) should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries and/or his/her 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 Informed Consent topic, and the subtopics of Required Elements and Vulnerable Populations for additional information regarding requirements for participant rights.

Additional Resources
No additional resources
Informed Consent > Special Circumstances/Emergencies
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.4.6, 3.4.7, and 4.8.15
Summary

Overview

The SL-GCPs make provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by special circumstances. Special circumstances include medical emergencies when prior consent from the participant is not possible.

Medical Emergencies

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 his/her legal representative(s) and/or guardian(s), if present, should be obtained. If prior consent of the participant and/or his/her legal representative(s) and/or guardian(s) 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 committees (ECs) (known as Independent Ethics Committees/Institutional Review Boards (IECs/IRBs) in Sierra Leone) 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 and/or the participant’s legal representative(s) and/or guardian(s) 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. In the event that emergency care research is unavoidable, once the investigator 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 his/her legal representative(s) and/or guardian(s) 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 patient 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

Research Involving Unconscious Persons

As indicated in the SL-GCPs, research involving unconscious persons requires consent to be provided by the participant’s legal representative(s) and/or guardian(s), 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 his/her legal representative(s) and/or guardian(s) are able to give consent in advance, the EC may approve a research project without prior consent if the conditions described in the preceding section on medical emergencies are met.

Additional Resources
No additional resources
Informed Consent > Vulnerable Populations
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1, 3.1, 3.4.4, and 3.4.6
(2) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 2.0 and 3.10
Summary

Overview

As per the SL-GCPs and the G-SLAppClinTrial, 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. The G-SLAppClinTrial characterizes vulnerable populations as those who are relatively (or absolutely) incapable of protecting their own interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect themselves. See Additional Resource (A) for further details.

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 examples of these participants include members of a group with a hierarchical structure such as medical, pharmacy, dental, and nursing students; subordinate hospital and laboratory personnel; pharmaceutical industry employees; members of the armed forces; and persons kept in detention. Other participants representing vulnerable populations include patients with incurable diseases, persons highly dependent on medical care, persons in nursing homes, persons in dependent relationships or comparable situations, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, pregnant women, children, cognitively impaired participants, prisoners, 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.

Persons in Subordinate or Dependent Groups

As set forth in the SL-GCPs, in clinical studies involving participants who are engaged in subordinate or dependent relationships, ethics committees (ECs) (known as Independent Ethics Committees/Institutional Review Boards (IECs/IRBs) in Sierra Leone) 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 health-care 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)

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. Investigators need to acknowledge that the participant’s medical condition may compromise his/her informed consent and affect his/her 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 his/her 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 Informed Consent topic, Children/Minors subtopic. 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. Investigators 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 – The distinguishing features of research involving persons 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 person’s degree of cognition and require different means of expression. In non-acute impairment states, the condition may prevent the person from expressing his/her wishes at all.
  • Research involving unconscious persons – Refer to the Informed Consent topic, Special Circumstances/Emergencies subtopic.

See the G-SLAppClinTrial for more detailed consent information on persons who are cognitively impaired by reason of mental or behavioral disorders.

See the Informed Consent topic, and the subtopics of Children/Minors; Pregnant Women, Fetuses & Neonates; and Mentally Impaired for additional information about these vulnerable populations.

Additional Resources
Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO)
Relevant Sections: 14, 15, 16, and 17
Informed Consent > Children/Minors
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1, 3.4.1, and Appendix 3 (Section I, 11)
(2) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 2.0 and 3.10
Summary

Overview

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

As set forth in the SL-GCPs, which complies with the ethical principles specified in the Declaration of Helsinki, when the participant is a minor, informed consent must be obtained from his/her legal representative(s) and/or guardian(s). When the minor participant is able to give consent, his/her consent must be obtained in addition to the consent of his/her legal representative(s) and/or guardian(s).

The G-SLAppClinTrial also states that before undertaking research involving minors (including infants), the investigator must ensure that:

  • Minors will not be involved in research that could be carried out equally well in adults
  • The research purpose is to obtain knowledge relevant to children’s health needs
  • The minor’s legal representative(s) and/or guardian(s) have given permission
  • The assent of each minor participant has been obtained to the extent of his/her capabilities
  • A minor’s refusal to participate or continue in the trial will be respected

Assent Requirements

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 ethics committee (EC) (known as Independent Ethics Committee/Institutional Review Board (IEC/IRB) in Sierra Leone) 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.

