Advice BAREC patient facing documents
Based on the Question & Answers document provided from the Clinical Trials Regulation (EU) No
536/2014, not all patient facing documents need to be submitted for EC review.
Based on the Question & Answers document provided from the Clinical Trials Regulation (EU) No
536/2014, not all patient facing documents need to be submitted for EC review.
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.
The participants in a clinical trial should reflect the target population. Adequate reporting of race and ethnicity can potentially contribute to better understanding of cultural, social, and biological differences, enabling the identification of population groups disproportionately affected by certain diseases, along with genetic information collected from study participants.
Some information concerning the compensation of participants in clinical research.
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.
On 3/9/2020, the general assembly of BAREC agrees on the following statement regarding the section “trial at a glance” of the ICF template for interventional clinical trials with IMP on adult patients:
Law on human material, consolidated version
Compendium – Biobanks dated July 20, 2018
On many occasions during previous meetings of BAREC, several members have expressed the wish to discuss harmonisation of insurance amounts used in the frame of clinical trials.