| Metadataspec |
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| CDASH Variable Name | | Question Text | Prompt | CRF Completion Instructions | CDASH Variable Name | SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
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| 1 |
DVYN | Were there any protocol deviations? | Any Deviations | Enter Yes if a protocol deviation occurred and No if none occurred. Ensure that any adverse event which triggers a protocol deviation (e.g., concomitant medication use, newly discovered medical history) is noted on the respective CRF. | DVYN | N/A | NOT SUBMITTED | (NY) | Yes; No |
| | 2 |
DVSPID | 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. | DVSPID | DVSPID | DVSPID |
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| | 3 |
DVDECOD | What was the protocol deviation? | Protocol Deviation | Record protocol deviations identified and/or select the appropriate code from the list of protocol deviation terms. | DVDECOD | DVDECOD | DVDECOD |
| INFORMED CONSENT NOT OBTAINED; INCLUSION CRITERIA NOT MET; STUDY PRODUCT ASSIGNMENT DEVIATION; STUDY PRODUCT ADMINSTRATION DEVIATION; EXCLUDED CONCOMITANT MEDICATION; OTHER |
| | 4 |
TERM | What was the protocol deviation term? | Specify Protocol Deviation | Record the protocol deviation | TERM | DVTERM | DVTERM |
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| | 5 |
DVSTDAT | 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. | DVSTDAT | DVSTDTC | DVSTDTC |
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| | 6 |
DVENDAT | 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. | DVENDAT | DVENDTC | DVENDTC |
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