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
Import & Export
Consent for Specimens
Sierra Leone
QUICK FACTS
Clinical trial application languageEnglish
Parallel regulatory and ethical review permittedYes
Clinical trial registration requiredYes
In-country sponsor presence/representation requiredNo
Age of minorsUnder 18
Specimens export allowedYes
Regulatory Authority > Regulatory Authority
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
As per the G-SLClinTrial, the Pharmacy Board of Sierra Leone (PBSL) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections in the country. Additional Resource (B) states that the PBSL was originally established as the drug regulatory authority by the Pharmacy and Drugs Act 1988, and was later re-established in 2001 by the PDA2001. The PBSL operates as a semi-autonomous agency under the Ministry of Health and Sanitation (MoHS). It 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 (A) 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 and Additional Resource (B), 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 and the Secretary General of the Pharmaceutical Society of Sierra Leone
  • One (1) pharmacy technician

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.

Additional Resource (B) also states that the PBSL’s administration is headed by a Registrar who is appointed by the Public Service Commission and who also serves as Secretary to the Board with no voting rights. The Board is further divided into six (6) departments: Inspection, Drug Registration and Evaluation, Pharmacovigilance, Policy Standards and Practice, Administration and Finance, and Quality Control.

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

For General Inquiries:
Phone: (+232 25) 282886
Website: www.pharmacyboard.gov.sl

ADDITIONAL RESOURCES

(A) (Document) Pharmaceutical Sector Country Profile Questionnaire – Sierra Leone (2011)
World Health Organization and The Global Fund, Geneva, Switzerland

Relevant Section: 5.0 Medicines Regulation

(B) (Website) Pharmacy Board of Sierra Leone - About Us (Current as of August 22, 2016)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

(C) (Application) Pharmacy Board of Sierra Leone Application Form to Conduct a Clinical Trial for Medicines, Vaccines and Medical Devices (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

(D) (Document) Drug Safety Monitoring Manual for Pharmacy Board of Sierra Leone Pharmacovigilance Department (March 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 1.0, 3.2, and 3.3

(2) (Legislation) The Pharmacy and Drugs Act, 2001 (PDA2001) (December 13, 2001)
Parliament, Republic of Sierra Leone

Relevant Section: Part II

Regulatory Authority > Scope of Assessment
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
In accordance with the G-SLClinTrial, the SL-GCPs, the G-MedProdReg, 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-SLClinTrial specifies that the scope of the PBSL’s assessment includes all clinical trials (Phases I-IV). Based on the G-SLClinTrial and Additional Resource (B), ethics committee (EC) approval must be obtained prior to applying for PBSL approval. As delineated in the G-SLClinTrial, the PBSL review and approval process may be conducted in parallel with the EC review. However, the PBSL’s approval will only be finalized once EC approval is obtained. According to Additional Resource (C), investigators are also required to obtain a research permit from their local institution prior to initiating a trial.

Clinical Trial Review Process
As set forth in the G-SLClinTrial and the SL-GCPs, the PBSL coordinates the clinical trial application process. Additional Resource (D) states that the Clinical Trials Unit within the PBSL’s Pharmacovigilance Department is responsible for reviewing and approving clinical trial applications. The G-SLClinTrial and the SL-GCPs state 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

(A) (Document) Pharmaceutical Sector Country Profile Questionnaire – Sierra Leone (2011)
World Health Organization and The Global Fund, Geneva, Switzerland

Relevant Section: 5.0 Medicines Regulation

(B) (Application) Pharmacy Board of Sierra Leone Application Form to Conduct a Clinical Trial for Medicines, Vaccines and Medical Devices (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

(C) NIAID Communication with Pharmacy Board of Sierra Leone (PBSL) (not available online) (October-November 2014)

(D) (Document) Drug Safety Monitoring Manual for Pharmacy Board of Sierra Leone Pharmacovigilance Department (March 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 1.0, 3.1, 3.2, 3.3, 3.10, and 7.3 – Appendix III

(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)

Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 10.0

(3) (Guidance) Guidelines for Medicinal Product Registration (G-MedProdReg) (Date Unavailable)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 2

Regulatory Authority > Regulatory Fees
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
As per the G-SLClinTrial, 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 3 & 4: $7,000 USD
  • Research Institution Funded: $5,000 USD
  • Academic research trial (Individual): $500 USD

Instructions for Payment of Clinical Trial Application Fee
For payment instructions and bank transfer details, please contact the PBSL by email: registrar@pharmacyboard.gov.sl.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 3.1 and 7.4 - Appendix IV

Ethics Committee > Ethics Committee
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
As per the G-SLEthics and the G-SLClinTrial, all clinical research conducted in Sierra Leone requires the principal investigator (PI) to obtain institutional and national level ethics committee (EC) approval for each clinical trial. For the initial review, the PI is required to obtain ethics approval from his/her local institution followed by national review and approval by the Sierra Leone Ethics and Scientific Review Committee (SLESRC). The SLESRC is located within the Ministry of Health and Sanitation (MoHS) and is responsible for EC oversight, formulating national health research policy, and defining health research priorities in Sierra Leone.

