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.
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...
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...
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...
This new template for the Informed Consent Form (ICF) for interventional clinical trials with an investigational medicinal product on adult patients was prepared by a dedicated working group. This...
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...
