Cancer Protocol Review Committee (CPRC)

REDCap Template

REDCap Template

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

In addition to using the updated template, MCC Data Managers must be granted access to every study in REDCap for CPRC and NCI reporting purposes. Once given access, they will have the ability to extract data without requesting further assistance from study personnel throughout the life cycle of the the study. Please grant access to:
  1. Vidhya Ramesh, REDCap username: rames007
  2. Thomas Phelan, REDCAp username: phela037
Please review the MCC REDCap Memo from MCC Leadership for more information.

Protocol Templates

Protocol Templates

IRB Protocol Templates

    • The UMN IRB now has required protocol templates for all submissions. Please refer to their forms website for templates and instructions.

Other Links

 

CPRC Data and Safety Monitoring Policy

CPRC Data and Safety Monitoring Policy

Mission

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

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.

  1. The CPRC responsibility is that of scientific review and prioritization.
  2. Review of consents and risk/benefit assessments are the purview of the IRB.
  3. Issues of risk may be discussed within the CPRC, but do not form the basis of Committee approval/disapproval.
  4. 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 not be submitted simultaneously to the CPRC and the IRB. Principal Investigators can submit their application to the IRB once initial CPRC approval is granted.

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

 

Contact

Contact

Contact CPRC via email at ccprc@umn.edu.

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