SLESRC Composition
As per the SL-GCPs, the SLESRC consists 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.

Specifically, the EC composition includes:

  • 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 PI and sponsor should vote or provide an opinion on any trial-related matters. A list of EC members and their qualifications should also be maintained.

Institutional EC Composition
No information is currently available on institutional EC composition requirements.

Terms of Reference, Review Procedures, and Meeting Schedule
As set forth in the SL-GCPs, the SLESRC performs its functions according to written standard operating procedures (SOPs), maintain written records of its activities and meeting minutes, and comply with good clinical practices (GCPs) and other applicable regulatory requirements. The SLESRC 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) (Document) Governance, Priorities & Policies in National Research for Health Systems in West Africa: Guinea Bissau, Liberia, Mali, Sierra Leone (March 2011)
Council on Health Research for Development, West Africa Health Organization, and International Development Research Centre - Canada

Relevant Sections: 4.1 - Governance, Management and Coordination Structures and 4.3 - Research for Health Capacity

REQUIREMENTS

(1) (Guidance) Sierra Leone Ethics and Scientific Review Committee - Guidelines (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Directorate of Training, Non-Communicable Diseases and Research, Connaught Hospital, Ministry of Health and Sanitation, Republic of Sierra Leone

(2) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 3.1.7 and 3.2

(3) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 3.2 and 3.3

Ethics Committee > Scope of Review
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
According to the SL-GCPs, the primary scope of information assessed by the Sierra Leone Ethics and Scientific Review Committee (SLESRC) and the institutional ethics committees (ECs) relate to maintaining and protecting the dignity 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.

Role in Clinical Trial Approval Process
As per the G-SLClinTrial and Additional Resource (A), the Pharmacy Board of Sierra Leone (PBSL)’s review and approval of a clinical trial application is dependent upon obtaining approval by the principal investigator’s (PI’s) local institutional EC and the national level EC, the Sierra Leone Ethics and Scientific Review Committee (SLESRC). As delineated in the G-SLClinTrial, the PBSL and the SLESRC may conduct their reviews in parallel. However, the PBSL’s approval will only be finalized once the SLESRC approval is obtained. As per Additional Resource (B), investigators are also required to obtain a research permit from their local institution prior to initiating a trial.

As per the SL-GCPs, 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 SL-GCPs.

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

ADDITIONAL RESOURCES

(A) (Application) Pharmacy Board of Sierra Leone Application Form to Conduct a Clinical Trial for Medicines, Vaccines and Medical Devices (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

(B) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October-November 2014)


REQUIREMENTS

(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 3.1 and 3.5

(2) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 3.1

Ethics Committee > Ethics Committee Fees
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
As set forth in the G-SLEthics, 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:

  • One hundred thousand Leones (Le100,000) for individuals in Sierra Leone; undergraduate students are exempted from this charge
  • Five hundred thousand Leones for non-governmental organizations (NGOs) (Le500,000) based in Sierra Leone
  • One hundred US dollars ($100 USD) for foreign students or individuals not normally residing in Sierra Leone
  • Five hundred US dollars ($500 USD) for institutions not based in Sierra Leone
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Sierra Leone Ethics and Scientific Review Committee - Guidelines (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Directorate of Training, Non-Communicable Diseases and Research, Connaught Hospital, Ministry of Health and Sanitation, Republic of Sierra Leone

Ethics Committee > Authorizing Body
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
As set forth in the G-SLEthics, the G-SLClinTrial, and Additional Resource (A), the Sierra Leone Ethics and Scientific Review Committee (SLESRC) is the central body responsible for overseeing local ethics committees (ECs). The SLESRC is an independent entity within the Ministry of Health and Sanitation (MoHS)’s Directorate of Training, Non-Communicable Diseases and Research.

According to Additional Resource (A), the SLESRC was initially established within the health research unit of the MoHS’s Directorate of Training, Non-Communicable Diseases and Research in 2008. In 2009, the Directorate endeavored to strengthen the existing national EC, and renamed it the Sierra Leone Ethics and Scientific Review Committee. As stated in the G-SLClinTrial, the SLESRC is also known as the National Independent Ethics Committee (IEC) of Sierra Leone.

SLESRC Composition
As per the SL-GCPs, the SLESRC consists 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.

Specifically, the SLESRC 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. A list of EC members and their qualifications is also maintained.

Registration, Auditing, and Accreditation
As per Additional Resource (B), ECs within universities and teaching hospitals must be accredited by their institutions.