Additional Resources
(A) (Document) Declaration of Helsinki (October 2013)
World Medical Association
Informed Consent > Pregnant Women, Fetuses & Neonates
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.4.2 and 3.8.4
(2) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.10
Summary

Overview

As per the SL-GCPs and the G-SLAppClinTrial, studies involving women of childbearing age or who are pregnant require additional safeguards to ensure that the research assesses the risks to the women and the fetuses.

The SL-GCPs and the G-SLAppClinTrial state that the following conditions must be met for research conducted with pregnant women:

  • The risks to the pregnant woman and her fetus must be discussed prior to enrolling in a study
  • Investigators and ethics committees (ECs) (known as Independent Ethics Committees/Institutional Review Boards (IECs/IRBs) in Sierra Leone) should ensure that prospective participants who are pregnant are adequately informed about the risks and benefits to themselves, their pregnancies, the fetus and their subsequent offspring, and to their fertility
  • When appropriate, studies on animals and non-pregnant individuals have been completed, particularly as to teratogenic and mutagenic risks
  • 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

In addition, the G-SLAppClinTrial indicates that if participation in the research might be hazardous to a fetus or a woman should she become pregnant, the sponsors/investigators should guarantee the prospective participant a pregnancy test and access to effective contraceptive methods before research commences. Where such access is not possible, for legal or religious reasons, investigators should not recruit women who might become pregnant for such possibly hazardous research.

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

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.

Additional Resources
No additional resources
Informed Consent > Prisoners
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.4.5
Summary

Overview

In accordance with the SL-GCPs, 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 ethics committee (EC) (known as Independent Ethics Committee/Institutional Review Board (IEC/IRB) in Sierra Leone) 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
  • 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
Additional Resources
No additional resources
Informed Consent > Mentally Impaired
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.4 and Appendix 3 (Section I, 11)
(2) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.10
Summary

Overview

According to the SL-GCPs and the G-SLAppClinTrial, ethics committees (ECs) (known as Independent Ethics Committees/Institutional Review Boards (IECs/IRBs) in Sierra Leone) must pay special attention to research participants with physical or mental disabilities including those with psychiatric, cognitive, or developmental disorders, to ensure the welfare of this vulnerable study population. The SL-GCPs states that this group of people insofar as research is concerned, is also applicable to studies involving individuals 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. Note: The SL-GCPs complies with the ethical principles as specified in the Declaration of Helsinki.

Per the SL-GCPs and the G-SLAppClinTrial, the following conditions must be met for clinical trials involving participants who are incapable by reason of physical and mental capacity to give consent:

  • Such research could not be carried out equally well with individuals who are in possession of their full mental faculties
  • The purpose of the research is to obtain knowledge relevant to the particular health needs of persons with mental or behavioral disorders
  • The consent of each participant has been obtained to his/her capabilities
  • The involvement of this study population can be justified
  • A prospective participant’s refusal to participate is always respected, unless, in exceptional circumstances, there is no reasonable medical alternative and local law permits overriding the objection
  • 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(s) and/or guardian(s)
  • Ensure that consent is free from coercion and risk to participants; and
  • 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 consent cannot be given that is contrary to the interests of the participant with mental or intellectual impairment. Accordingly, consent must be obtained from one (1) of the following:

  • The participant to the extent that he/she is competent to give informed consent
  • The participant’s legal guardian(s) and/or representative(s) when he/she is deemed not competent to do so
  • An authority, organization, or individual legally authorized to do so
Additional Resources
(A) (Document) Declaration of Helsinki (October 2013)
World Medical Association
Investigational Products > Definition of Investigational Product
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 2.0
(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1
Summary

Overview

As delineated in the G-SLAppClinTrial and the SL-GCPs, an investigational product is defined as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial. 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.

