This new template for the Informed Consent Form (ICF) for interventional clinical trials with IMP on adult healthy volunteers was prepared by Healixia and BAREC and is based on the already existing ICF template for vaccine trials. During October – November 2024, feedback was requested from the ethics committees recognized for phase I trials under the law of 7 May 2017. If necessary, changes to the templates will be implemented in future versions.
The template was approved by the College Board on 24/01/2025. As of August 1st 2025, the use of this template will become mandatory for all new initial applications for interventional clinical trials with an investigational medicinal product in adult healthy volunteers.
This template (in 3 languages) was approved by the CT College. Only the study specific text should be translated while standard text should be maintained. Sponsors should refrain from having the full ICF translated and restrict any modifications/translations to study-specific sections.
