Protocol Review Process

Prior to submitting your proposal involving cancer patients to the University of Pittsburgh Institutional Review Board (IRB), you must submit it to and receive approval from the UPMC Hillman Cancer Center Protocol Review Committee/Protocol Review and Monitoring System (Hillman PRC/PRMS).

      1. The Hillman PRC/PRMS meets twice per month to review new proposals. A copy of the schedule of meetings is available here.
      2. Complete a PRC/PRMS Checklist Form and CTMA# form (either therapeutic or non-therapeutic/exempt) to submit with your new study.
      3. Your proposal should include the following:
        • Completed PRC/PRMS checklist
        • Full, complete protocol and appendices
        • Summary or synopsis of protocol (optional)
        • Informed Consent form(s) (institution or sponsor’s consent forms)
        • Investigational drug brochure
        • Investigator-initiated study, including biostatistical approval
      4. Submit all documents electronically to:
        Brandon Kaukus, BS
        Sr. Research & Risk Mgmt Review Specialist
        Clinical Protocol and Data Management (CPDM)
        UPMC Cancer Pavilion
        5150 Centre Avenue, Suite 301
        Pittsburgh, PA 15232-1305
        Phone: 412-623-3376
        Fax: 412-648-6650
      5. Results of the Hillman PRC/PRMS review will be sent to you approximately one week after the scheduled meeting.

        The committee may request additional information or clarifications to questions generated at the meeting. Please provide a prompt response to the committee’s comments so that your proposal can be approved quickly. Approval will not be granted until all questions/clarifications have been addressed and the committee has accepted the responses. Electronic submissions are preferred.

        Protocols do not require an annual review by the Hillman PRC/PRMS unless there are significant modifications to the study design.