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...

28-06-2019
Forms

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.

28-06-2019
Atachments

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...

28-06-2019
Atachments

This document contains FAQs on the IC procedure in trials ongoing at or completed before the implementation of the GDPR.

A link to the English version of the annex has been added on 04/...

05-12-2018
Publications

This presentation gives you more information on how the CTR has an impact on :

  • the approval process of a clinical trial
  • the ethical review process
12-06-2018
PublicationsPresentation