Healthcare profession

This new template for the Informed Consent Form (ICF) for clinical investigations for adult patients involving a medical device was prepared by a BAREC working group consisting of representatives from some Ethics committees. During September – October 2024, feedback was requested from different...

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 Board on 24/01/2025.

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

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 mandatory (black) text of the template and for which reason. This document is a template for this...

This information brochure contains an overview of the general (non-study-specific) information that is present in every informed consent form (ICF) that is presented to adult patients who wish to participate in a clinical trial with an investigational medicinal product (IMP). Are you a treating...

This information brochure contains an overview of the general (non-study-specific) information that is present in every informed consent form (ICF) that is presented to adult patients who wish to participate in a clinical trial with an investigational medicinal product (IMP). Are you a treating...

This new version of the template for the Informed Consent Form (ICF) for interventional clinical trials with an investigational medicinal product on adult patients was prepared by a dedicated BAREC working group consisting of representatives from some Ethics committees. During September – October...

This document contains an example of the chapter “The trial at a glance” of the Model ICF for interventional clinical trials with IMP on adult patients.

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 mandatory (purple) text of the template and for which reason. The color codes are used as described in...