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

Example

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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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