This document describes the restrictions that should be taken into account when using electronic methods to inform a potential participant of a clinical trial and/or to have the ICF signed.

30-09-2020

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

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...

19-03-2020
Publications

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...

19-03-2020
Publications

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 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 template for the Informed Consent Form (ICF) for interventional clinical trials with an investigational vaccine in adult healthy volunteers was prepared by a dedicated working group. This...

12-10-2020