SSStudyParticipantsInformedConsent object
Standard IC form (ICF) available
Not specified
Informed Consent - Definition/ Requirements
The definition for “Informed subject consent” resp. “willing informed consent” is provided in Art 2 (9) of Rulebook Application 2011.
Informed consent must be obtained from the study participants in written form (in verbal form under special provisions) and in Serbian language according Art 61 of Law on MP & MD 2010
Applicable national legal framework/ Reference
Art 2 (9) of Rulebook Application 2001
At 61, 63-67 Law on MP & MD 2010
Additional Information
There are specific requirements to be considered for vulnerable populations such as children, pregnant and lactating women, prisoners and adults who are not able to give written consent for trial participation (according to Art 63-67 of Law on MP & MD 2010).