# Protocol Review and Monitoring System (PRMS)

> **NIH NIH P30** · UNIVERSITY OF CALIFORNIA-IRVINE · 2022 · $133,023

## Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM
 PROJECT SUMMARY/ABSTRACT
The Chao Family Comprehensive Cancer Center (CFCCC) Protocol Review and Monitoring System (PRMS)
ensures rigorous internal oversight of the scientific aspects of all cancer-related, hypothesis-driven clinical
research studies conducted at the University of California, Irvine. The Disease-Oriented Teams (DOTs) and
Protocol Review and Monitoring Committee (PRMC) together comprise CFCCC's two-stage PRMS. The PRMS
consists of qualified UCI faculty and staff with the necessary level of expertise within their respective scientific
research areas. Committee membership is of sufficient size and breadth of expertise to provide oversight and
review of all cancer-related research protocols. PRMS processes are governed by standard operating
procedures and guidelines. The PRMS is facilitated and supported by the Sue and Ralph Stern Center for Cancer
Clinical Trials & Research (Stern Center), the centralized office for clinical trial operations at the CFCCC.
The first component of the CFCCC's two-stage review process, the DOTs, are multidisciplinary groups of basic,
translational, clinical, and population health investigators who collaborate on a specific anatomic cancer area in
order to further the translation of CFCCC discoveries through the pipeline towards interventional clinical trials.
The focus of the DOTs is to ensure rigorous internal scientific review of protocols, manage the clinical trial
portfolio, and drive innovation. The DOTs formally score protocols for prioritization based on investigator input,
scientific merit, the potential for correlative science and academic credit for CFCCC investigators, study accrual
potential, existence of active competing trials and whether the disease under investigation disproportionately
affects minority populations in the CFCCC's Catchment Area. The DOTs also perform the assessment of
scientific quality for NCTN and industry studies.
The PRMC is responsible for the second stage of scientific and feasibility review of protocols and has the sole
authority to authorize activation of clinical studies. The PRMC assesses scientific merit and quality for institutional
investigator-initiated trials (IITs), determines if the CFCCC has the appropriate resources to support the trial and
determines how the trial fits into the broader research agenda of the CFCCC. The PRMC is responsible for the
continuing review of open protocols for scientific progress and has sole authority to close trials due to lack of
progress, new safety information, or scientific relevance. The rigor of the CFCCC PRMS ensures the scientific
quality and progress of clinical research conducted at the Cancer Center and the appropriate management of
the Center's resources. The PRMS is critical to the CFCCC's mission to develop new knowledge about the
causes, prevention, detection, treatment, and survival of cancer to shift scientific paradigms, change public policy
and clinical practice, and...

## Key facts

- **NIH application ID:** 10334389
- **Project number:** 2P30CA062203-24
- **Recipient organization:** UNIVERSITY OF CALIFORNIA-IRVINE
- **Principal Investigator:** Joseph Christopher Carmichael
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $133,023
- **Award type:** 2
- **Project period:** 1997-09-11 → 2027-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10334389

## Citation

> US National Institutes of Health, RePORTER application 10334389, Protocol Review and Monitoring System (PRMS) (2P30CA062203-24). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10334389. Licensed CC0.

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