CT-College (Clinical Trial College)

Comittee left menu

Activity

Vertical Tabs

Mission

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 :

within the harmonised European approval process;
with the required quality; and
independently of the sponsor, the clinical trial site, the investigators involved and any other undue influence.

The safety of the participants in the clinical trials is essential in this regard.

Tasks & Competences

As described in the law of 7 May 2017, the mission of the CT-College is as follows:

to guarantee the communication between the FAMHP[1] and the ethics committees (ECs) as unique point of contact;
to select the independent EC that will carry out the ethical assessment of the clinical trial dossiers submitted, and to follow up these submission dossiers;
to ensure a coherent application of the law during this assessment;
to ensure the coordination, harmonisation and quality control of these ECs.

[1] Federal Agency for Medicines and Health Products

Organogram

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?

As of now, our administrative cell comprises:
- a project leader, who coordinates the implementation of this new mission within the FPS HFSCS and represents the project during national and European meetings;
- a quality expert, who mainly focuses on the development, implementation and follow up of a quality system for the CT-College as well as for the recognized ethics committees;
- file managers, who follow up the ongoing assessment dossiers.

In the future, the minister will appoint a Board of the CT-College, which will at least comprise:
- an expert in quality control systems;
- two doctors with experience in performing or evaluating clinical trials;
- a jurist.

Administrative Staff
Project leader	Lisa Marynen (NL)
Quality expert	Katelijne Anciaux (NL)
File managers	Sébastien Vanhiesbecq (FR)
Board (to be appointed)
President
Vice-president
Expert in Quality control systems
Doctor with experience in clinical tests
Doctor with experience in clinical tests
Jurist

Legislation

Links to Belgian legislation:

Links to European legislation:

Clinical trial regulation 536/2014 (CTR)

On the website of the European Commission

PDF version in English

Workgroups

Pilot project according to Art. 58 of the law of 7 May 2017)
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.
Working group Assessment Report & Workflow
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 in Belgium.
Working group Informed Consent Form
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
contribute to the revision of templates for the Informed Consent Form.
Information sessions for fully recognized ethics committees wishing to take part in the pilot project
In cooperation with the cabinet of Minister De Block and the FAMHP, the administrative staff of the CT-College organises every three months 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