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. |
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| Row 2: | Shows an example of a deviation due to the subject taking a prohibited concomitant medication. |
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| 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 | 2003-09-21 |
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| 2 | ABC123 | DV | 123103 | 1 | BUPROPION ADMINISTERED DURING STUDY PRODUCT EXPSOURE | EXCLUDED CONCOMITANT MEDICATION | STUDY PRODUCT EXPOSURE | 2003-10-30 |
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| 3 | ABC123 | DV | 123103 | 2 | VISIT 3 DOSE <15 MG | STUDY PRODUCT ADMINISTRATION DEVIATION | STUDY PRODUCT EXPOSURE | 2003-10-30 |
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| 4 | ABC123 | DV | 123104 | 1 | TOOK ASPIRIN | EXCLUDED CONCOMITANT MEDICATION | STUDY PRODUCT EXPOSURE | 2003-11-30 |
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