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...

ICF templates voor niet interventionele studies

Apr 18, 2023 | Document

ICF templates voor niet interventionele studies EN_Model for non-interventional study-20181109 FR_Modèle DIC étude non interventionnelle-20181109 NL_Model ICD niet-interventionele studie-20181109     If you would like to read more about this, please consider...

Submission study before 31 January 2023

Jan 9, 2023 | News

Submission study before 31 January 2023 CTIS was launched on 31 January 2022, starting the clock for the one-year transition time for all sponsors of clinical trials. During the first year of the transition period, clinical trial sponsors can choose whether to submit...

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...