1 | SUCAT | 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. | N/A | NOT SUBMITTED | (NY) | Yes; No | 2 | SUYN | 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 | 3 | SUREASND | 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 | INFORMED CONSENT NOT OBTAINED; INCLUSION CRITERIA NOT MET; STUDY PRODUCT ASSIGNMENT DEVIATION; STUDY PRODUCT ADMINSTRATION DEVIATION; EXCLUDED CONCOMITANT MEDICATION; OTHER | 4 | SUTRT | What was the protocol deviation term? | Specify Protocol Deviation | Record the protocol deviation | DVTERM | DVTERM | 5 | SUNCF | 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. | DVSTDTC | DVSTDTC | 6 | SUDSTXT | 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. | DVENDTC | DVENDTC | SUDOSU | SUDOSFRQ |
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