This example DV CRF has 2 sections: Section 1 collects whether the subject had any protocol deviations, and the second section creates a row/record for every deviation each subject experienced. 

Section 1 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList 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.TextDVYN
Not Submitted(NY)No;Yes;
Section 2 
OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
2What is the protocol deviation identifier?DV NumberIf collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier.TextDVSPIDDVSPID



3What was the protocol deviation?Protocol DeviationRecord protocol deviations identified and/or select the appropriate code from the list of protocol deviation terms.TextDVDECODDVDECOD

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 TextDVTERMDVTERM



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.DateDVSTDTCDVSTDTC



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.DateDVENDTCDVENDTC