CPMC IRB Protocol
Download Protocol Violation/Deviation/Exemption Summary Report in Word Format
Protocol Violation/Deviation/Exemption Summary Report
CPMC IRB Number:
Study Title:
CPMC Principal Investigator (PI):
Name/ phone# of contact person
Today's Date:
Did your site have any protocol violations, deviations, or exemptions in the last review cycle?
Yes/No
If yes, please complete the summary grid below.
| Date of Occurrence | Type | Summary of Violation / Deviation / Exemption during the last review cycle | Previously reported to IRB? | |
|---|---|---|---|---|
| Yes | No | |||
Types of Occurences:
- V = Protocol Violation:
- A departure from the IRB-approved research plan that may, or does, jeopardize the health, safety, welfare, and privacy of a research participant or the integrity of the study (i.e., medication errors, consent form/privacy rule errors, inclusion/exclusion errors, treatment errors).
- D = Protocol Deviation:
- A departure from the IRB-approved research plan that does not constitute a threat to the health, safety and welfare of a research participant, and has minimal effect on the integrity of the data collected.
- E = Protocol Exemption:
- A prospectively approved deviation granted by the study sponsor that does not increase the risk to the participant.
Attach to each IRB Progress Report or Final Report
January 27, 2011
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