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 participate in a clinical trial with an investigational medicinal product (IMP).
Are you a treating physician of a patient who might be eligible to participate in a clinical trial with an IMP?
This brochure can be useful to you as a tool to help inform your patients about their general rights and obligations when participating in a clinical trial before referring them to an investigator.
Are you a patient and considering potentially participating in a clinical trial, but haven’t yet contacted your treating physician or an investigator (this is the specialist who will lead the clinical trial)?
In case you wish to participate in a clinical trial as an adult, you will need to sign an informed consent form (ICF). This brochure can already give you a general idea of the contents of this ICF, and of your rights and obligations as a participant in a trial with an investigational drug.
Are you a patient representative or ombudsperson?
This brochure can be used by anyone who has not yet participated in a clinical trial and is looking for more information about their rights and obligations in case of a possible participation.