SSStudyParticipantsInformedConsent object
Standard IC form (ICF) available
Not specified
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements
Definition: 'a voluntary and provable expression of the will of the person who is to become a trial subject, or his/her guardian or custodian, to undergo the clinical investigation, confirmed by the signature of the trial subject or, where applicable, his/her guardian or custodian.'
Definition and specific requirements are provided in Section 18 of Act No 268/2014 Coll. on Medical Devices
Applicable national legal framework/ Reference
Section 18 of Act No 268/2014 Coll. on Medical Devices