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OrderQuestion TextPromptCRF Completion InstructionsCDASH Variable Name SDTMIG Target VariableSDTM Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated Value
1Were there any protocol deviations?Any DeviationsEnter Yes if a protocol deviation occurred and No if none occurred. Ensure that any adverse event which triggers a protocol deviation (e.g., concomitant medication use, newly discovered medical history) is noted on the respective CRF.DVYNN/ANOT SUBMITTED(NY)Yes; No
2What is the protocol deviation identifier?DV NumberIf collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier.DVSPIDDVSPIDDVSPID


3What was the protocol deviation?Protocol DeviationRecord protocol deviations identified and/or select the appropriate code from the list of protocol deviation terms.DVDECODDVDECODDVDECOD
INFORMED CONSENT NOT OBTAINED; INCLUSION CRITERIA NOT MET; STUDY PRODUCT ASSIGNMENT DEVIATION; STUDY PRODUCT ADMINSTRATION DEVIATION; EXCLUDED CONCOMITANT MEDICATION; OTHER
4What was the protocol deviation term?Specify Protocol DeviationRecord the protocol deviation TERMDVTERMDVTERM


5What was the protocol deviation start date?Start DateRecord the start date for the protocol deviation using this format (DD-MON-YYYY). This should be the start or occurrence of the protocol deviation, not the date it was discovered or reported.DVSTDATDVSTDTCDVSTDTC


6What was the protocol deviation end date?End DateRecord the end date of the protocol deviation using this format (DD-MON-YYYY). This should be the date the protocol deviation stopped, not the date it was discovered or reported.DVENDATDVENDTCDVENDTC


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