Cancer Protocol Review Committee (CPRC)

Announcements

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Announcements

Recent document updates

August 2023: Population Science Initial Review application version 7 added

August 2023: Amendment Application v9 added

CPRC continuing reviews will now be conducted biannually. Studies will be closed if accruing <50% of annual goal. (MAY 2023)

The updated process will facilitate a focus on identifying and closing underperforming studies so that resources may be allocated to studies with a demonstrated ability to make adequate progress toward meeting accrual goals. 

  • The CPRC will review accrual totals twice per year and send notices for any studies with:

    • Zero accruals after 6 months of initially opening to accrual or,

    • <50% of the annual accrual goal after being open to accrual for >6 months.

  • Studies which do not meet the above outlined thresholds after subsequent review in 6 months will be permanently closed.

  • Observational studies continue to be exempt from continuing review.

Dose-escalation trials will not be accepted for review without documentation of operating characteristics. (JUN 2023)

See Appendix A for more detailed information on operating characteristics.

CPRC review decisions for industry-sponsored studies will no longer include "major" stipulations. (MAY 2023)

Possible CPRC review outcomes for business and industry trials will now be deferral/disapproval, approval with minor stipulations, or full approval. Review options for investigator-initiated or university consortium trials will not change.

Access Requirements for CPRC Submission

  1. OnCore access is required to submit to the CPRC.
  2. Applications must be submitted via ePRMS in OnCore.
  3. 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.
  4. 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.

 

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

 

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 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.