Guidelines
1. List of AVAREF Guidelines & Tools
AVAREF technical guidelines and regulatory tools were developed by the Steering Committee (SC) through the Working Group and the Technical Coordination Committee (TCC). The tools were reviewed by the TCC and SC in February and September 2018 as part of the statutory meetings, and endorsed by the AVAREF Assembly in Victoria Falls, Zimbabwe, in October 2019.
The regulatory tools developed include:
- Standardized templates and checklist for submission and assessment of clinical trial applications
- Guide and checklist for Good Clinical Practice (GCP) Inspection
- Guideline for joint review of clinical trial application
- Guideline for Compassionate Use Access
- Application form for Compassionate Use Access
Use of these tools is further an example of the shift to standardized clinical trial applications and assessments, and proof of ongoing harmonization initiatives on the continent, which will ultimately lead to shorter timelines for product development.
To facilitate the implementation of the AVAREF Guidelines for Clinical Trials, a one-page document explaining the AVAREF Guideline consultation and subsequent approval process was circulated to Member States in May 2020. The documents were posted on the AUDA-NEPAD, WHO and other websites as appropriate for access by NMRAs, NECs, regional economic communities (RECs) and other key stakeholders.
2. AVAREF Guidelines and regulatory tools
AVAREF Guidelines One-Pager: Tools for Processing Clinical Trial Applications by Ethics Committees and National Regulatory Authorities in Africa
Final One-pager AVAREF regulatory tools (ENG)
Final One-pager AVAREF regulatory tools (FRA)
AVAREF Strategy and Guide for Emergency Preparedness
This document provides guidance to NRAs, ECs, trial sponsors and their investigators on a joint review model for submission and review of CTAs in Africa. The document addresses the criteria for triggering a joint review using the AVAREF platform, the key participants and their respective roles, as well as the steps and expected outcomes from the joint review process. AVAREF countries are encouraged to incorporate this joint review model and guideline into their review process as a means of fulfilling regulatory requirements.
Guideline for Joint and Assisted Reviews of CTAs for NRAs and ECs (ENG)
Lignes Directrices Pour Les Examens Conjoints Et Assistés Des Demandes D’essais Cliniques (FRE)
Guideline for Joint Review of Clinical Trial Applications
This document provides guidance to NRAs, ECs, trial sponsors and their investigators on a joint review model for submission and review of CTAs in Africa. The document addresses the criteria for triggering a joint review using the AVAREF platform, and describes the key participants and their respective roles, as well as the steps involved in and expected outcomes from the joint review process.
AVAREF Joint review guideline (ENG)
Lignes Directrices Pour Les Examens Conjoints Et Assistés Des Demandes D’essais Cliniques (FRA)
Clinical Trial Application Form
The Clinical trial application form is developed for phase I to III clinical trials of medical products (i.e., medicines, vaccines). It provides a snapshot of key details necessary in an application, and should be completed by the sponsor and submitted as part of the application package. It is not meant to replicate the depth of detail provided in other documents submitted as part of the application.
AVAREF Clinical trial application form (ENG)
Formulaire De Demande D’essai Clinique (FRA)
Clinical Trial Application Checklist
The clinical trial application checklist provides National Regulatory Authorities and Ethics Committees a tool to screen and validate applications, and to determine whether the application is complete and ready for assessment. Likewise, this checklist provides prospective sponsors with a list of requirements needed for submission of clinical trial applications on the continent.
AVAREF Clinical trial application form checklist (ENG)
Liste De Contrôle Des Demandes D’essai Clinique (FRA)
Templates for Assessment of the Quality, Nonclinical, and Clinical Parts of the Clinical Trial Application
The templates for assessment (quality, non-clinical and clinical) are adopted to guide assessors in a systematic review of the quality, non-clinical and clinical aspects of clinical trial applications. These templates are dynamic documents and will be amended as necessary.
AVAREF Clinical assessment template (ENG)
Modèle D’évaluation Clinique des Demandes D’essai Clinique: ÉVALUATION CLINIQUE (FRA)
3. Good Clinical Practice (GCP) Inspection of Clinical Trials
The GCP Guide and Checklist for the Inspection of Clinical Trial Sites
The GCP inspection guide provides a set of harmonized recommendations to conduct a clinical trial inspection for NRA inspections or joint inspections by NRAs and Ethics Committees. This guidance document is adopted to inspect a clinical trial at any stage, including bio-equivalence studies. This is to ensure that there is a foundation to guarantee the ethical and scientific integrity of the trial and the data.
