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This presentation gives you more information on:
- the implementation of the CTR, MDR and IVDR in Belgium
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
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Title | Language | Publication date |
---|---|---|
Advice for Belgian ECs regarding the assessment of safety reports in CTR applications | EN | 18/02/2022 |
Advice of BAREC for patient facing documents | EN | 20/10/2023 |
Recommendation for Belgian ECs regarding the use of force majeure | EN | 20/10/2023 |
Recommendation for Belgian ECs to reduce the number of RFIs | EN | 20/10/2023 |
Title |
Language | Publication date |
---|---|---|
Rapport annuel 2021-2022 du CT-Collège | FR |
29/02/2024 |
Jaarverslag 2021-2022 van het CT-Collège | NL | 29/02/2024 |
Title | Language | Publication date |
---|---|---|
Brochure d'information relative aux études cliniques interventionnelles sur des patients adultes | FR | 06/02/2020 |
Informatiebrochure voor interventionele studies met geneesmiddel bij volwassen patiënten |
NL | 06/02/2020 |
Title | Language | Publication date |
---|---|---|
Guidance for sponsors on the use of electronic informed consent in interventional clinical trials in Belgium | EN | v2. 20/05/2022 |
Recommendation paper on decentralised elements in clinical trials | EN | 14/12/2022 |
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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Title | Language | Publication date |
---|---|---|
Model ICF for interventional clinical trials with IMP on adult patients | FR, NL, EN | 15/09/2023 |
EN | 28/06/2019 | |
FR, NL, EN | 21/09/2020 |
Recommendation of EU on decentralised elements in clinical trials
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.