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

  • the approval process of a clinical trial, a clinical investigation, and a performance
  • ...
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

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

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 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