SSStudyParticipantsInformedConsent object
Standard IC form (ICF) available
Not specified
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements
Prior to the commencement of a clinical trial, informed consent must be obtained from study subjects. Specific provisions specified in 37b(2) and 37f Pharmaceutical Law 2001 (en) and Art 25(1) Physician’s Profession Act 1996 (Dz.U. 1997 nr 28 poz. 152).
Applicable national legal framework/ Reference
37b(2) and 37f Pharmaceutical Law 2001 (en)
Art 25(1) Physician’s Profession Act 1996 (Dz.U. 1997 nr 28 poz. 152)
Additional Information
Special provisions apply to vulnerable populations such as minors, incapacitated adults and subjects in emergency situations according to Art 37h & 37i Pharmaceutical Law 2001.