ADDITIONAL RESOURCES

(A) (Document) Governance, Priorities & Policies in National Research for Health Systems in West Africa: Guinea Bissau, Liberia, Mali, Sierra Leone (March 2011)
Council on Health Research for Development, West Africa Health Organization, and International Development Research Centre - Canada

Relevant Sections: 4.1 -Governance, Management and Coordination Structures and 4.3 - Research for Health Capacity

(B) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October-November 2014)

REQUIREMENTS

(1) (Guidance) Sierra Leone Ethics and Scientific Review Committee - Guidelines (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Directorate of Training, Non-Communicable Diseases and Research, Connaught Hospital, Ministry of Health and Sanitation, Republic of Sierra Leone

(2) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 3.1.7 and 3.2

(3) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 3.2 and 3.3

Clinical Trial Lifecycle > Submission Process
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
In accordance with the G-SLClinTrial, the G-SLEthics, and the SL-GCPs, Sierra Leone requires the sponsor to obtain clinical trial authorization from the Pharmacy Board of Sierra Leone (PBSL). The sponsor is also required to ensure the principal investigator (PI) obtains ethics committee (EC) approval from his/her local institution and the Sierra Leone Ethics and Scientific Review Committee (SLESRC) prior to initiating a study. As indicated in the G-SLClinTrial, the PI may jointly submit the clinical trial application with the sponsor or submit it on the sponsor’s behalf. The G-SLClinTrial also states that the PBSL and the SLESRC may conduct their reviews in parallel. However, the PBSL’s approval will only be finalized once the SLESRC approval is obtained. In addition, as per Additional Resource (C), investigators are also required to obtain a research permit from 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
Sierra Leone
P.M.B. 322

Assembly and Number of Copies
While the G-SLClinTrial indicates applicants must submit two (2) copies of the application form signed by all of the authorized parties and one (1) hard and (1) soft copy of all application documents, Additional Resource (C) has indicated that applicants must submit 15 hard copies and one (1) soft copy of the application and related documents. In addition, the G-SLEthics states that the SLESRC requires seven (7) copies of the research proposal to be submitted for review purposes.

Clinical Trial Application Language Requirements
As per Additional Resource (C), the clinical trial application and accompanying material must be provided in English.

ADDITIONAL RESOURCES

(A) (Application) Pharmacy Board of Sierra Leone Application Form to Conduct a Clinical Trial for Medicines, Vaccines and Medical Devices (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

(B) (Website) Pharmacy Board of Sierra Leone - Contact Us (Current as of August 22, 2016)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

(C) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October–November 2014; June 2016)

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 1.0, 3.1, 3.2, and 3.3

(2) (Guidance) Sierra Leone Ethics and Scientific Review Committee - Guidelines (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Directorate of Training, Non-Communicable Diseases and Research, Connaught Hospital, Ministry of Health and Sanitation, Republic of Sierra Leone

(3) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 10

Clinical Trial Lifecycle > Submission Content
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
As set forth in the G-SLClinTrial, the G-SLEthics, and the SL-GCPs, Sierra Leone requires the sponsor to obtain clinical trial authorization from the Pharmacy Board of Sierra Leone (PBSL), and to ensure the principal investigator (PI) obtains ethics committee (EC) approval from his/her local institution followed by national approval from the Sierra Leone Ethics and Scientific Review Committee (SLESRC) prior to initiating a study. As indicated by the G-SLClinTrial, the PI may jointly submit the clinical trial application with the sponsor, or on the sponsor’s behalf. In addition, as per Additional Resource (B), investigators are also required to obtain a research permit from their local institution prior to initiating a trial.

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

  • Cover letter
  • Clinical trial application form
  • Protocol (see below for detailed protocol requirements)
  • Original copy of approval letter/certificate from the PI’s institutional EC or a recognized independent EC. In the case of multicenter studies, an approval from each institution’s EC will be required
  • Proof of registration with a PBSL-approved clinical trials registry
  • Patient Information Leaflet (PIL) and Informed Consent Form (ICF)
  • Investigator’s Brochure (IB)
  • Signed declaration by the sponsor or authorized person
  • Investigator’s Curriculum Vitae (CV)
  • Certificate of Analysis/Good Manufacturing Practice (GMP) certificate for the investigational product (IP)
  • Insurance certificate
  • Data Safety Monitoring Board (DSMB)
  • Financial declaration by the sponsor and the PI
  • Copy of recruitment advertisement
  • Chemistry, manufacturing, and control (CMC) data for the IP; for a new chemical entity (NCE), pre-clinical data should be included
  • Nonrefundable application fee as specified in the PBSL’s Fee Schedule

Sierra Leone Ethics and Scientific Review Committee Requirements (SLESRC)
As per the G-SLEthics, the SLESRC requires the PIs to submit the following documentation for ethics approval:

  • Cover letter to the Chairman
  • Seven (7) copies of the research proposal
  • Seven (7) copies of the Informed Consent Form (ICF)
  • Completed check lists for the Essential Elements in the Application for Approval and the Essential Elements Included in the Consent Form (see the G-SLEthics)
  • Brief CV for the PI
  • 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-SLClinTrial, 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-SLClinTrial.

