This is an example of the SDTM data that was collected on a protocol-deviations DV CRF. The DVDECOD column is for controlled terminology, whereas ; the DVTERM is captures free text.
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| Rows 1, 3: | Show examples of a STUDY PRODUCT ASSIGNMENT and STUDY PRODUCT ADMINSTRATION DEVIATION type of protocol deviationstudy 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. | |
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| Row | STUDYID | DOMAIN | USUBJID | DVSEQ | DVTERM | DVDECOD | EPOCH | DVSTDTC |
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| 1 | ABC123 | DV | 123101 | 1 | IVRS PROCESS DEVIATION - NO DOSE CALL PERFORMED. | STUDY PRODUCT ASSIGNMENT DEVIATION | STUDY PRODUCT | EXPOSURE | EXPOSURE | 2003-09-21 | | 2 | ABC123 | DV | 123103 | 1 |
DRUG XXX | BUPROPION ADMINISTERED DURING STUDY PRODUCT |
EXPSOURE | EXPSOURE | EXCLUDED CONCOMITANT MEDICATION | STUDY PRODUCT |
EXPOSURE | EXPOSURE | 2003-10-30 | | 3 | ABC123 | DV | 123103 | 2 | VISIT 3 DOSE <15 MG | STUDY PRODUCT |
ADMINSTRATION | ADMINISTRATION DEVIATION | STUDY PRODUCT |
EXPOSURE | EXPOSURE | 2003-10-30 | | 4 | ABC123 | DV | 123104 | 1 | TOOK ASPIRIN | EXCLUDED CONCOMITANT MEDICATION | STUDY PRODUCT |
EXPOSURE |
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