Table 3 Protocol deviations

DEVIATION CATEGORIES:

 A. Safety

 B. Informed Consent

 C. Eligibility

 D. Protocol implementation

 E. Other, specify in log

DEVIATION CODES: Numbers listed by the sample protocol deviations

Eligibility (Category C)

 12. Participant did not meet eligibility criterion

 13. Randomization of an ineligible participant

 14. Participant randomized prior to completing Baseline Assessment, etc.

 15. Randomization and/or treatment of participant prior to IRB approval of protocol

 16. Other, specify in log

Safety (Category A)

 1. Not reporting an SAE within 24 h

 2. Laboratory tests not done

 3. AE/SAE is not reported to IRB

 4. Other, specify in log

Protocol implementation (Category D)

 17. Failure to keep IRB approval up to date

 18. Participant receives wrong treatment

 19. Participant seen outside visit window

 20. Use of unallowable concomitant treatments

 21. Prescribed dosing outside protocol guidelines

 22. Missed assessment

 23. Missed visit

 24. Other, specify in log

Informed Consent (Category B)

 5. Failure to obtain informed consent

 6. Consent form used was not current IRB-approved version

 7. Consent form does not include updates or information required by IRB

 8. Consent form missing

 9. Consent form not signed and dated by participant

 10. Consent form does not contain all required signatures

 11. Other, specify in log