Final Advice Clinical studies with questionnaires

Aug 16, 2023 | Advice

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...

Statement on decentralized trials

Apr 18, 2023 | Advice

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.   Fully decentralized trials, where there is no contact between the...

Medical Device Regulation (MDR): role local EC + timelines EC  

Apr 18, 2023 | Advice

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...

EC forms for evalution of biobanks

Nov 8, 2022 | Advice

EC forms for evalution of biobanks EC forms for evaluation of biobanks (last versions) EC forms for evaluation of biobanks (last versions) developed by the BAREC workgroup on biobanks, in consultation with different stakeholders. Initial submission Biennial evaluation...

ICF – Trial at a glance

Sep 3, 2020 | Advice

ICF – Trial at a glance ICF – 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: BAREC...

Biobank

Jul 20, 2018 | Advice

Biobank Law on human material, consolidated version Compendium – Biobanks dated July 20, 2018 Submission for ethics committee: A submission form has been developed in consultation with different stakeholders and is intended to harmonise the way advice should be...