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This is an example of data that was collected on a protocol-deviations CRF. The DVDECOD column is for controlled terminology, whereas the DVTERM is free text.

Rows 1, 3:Show examples of a STUDY PRODUCT ASSIGNMENT and STUDY PRODUCT ADMINSTRATION DEVIATION type of protocol deviation.
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
2ABC123DV1231031DRUG XXX ADMINISTERED DURING STUDY PRODUCT EXPSOURE EXCLUDED CONCOMITANT MEDICATIONSTUDY PRODUCT EXPOSURE2003-10-30
3ABC123DV1231032VISIT 3 DOSE <15 MGSTUDY PRODUCT ADMINSTRATION DEVIATIONSTUDY PRODUCT EXPOSURE2003-10-30
4ABC123DV1231041TOOK ASPIRINEXCLUDED CONCOMITANT MEDICATIONSTUDY PRODUCT EXPOSURE2003-11-30

Dataset Debug Message

There is a leading, trailing, or non-breaking space in the dataset.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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