# Protocol Review and Monitoring System

> **NIH NIH P30** · UNIVERSITY OF MINNESOTA · 2024 · $187,552

## Abstract

Protocol Review and Monitoring System Summary
The Cancer Protocol Review Committee (CPRC), Interdisciplinary Site-Specific Care (ISC) teams, and Clinical
Trials Office (CTO) Senior Leadership Team (SLT) function as the Protocol Review and Monitoring System
(PRMS) for the Masonic Cancer Center (MCC). The CPRC, ISC teams, and CTO SLT are responsible for
reviewing all hypothesis-driven protocols involving human subjects with cancer or at risk of developing cancer.
The goals of these committees are to ensure that studies are feasible and have scientific merit.
Protocol review takes place in 2 stages. First, the disease-specific ISC team evaluates the study to ensure
accrual goals are feasible, competing trials have been addressed, adequate funding is in place, and study
prioritization is considered (IIT > cooperative group > industry). In July 2022, the CTO SLT was added to the
feasibility review process to provide a review of CTO staffing and to grant final approval of feasibility. The CTO
SLT review was added to satisfy a new mandate by the Dean of the Medical School for a Departmental Clinical
Research Resource Review (CR3). Prior to the Medical School implementing the CR3 process, the CPRC sent
a feasibility review form to ISC Team Chairs for completion prior to the CPRC meeting.
In the second stage of review, the CPRC reviews scientific quality and merit. The CPRC reviews the adequacy
of the objectives, treatment plan, study justification, statistical plan, data and safety monitoring plan, and
accrual goals. Protocols must receive CPRC approval or stipulated approval with permission to proceed with
the Institutional Review Board application and submission.
The CPRC is also responsible for continuing review of scientific progress and accrual throughout a trial’s
enrollment period. The CPRC may disapprove or close a study for lack of scientific or accrual progress. Annual
review of all CPRC-approved studies begins 1 year after the initial CPRC approval date. The annual accrual
minimum has been increased to 35% of the projected goal. If a protocol does not meet the accrual threshold, if
scientific merit is in question, or if there has been a delay in study activation, a letter is sent to the PI requesting
justification.
The CPRC is composed of members with scientific expertise in solid tumors, hematology, blood and marrow
transplant, pediatrics, epidemiology, pharmacology, and cancer prevention and control to encompass the
portfolio of research conducted at the MCC. Co-Chairs of the committee are appointed by MCC Executive
Leadership. The ISC teams are composed of faculty and staff representatives from disease specific disciplines
who currently serve as treating physicians, Advanced Practice Providers (APP), or study staff within that
disease portfolio. The CTO SLT is composed of senior MCC and CTO leadership.

## Key facts

- **NIH application ID:** 10768156
- **Project number:** 2P30CA077598-26
- **Recipient organization:** UNIVERSITY OF MINNESOTA
- **Principal Investigator:** Brenda J. Weigel
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $187,552
- **Award type:** 2
- **Project period:** 1998-06-01 → 2029-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10768156

## Citation

> US National Institutes of Health, RePORTER application 10768156, Protocol Review and Monitoring System (2P30CA077598-26). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10768156. Licensed CC0.

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