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    Institutional Review Board (IRB) - Serious Adverse Event Report Form (Local Events)

    Printer-friendly version: Serious Adverse Event Report Form (Local Events) [MSWord 61KB]

    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.

    What to do if there has been a Serious Adverse Event

    The Principal Investigator must promptly report to the IRB, in writing, any unanticipated side effects, hazards, or other problems involving risks to subjects or others. (If the unanticipated problem arises during the course of a study under the jurisdiction of the U.S. Department of Health and Human Services or the Food and Drug Administration, the Principal Investigator shall also report to one or both of these agencies, as appropriate.)

    Please provide the following Serious Adverse Event Information

    ALL serious adverse reactions must be reported to the IRB within five (5) days.

    • Submit Serious Adverse Event form to the IRB Office, 2200 Webster Street, 5th Floor, PACIFIC CAMPUS, San Francisco, 94115.
    • Include any Serious Adverse Event notifications to sponsor or Federal agencies.
    • Title of IRB approved study:
    • Principal Investigator's name:
    • IRB Number:
    • Subject Identifier:
    • Age of subject:

    • Gender (male or female):
    • Date of Serious Adverse Event:
    • Date principal investigator was made aware:
    • Type of Serious Adverse Event report (initial or follow up):
    • Did the subject remain on the study or protocol? Yes/No
    • 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 email address.

    Provide a narrative description of the Serious Adverse Event

    Include in the description the subject's relevant medical history and medications/interventions, timing and nature of the event in relation to the study drug, device use, procedure, the action taken by the investigator and the outcome. (For clinical studies, submission of study sponsor’s SAE report form is acceptable.)

    1. This is a (an):
      • Unanticipated/Unexpected Event
        (Any untoward event that is not identified with the current investigator brochure or study protocol)
      • Serious Adverse Event
        (Any untoward medical occurrence that results in death, is life-threatening, requires patient hospitalization, prolongs existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital abnormality)
    2. The opinion of the Principal Investigator is that the relationship of the study drug, device or procedure is:
      • Unrelated
      • Probably not related
      • Possibly related
      • Probably related
      • Related
      • Other, please explain:
    3. Is the event described in the current IRB approved protocol, investigator’s brochure or consent form? Yes/No
      • If No: The opinion of the Principal Investigator is that the serious adverse event warrants a change in the IRB approved protocol or consent form. Yes/No

        If the SAE does not warrant a change, please explain why.
      • If yes, submit a copy of the revised IRB protocol or consent form with the change (s) highlighted within 30 days.

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


    Principal Investigator should provide signature/date