Additional Resources
No additional resources
Investigational Products > Manufacturing & Import
Last content review/update: November 25, 2019
Requirements
(1) (Legislation) The Pharmacy and Drugs Act, 2001 (PDA2001) (December 13, 2001)
Parliament, Republic of Sierra Leone
Relevant Sections: Parts V and IX
(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1.2, 5.13, and 5.14
(3) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.1, 3.8, and 7.0 – Appendix Ic
(4) (Guidance) Guidelines for the Fast Track Registration of Medicinal Products (G-FastReg) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Summary

Overview

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 also states that the PBSL is responsible for authorizing the import of IPs. As per the G-SLAppClinTrial, a request to import an IP may be submitted after the PBSL has approved the clinical trial application. (G-SLAppClinTrial states that IP import approval is required from the National Medicines Regulatory Authority (NMRA). Per the SL-GCPs, the NMRA is the same entity as the PBSL).

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 products to be imported

  • 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 clinical research entity’s name and address

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 PBSL’s processing time for IP import permits is 10 days.

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 applicant will be granted marketing authorization by the PBSL within two (2) weeks.

See the G-SLAppClinTrial for detailed IP import requirements.

Additional Resources
No additional resources
Investigational Products > IMP/IND Quality Requirements
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 2.0 and 3.1
(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1.2, 5.12, 5.13, 5.14, and 7
Summary

Overview

In accordance with the G-SLAppClinTrial and the SL-GCPs, the Investigator’s Brochure (IB) must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. 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 the annual update of the IB is not always considered a substantial amendment, but the sponsor must verify whether the update relates to substantial changes. In that case, the rules for notification of substantial amendments apply to the change.

IB Content Requirements

As specified in the G-SLAppClinTrial and the SL-GCPs, the IB must provide coverage of the following areas:

  • Physical, chemical, and pharmaceutical properties and formulation parameters
  • Preclinical studies
  • Human pharmacological and clinical data
  • Marketing experience in countries where the IP is being marketed or approved
  • Summary of data and guidance for the investigator
  • Sample of label to be used for the IPs
  • Clear instructions on storage and handling of IPs
  • Pharmaceutical aspects
  • Pharmacokinetics and metabolism
  • Toxicological effects in any animal species tested under a single dose study, a repeated dose study, or a special study
  • Results of clinical pharmacokinetic studies
  • Information regarding safety, pharmacodynamics, efficacy, and dose responses obtained from prior clinical trials in humans

See the G-SLAppClinTrial and the SL-GCPs for detailed content guidelines.

As defined in the SL-GCPs, the sponsor must also supply the investigator(s)/institution(s) with the IPs, including the comparator(s) and placebo, if applicable. The sponsor should not supply either party with the IP(s) until he/she obtains approval from the Pharmacy Board of Sierra Leone (PBSL). (See Investigational Products topic, Product Management subtopic for additional information on IP supply, storage, and handling requirements).

Drug Manufacturing Certificate Requirements

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. In addition, per the SL-GCPs, the sponsor should ensure that the IP, active comparator(s), and placebo are manufactured in accordance with any applicable GMP.

Additional Resources
No additional resources
Investigational Products > Labeling & Packaging
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.8 and 7.0 – Appendix IV
(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 5.13
Summary

Overview

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
  • Investigator’s name
  • 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
  • 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

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 (e.g., contamination and unacceptable deterioration) during transport and storage
  • Each sample should contain an insert

According to the SL-GCPs, the IP(s) should be packaged to prevent contamination and unacceptable deterioration during transport and storage. 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.

Additional Resources
No additional resources
Investigational Products > Product Management
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 2.0 and 3.1
(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 02) (SL-GCPs) (January 31, 2018)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1, 1.2, 5.5.6, 5.5.7, 5.5.8, 5.12, 5.13, 5.14, 6.13, and 7
Summary

Overview

In accordance with the G-SLAppClinTrial and the SL-GCPs, the Investigator’s Brochure (IB) must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. The SL-GCPs further specifies that the sponsor is responsible for providing the investigators with an IB, and that the sponsor should update the IB as significant new information becomes available.

