Deadline for application by registered letter: 25/02/2021.
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The European Medicines Agency is organizing an online two-part information and training session about Clinical Trial Information Systems (CTIS). This webinar is meant for micro, small and medium enterprises (SMEs) as well as for non-commercial sponsors (academia).
CTIS for SME and non-commercial sponsors: two-part information/training event foreseen Q1 2021. EU Portal.
For Micro, Small to Medium Enterprises (SMEs) and academia, EMA is organizing a targeted webinar to provide training on CTIS and its functionalities. The webinar is divided into two parts (Day 1 and Day 2) and participants are advised to attend both. This two-part event is free of charge.
Day 1: 22 Feb 2021 SME and academia Clinical Trials Information System (CTIS) two-part training webinar: Day 1 | European Medicines Agency (europa.eu)
Day 2: 4 Mar 2021 SME and academia Clinical Trials Information System (CTIS) two-part training webinar: Day 2 | European Medicines Agency (europa.eu)
As per current planning, Day 1 on 22ndFebruary 2021 will present CTIS access management, user management and different roles in CTIS. Day 2 on 4thMarch 2021 will focus on CTIS functionalities -how to submit and manage a clinical trial application. Transparency of reporting of results will also be presented on Day 2.
The webinar will include presentations by speakers from EMA system experts and presenters from SME and academic institutions, demonstration of the system, and opportunities for questions and answers. The webinar will be recorded and published for future perusal.
The CT-college recently published a template for informed consent form (ICF), that can be used for interventional clinical trials with an investigational vaccine in adult healthy volunteers.
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The CT-college recently published the following guidance on its website. This document describes the restrictions that should be taken into account when using electronic methods to inform a potential participant of a clinical trial and/or to have the ICF signed.
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In addition to the initial submissionform, the BAREC WG for biobanks has developed and finalized a document that aims to support the ethics committees performing the biannual evaluation of biobanks.
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On its latest general assembly, BAREC agrees on a statement concerning the section “trial at a glance” of the model ICF for interventional clinical trials with IMP adults.
A call for membership of the college for clinical trials has recently been published by the CT college.
Would you like to become a member of the Board of the Clinical Trials College?
The Clinical Trials College is looking for physicians, lawyers, and experts in quality control systems. For more information about the mission, tasks and competences of the College, the law, and its decrees, please visit www.ct-college.be.
A call to candidates was published in the Belgian Official Gazette on 03/08/2020:
If you meet the described conditions, you can send your application by registered letter to the federal Minister of Health, through Mr. Pedro Facon, Director-General of Healthcare, Eurostation, Blok II, Place Victor Horta 40, box 10, 1060 Brussels and this at the latest two months after publication of the call to candidates in the Belgian Official Gazette.
The aim is to provide sponsors and investigators with guidance on how to mitigate the effects of the pandemic in order to protect the safety, well-being and integrity of trial participants and the integrity of the trial.
The new version contains additional or new information about:
Informed consent in trials with COVID-19 patients;
IMP transfer and stocks with patients or at sites;
Communication with authorities of temporary trial halts due to reasons which are unrelated to the safety of the trial participants;
Stocks of in critical vitro diagnostics and other medical devices used in a particular trial;
