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This presentation gives more information on:
- the changes that comes with the CTR in the approval process of a clinical trial; and
- the impact on the ethical evaluation.
Implementation of CTR in Belgium and the impact on the ethical review process
General mailbox: ct.college@health.fgov.be
Title |
Language |
Publication date |
Model ICF for Vaccine trials in adult Healty Volunteers | EN, FR, NL | 12/10/2020 |
EN | 30/09/2020 | |
Information brochure for interventional trials with medicinal products for adult patients |
NL |
19/03/2020 |
Information brochure for interventional trials with medicinal products for adult patients |
FR | 19/03/2020 |
Model ICF for interventional clinical trials with IMP on adult patients |
EN |
28/06/2019 |
EN |
28/06/2019 |
|
EN |
05/12/2018 |
|
EN |
05/12/2018 |
|
Implementation of CTR in Belgium and the impact on the ethical review process (pdf) |
EN |
12/06/2018 |
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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.
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Call for candidates for membership of the Clinical Trials College
The Clinical Trials College is looking for:
- four physicians experienced in the execution or evaluation of clinical trials;
- two lawyers
- two experts in quality control systems.
Interested?
- For more information, refer to the call for candidates that was published in the Belgian Official Gazette on 11/02/2021, which is available on the FPS website (only in Dutch and French).
- Apply by registered letter before 25/02/2021.
European guidance on the management of clinical trials during the COVID-19 (Coronavirus) pandemic
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:
- clinical trials for treatment or prevention of COVID-19,
- ongoing clinical trials in Belgium, and
- the advice for new non-COVID-19-related clinical trials.
This guidance is supported by the FAMHP, the CT-College and Barec and will be adapted regularly to the evolution of the pandemic.
Coronavirus: National guidance clarifying the European guidance for the management of clinical trials during the coronavirus 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:
- clinical trials for treatment or prevention of COVID-19, and
- ongoing clinical trials in Belgium.
The national guidance now includes answers to frequently asked questions and will be regularly adapted to the evolution of the pandemic.
Coronavirus: Circular of the FAMHP with shortened delays for clinical trials
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).
The law on clinical trials with medicinal products for human use
Press release of 21 April 2017 on the publication of the law on clinical trials with medicinal products for human use.
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Information session for fully recognized ethics committees taking part in the pilot project:
- The next session will take place on 27/05/2021.