Clinical Research Operations

Deviation/Violation Reporting

STEP 1: Deviation/Violation Reporting

1. Deviation/Violation Reporting to NCI IRB
   • Sites should be aware of the expedited NCI IRB deviation/violation definitionsand reporting requirements as listed in the protocol:
     • 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

1. 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