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
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
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.
DVDECOD
DVDECOD
DVDECOD
INFORMED CONSENT NOT OBTAINED; INCLUSION CRITERIA NOT MET; STUDY PRODUCT ASSIGNMENT DEVIATION; STUDY PRODUCT ADMINSTRATION DEVIATION; EXCLUDED CONCOMITANT MEDICATION; OTHER
4
What was the protocol deviation term?
Specify Protocol Deviation
Record the protocol deviation
TERM
DVTERM
DVTERM
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.
DVSTDAT
DVSTDTC
DVSTDTC
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.