SSStudyParticipantsInformedConsent object
Standard IC form (ICF) available
Not specified
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements
The investigator must inform the participant orally and in writing on the nature, benefits, risks and implication of the clinical trial as well as his/her right to withdraw from the clinical trial at any time for any reason without disadvantaging the participant. The written informed consent form should be signed and personally dated by the subject.
Applicable national legal framework/ Reference
Art 38 & 39 AMG
Additional Information
Specific provisions apply to certain groups of persons such as minors, incapacitated persons, pregnant women, subjects in emergency situations (At 42-44 AMG).
