This template is intended to prepare an informed consent form (ICF) for adult patients participating in a clinical investigation with a medical device, that is assessed by an independent Belgian Ethics Committee recognized under the Belgian legislation of 7 May 2017.
As a kind reminder, the use of the ICF templates will become mandatory as of 1 August.
We are delighted to invite you to our next Symposium on the 23rd of November 2024.
BAREC wishes to provide clear guidance on the reimbursement of contraception-related expenses in the context of clinical trials, emphasizing the principle that sponsors should cover these costs when a participant is required to use contraception as part of the study protocol.
If you would like to read more about this, please consider becoming a Barec-member and acquire access to our member area.
Please contact us for more information on becoming a member via: info@barec.be
Some information concerning the compensation of participants in clinical research.
If you would like to read more about this, please consider becoming a Barec-member and acquire access to our member area.
Please contact us for more information on becoming a member via: info@barec.be
Clinical studies with questionnaires (outside SoC): Interventional vs non-interventional?
From BAREC, we give an advice on how to consider studies involving questionnaires (outside standard of care (SoC)) and which fall under the (Belgian) law of 7 May 2004 to be interventional or non-interventional.
BAREC STATEMENT on decentralized trials
Decentralized elements are trial related actions that are subcontracted by the sponsor to an external party and not offered via the site.
If the clinical investigation with a CE-marked medical device, that is used within its intended purpose, is not considered to be a PMCF, only positive advice from the relevant EC(s) is necessary and “Regulatory pathway: EC only” needs to be followed. The “Other clinical investigations” are regulated under the Royal Decree of 18 May 2021 and as such a timeline of 45 days is applicable to issue an EC-decision.