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The Protocol Deviations (DV) is an events domain that contains protocol violations and deviations during the course of the study.

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



 

This is the SDTM data that was collected on a DV CRF. The DVDECOD column is for controlled terminology; the DVTERM captures free text.
Rows 1, 3:Show examples of a study product assignment and study product administration protocol deviations.
Row 2:Shows an example of a deviation due to the subject taking a prohibited concomitant medication.
Row 4:Shows an example of a medication that should not be taken during the study.

dv.xpt

xx.xpt

RowSTUDYIDDOMAINUSUBJIDDVSEQDVTERMDVDECODEPOCHDVSTDTC
1ABC123DV1231011IVRS PROCESS DEVIATION - NO DOSE CALL PERFORMED.STUDY PRODUCT ASSIGNMENT DEVIATIONSTUDY PRODUCT EXPOSURE2003-09-21
2ABC123DV1231031BUPROPION ADMINISTERED DURING STUDY PRODUCT EXPSOUREEXCLUDED CONCOMITANT MEDICATIONSTUDY PRODUCT EXPOSURE2003-10-30
3ABC123DV1231032VISIT 3 DOSE <15 MGSTUDY PRODUCT ADMINISTRATION DEVIATIONSTUDY PRODUCT EXPOSURE2003-10-30
4ABC123DV1231041TOOK ASPIRINEXCLUDED CONCOMITANT MEDICATIONSTUDY PRODUCT EXPOSURE2003-11-30
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Dataset Wrapper Debug Message

Please add a row column to your dataset.

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