Procedure Number: 55.A
Title: Procedure for Protocol Deviation and Violation Reporting
Procedure:
This procedure provides guidance in the reporting requirements and responsibilities of the Investigator and
the UC Irvine (UCI) Institutional Review Board (IRB) regarding protocol deviations and/or violations.
I.
Lead Researcher (LR) Responsibilities
A.
The LR submits any changes in the protocol prior to implementation to the IRB for review
and approval as required by the Federal regulations using the “Modification Request.”
B.
The LR monitors research activities for adherence to the protocol and to determine if
protocol deviations or violations have occurred.
C.
Violations must be reported to the IRB via the “Adverse Event/Unanticipated Problems
Involving Risk to Participants or Others” in accordance with IRB Policy 19.
D.
An LR may choose to report deviations to the IRB that do not affect the risk/benefit ratio or
the participant’s or other’s rights, safety or welfare and/or on the integrity of the data, the
LR uses the “Tracking Log for Non-Reportable Events.”
E.
All protocol violations and other reportable events per IRB Policy 19 should be reported to
the Data and Safety Monitoring Board.
II.
IRB Committee Responsibilities
The IRB will review violations reported under this policy according to IRB Policy 19.
III.
IRB Analyst or Higher Responsibilities
A.
The Analyst will verify if deviations submitted by the LR qualify as a deviation per IRB
definition and did not affect the risk/benefit ratio, the participant’s or other’s rights, safety
or welfare and/or on the integrity of the resultant data.
1. The Analyst will stamp the original document as received as an administrative
acknowledgement of receipt.
2. A copy of the document will be placed in the IRB file and the original returned to the
LR.
B.
If the Analyst determines the deviation constitutes a violation that may have affected the
risk/benefit ratio, the participant’s or other’s rights, safety or welfare, and/or on the
integrity of the data, the Analyst will request the event be reported to the IRB utilizing the
“Adverse Event/Unanticipated Problem Involving Risks to Participants or Others” reporting
process.
C.
At any time, the Analyst may consult with the IRB Chairperson or his/her designee for
guidance.
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