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Author: Editor

Outstanding FAMHP subidies 2018

Written by Editor on . Posted in News.

In December we were informed by the FAMHP, that the outstanding payments for 2018 would be paid within 4 months. The Royal Decree has been published on 19 December 2024, see below.

Het Koninklijk Besluit betreffende de toekenning van de subsidie 2018 aan ethische comités werd op 19/12/2024 gepubliceerd in het Belgisch Staatsblad. U kan de publicatie raadplegen via volgende link: https://www.ejustice.just.fgov.be/mopdf/2024/12/19_1.pdf#page=102. De tabel vermeldt het bedrag waarop uw Ethisch comité recht heeft.

L’Arrêté Royal relatif à relatif à l’octroi du subside 2018 aux comités d’éthique a été publié au Moniteur belge en date du 19/12/2024. Vous pouvez consulter la publication via le lien suivant : https://www.ejustice.just.fgov.be/mopdf/2024/12/19_1.pdf#page=102. Le tableau reprend le montant auquel votre comité d’éthique a droit.

ICF template for adult patients participating in a clinical investigation involving a medical device (MDR-studies)

Written by Editor on . Posted in ICF.

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.

SponsorStatementModel_ICF_clinical investigation_adult_patients_V2_20250206Download
EN_Model ICF_clinical investigation_Adult_Patients_version1_2_20250718Download
NL_Model ICF_Clinical_Investigation_Adult_Patients_version2_2_20250718Download
FR_Model ICF_Clinical_Investigation_Adult_Patients_version1_3_20250925Download

Compensation contraception

Written by Editor on . Posted in Compensation.

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.

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Final Advice Clinical studies with questionnaires

Written by Editor on . Posted in 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.

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