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guidance_on_use_of_e-icf_vf.pdf

Guidance for sponsors on the use of electronic informed consent in interventional clinical trials in Belgium

Dieses Dokument beschreibt die Einschränkungen, die bei der Verwendung elektronischer Methoden zur Information eines potenziellen Teilnehmers über eine klinische Prüfung und/oder zur...

30-09-2020

Publikationen›Dokumente

CT-Kollegium (Kollegium Klinische Prüfungen)

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info_ctr_ec_vf2_20180612.pdf

Implementation of CTR in Belgium and the impact on the ethical review process

This presentation gives you more information on how the CTR has an impact on :

the approval process of a clinical trial
the ethical review process

12-06-2018

Publikationen›Präsentation

CT-Kollegium (Kollegium Klinische Prüfungen)

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icf_gdpr_advice_en_vf2_20181205_url_annex_nl_fr.pdf

FAQs on IC procedure in trials ongoing at or completed before 25th May 2018 (v2.0)

Information for ethics committees and sponsors on the informed consent procedure in trials ongoing at or completed before 25th May 2018

This document contains FAQs on the IC procedure in trials ongoing at or completed before the implementation of the GDPR.

05-12-2018

Publikationen

CT-Kollegium (Kollegium Klinische Prüfungen)

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en_model_icf_interv_trial_adult_patients_version1_20190628_inclurl.docx

ICF-template-interv-trial-adult-patient-EN

Model ICF for interventional clinical trials with IMP on adult patients

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...

28-06-2019

Formulare

CT-Kollegium (Kollegium Klinische Prüfungen)

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protocol_socialeezkerheidsstelsel_verstrekkingen_bij_ziekte.pdf

Protocolakkoord - coördinatie van de socialezekerheidsstelsels op het gebied van verstrekkingen bij ziekte

Protocolakkoord tussen de Federale Regering en bepaalde in artikel 128, 130, 135 en 138 van de Grondwet bedoelde overheden inzake de toepassing van de Verordeningen (EG) 883/2004 en 987/2009...

25-03-2019

Protocol

Interministeriële conferentie volksgezondheid

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