Cancer Protocol Review Commitee
The Cancer Protocol Review Committee's (CPRC) mission is to evaluate, approve or reject, monitor, and re-review on an annual basis all University of Minnesota clinical cancer research protocols.
- When evaluating the scientific merit of a cancer research protocol, the scientific relevance, validity of the hypothesis, adequate study design, biostatistical input, adequate patient population, and feasibility of timely completion are considered.
- When evaluating the priority of the proposed study in regards to competing protocols, scientific merit, impact on existing studies, patient availability, and Cancer Center resources are considered.
Primary and secondary protocol reviewers are designated to review each protocol. In addition, a biostatistician reviews the protocol for biostatistical methodology. At a subsequent CPRC meeting, the reviewers critique the protocol and make the recommendation for approval, approval with stipulations, deferment, or disapproval. The committee discusses the protocol and then votes on the motion.
Protocols are reviewed annually by progress reports that indicate the accrual rate and progress toward study endpoints. Protocols determined to have inadequate accrual, to be without scientific progress, or have little likelihood of completion may be terminated based on committee vote.
- CPRC submission deadlines and committee meeting schedules (PDF)
- CPRC Standard Application (PDF) (Word)
- Request IRB Approval for a Change in Protocol Form
- CPRC/Therapeutic Interventional (CPRC/TI) Review and Monitoring
- Classifications of Protocols Reviewed by the CPRC/Non-Therapeutic Interventional (CPRC/NTI)
How to get your protocol approved by the Cancer Protocol Review Committee on the first submission
- Watch the "Writing Strong Research Protocols" video (UM Connect)
- Download the presentation (PDF)
- Non-therapeutic Protocol Template (MSWord doc)
Interaction with the Institutional Review Board
A. The responsibilities of the Institutional Review Board (IRB) and the Cancer Protocol Research Committee (CPRC) are distinct. The CPRC operates independently from the IRB. The CPRC collaborates with the IRB to assure a minimum of administrative overlap.
- The CPRC/TI responsibility is that of scientific review and prioritization.
- Review of consents and risk/benefit assessments are the purview of the IRB.
- Issues of risk may be discussed within the CPRC/TI, but do not form the basis of Committee approval/disapproval.
- Clinical cancer research protocols approved by the CPRC/TI will be reviewed for safety, ethical considerations and quality control by the IRB.
B. Clinical cancer research protocols may be submitted simultaneously to the CPRC/TI and the IRB. The IRB will be notified by the CPRC/TI when the committee has approved a protocol.
C. Approval by the CPRC/TI and the IRB is required before any cancer-related clinical research protocol is activated.