| Order | Question Text | Prompt | Case Report Form Completion Instructions | Type | Collection Variable | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
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| 2 | What is the protocol deviation identifier? | DV Number | If collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier. | Text | DVSPID | DVSPID |
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| 3 | What was the protocol deviation? | Protocol Deviation | Record protocol deviations identified and/or select the appropriate code from the list of protocol deviation terms. | Text | DVDECOD | DVDECOD |
| INFORMED CONSENT NOT OBTAINED; INCLUSION CRITERIA NOT MET; STUDY PRODUCT ASSIGNMENT DEVIATION; STUDY PRODUCT ADMINSTRATION DEVIATION; EXCLUDED CONCOMITANT MEDICATION; OTHER |
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| 4 | What was the protocol deviation term? | Specify Protocol Deviation | Record the protocol deviation | Text | DVTERM | DVTERM |
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| 5 | What was the protocol deviation start date? | Start Date | Record the start date for the protocol deviation using this format (DD-MON-YYYY). This should be the start or occurrence of the protocol deviation, not the date it was discovered or reported. | Date | DVSTDTC | DVSTDTC |
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| 6 | What was the protocol deviation end date? | End Date | Record the end date of the protocol deviation using this format (DD-MON-YYYY). This should be the date the protocol deviation stopped, not the date it was discovered or reported. | Date | DVENDTC | DVENDTC |
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