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Diese Präsentation bietet weitere Informationen über:
- die Änderungen, die die CTR im Rahmen des Zulassungsverfahrens für eine klinische Prüfung zur Folge hat, und
- die Auswirkungen auf die ethische Auswertung.
Implementation of CTR in Belgium and the impact on the ethical review process
Allgemeines Postfach:
Titel |
Sprache |
Veröffentlichungsdatum |
Stellungnahme für belgische EK bezüglich der Bewertung von Sicherheitsberichten in CTR-Anträge |
EN | 03/06/2022 |
Model ICF for Vaccine Trials in adult Healthy Volunteers | EN, FR, NL | 12/10/2020 |
EN |
30/09/2020 v2.0 29/06/2022 |
|
Brochure d’information relative aux études cliniques interventionnelles sur des patients adultes |
FR |
19/03/2020 |
FR |
28/06/2019 |
|
FR |
28/06/2019 |
|
EN |
05/12/2018 |
|
EN |
05/12/2018 |
|
Implementation of CTR in Belgium and the impact on the ethical review process (pdf) |
EN |
12/06/2018 |
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This new template for the Informed Consent Form (ICF) for interventional clinical trials with an investigational medicinal product on adult patients was prepared by a dedicated working group. This working group consisted of representatives of BAREC (Belgian Association of Research Ethics Committees), pharma.be (the Belgian association of the innovative (bio)pharmaceutical industry) and patient organizations, and was coordinated by the CT-College at the FPS Health Food chain safety and Environment. During the review process of the proposed template the feedback on the content and format was also provided by laypersons.
Sponsors are highly recommended to use the template, when preparing the ICF(s) for all new initial interventional clinical trials on adult patients. During the next six months a transitional period will be in place during which both the old and the new template can be used. From 1st January 2020, the ethics committees will require that only the new template is used by all sponsors.
Questions on the use of this template may be sent to ct.college@health.fgov.be”. Please mention “ICF_Template” in the subject of your mail.
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Informationsaktivität für vollständig anerkannte Ethik-Kommissionen, die an dem Pilotprojekt teilnehmen :
Die folgende Aktivität findet am 04/10/2022 statt.