The G-SLAppClinTrial further specifies that the annual update of the IB is not always considered a substantial amendment, but the sponsor must verify whether the update relates to substantial changes. In that case, the rules for notification of substantial amendments apply to the change.

Investigational Product Supply, Storage, and Handling Requirements

As defined in the SL-GCPs, the sponsor must also supply the investigator(s)/institution(s) with the IPs, including the comparator(s) and placebo, if applicable. The sponsor should not supply either party with the IP(s) until he/she obtains approval from the Pharmacy Board of Sierra Leone (PBSL).

The SL-GCPs specifies that the sponsor must ensure the following:

  • Timely delivery of the IP(s)
  • Records maintained for document shipment, receipt, disposition, return, and destruction of the IP(s)
  • Written procedures including instructions for handling and storage of the IP(s), adequate and safe receipt of the IP(s), dispensing of the IP(s), retrieval of unused IP(s), return of unused IP(s) to the sponsor, and disposal of unused IP(s) by the sponsor
  • IP product quality and stability over the period of use
  • IP manufactured according to any applicable Good Manufacturing Practices (GMPs)
  • Proper coding, packaging, and labeling of the IP(s)
  • Acceptable IP handling and storage conditions and shelf-life

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

Record Requirements

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 secured 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.

Additional Resources
No additional resources
Specimens > Definition of Specimen
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 2.0
Summary

Overview

In Sierra Leone, a specimen is referred to as a biological specimen or a biological sample. As delineated in the G-SLAppClinTrial, a biological specimen or a biological sample is defined as material derived from various animal and human sources (e.g., blood, tissues, and cells) used to treat and prevent diseases.

Additional Resource (A) further defines biological material as original material, progeny, and unmodified derivatives, but not new intellectual property. The terms referenced in this definition are explained as follows:

  • Progeny refers to an unmodified descendant from the original material, such as a virus from a virus, a cell from a cell, or an organism from an organism
  • Unmodified derivatives refers to substances and other materials created by the recipient that constitute an unmodified functional subunit or product expressed by the original material, including subclones of unmodified cell lines, purified or fractionated subsets of the original material, proteins expressed by DNA/RNA supplied by the provider, or monoclonal antibodies secreted by a hybridoma cell line

New intellectual property includes the following:

  • Modifications (but not the material that is contained or incorporated therein)
  • Other substances and materials created by recipient through the use of the material or modifications, but that are not progeny, unmodified derivatives, or modifications (i.e. do not contain the original material, progeny or unmodified derivatives)
  • Any new use of the material, modifications, or the substances and materials created by the recipient, and
  • Any new or improved process, method, or technique conceived or developed by recipient through the use of the material, modifications, or the substances and materials previously described
Additional Resources
(A) (Document) Materials Transfer Template (Date Unavailable)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 1
Specimens > Specimen Import & Export
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.8, 3.11, and 7.0 – Appendices V and VIII
(2) (Guidance) Guidelines for Material Transfer Agreement (G-MTA) (Version 01) (January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Summary

Overview

According to the G-SLAppClinTrial and Additional Resource (A), the Pharmacy Board of Sierra Leone (PBSL) is responsible for authorizing the import and export of all biological specimens in Sierra Leone. Refer to the Investigational Products topic, Manufacturing & Import subtopic for additional import information.

As set forth in the G-SLAppClinTrial and Additional Resource (A), all institutions or individuals that wish to export and use any clinical information, medical records, and/or biological samples from Sierra Leone to an institution outside of the country, must complete PBSL’s requirement for material transfer authorization.

Per the G-SLAppClinTrial and the G-MTA, the applicant should 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 of $100 USD

Please refer to Additional Resource (B) for additional information.

Additional Resources
(A) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October 2014–July 2018)
(B) (Document) Materials Transfer Template (Date Unavailable)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
(C) (Website) Pharmacy Board of Sierra Leone - Frequently Asked Questions (Current as of November 7, 2019)
Pharmacy Board of Sierra Leone
Specimens > Consent for Specimen
Last content review/update: November 08, 2019
Requirements
(1) (Guidance) Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements (G-SLAppClinTrial) (Version 01) (Issue Date: January 8, 2019) (Effective Date: January 10, 2019)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 3.11
Summary

Overview

In accordance with the G-SLAppClinTrial, consent forms for the research protocol should include a separate section for trial participants who are requested to provide their consent for the use of their biological specimens for research purposes. Separate consent may be appropriate in some cases (e.g., if investigators are requesting permission to conduct basic research which is not a necessary part of the trial), but not in others (e.g., the trial requires the use of participants’ biological materials).

