Following several discussions between the College, the AFMHP, and some industrial and academic sponsors, this recommendations to ethics committees concerning the approval of pre-recruitment...

24-10-2024
PublicationsAdvices

In this advice given by the BAREC and approved by the Board, you’ll find more information about the Patient facing documents and their submissions for EC review. Version 2.0 was approved by the...

31-07-2024
PublicationsAdvices

This presentation gives you more information on how the CTR, MDR, and IVDR have an impact on :

  • the approval process of a clinical trial, 
  • the ethical review process
  • ...
11-04-2023
PublicationsPresentation

The CT College Board clarifies the role of the Ethics Committees (ECs) in evaluating clinical trial safety reports submitted under the European CTR.

According to...

03-06-2022
PublicationsAdvices
ethics committee

Please note that a new version of the template for the Informed Consent Form (ICF) for interventional clinical trials with an investigational vaccine in adult healthy volunteers is being prepared...

12-10-2020
FormsModels

Intention of this template: The sponsor must add to the submission file a statement which describes which version of the ICF template was used, and (if applicable) which changes were made to the...

12-10-2020
Atachments