Protocol Deviation: A protocol deviation is any change, divergence, or departure from the study design or procedures of a research protocol that is under the investigator’s control and that has not been approved by the IRB.
Protocol Violation: A protocol violation is a deviation from the IRB-approved protocol that may affect the subject’s rights, safety, or well being or the completeness, accuracy and reliability of the data.
External participating sites should complete the CCR Deviation/Violation form provided and send to the Study Coordinator either by email or fax.
The CCR Study Coordinator should submit the external site’s copy of the Deviation/Violation form in the CCR Integrated Medical Research Informational System (iRIS) to the NCI IRB under the Deviation Violation submission form.
Participating site will follow local IRB policy to report Deviations/Violations.
STEP 2: File Deviation/Violation Documentation
The Coordinating Center should file copy of Deviation/Violation form in their master regulatory binder and in their regulatory binder for that site.
Include all related correspondence
Include documentation of submission to NCI IRB, and confirmation of receipt
Include documentation of submission to local IRB, if applicable