Patients, and/or in specific circumstances their legally designated representative(s), are requested to give written consent before participating in a clinical trial.
Informed Consent Form
An ICF is the document with which the subjects (and/or their representative(s)) confirm that they agree to participate in a clinical trial. The term ‘informed’ reflects the fact that the subject has been fully informed about the clinical trial in a prior interview and with the help of the Patient Information Leaflet. The ICF is dated and signed by both the subject/representative(s) and the member of the investigating team who conducted the interview. Assent means that they agree to take part.
ICF in the European Union
According to the Directive 2001/20/EC, the procedure for obtaining informed consent is one of the aspects to be considered by the Ethics Committees (ECs) in their assessment of a clinical trial. The ICF is therefore included in all EC applications. It should be written in the appropriate language(s) of the country concerned by the clinical trial. It is classically attached to the Patient Information Leaflet.
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