Fillable Protocol Deviations Log (National Institutes of Health)

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Protocol Deviations Log (National Institutes of Health)

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Protocol Deviations Log
Protocol Deviation Page ____ of _____ Version 1.0
STUDY NAME
Site Number:
Pt_ID:
_____________________
______________________
V
isit Date
:
___ ___ / ___ ___ ___ / 2 0 ___ ___
d d m m m y y y y
Did this participant have any protocol deviations? Yes No
Description of Protocol Deviation:
Deviation
Category*
Deviation
Code**
Date Deviation
Occurred:
(dd/mmm/yyyy)
Date IRB Notified
(if applicable):
Principal
Investigator’s
Signature
Date Signed
(dd/mmm/yyyy)
Protocol Deviation Page ____ of _____ Version 1.0
Protocol Deviations Log
*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
Safety (Category A)
1. Not reporting an SAE within 24 hours
2. Laboratory tests not done
3. AE/SAE is not reported to IRB
4. 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
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
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
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Protocol Deviations Log (National Institutes of Health)

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Completed 19 July 2020

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