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This is an example CRF used to collect informed consent.



OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1What was the category of the disposition?Disposition CategoryIf collected on the CRF, the applicant provides instructions to ensure the data is entered as intended.TextDSCATDSCATDSCAT="PROTOCOL MILESTONE" where DSDECOD and DSTERM="INFORMED CONSENT OBTAINED"(DSCAT)
PROTOCOL MILESTONE
2What was the informed consent date?Informed Consent DateRecord the date of informed consent as defined in the protocol and/or CRF completion instructions using this format.DateDSSTDATDSSTDTC



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