PROTOCOL DEVIATION / VIOLATION REPORT

version February 2025

POLICY: In accordance with Piedmont Healthcare Institutional Review Board (PHCIRB) policy #6422, protocol deviations or violations requiring reporting (described below) must be reported to the PHCIRB within 10 working days of the investigator's knowledge of the event.


Protocol deviation: non-compliance with the study protocol and/or procedures that do not usually impact study participant's rights, safety and/or welfare, compromise the integrity of the study data and/or study participant willingness to participate in the study.


Protocol violation: non-compliance with the study protocol and/or procedures that may impact participant rights, safety and/or welfare, compromise the integrity of the study data and/or participant willingness to participate in the study.

Name and credentials

Email address of PI or knowledgeable designee

Use MM/DD/YYY format

Use MM/DD/YYY format

Event*

Provide details in the 'Details' section below

Reporting Requirements

Reporting is required for deviations or violations that meet one or more of the following criteria. Check all that apply AND provide a brief explanation/rationale for the selection(s):

Select or enter value
Caret IconCaret symbol

Provide details to support the selection(s) above

Describe how the event(s) will be prevented going forward:

Has the event been reported to the sponsor?*
Are changes needed to the protocol and/or consent?*
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