Protocol Review Process

Prior to submitting your proposal involving cancer patients to the University of Pittsburgh Institutional Review Board (IRB)/PittPRO, 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 interventional proposals. 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
        Email: kaukusbm@upmc.edu
        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.