Cancer Protocol Review Committee (CPRC)

Access Requirements for CPRC Submission

OnCore access is required to submit to the CPRC.
Applications must be submitted via ePRMS in OnCore.
- ePRMS Submission Guidelines
- This requirement is exempted for studies not requiring OnCore entry.
PIs are responsible for completing PI Signoff in the ePRMS console by logging into OnCore (required for all applications except Expedited and Amendments). This cannot be done by study staff on their behalf.
- Instructions for PI Signoff
If your OnCore password has expired or you require OnCore training, please contact oncore@umn.edu or 612-626-3080. The CPRC does not provide OnCore technical support or training. See the OnCore new user request form here.

Applications

FULL REVIEW:

CPRC Initial Full Review Application
Main application for CPRC initial review. If cede, population science, or expedited, see below.
- See Appendix A for Phase I trials with dose-escalation designs (referenced in the Initial Full Review Application question #4).
CPRC Initial Population Science Application
This application should be filled out in lieu of the CPRC Initial Full Review Application if your study is population science or tobacco research based, not CTO managed, and non-interventional.

EXPEDITED REVIEW:

CPRC Initial Cede Review Application
For expedited review of:
- Multi-site investigator initiated studies previously approved by a Protocol Review and Monitoring System (PRMS) at an NCI-designated Cancer Center
- Any study previously approved by the NCI Cancer Therapy Evaluation Program (CTEP) or Cancer Control Protocol Review Committee.

AMENDMENT REVIEW:

CPRC Amendment Application
All protocol amendments must be submitted to the CPRC for review. Cede review protocol amendments will be acknowledged.

MCC REDCap Subject Registration Template

You must grant access to MCC Data Managers and utilize guidelines outlined in the code book:
MCC REDCap Subject Registration Codebook

To import the UMN MCC Subject Registration Template for your project:

From the Online Designer page in a project, click on the button to "Import a new instrument from the official REDCap Shared Library."
Once the shared library page is displayed, enter "UMN" (without the quotes) into the Keyword Search box and click on the "Search the library" button.
Click on the link titled If you click on that then it will give you information about it and have links to see it as a web page, view it as a PDF, or "Import into my REDCap project". The last one is the one that will add it to your existing project.

This template must be used on all studies approved by the CPRC which select REDCap as their database

Mission

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, scientific relevance, validity of the hypothesis, adequacy of the study design, 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.

Interaction with IRB

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 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, but do not form the basis of Committee approval/disapproval.
Clinical cancer research protocols approved by the CPRC will be reviewed for safety, ethical considerations and quality control by the IRB.

Clinical cancer research protocols may be submitted simultaneously to the IRB for pre-review but will not be reviewed by the IRB committee until CPRC approval is granted.

Approval by the CPRC and the IRB is required before any cancer-related clinical research protocol is activated.