Guidance on Compensation of Clinical Research Participants
Some information concerning the compensation of participants in clinical research.
Final Advice Clinical studies with questionnaires
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.
Statement on decentralized trials
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.
Medical Device Regulation (MDR): role local EC + timelines EC
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.
ICF – Trial at a glance
As the use of the ICF templates for CTR and MDR studies is mandatory since 01/08/2025, the advice below is thus complied with. The ICF templates already include a section ‘Trial at a glance’.
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:
Biobank
Law on human material, consolidated version
Compendium – Biobanks dated July 20, 2018
Insurance Coverage – Clinical Trials
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.