Minor or Administrative Protocol Deviation

advertisement
Mother Frances Hospital Tyler
Institutional Review Board
[email protected] / (903) 606-2472
Minor or Administrative
Protocol Deviation Log
Principal Investigator:
IRB# and Protocol title:
A minor or administrative protocol deviation is a protocol deviation that was not due to the
action or inaction of any member of the research team; or does not affect the scientific soundness
of the research plan; or does not affect the rights, safety, or welfare of human subjects. Repeated
deviations should be reported to the IRB because they may suggest the protocol’s design may
need to be revised or a subject-specific problem.
Use the following codes to describe the deviation:
A) Follow up visits that occurred outside the protocol required time frame because of the
subject’s actions (for example: weather, vacation, transportation, personal issues, etc.)
B) Study interventions (lab tests, diagnostic tests) that occurred outside the protocol required
time frame because of the subject’s actions
C) Biological samples (e.g., blood, urine) obtained at times close to but not precisely at the time
points specified in the protocol, especially if the samples are not obtained for safety reasons
D) A single instance when biological samples (e.g., blood, urine) were not collected and the
samples were not being obtained to monitor subject safety
E) Failure of subject to return unused study medication
F) Failure of subject to transmit device data within the protocol required time frame
G) Subject takes the study drug at a different dose or frequency than instructed and safety was
not affected
H) Sponsor required reporting outside the protocol required time frame
I) Other
Add lines as needed. Submit with Continuing Review
Date of
Date PI
Subject ID
Code Brief description
deviation aware
Minor or Administrative
Protocol Deviation Log
Last revised 01/14/2015
Page 1 of 1
Download
Related flashcards
Doping in sport

16 Cards

Mood stabilizers

27 Cards

Pharmacology

22 Cards

Antipsychotics

78 Cards

Doping in sport

21 Cards

Create flashcards