SSStudyParticipantsInformedConsent object
Standard IC form (ICF) available
Not specified
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements
The provisions related to the informed consent form and the patient information sheet is provided in Royal Decree 1090/2015 art 4 and Regulation (UE) n.º 536/2014
Additional Information
Informed consent obtained from vulnerable subjects (e.g. minors and incapacitated adults) who are potentially involved in the CT is specifically covered in Art 4 of Royal Decree 1090/2015.