AVAREF GUIDELINES - Tools for Processing Clinical Trial Applications by Ethics Committees and National Regulatory Authorities in Africa
To facilitate the review and monitoring of clinical trials on the continent, the AVAREF technical working group on inspection of good clinical practices (GCP) and clinical trials working group (CTWG). The CTWG was selected from experts from AVAREF’s Technical Coordinating Committee representing NRAs and ECs from Burkina Faso, Ghana, Kenya, Malawi, Nigeria, Uganda and Zimbabwe on voluntary basis. The group was technically supported by experts from other regulatory agencies (Paul Ehrlich Institute). Other partners (CEPI, BMGF, USFDA,) also provided inputs into the development of these documents. The CTWG developed standardized templates and guides for GCP Inspection, the submission and assessment of clinical trial applications, as well as the checklist and guides for monitoring of clinical trials on the continent.
