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 TREATMENT 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
Row
STUDYID
DOMAIN
USUBJID
DVSEQ
DVTERM
DVDECOD
EPOCH
DVSTDTC
1
ABC123
DV
123101
1
IVRS PROCESS DEVIATION - NO DOSE CALL PERFORMED.
TREATMENT DEVIATION
TREATMENT
2003-09-21
2
ABC123
DV
123103
1
DRUG XXX ADMINISTERED DURING STUDY TREATMENT PERIOD