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Liberia
GUIDELINE FOR APPLICATION TO CONDUCT OF CLINICAL TRIALS IN LIBERIA.
This is the first edition of the guideline from the LMHRA, providing mandatory application requirements and procedures for all clinical trials involving medicines and health products in Liberia. It enforces a legal requirement for written authorization from the LMHRA prior to commencing any study. The guideline emphasizes adherence to Good Clinical Practice (GCP) standards and ethical principles, adopting the International Conference on Harmonization (ICH) Tripartite Guideline for GCP. It outlines specific requirements for protocol submission, informed consent, SAE/SUSAR reporting, and trial termination/inspection.
Use Cases
- Sponsors – Obtain Regulatory Authorization: They must submit a formal application, pay the prescribed fees (e.g., US$3,000 application fee), and secure a written authorization from the LMHRA before initiating any clinical trial.
- Principal Investigators (PIs) – Ensure Ethical Compliance: They must obtain an Ethical Clearance Certificate from an approved institute (like the MHEC) and ensure all trial conduct aligns with the World Medical Assembly (WMA) Declaration of Helsinki.
- LMHRA (Liberia Medicines & Health Products Regulatory Authority) – Oversight and Inspection: The Authority is responsible for evaluating all applications, making approval decisions, and conducting mandatory inspections of trial sites, sponsors’ offices, and CROs to validate data quality and ensure GCP adherence.
- Monitors – Oversee Protocol Adherence: They are contracted by the Sponsor to conduct on-site monitoring, ensuring the trial is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and regulatory requirements.
- Clinical Trial Participants – Provide Informed Consent: They must voluntarily confirm their willingness to participate after receiving comprehensive information on the trial’s objectives, potential risks, benefits, and their rights, with the process being documented and signed.
- Investigators/Sponsors – Report Serious Adverse Events (SAEs): They must immediately report all fatal Serious Adverse Events within 24 hours, and all other SAEs/Suspected Unexpected Serious Adverse Reactions (SUSARs) within 8 working days to the LMHRA
Key takeaways you'll learn
The resource’s purpose is to establish clear, consistent, and uniform documentation and procedural standards for clinical trial applications in Liberia. This is intended to facilitate the Authority’s evaluation process while ensuring that trials conducted on human participants are ethical and scientifically sound.
- Mandatory Prior Authorization: Conducting any clinical trial involving medicines or health products in Liberia is strictly prohibited without first obtaining a written authorization from the LMHRA.
- Dual Regulatory & Ethical Approval: Applications require both the LMHRA’s regulatory authorization and an Ethical Clearance Certificate issued by an approved institution, emphasizing the critical role of the Medicines and Health Products Ethics Committee (MHEC).
- International Standards Adopted: The guideline officially adopts and requires adherence to the ICH-GCP (International Conference on Harmonization – Good Clinical Practice) Tripartite Guideline, ensuring international quality and ethics standards.
- Financial & Safety Requirements: Applicants must submit the required fees (e.g., US$3,000 application fee) and a certified copy of insurance for study participants, alongside financial declarations from the Sponsor and PI.
- Rigorous Safety Reporting: A strict timeline is imposed for reporting serious events: fatal SAEs/SUSARs must be reported within 24 hours, and non-fatal events within 8 working days, followed by detailed written reports.
