SSStudyParticipantsInformedConsent object
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements
Definition provided in Art 4 (2b) GCP-V.
Requirements: The participant of a clinical trial must be informed by the investigator who must be a physician about the nature, significance, risks and implications of the clinical trial as well as about his/her right to withdraw from the clinical trial at any time; without reason; a generally comprehensible written information is to be handed out to him/her.
The clinical trial may only be commenced after the participant has given his/her consent to participate in writing.
The declaration of consent to participate in a clinical trial can be revoked at any time, orally or in writing, without disadvantaging the participant.