| Rowcaps |
|---|
| Rows 1, 3: | Show examples of a TREATMENT 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. | |
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | DVSEQ | DVTERM | DVDECOD | EPOCH | DVSTDTC |
|---|
| 1 | ABC123 | DV | 123101 | 1 | IVRS PROCESS DEVIATION - NO DOSE CALL PERFORMED. | TREATMENT | STUDY PRODUCT ASSIGNMENT DEVIATION |
TREATMENT| STUDY PRODUCT EXPOSURE | 2003-09-21 | | 2 | ABC123 | DV | 123103 | 1 | DRUG XXX ADMINISTERED DURING STUDY |
TREATMENT PERIOD| PRODUCT EXPSOURE | EXCLUDED CONCOMITANT MEDICATION |
TREATMENT| STUDY PRODUCT EXPOSURE | 2003-10-30 | | 3 | ABC123 | DV | 123103 | 2 | VISIT 3 DOSE <15 MG |
TREATMENT | STUDY PRODUCT ADMINSTRATION DEVIATION |
TREATMENT| STUDY PRODUCT EXPOSURE | 2003-10-30 | | 4 | ABC123 | DV | 123104 | 1 | TOOK ASPIRIN |
PROHIBITED MEDS | TREATMENT| EXCLUDED CONCOMITANT MEDICATION | STUDY PRODUCT EXPOSURE | 2003-11-30 |
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