As per the G-SLAppClinTrial, participants have a right to know that their records or specimens may be used for research. Records or specimens should not be used when patients/participants refuse to give their permission unless the records are being used to aid in public health emergencies.

As set forth in the G-SLAppClinTrial, if informed consent or permission was required to authorize the original collection or use of such records or specimens for research purposes, then the secondary use of this information will generally be limited by the conditions specified in the original consent. During the initial consent process, prospective participants should be informed about the following potential uses of their records or specimens:

  • Whether there will or may be secondary use of their research records or biological specimens, and whether this use will be limited to specific types of studies
  • The conditions under which the investigators will be required to contact the participants for additional authorization for secondary use
  • The investigators’ plans, if any, to destroy or to strip the records or specimens of personal identifiers
  • The participants’ rights to request that their specimens or records be destroyed or personal identifiers removed for those parts of the records that they might consider to be particularly sensitive, such as photographs, videotapes, or audiotapes

In addition, per Additional Resource (A), the Pharmacy Board of Sierra Leone (PBSL) requires the recipient of the transferred original materials to agree to treat the material and provider information as confidential except when the material or information falls under the following conditions:

  • It is in the public domain at the time it is received by the recipient
  • It enters the public domain after the recipient’s receipt other than through his/her breach of the Materials Transfer Agreement (MTA)
  • The recipient can show that the material or information was, prior to his/her receipt, lawfully in his/her possession and therefore he/she is not obligated to maintain confidentiality
  • The recipient can demonstrate the material or information was independently developed by employees, agents, or consultants of the recipient without any knowledge or use of the information disclosed by the provider under the MTA, or
  • It was approved in writing by the provider for disclosure, provided that such disclosure was made by the recipient in accordance with the terms of such approval

Additional Resource (A) further states that during the period of use and for five (5) years after, the recipient will use reasonable effort to maintain the confidentiality of the material and provider information covered by the MTA. To this end, the recipient will not, directly or indirectly, deal with, use, exploit, or disclose the material or provider information to any person or entity for any purpose other than those established in the MTA, or, unless the provider expressly authorizes the recipient to do so in writing. If the recipient is required by judicial, administrative, or any other legal process to provide or disclose the materials or provider information, he/she will promptly notify the provider and allow the provider reasonable time to oppose the process prior to taking action.

See the Informed Consent topic, Required Elements and Participant Rights subtopics for additional information on informed consent.

Additional Resources
(A) (Document) Materials Transfer Template (Date Unavailable)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Relevant Sections: 11
Sections Country Announcement
Country Announcement
x

The Sierra Leone profile has been reviewed and updated where appropriate to reflect current regulatory requirements including:

  • Guidelines for Application and Authorisation of Clinical Trials of Medicines, Vaccines, Medical Devices and Food Supplements
  • Guideline for Detecting and Reporting Adverse Drug Reactions

Specific revisions to the profile include:

This message was created on November 8, 2019
Use the symbols below to refine your search
SymbolExplanation
No symbol At least one of the keywords must be present
Search example: serious adverse event
Result: Will contain serious and/or adverse and/or event
+ Leading plus sign indicates that the word must be present
Search example: serious +adverse event
Result: Will contain adverse and may contain serious and/or event
- Leading minus sign indicates that the word must not be present
Search example: serious adverse -event
Result: Will contain serious and/or adverse but won’t contain event
“ ” Exact phrase must be present
Search example: “serious adverse event”
Result: Will contain the phrase serious adverse event
Call for online focus group participants!
x

ClinRegs content is published in English. ClinRegs offers translations of the content through Google Translate, which is an external translation service. ClinRegs does not control the quality or accuracy of translated content and may result in unexpected and unpredictable degradation of portions of text, images and the general appearance on translated pages.