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Table 3 Protocol deviations

From: Study protocol, randomized controlled trial: reducing symptom burden in patients with heart failure with preserved ejection fraction using ubiquinol and/or D-ribose

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