AVAREF GCP inspection guide (ENG)
Guide D’inspection des Essais Cliniques (FRA)
Checklist for the Inspection of Clinical Trials
This clinical trial inspections checklist is to complement the comprehensive guide during inspections of clinical trials.
AVAREF GCP inspection checklist (ENG)
Liste de Contrôle Pour L’inspection des Essais Cliniques (FRA)
AVAREF Quality Assessment Template
The Quality Assessment Template is designed for reviewers to use in assessing quality (e.g. to the manufacture of investigational medicinal product) part of clinical trial application as a guide. The pre-populated questionnaires are helpful for assessors to conduct a thorough and detailed review of application dossier.
AVAREF Quality assessment template (ENG)
AVAREF Évaluation de La Qualité (FRA)
AVAREF Statistical Assessment Template
The Statistical Assessment Template is designed for reviewers to use in assessing statistical analysis of clinical trials and statistical aspects of the application as a guide. The pre-populated questionnaires are helpful for assessors to conduct a thorough and detailed review of application dossier.
4. Other Related WHO Tools
WHO Global Benchmarking Tool (GBT)
The Global Benchmarking Tool (GBT) represents the primary means by which the World Health Organization (WHO) objectively evaluates regulatory systems, as mandated by WHA Resolution 67.20 on Regulatory System Strengthening for medical products. The tool and benchmarking methodology enables WHO and regulatory authorities to: 1) identify strengths and areas for improvement; 2) facilitate the formulation of an institutional development plan (IDP) to build upon strengths and address the identified gaps; 3) prioritize institutional development plan (IDP) interventions; and 4) monitor progress and achievements.
WHO handbook on Effective Media Communication during Public Health Emergencies
This handbook describes a seven-step process to assist public health officials and others to communicate effectively through the media during emergencies. At the core of this process is the belief that positive action must be taken to interactively facilitate effective media coverage of events and situations rather than simply responding to the resulting coverage. By implementing such a “proactive” and interactive approach, public health organizations and officials will be in a stronger position to ensure that their messages are accurately reported, highly visible and clearly heard. This will greatly increase the likelihood of successfully informing people, encouraging helpful behaviours by those affected or threatened, and significantly reducing the impact of events.
WHO Simulation Exercise Manual
WHO simulation exercise manual: a practical guide and tool for planning, conducting and evaluating simulation exercises for outbreaks and public health emergency preparedness and response
The AVAREF Guideline for Joint and Assisted Reviews of Clinical Trial Applications for National Regulatory Authorities (NRAs) and Ethics Committees (ECs)
https://www.afro.who.int/health-topics/immunization/avaref
This exercise manual has been designed to meet the needs of WHO, its Member States and its partners to support and develop exercise practitioners’ competency to plan, implement and evaluate simulation exercises. Simulation exercises can help develop, assess, and test the functional capabilities of emergency systems, procedures and mechanisms to respond to outbreaks and public health emergencies. The manual complements existing WHO exercise methodologies, helping ensure common understandings and approaches across the organization. It describes how exercise teams work, and can supplement future training courses for WHO staff, ministries of health, governments, and preparedness and response partners. It has been developed with key support from WHO regional offices and HQ technical units, and with input generated in country pilots run both by ministries of health and by WHO country offices.
WHO TRS No 1004 Annex 7 –Guideline on Regulatory Preparedness for Provision of Marketing Authorization of Human Pandemic Influenza Vaccines in Non-vaccine Producing Countries
https://apps.who.int/medicinedocs/documents/s23326en/s23326en.pdf
WHO Emergency Use Assessment and Listing Procedure (EUAL) for candidate vaccines for use in the context of a public health emergency
https://apps.who.int/medicinedocs/documents/s21987en/s21987en.pdf
WHO Guidelines for Safe Disposal of Unwanted Pharmaceuticals in and after Emergencies
WHO TRS No. 924-Guidelines on Clinical Evaluation of Vaccines: Regulatory Expectations
The Global Vaccine Safety Initiative Blueprint (GVSIB)
Global Vaccine Safety Blueprint 2.0 Background Research, 2019
The SAGE Global Vaccine Action Plan (GVAP) 2011-2020 Review
Global Vaccine Action Plan 2011-2020 (ENG)
Plan d’Action Mondial pour les Vaccins 2011-2020 (FRA)
GVAP Review and Lessons Learned (ENG)
The Regional Strategic Plan for Immunization (RSPI) 2014-2020
The Regional Strategic Plan for Immunization (RSPI) 2014-2020 Mid Term Review