University of Pittsburgh Cancer Institute (UPCI)

UPCI Protocol Review Committee

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 (UPCI PRC).

1. The UPCI PRC meets twice per month to review new proposals. A copy of the schedule of meetings is available here.

2. Complete a UPCI PRC Processing Checklist Form and submit with your proposal. This form is available on the Forms page.

3. Your proposal should include the following:

• Completed PRC 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
Research Project Clinician / PRC Coordinator
Clinical Research Services
UPCI - Hillman Cancer Center
Suite A410, 5115 Centre Avenue
Pittsburgh, PA 15232-1305
Phone: 412-623-3376
Fax: 412-647-0949
E-mail: kaukusbm@upmc.edu

5. Results of the UPCI PRC review will be sent to you approximately one week after the scheduled meeting.

• 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 unless there are significant modifications to the study design.