The Clinical Trial College (CT College) ensures that the ethical assessment of clinical trials on medicinal products for human use is carried out in Belgium :
The safety of the participants in the clinical trials is essential in this regard.
As described in the law of 7 May 2017, the mission of the CT-College is as follows:
[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
Sébastien Vanhiesbecq (FR)
Julien Frgacic (FR)
Marlène Keck-Antoine (FR)
Lisa Reyckers (NL)
Quality expert
Katelijne Anciaux (NL)
Board (to be appointed)
President
Vice-president
Expert in Quality control systems
Physician with experience in clinical trials
Jurist
Links to European legislation:
Links to Belgian legislation:
List of ethics committees recognised under the law of 7 May 2017:
Name Ethics Committee
Recognized for Clinical trials of Phase 1
Recognized since (date)
Comité d'éthique hospitalo-facultaire universitaire de Liège
Y
01/04/2019
Comité d'Ethique hospitalier CHU UCL Namur, site Godinne
N
Comité d'Ethique Hospitalo-Facultaire Erasme-ULB
01/10/2019
Ethische Toetsingscommissie Jessa Ziekenhuis
Ethisch Comité Onze-Lieve-Vrouwziekenhuis (Aalst)
01/10/2018
Comité d'Ethique Hospitalo-Facultaire Saint-Luc - UCLouvain
Ethische commissie onderzoek UZ/KULeuven
To prepare the implementation of the CTR[1] in Belgium, a number of clinical trial applications have been submitted by sponsors to the FAMHP as pilot projects since May 2017. The procedure to approve clinical trials complies with the national legislation of 7 May 2004, but the application dossier as well as the assessment follow the spirit of the new European Regulation and the Belgian law of 7 May 2017.
The administrative staff of the CT-College works during our pilot projects according to the tasks and competences described. You will find more information about this pilot project on the FAMHP’s website.
Along with the administrative staff of the CT-College and with the FAMHP, a few members of fully recognized ethics committees contribute to the procedures for implementing the CTR and MDR in Belgium.
Along with the administrative staff of the CT-College and with BAREC[2], a few members of fully recognized ethics committees, representatives of patient organisations and Pharma.be[3] contribute to the revision of templates for the Informed Consent Form.
Along with the administrative staff of the CT-College and with BAREC, a few members of fully recognized ethics committees, representatives of Pharma.be, BeCRO[4] and BAPU[5] contribute to the creation of a template for an Informed Consent Form for clinical trials in healthy volunteers.
In order to develop a separate template for vaccine trials in healthy volunteers, the working group has been expanded to include representatives of the Belgian vaccine centers.
In cooperation with the cabinet of Minister De Block and the FAMHP, the administrative staff of the CT-College organises three times a year an information session for the fully recognized ethics committees to inform them about the progress of the aforementioned initiatives.
[1]Clinical Trial Regulation
[2]Belgian Association of Research Ethics Committees
[3]The umbrella organization for the Belgian pharmaceutical industry
[4]Belgian association of Clinical Research Organizations
[5]Belgian association of Phase I units
This presentation gives more information on:
Implementation of CTR in Belgium and the impact on the ethical review process
General mailbox: ct.college@health.fgov.be
Title
Language
Publication date
Guidance for sponsors on the use of electronic informed consent in interventional clinical trials in Belgium
Informatiebrochure voor interventionele studies met geneesmiddel bij volwassen patiënten (pdf)
NL
19/03/2020
Brochure d’information relative aux études cliniques interventionnelles sur des patients adultes
Model ICF for interventional clinical trials with IMP on adult patients
EN
28/06/2019
Example – The trial at a glance
Information for ethics committees and sponsors on the informed consent procedure in trials ongoing at or completed before 25th may 2018 (pdf)
05/12/2018
ANNEX to the “Information for ethics committees and sponsors on the informed consent procedure in trials ongoing at or completed before 25th May 2018” (docx)
Implementation of CTR in Belgium and the impact on the ethical review process (pdf)
12/06/2018
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/...
This presentation gives you more information on how the CTR has an impact on :
A 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 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.
Sponsors are highly recommended to use the template, when preparing the ICF(s) for all new initial interventional clinical trials on adult patients. During the next six months a transitional period will be in place during which both the old and the new template can be used. From 1st January 2020, the ethics committees will require that only the new template is used by all sponsors.
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.
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...
The Clinical Trial College is looking for physicians, lawyers, and experts in quality control systems.
On the 8th of August 2020, a new call for members of the Clinical Trials college was published in the Belgian Monitor.
Link to PDF (only available in French and Dutch).
If you meet the conditions described, you can send your application by registered letter to the federal Minister of Health, through Mr. Pedro Facon, Director-General of Healthcare, Eurostation, Blok II, Place Victor Horta 40, box 10, 1060 Brussels and this at the latest two months after publication of the call to candidates in the Belgian Official Gazette.
A European guidance has been available on Eudralex since 20/03/2020.
This document will provide directions to sponsors and investigators on the subject of:
This guidance is supported by the FAMHP, the CT-College and Barec and will be adapted regularly to the evolution of the pandemic.
On 29/04/2020, a new version of the national guidance was published on the website van the FAMHP. This national guidance is to be read in conjunction with the latest version of the European guidance on the management of clinical trials during the COVID-19 (Coronavirus) pandemic.
The national guidance is the result of a collaboration between the FAMHP, the CT-College, Barec and some clinical trial sites. The guidance is applicable at the time of publication and complements the European guidelines. The document will provide directions to clinical trial sponsors in the management of:
The national guidance now includes answers to frequently asked questions and will be regularly adapted to the evolution of the pandemic.
Since 25 March 2020, shortened delays are used for the applications for clinical trials with medicinal products for the treatment or prevention of COVID-19. These were officially anchored by the FAMHP in the circular of 8 July 2020.
Applications for clinical trials within the procedure for pilot projects contained in art. 34/1, §1. of the law on Experiments of 2004, will be treated in four working days.
For clinical trials with advanced therapies (medicinal products for somatic cell therapy, tissue manipulation products, or medicinal products for gene therapy) or for medicinal products that contain genetically modified organisms (GMOs), a shortened delay of ten working days is applied.
The details can be found in Circular 650 (only available in French and Dutch).
Press release of 21 April 2017 on the publication of the law on clinical trials with medicinal products for human use.
Information session for fully recognized ethics committees taking part in the pilot project:
