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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Online information session organized by BAREC WG biobank and BBMRI.be (members only)
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Evaluation of Biobanks
In addition to the initial submission form, the BAREC WG for biobanks has developed and finalized a document that aims to support the ethics committees performing the biannual evaluation of biobanks.
EC Submission form for Biobanks
EC Form for 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.
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:
Members only.
September 3rd, 2020
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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:
https://overlegorganen.gezondheid.belgie.be/sites/default/files/documents/290583_ka_pub.pdf
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.
Today an updated version of the European guidance was published on EudraLex10:
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
The related press release announcing the publication can be found here: https://ec.europa.eu/commission/presscorner/detail/en/ip_20_759
The new version contains additional or new information about:
Please find an updated version of the European guidance was published on EudraLex-10.
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:
