The Clinical Trial College (CT College) ensures that the ethical assessment of both clinical trials on medicinal products for human use and clinical investigations with medical devices is carried out in Belgium:
The safety of the participants in the clinical trials and investigations is essential in this regard.
As described in the art. 9 §3 of the Belgian law of 7th May 2017 (see tab ‘legislation’), the mission of the CT-College is as follows:
List of ethics committees recognised under the law of 7 May 2017:
Below, you will find a list containing all ethics committees that have obtained a recognition in accordance with the law of 7 May 2017. This list also specifies whether the recognition is valid for the evaluation for Phase I clinical trials. The first recognition of each ethics committee is valid for a period of two years. Every renewal of this recognition is valid for a period of four years. This is the maximum validity period as determined by law (Art.6 §4 of the Law concerning clinical trials with medicinal products for human use of 7 May 2017).
Name Ethics Committee
Recognized for Clinical trials of Phase 1
Recognition valid until (date)
Commissie medische ethiek AZ Delta
/
01/04/2026
Commissie voor Ethiek van het AZ Sint-Jan Brugge
Comité d'éthique hospitalo-facultaire universitaire de Liège
X
01/04/2025
Comité d'Ethique hospitalier CHU UCL Namur, site Godinne
Comité d'Ethique Hospitalo-Facultaire Erasme-ULB
01/10/2025
Comité d'Éthique de l’Institut Jules Bordet
Ethische Toetsingscommissie Jessa Ziekenhuis
Ethisch Comité van het Onze-Lieve-Vrouwziekenhuis (Aalst-Asse-Ninove)
01/10/2024
Comité d'Ethique Hospitalo-Facultaire Saint-Luc - UCLouvain
Ethisch Comité UZA/UAntwerpen
01/10/2026
Ethische commissie onderzoek UZ/KULeuven
[1] Federal Agency for Medicines and Health Products
The CT College is an independent body set up within the FPS for Public Health, Food Chain Safety and Environment (FPS HFCSE).
How are we organized?
Administrative Staff
File managers
Marlène Keck-Antoine (FR)
Lisa Reyckers (NL)
Jean Pirard (FR)
Annelies Marin (NL)
Bram Ottenbourgs (NL)
Julie Seronvalle (FR)
Marine Gillain (FR)
David Muls (NL)
Myriam De Rudder (FR)
Soetkin Theunynck (NL)
Board
Effective
Substitute
Physicians with experience in phase I clinical trials
Lucas Van Bortel, President (NL)
Rene Westhovens (NL)
Didier Verhoeven (NL)
Philip Debruyne (NL)
Experts in Quality control systems
Jurists
Links to European legislation:
Links to Belgian legislation:
Along with the administrative staff of the CT-College and with the FAMHP, a few members of fully recognized ethics committees recognized under the 2017 law contribute to the procedures for implementing the CTR,MDR and IVDR in Belgium.
The administrative staff of the CT-College, in collaboration with the FAMHP, organises an information session four times a to keep them informed of the principles and recommendations of the CT-College, changes of procedures, new documents to be used (templates), the application of the legislation and the new guidelines.
This presentation gives you more information on:
You'll find this presentation via this link.
General mailbox: ct.college@health.fgov.be
In this tab, you’ll find documents that have been approved and endorsed by the College Board. They have been classified by type: advices, guidelines, brochures and annual reports. You’ll find the Informed Consent Forms in the “Forms” tab.
Any questions or remarks regarding one document can be addressed to this email : ct.college(at)health.fgov.be
Recommendation regarding pre-recruitment for phase I clinical trials
Title
29/02/2024
Informatiebrochure voor interventionele studies met geneesmiddel bij volwassen patiënten
Following several discussions between the College, the AFMHP, and some industrial and academic sponsors, this recommendations to ethics committees concerning the approval of pre-recruitment...
Following several discussions between the College, the AFMHP, Healixia Early Development and the vaccine centrum (CEVAC and Vaccinopolis), this recommendations concerning the use of force majeure...
Following several discussions between the College, the FAMHP, and some industrial and academic sponsors, this recommendation to ethics committees concerning the reduction of the number of RFIs...
This presentation gives you more information on how the CTR, MDR, and IVDR have an impact on :
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...
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 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 working group consisted of representatives of BAREC (Belgian Association of Research Ethics Committees), pharma.be (the Belgian association of the innovative (bio)pharmaceutical industry) and patient organizations, and was coordinated by the CT-College at the FPS Health Food chain safety and Environment. During the review process of the proposed template the feedback on the content and format was also provided by laypersons.
Since the 1st of January 2020, this template has been used as a reference by the ethics committees evaluating the dossiers for clinical trials. To reduce the number of considerations, it is recommended for the sponsors to use this template for all the ICF’s for interventional clinical trials with an investigational medicinal product on adult patients.
Version 1.1. of the template was published in October 2013. This version contains decisions by the CT College Board and some minor adjustments. The changes compared to the version 1.0. are indicated in yellow.
Questions on the use of this template may be sent to ct.college@health.fgov.be”. Please mention “ICF_Template” in the subject of your mail.
Example - Trial at a glance
Model ICF for Vaccine Trials in adult Healthy Volunteers
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...
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...
In December 2022 the European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the use of decentralised elements in clinical trials as an outcome of their joint initiative to Accelerate Clinical Trials in the European Union (ACT EU).
The EU recommendations include an overview of national provisions for specific decentralised clinical trial elements to be used in clinical trials. Their primary goals are safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected.
Evidently, the recommendations are expected to evolve as knowledge increases and experience is gained. In particular, the overview of national provisions will be updated on a continuous basis.
ACT EU
The joint initiative ACT EU is a collaboration between EC, HMA and EMA that seeks to transform how clinical trials are initiated, designed and run.
The initiative was launched in January 2022 and aims to further develop the EU as a focal point for clinical research, to promote the development of high-quality, safe and effective medicines, and to better integrate clinical research in the European health system.
ACT EU will strengthen the European environment for clinical trials, whilst maintaining the high level of protection of trial participants, data robustness and transparency that EU/EEA citizens expect. ACT EU features ten priority action areas that are the basis for the ACT EU 2022-2026 workplan.
The original publication of the above mentioned EU recommendations concerning decentralised elements in clinical trials is available for downloading on the Public Health website of the EC: ‘Recommendation paper on decentralised elements in clinical trials’.
For more information and the official press release, please visit the EMA website.
