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 interventional 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. If your protocol is non-interventional, only need to provide the non-therapeutic # request form above, as well as protocol. This should be provided PRIOR to submission in PittPRO. Please also indicate the HCC# if making a submission in PittPRO.
      5. 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
      6. 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.