SSStudyParticipantsInformedConsent object
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements
Informed consent needs to be obtained in writing before the commencement of a clinical trial. Definition according to Article L1122-1 Chapter 2 CSP.
Applicable national legal framework/ Reference
Art L1122-1 Chapter 2 CSP
Art L1121-5 to 9 (Chapter 1 CSP), L1122-1 & 2
Additional Information
Special conditions apply for the inclusion of vulnerable persons (e.g. children, pregnant and lactating women and adult protected by the law.