ADDITIONAL RESOURCES

(A) (Application) Pharmacy Board of Sierra Leone Application Form to Conduct a Clinical Trial for Medicines, Vaccines and Medical Devices (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

(B) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October-November 2014)

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 1.0, 3.1, 3.2, and 3.3

(2) (Guidance) Sierra Leone Ethics and Scientific Review Committee - Guidelines (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Directorate of Training, Non-Communicable Diseases and Research, Connaught Hospital, Ministry of Health and Sanitation, Republic of Sierra Leone

(3) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 10

Clinical Trial Lifecycle > Timeline of Review
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
Based on the G-SLClinTrial, the G-SLEthics, and the SL-GCPs, the Pharmacy Board of Sierra Leone (PBSL) review and approval of a clinical trial application is dependent upon the principal investigator (PI) obtaining ethics committee (EC) approval from his/her local institution followed by approval from the Sierra Leone Ethics and Scientific Review Committee (SLESRC). As indicated by Additional Resource (A) and the G-SLClinTrial, the PI may jointly submit the clinical trial application with the sponsor, or on the sponsor’s behalf. The G-SLClinTrial also states that the PBSL and the SLESRC may conduct their reviews in parallel. However, the PBSL’s approval will only be finalized once the SLESRC approval is obtained.
In addition, as per Additional Resource (A), investigators are also required to obtain a research permit from their local institution prior to initiating a trial.

PBSL Approval
Clinical Trial Application Submission
As per the G-SLClinTrial and Additional Resource (A), the PBSL’s Pharmacovigilance Department review and approval process for clinical trial applications takes 60 days.

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

Sierra Leone Ethics and Scientific Review Committee Approval
The G-SLEthics states that PIs should submit their applications to the committee at least two (2) calendar months before the anticipated commencement of the proposed study.

Institutional EC Approval
The EC review and approval process will vary by institution.

ADDITIONAL RESOURCES

(A) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October-November 2014)

(B) (Document) Drug Safety Monitoring Manual for Pharmacy Board of Sierra Leone Pharmacovigilance Department (March 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 1.0, 3.1, 3.2, 3.3, 7.1 – Appendix Ib

(2) (Guidance) Sierra Leone Ethics and Scientific Review Committee - Guidelines (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Directorate of Training, Non-Communicable Diseases and Research, Connaught Hospital, Ministry of Health and Sanitation, Republic of Sierra Leone

(3) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 10

Clinical Trial Lifecycle > Trial Initiation
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
In accordance with the G-SLClinTrial and the G-SLEthics, a clinical trial can only commence after the sponsor receives authorization from Sierra Leone’s Pharmacy Board of Sierra Leone (PBSL) via a Clinical Trial Certificate. Also, the principal investigator (PI) must obtain ethics approval from his/her local institution followed by approval from the Sierra Leone Ethics and Scientific Review Committee (SLESRC) prior to initiating a study. As indicated in the G-SLClinTrial, the PI may jointly submit the clinical trial application with the sponsor or submit it on the sponsor’s behalf. The G-SLClinTrial also states that the PBSL and the SLESRC may conduct their reviews in parallel. However, the PBSL’s approval will only be finalized once the SLESRC approval is obtained. In addition, as per Additional Resource (A), investigators are also required to obtain a research permit from 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-SLClinTrial, the sponsor is required to obtain an import license for the shipment of an investigational product to be used in the trial from the PBSL. (See the Investigational Products topic, Manufacturing Authorization subtopic for additional information).

As stated in the G-SLClinTrial, 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 also be in good standing with the Sierra Leone Medical and Dental Council and the PBSL, be an expert in the pathology and the clinical handling of the particular disease or condition being studied, and be responsible for the proper conduct of the trial(s). All investigators involved in the trial must have proof of formal training in good clinical practices (GCPs) for at least two (2) years. In addition, non-medically qualified scientists may participate as co-investigators or in other roles, but not as PIs. See the G-SLClinTrial additional requirements.

Clinical Trial Agreement
While a signed clinical trial agreement is not an official requirement, the G-SLClinTrial states that the clinical protocol to be submitted to the PBSL must include a contractual agreement between the sponsor and the investigator.

EC Confirmation of Review and Approval
The G-SLClinTrial requires the sponsor to obtain an original copy of the approval letter/certificate from the SLESRC, 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-SLClinTrial and Additional Resource (A), the sponsor is required to register the clinical trial preferably with the Pan African Clinical Trial Registry (PACTR) or with any other recognized registries in the World Health Organization (WHO) Registry Network.

Data and Safety Monitoring Board
According to Additional Resource (A), the sponsor is required to establish a Data Safety Monitoring Board (DSMB) to regularly assess the progress of the trial and analyze safety data. The G-SLClinTrial also requires the sponsor to provide proof, in the clinical trial application, that a DSMB has been established.

ADDITIONAL RESOURCES

(A) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October-November 2014)

(B) (Application) Pharmacy Board of Sierra Leone Application Form to Conduct a Clinical Trial for Medicines, Vaccines and Medical Devices (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 1.0, 2.0, 3.1, 3.2, 3.3, and 3.6

(2) (Guidance) Sierra Leone Ethics and Scientific Review Committee - Guidelines (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Directorate of Training, Non-Communicable Diseases and Research, Connaught Hospital, Ministry of Health and Sanitation, Republic of Sierra Leone

(3) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 2, 5.5, and 10

Clinical Trial Lifecycle > Safety Reporting
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Last content review/update: July 19, 2017. Submit updates or comments.
SUMMARY

Overview
According to the G-SLClinTrial 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 a 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 (ADR) – 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 – A reaction where the nature or severity is inconsistent with the applicable product information

Reporting Requirements for AEs/ADRs
As stated in the G-SLClinTrial and the SL-GCPs, 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, unless the investigator’s brochure states that such incidents do not require immediate reporting.

