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    Institutional Review Board (IRB) - Protocol Exception or Deviation Report Form

    Printer-friendly version: Protocol Exception or Deviation Report Form [MSWord 59KB]

    If you have problems using the Word document, provide the IRB with the information below and submit to:
    IRB Office
    2200 Webster Street, 5th Floor, P-Campus,
    San Francisco, CA 94115

    For questions and help, please call:
    Leigh Pruneau, PhD, RN, CIP., Human Research Protection Program Administrator at (415) 600-3688.

    IRB Policy of Protocol Exception or Deviation

    1. In order to comply with: 21 CFR 56.108 (a) (3): “In order to fulfill the requirements of these regulations, each IRB shall… (a) follow written procedures: (3) for ensuring prompt reporting to the IRB changes in research activity….”, the IRB classifies violations into 2 categories:
      • Exception: A permission is granted by the sponsor to make an exception to the protocol to accommodate the needs of individual subjects

        • Examples:
        • Enrolling a 70 year old patient when the inclusion criteria specifies 25-65 years of age.
        • enrolling a patient with serious disease that is precluded from participation in
          the protocol exclusion criteria

      • Deviation: A protocol requirement is violated to accommodate an individual without seeking permission.

        • Examples:
        • drawing a 13th tube of blood from a subject where the protocol specifies that 12 samples will be collected for the study
        • instituting a procedure on one or more enrolled subjects that is not specified
          in the protocol.

    2. Any exception or deviation from the approved process must be reported to the IRB within five days of the event or of discovery of the event.

    Instructions on submitting Protocol Exception or Deviation Report

    1. Please provide the following information and submit Exception or Deviation Report to IRB Office, 2200 Webster Street, 5th Floor, San Francisco, 94115.

      • IRB Number and Title of Project:
      • Principal Investigator's name:
      • Sutter Affiliation:
      • Department:
      • Mailing Address:
      • Phone Number:
      • Fax Nnumber:
      • E-mail address:
      • If you wish to designate a contact other than the PI to receive correspondence regarding this IRB submission, please include their information: Name of Contact and E-mail address
      • Date of Protocol Violation or Incident:

    2. Indicate type of deviation, exception, or incident below.

      • Randomization of ineligible subject. Please provide explanation for each event.
      • Failure to report SAEs (unreported). Please provide explanation for each event.
      • Eligibility criteria exception approved by the Sponsor
      • Study procedure (lab, MRI, ECG, EKG, etc.) required by protocol not completed or performed
      • Study procedure performed outside the protocol window
      • Study visit outside the protocol window
      • Incorrect research treatment or intervention given to subject (ex. under dose, over dose)
      • Drug accountability discrepancy. Please provide explanation for each event.
      • Problem with the informed consent process. Please provide explanation for each event.
      • Other: Please provide explanation for each event.

    3. Please explain how the violation or incident happened:
    4. Did the violation or incident involve increased risks to subject (s)? Yes/No
      If yes, please explain.
    5. What measure(s) have you taken to assure that the violation or incident does not happen again?
    6. Did you notify the study sponsor of the event? Yes/No
      If yes, please indicate sponsor’s response to the event.
    7. Does the protocol or consent need modification due to the event(s) reported? Yes/No
      If yes, please attach with this report.

    Other comments (optional):

    Principal Investigator’s acknowledgement that the information provided above is complete and correct


    Please provide Principal Investigator’s Signature and Date