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 working group consisted of representatives from pharma.be (the Belgian association of the innovative (bio)pharmaceutical industry), BeCRO, (the Belgian association of CRO’s), ethics committees and vaccine trial sites, and was coordinated by the Federal Agency for Health and Medicinal Products (FAMHP) in collaboration with the CT-College at the FPS Health Food chain safety and Environment.
Additional guidance on the use of this template is given in the power point.
To avoid questions from ethics committees, sponsors are highly recommended to use the template, when preparing the ICF(s) for all new initial interventional clinical trials with an investigational vaccine in adult healthy volunteers. Ethics committees will use this template as a reference when evaluating this type of trials.
The attached zip-file contains
- the template in English, French and Dutch
- a power point with guidance for the sponsor on how to use the template documents in English, French and Dutch
- a template to prepare a sponsors’ statement (in English)
Questions on the use of this template may be sent to firstname.lastname@example.org”. Please mention “ICF_Template Vx trials in HV” in the subject of your mail.