A detailed follow-up SAE report form conforming to the Council for International Organizations of Medical Sciences (CIOMS) format (Additional Resource (B)) or a PBSL-approved form (Additional Resource (A)) should be completed. The form should identify participants by unique code numbers, and include detailed information to enable a causality assessment report to be prepared by the PBSL’s Expert Committee on Drug Safety.

Investigator Responsibilities
As specified in the G-SLClinTrial and the SL-GCPs, 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 G-SLClinTrial and the SL-GCPs, the PI should also comply with applicable regulatory requirements relating to reporting unexpected SAEs/SADRs to the PBSL within 48 hours of site awareness. 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-SLClinTrial also indicates that either the PI or the sponsor is required to provide information to the PBSL in all fatal cases and must be accompanied by a formal autopsy report. In those cases where only a verbal autopsy report is available, the PI or the sponsor must obtain prior PBSL approval.

Sponsor Responsibilities
According to the G-SLClinTrial and the SL-GCPs, the sponsor is responsible for the ongoing safety evaluation of investigational products (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). In addition, a participant that experiences frequent AEs/ADRs or an SAE/SADR from an IP should receive immediate medical attention. Any frequent AEs/ADRs should be reported to the PBSL within seven (7) days.

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
As per the G-SafeMeds and Additional Resource (A), all SAEs/SADRs and Suspected Unexpected Serious Adverse Reactions (SUSARs) must be reported on the PBSL’s Suspected Adverse Drug Reaction Reporting Form (Additional Resource (A)) or the CIOMS form (Additional Resource (B)), and emailed to registrar@pharmacyboard.gov.sl or mailed to the following address:

The Coordinator
Drug Safety Monitoring Programme
Pharmacovigilance Department
Pharmacy Board of Sierra Leone
64 Siaka Stevens Street
Freetown
Sierra Leone
P.M.B. 322

Tel: (+232 25) +282886
Fax: (+232 22) +224526

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 7.1 (Ia) of the G-SLClinTrial for detailed requirements.

Data and Safety Monitoring Board
According to Additional Resource (B), the sponsor is required to establish a Data Safety Monitoring Board (DSMB) to regularly assess the progress of the trial and analyze safety data. The G-SLClinTrial also requires the sponsor to provide proof that a DSMB has been established when submitting the clinical trial application.

ADDITIONAL RESOURCES

(A) (Form) Suspected Adverse Drug Reaction Reporting Form (Date Unavailable)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

(B) (Form) Suspect Adverse Reaction Report Form (CIOMS Form I) (Date Unavailable)
Council for International Organizations of Medical Sciences, Geneva, Switzerland

(C) (Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Efficacy Guidelines (E2A and E2B) (November 1995)
International Conference on Harmonisation
Geneva, Switzerland

(D) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October-November 2014)


REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 2.0, 3.1, 3.4, and 7.1 – Appendix Ia and Appendix Ib

(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 2, 3.4, 4.11, 5.5, 5.16, and 5.17

(3) (Guidance) Safety of Medicines in Sierra Leone: A Guide for Detecting and Reporting Adverse Drug Reactions – Why Health Professionals Need to Act? (G-SafeMeds) (December 2005)
Drug Safety Monitoring Programme, Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 7 and 8

Clinical Trial Lifecycle > Progress Reporting
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
In accordance with the G-SLClinTrial 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 stated in the SL-GCPs, the investigator should submit written summaries of the trial status to the Pharmacy Board of Sierra Leone (PBSL) on a quarterly basis, or more frequently, if requested, using the Quarterly Progress Report Form (see 7.2 Appendix II, G-SLClinTrial). 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-SLClinTrial indicates that the PBSL should be informed in writing of the exact date the trial commences. Quarterly progress reports must also be submitted to the PBSL within 21 days following the end of the previous quarter. See the G-SLClinTrial for additional details on preparing progress reports.

Final Report
The G-SLClinTrial states that the principal investigator (PI) or the sponsor must notify the PBSL not later than 30 days following the trial’s completion and submit a preliminary ethical evaluation report on the trial. According to the G-SLClinTrial and the SL-GCPs, the PI or the person authorized to conduct the trial must, not later than 90 days following the trial’s completion, compile and submit a comprehensive formal report to the PBSL. The report should conform to the International Conference on Harmonisation (ICH) Harmonised Tripartite Efficacy Guidelines (E3) or the Consolidated System of Reporting Trials (CONSORT), unless otherwise specified in the conditions issued with the Clinical Trial Certificate.

