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HRPP Manual Section 9-8

Protocol Deviations or Violations

A protocol deviation/violation is any change, divergence, or departure from the study design or procedures of a research protocol that has not been approved by the IRB. The principal investigator (PI) is responsible for reporting the protocol deviation/violation to the IRB using the Protocol Deviation/Violation reporting form. The IRB chair or IRB member will review this form to determine if additional information or further reporting is necessary. If a protocol deviation/violation may be noncompliance, HRPP Manual 9-2 “Noncompliance” must be followed. Protocol deviations/violations which may meet the definition of an unanticipated problem involving risks to subjects or others must be reported promptly and HRPP Manual 9-1 “Unanticipated Problems Involving Risks to Subjects or Others” must be followed.

Urgent protocol deviations/violations that may affect the subject's rights, safety, or well-being and/or affect subject’s willingness to participate in the study should be reported within 72 hours.

Examples of protocol deviations/violations include but are not limited to:

  • Failure to follow the approved study procedure

    • Study procedure conducted out of sequence

    • Omitting an approved portion of the protocol

    • Failure to perform a required lab test

    • Missing lab results

    • Enrollment of ineligible subject (e.g., subject’s age was 6 months above age limit)

    • Study visit conducted outside of required timeframe

  • Failure of subject to return study medication

  • Over-enrollment

  • Dosing errors that have been cleared by the Sponsor

  • Failure to perform or collect required labs or other statistics

  • Sponsor approved changes in protocol

  • Data collection that occurs outside of the planned time window or location

  • Failure to obtain informed consent prior to initiation of study-related procedures

  • Enrollment of a subject who did not meet all inclusion/exclusion criteria

  • Performing study procedure not approved by the IRB

  • Failure to report a unanticipated problem involving risks to subjects or others to the IRB and/or sponsor

  • Drug/study medication dispensing or dosing error

  • A research subject received an excluded concomitant medication

  • Incorrect storage of study medications

  • Study visit conducted outside of required timeframe that, in the opinion of the PI, may affect subject safety

  • Failure to follow safety monitoring plan

See HRPP Manual 9-5, “Unapproved Change in Protocol” for requirements when an immediate change in a research study is necessary to eliminate a hazard to subjects.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 7-19-2011.Revision 1 approved by VP Research & Graduate Studies on 12-9-2015.  Revision 2 approved by Assistant VP Regulatory Affairs on 7-21-2016.

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