SSStudyParticipantsInformedConsent object
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements
Informed Consent is covered in Art 6 Decree No 35/2005 and Art 10 Decree No 33/2009 of the Minister of Health in detail.
Specific requirements for the consent form are provided in Art 10 (5) Decree No 33/2009 of the Minister of Health.