ADDITIONAL RESOURCES

(A) (Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Efficacy Guidelines (E3) (November 1995)
International Conference on Harmonisation
Geneva, Switzerland

(B) (Website) Consolidated System of Reporting Trials (CONSORT) (Current as of August 22. 2016)
Ottawa, Canada

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 3.5, 7.1 – Appendix Ib, and 7.2 – Appendix II

(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 4.10 and 4.13

Sponsorship > Definition of Sponsor
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
As per the G-SLClinTrial and the SL-GCPs, a sponsor is defined as an individual, group of individuals, company, institution, or organization who takes ultimate responsibility for the initiation, management, and financing of a trial. An individual, company, institution or organization which 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-SLClinTrial and the SL-GCPs, the sponsor may authorize a contract research organization (CRO) to perform one 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. A sponsor may be domestic or foreign.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 2.0

(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 2 and 5.2

Sponsorship > Trial Authorization
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
In accordance with the G-SLClinTrial, the G-SLEthics, and the SL-GCPs, the sponsor is responsible for submitting a clinical trial application to the Pharmacy Board of Sierra Leone (PBSL) to obtain authorization to conduct a clinical trial (see Additional Resource (A)). As indicated by the G-SLClinTrial, the principal investigator (PI) may jointly submit the clinical trial application with the sponsor or submit it on the sponsor’s behalf.

The sponsor must also ensure the PI obtains ethics committee (EC) approval from his/her local institution and the Sierra Leone Ethics and Scientific Review Committee (SLESRC). The G-SLClinTrial also states that the PBSL and the SLESRC may conduct their reviews in parallel. However, the PBSL’s approval will only be finalized once the SLESRC approval is obtained.

In addition to the completed application, the sponsor 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

(A) (Application) Pharmacy Board of Sierra Leone Application Form to Conduct a Clinical Trial for Medicines, Vaccines and Medical Devices (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 1.0, 3.1, 3.2, and 3.3

(2) (Guidance) Sierra Leone Ethics and Scientific Review Committee – Guidelines (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Directorate of Training, Non-Communicable Diseases and Research, Connaught Hospital, Ministry of Health and Sanitation, Republic of Sierra Leone

(3) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 10

Sponsorship > Insurance
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
As set forth in the G-SLClinTrial and the SL-GCPs, it is a legal requirement for the sponsor to carry a valid insurance policy for the expected duration of the study for any unforeseen injury to research participants. The G-SLClinTrial states that for all sponsor-initiated trials, the sponsor must provide an insurance certificate to the Pharmacy Board of Sierra Leone (PBSL) and include a copy of this coverage in the clinical trial application submission. 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-SLClinTrial.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 3.1

(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 5.8

Sponsorship > Compensation
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
As specified in the G-SLClinTrial and the SL-GCPs, the sponsor is responsible for providing a clear compensation and benefits package in its clinical trial protocol, and having insurance that satisfactorily insures all research participants and/or their legal heirs in the event of trial-related injuries or death. In addition, 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

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 3.1.4 and 3.1.8

(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 4.8 and 5.8

Sponsorship > Quality, Data & Records Management
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
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.

The sponsor must also obtain the investigator(s) and the institution(s) agreement to:

  • conduct the trial in compliance with the SL-GCPs, the PBSL and ethics committee (EC) 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 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.

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 the auditor’s qualifications should be 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 prematurely terminated or suspended, 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

REQUIREMENTS

(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 2, 5.1, 5.5, 5.6, 5.19, 5.21, 5.23, 6.11, and 6.13


(2) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 2.0 and 3.1.4

Sponsorship > Site/Investigator Selection
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Last content review/update: August 22, 2016. Submit updates or comments.
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.

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

Foreign Sponsor Responsibilities
No information is currently available specifying foreign sponsor regulatory requirements.

Data Safety Monitoring Board (DSMB)
According to Additional Resource (A), the sponsor is required to establish a Data Safety Monitoring Board (DSMB) to regularly assess the progress of the trial and analyze safety data. The G-SLClinTrial also requires the sponsor to provide proof, in the clinical trial application, that a DSMB has been established.

ADDITIONAL RESOURCES

(A) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October-November 2014)

REQUIREMENTS

(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 2, 5.6, and 5.7

(2) (Guidance) Sierra Leone Ethics and Scientific Review Committee – Guidelines (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Directorate of Training, Non-Communicable Diseases and Research, Connaught Hospital, Ministry of Health and Sanitation, Republic of Sierra Leone

(3) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 3.1 and 3.2

Informed Consent > Documentation Requirements
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Last content review/update: August 22, 2016. Submit updates or comments.
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, the G-SLClinTrial, and the G-SLEthics, the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by the principal investigator’s (PI) institutional ethics committee (EC) and the Sierra Leone Ethics and Scientific Review Committee (SLESRC), and it must be submitted by the sponsor to the Pharmacy Board of Sierra Leone (PBSL) with the clinical trial application. (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. After the written ICF and any other written information to be provided to the participant is read and explained to the participant and his/her legal representative(s) and/or guardian(s), and after the participant and his/her legal representative(s) and/or guardian(s), have orally consented to the participant’s involvement in the trial, and has signed and dated the ICF, if capable of doing so, the witness should sign and date the ICF.

