SSStudyParticipantsInformedConsent object
Standard IC form (ICF) available
Yes
Standard IC form (ICF)
Templates for the Dutch informed consent form, the Dutch Patient Information Form (PIF) and for other information material for research subjects are provided on the CCMO website in section Home>Investigators>Standard research file (E. Information for the research subjects)
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements
“informed, written, dated and signed consent to take part in a clinical trial” (pursuant to Section 1(1.u) WMO (en))
Applicable national legal framework/ Reference
Special provisions regarding informed consent including consent obtained in vulnerable populations are specified in section 6 of WMO (en)