This template for the Informed Consent Form (ICF) for interventional clinical trials with an investigational vaccine in adult healthy volunteers was prepared by a dedicated working group. This...


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...


This document describes the restrictions that should be taken into account when using electronic methods to inform a potential participant of a clinical trial and/or to have the ICF signed.