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 University of Pittsburgh Cancer Institute Protocol Review Committee/Protocol Review and Monitoring System (UPCI PRC/PRMS).
- The UPCI PRC/PRMS meets twice per month to review new proposals. A copy of the schedule of meetings is available here.
- Complete a UPCI PRC/PRMS Checklist Form and UPCI CTMA# form (either therapeutic or non-therapeutic/exempt) to submit with your new study.
- 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
Brandon Kaukus, BS
Sr. Research & Risk Mgmt Review Specialist
Clinical Protocol and Data Management (CPDM)
UPMC CancerCenter Pavilion
5150 Centre Avenue, Suite 301
Pittsburgh, PA 15232-1305
- A flowchart of procedures for review of PRC comments available for viewing, or can be downloaded as a PDF.
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 UPCI PRC/PRMS unless there are significant modifications to the study design.