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–November 2014)

REQUIREMENTS

(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 4.8 and 8

(2) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 3.1

(3) (Guidance) Sierra Leone Ethics and Scientific Review Committee – Guidelines (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Directorate of Training, Non-Communicable Diseases and Research, Connaught Hospital, Ministry of Health and Sanitation, Republic of Sierra Leone

Informed Consent > Required Elements
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
As delineated in the SL-GCPs, the G-SLClinTrial, and the G-SLEthics, prior to beginning a clinical trial, the principal investigator (PI) is required to obtain ethics committee (EC) approval from his/her local institution followed by national review and approval by the Sierra Leone Ethics and Scientific Review Committee (SLESRC) for 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).

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 to 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
  • The expected duration of the participant's participation
  • The participant’s responsibilities in participating in the trial
  • Experimental aspects of the study
  • Approximate number of participants involved in the trial
  • The probability for random assignment to each treatment
  • Any foreseeable risks or discomforts to the participant, and when applicable, to an embryo, fetus, or nursing infant
  • Any expected benefits or prorated payment to the participant; if no benefit is expected, the participant should also be made aware of this
  • Alternative procedures or treatment that may be available to the participant
  • 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 to the participant 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 ethics committee (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

REQUIREMENTS

(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 4.8 and 8

(2) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 3.1

(3) (Guidance) Sierra Leone Ethics and Scientific Review Committee – Guidelines (G-SLEthics) (Date Unavailable)
Office of the Sierra Leone Ethics and Scientific Review Committee, Directorate of Training, Non-Communicable Diseases and Research, Connaught Hospital, Ministry of Health and Sanitation, Republic of Sierra Leone

Informed Consent > Compensation Disclosure
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Last content review/update: August 22, 2016. Submit updates or comments.
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

REQUIREMENTS

(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 4.8

Informed Consent > Participant Rights
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Last content review/update: August 22, 2016. Submit updates or comments.
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-SLClinTrial 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-SLClinTrial, 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-SLClinTrial, 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

REQUIREMENTS

(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 4.8 and Appendix 3 (Section I, 5 and 6)

(2) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 2.0 and 3.2

Informed Consent > Special Circumstances/Emergencies
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Last content review/update: August 22, 2016. Submit updates or comments.
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, in an emergency, if the signed informed consent form (ICF) cannot be obtained from the research participant, the consent of his/her legal representative(s) and/or guardian(s), if present, should be obtained. If the prior consent of the participant and/or his/her legal representative(s) and/or guardian(s) cannot be obtained, the participant’s enrollment should follow measures specified in the protocol, and/or elsewhere, with documented approval/favorable opinion by the ethics committees (ECs) and by the Pharmacy Board of Sierra Leone (PBSL) to protect the rights, safety, and well-being of the participant, and to 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.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 4.8

Informed Consent > Vulnerable Populations
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
As per the SL-GCPs and the G-SLClinTrial, 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 SL-GCPs and the G-SLClinTrial characterize 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. This may 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. 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 in nursing homes, 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.

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

(A) (Guidance) International Ethical Guidelines for biomedical Research Involving Human Subjects (2002)
Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO)

Relevant Sections: 14, 15, 16, and 17

REQUIREMENTS

(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 2, 3.1, and 9

(2) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 2.0 and 3.8

Informed Consent > Children/Minors
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Last content review/update: July 19, 2017. Submit updates or comments.
SUMMARY

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

As set forth in the SL-GCPs which complies with the ethical principles as specified in the Declaration of Helsinki (Appendix 3, SL-GCPs), 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 SL-GCPs and the G-SLClinTrial also state 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
ADDITIONAL RESOURCES

(A) (Document) Declaration of Helsinki (October 2013)
World Medical Association

REQUIREMENTS

(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 2, 9.1, and Appendix 3 (Section I, 11)

(2) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 2.0 and 3.8.1

Informed Consent > Pregnant Women, Fetuses & Neonates
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
As per the SL-GCPs and the G-SLClinTrial, 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-SLClinTrial state that the following conditions must be met for research to be conducted with women of child-bearing age:

  • 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

The SL-GCPs and the G-SLClinTrial state that the following conditions must be met for research to be 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) 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
  • The research is relevant to the particular health needs of a pregnant woman or her fetus, or to the health needs of pregnant women in general, and, when appropriate, it is supported by reliable evidence from animal experiments, particularly as to the risks of teratogenicity and mutagenicity
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 9.3 and 9.4

(2) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 3.8.3 and 3.8.4

Informed Consent > Prisoners
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Informed Consent > Mentally Impaired
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Last content review/update: July 19, 2017. Submit updates or comments.
SUMMARY

Overview
According to the SL-GCPs which complies with the ethical principles as specified in the Declaration of Helsinki (Appendix 3, SL-GCPs) and the G-SLClinTrial, 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
  • 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
  • In the case of legal incompetence, or where physical or mental incapacity makes it impossible to obtain informed consent, consent should be obtained from the participant’s legal representative(s) and/or guardian(s)
ADDITIONAL RESOURCES

(A) (Document) Declaration of Helsinki (October 2013)
World Medical Association

REQUIREMENTS

(1) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 9.2 and Appendix 3 (Section I, 11)

(2) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 3.8.2

Investigational Products > Definition of Investigational Product
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
As delineated in the G-SLClinTrial 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

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 2.0

(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 2.0

Investigational Products > Manufacturing & Import
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
According to the PDA2001 and the G-MedProdReg, the Pharmacy Board of Sierra Leone (PBSL) is responsible for authorizing the manufacture of all drug products, including investigational products (IPs), in Sierra Leone.

