To facilitate the review and monitoring of clinical trials in the African Region, standardized templates have been developed for the submission and assessment of clinical trial applications (CTAs) in the Region. The standard reporting will impact positively on the quality of reviews, the consistency and predictability of National Regulatory Authorities (NRAs) and Ethics Committees (ECs) reports, as well as be used as a training tool.
The harmonized CTA forms, assessment templates, Good Clinical Practices inspection guide and related checklists were further discussed by the Technical Coordinating Committee (TCC) and endorsed by the Steering Committee (SC) at their 5th meetings in September 2018. The documents agreed upon at those meetings will be used for the submission and assessment of CTAs and GCP inspections. They include the following:
- CTA form for the sponsors;
- Clinical trial checklist for the sponsors and NRAs;
- Templates for assessors at the NRAs to evaluate the quality i.e. Chemistry, Manufacturing and Control (CMC), nonclinical, and clinical aspects of a CTA;
- GCP inspections guide and checklist for the NRAs. The proposed guide can be used to perform an inspection at any stage of a clinical trial. It can also be used after the completion of a clinical trial.
These harmonized templates will be tabled at the next AVAREF Assembly (2nd October 2019) for adoption. The purpose is to have all 55 African Member States adopt the templates and incorporate them into their tools for the evaluation of CTAs, including emergency preparedness. The adoption of these templates by African NRAs will promote standardized CTAs and assessments, and further the ongoing harmonization initiatives on the continent. This will ultimately lead to all countries meeting AVAREF’s timeline of 60 working days to review and approve or reject clinical trials.