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