The PDA2001 and the G-MedProdReg also state that the PBSL is responsible for authorizing the import of IPs. As per the G-SLClinTrial, the sponsor may submit a request to import an IP after the PBSL has approved the clinical trial application.

According to the G-SLClinTrial, documentation requirements for the import permit application are as follows:

  • Letter stating the 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
  • Innovator’s name and address
  • Sponsor’s name
  • Clinical research entity’s name

According to the G-SLClinTrial and the SL-GCPs, the sponsor must also ensure that a Good Manufacturing Practice (GMP) certificate or statement issued by the regulatory authority is provided from the country of manufacture for the product or placebo.

The PBSL processing time for IP import permits is 15 days. The G-MedProdReg also states that if the applicant is a foreign company, it should appoint a local agent through whom the import permit application must be submitted.

See the G-SLClinTrial and the G-MedProdReg for detailed IP import requirements.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 3.1, 3.6 and 7.1 (Appendix Ib)

(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 2.0 and 5.1.3

(3) (Guidance) Guidelines for Medicinal Product Registration (G-MedProdReg) (Date Unavailable)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 2

(4) (Legislation) The Pharmacy and Drugs Act, 2001 (PDA2001) (December 13, 2001)
Parliament, Republic of Sierra Leone

Relevant Sections: Parts V and VI

Investigational Products > IMP/IND Quality Requirements
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

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

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

  • Physical, chemical, and pharmaceutical properties and formulation parameters
  • Pharmaceutical aspects
  • Pharmacokinetics and metabolism
  • Toxicological effects in any animal species tested under a single dose study, a repeated dose study, or a special study
  • Results of clinical pharmacokinetic studies
  • Information regarding safety, pharmacodynamics, efficacy, and dose responses obtained from prior clinical trials in humans

See the G-SLClinTrial 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) and ensures the principal investigator (PI) obtains approvals from the local and national ethics committees (ECs). (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-SLClinTrial and the SL-GCPs, the sponsor must ensure that a Good Manufacturing Practice (GMP) certificate or statement issued by the regulatory authority is provided from the country of manufacture for the product or placebo.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 2.0, 3.1, 3.1.6, and 3.6

(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 5.12, 5.13, 5.14, and 8

Investigational Products > Labeling & Packaging
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
Investigational product (IP) labeling in Sierra Leone must comply with the requirements set forth in the G-SLClinTrial and the SL-GCPs. While there is no specified language requirement for IP labeling, according to Additional Resource (A), the clinical trial application and accompanying material must be provided in English.

As set forth in the G-SLClinTrial and the SL-GCPs, both the IP and the placebo should be appropriately labeled in accordance with the Pharmacy Board of Sierra Leone (PBSL) approved labels to indicate that they are samples for use in clinical trials only.

ADDITIONAL RESOURCES

(A) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October–November 2014)

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 3.1.6 and 3.6

(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 5.13

Investigational Products > Product Management
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

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

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) and ensures that the principal investigator (PI) obtains approvals from the local and national ethics committees (ECs).

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

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 2.0, 3.1, and 3.1.6

(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 4.4, 5.5, 5.10, 5.12, 5.13, 5.14, 6.13, and 7

Specimens > Definition of Specimen
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
In Sierra Leone, a specimen is referred to as a biological specimen or a biological sample. As delineated in the G-SLClinTrial, 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 RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 2.0

Specimens > Import & Export
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
According to Additional Resource (A), the Pharmacy Board of Sierra Leone (PBSL) is responsible for authorizing the import of all biological specimens in Sierra Leone. The sponsor should follow the same requirements as those stated in the G-SLClinTrial and the G-MedProdReg to import investigational products (IPs).

Additionally, according to Additional Resource (A), a material transfer agreement (MTA) is required when importing and exporting biological specimens.

See the Investigational Products topic, Manufacturing & Import subtopic for detailed IP import requirements.

ADDITIONAL RESOURCES

(A) NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (not available online) (October 2014–January 2015)

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 3.1, 3.6 and 7.1 (Appendix Ib)

(2) (Guidance) Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Sections: 2.0 and 5.1.3

(3) (Guidance) Guidelines for Medicinal Product Registration (G-MedProdReg) (Date Unavailable)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 2

Specimens > Consent for Specimens
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Last content review/update: August 22, 2016. Submit updates or comments.
SUMMARY

Overview
In accordance with the G-SLClinTrial, 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-SLClinTrial, 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.

According to the G-SLClinTrial, 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 personal data, and 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

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

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial) (September 1, 2014)
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation, Republic of Sierra Leone

Relevant Section: 3.9

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OMB #: 0925-0668
Expiration Date: 2/28/2019