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Author: Editor

ICF – Trial at a glance

Written by Editor on . Posted in ICF.

As the use of the ICF templates for CTR and MDR studies is mandatory since 01/08/2025, the advice below is thus complied with. The ICF templates already include a section ‘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:

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Membership board clinical trials college

Written by Editor on . Posted in News.

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.

European Guidance: UPDATE

Written by Editor on . Posted in News.

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:

  • distributor to trial participant IMP shipment,
  • monitoring,
  • remote source data verification and
  • communication with authorities

2nd version European Guidance

Written by Editor on . Posted in News.

Please find an updated version of the European guidance was published on EudraLex-10.

Go to document

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;
  • Safety reporting

Coronavirus: National Guidance

Written by Editor on . Posted in News.

A national guidance has been published on the website van the FAMHP:
https://www.fagg.be/nl/news/coronavirus_belgische_richtsnoer_voor_het_beheer_van_klinische_proeven_tijdens_de

This national  guidance is to be read together with the latest version of the European guidance on the management of clinical trials during the COVID-19 (Coronavirus) pandemic:
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf.

The document is the result of a collaboration between the FAMHP, the CT-College, BAREC and some clinical trial sites.

It is complementary to the European guidance and provides additional directions to clinical trial sponsors in the management of Belgian

(i) clinical trials for treatment or prevention of COVID-19, and
(ii) ongoing clinical trials.

This national guideline will be regularly adapted to the evolution of the pandemic.

European guidance on the management of clinical trials during the COVID-19 pandemic

Written by Editor on . Posted in News.

A European guidance
(https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf) has been published, which will provide directions to sponsors and investigators on the subject of

  • clinical trials for treatment or prevention of COVID-19,
  • ongoing clinical trials in Belgium, and
  • the advice for new non-COVID-19-related clinical trials.

This guidance is supported by the FAMHP, BAREC and the CT-College.

Please note that on some subjects, a more detailed national guidance is being prepared on the conditions for direct distribution of the medicinal product to the patient.

This national guidance is expected to be published by the 25th of March 2020 and will be attuned to the European guidance.

NEWStemplate

Written by Editor on . Posted in Old Templates.

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If you would like to read more about this, please consider becoming a Barec-member and acquire access to our member area.
Please contact us for more information on becoming a member via: info@barec.be

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