AVAREF Documents
The AVAREF Documents and Tools provide a comprehensive and standardized framework for the submission, evaluation, and oversight of clinical trials across African regulatory authorities.
Developed to strengthen regulatory capacity, harmonization, and transparency, the toolkit includes interrelated components that guide every step of the clinical trial regulatory process.
These resources ensure that National Regulatory Authorities (NRAs) and Ethics Committees (ECs) operate under harmonized procedures, fostering efficiency, predictability, and quality assurance across the continent.
Each document listed below includes a short description and a link to download the resource.
CTA Application
A standardized form designed to collect all essential information on a CTA Application. EN
CTA Checklist
A standardized checklist guiding sponsors and investigators through every step of the clinical trial application process.
EN
Assessment Tools
A set of four specialized evaluation grids has been developed to support technical assessment of clinical trial applications. Each grid follows a structured, question-driven approach that enables evaluators to review dossiers methodically and consistently.
- Clinical Evaluation Grid – Reviews study design, risk–benefit balance, and participant safety. EN PT
- Statistical Evaluation Grid – Assesses endpoints, sample size, and statistical validity for data reliability. EN PT
- Non-Clinical Evaluation Grid – Evaluates pharmacology, toxicology, and preclinical safety for human trial readiness. EN PT
- Quality Evaluation Grid – Examines GMP compliance, product stability, and IMP quality. EN PT
Guides and checklists for Good Clinical Practice (GCP) inspections — helping regulators verify ethical standards, data reliability, and participant safety during trial implementation.
Other guidelines have been developed to facilitate joint regulatory reviews and strengthen emergency response mechanisms:
- Joint Review Guideline – Establishes a structured, multi-country framework that enables NRAs and ECs to conduct collaborative evaluations of clinical trial applications, reducing duplication and approval timelines. EN
- Guidance on Emergency Preparedness – Equips regulators with strategies to respond rapidly during public-health emergencies, providing risk-based decision-making tools and expedited pathways for the review and authorization of medical products. EN
AVAREF documents are currently under revision to ensure alignment with the latest regulatory developments. Stakeholders are encouraged to share feedback or suggestions with the AVAREF Secretariat →