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    Institutional Review Board (IRB) - Protocol Amendment or Modification Form

    Printer-friendly version: Protocol Amendment or Modification Form [MSWord 73KB]

    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.

    Please provide the following information if there has been a change in the IRB Protocol, Investigator’s Brochure, and/or IRB Consent Form

    1. Provide the IRB with a packet collated in the following order:

      • This amendment form
      • Proposed document(s) (or portions thereof) (with proposed consent additions bolded and deletions marked using strikethrough)

    2. Submit IRB original approved protocol plus ONE copy to IRB Office, 2200 Webster Street, 5th Floor, PACIFIC CAMPUS, San Francisco, 94115.
    3. Please complete each of the following quesitons;
      • IRB Study Number and Title of Project:
      • Principal Investigator:

      • Sutter Affiliation:
      • Dept.:
      • 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

    4. Date of next IRB continuing review:
    5. How many subjects are currently enrolled in the study?
    6. Please indicate the current status of your research study:
      • Not yet initiated
      • Following up on previously enrolled subjects and/or anticipating enrollment of new subjects
      • Following up on previously enrolled subjects and not enrolling new subjects
      • Data analysis only
      • Study Closed / Completed
      • Other (please explain):

    7. Briefly summarize and provide the reason(s) for the proposed changes. [If the sponsor provided a summary of changes; please attach summary document.
    8. Do the proposed changes involve increased risks to subjects? Yes/No
    9. Do the proposed changes involve revisions to the consent document? Yes/No

      If yes, please describe or highlight the changes in the attached approved IRB consent.

      If no, please explain why.
    10. Will already enrolled subjects be notified of the proposed changes?


      11. If Yes. Explain how subjects wil be notified?
      • By re-consent (long consent)
      • By partial consent (addendum)
      • By informational letter
      • Other (please explain):

      If No. Explain why?

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


    Provide Principal Investigator’s signature/date