This information brochure contains an overview of the general (non-study-specific) information that is present in every informed consent form (ICF) that is presented to adult patients who wish to...
This new version of the template for the Informed Consent Form (ICF) for interventional clinical trials with an investigational medicinal product on adult patients was prepared by a dedicated...
This document contains an example of the chapter “The trial at a glance” of the Model ICF for interventional clinical trials with IMP on adult patients.
Intention of this template: The sponsor must add to the submission file a statement which describes which version of the ICF template was used, and (if applicable) which changes were made to the...
