# Protocol Review and Monitoring System (PRMS)

> **NIH NIH P30** · UNIVERSITY OF CALIFORNIA-IRVINE · 2020 · $83,908

## Abstract

Core 011 – Project Summary/Abstract – Protocol Review and Monitoring System 
The Chao Family Comprehensive Cancer Center (CFCCC) Protocol Review and Monitoring System is 
implemented through the activities of its review committees and is supported and facilitated by administrative 
staff. The system is designed to increase the translation of CFCCC discoveries from the laboratory into the 
clinic and improve the efficiency of opening and managing clinical trials. Proposed protocols are brought 
forward by individual investigators to either a Disease-Oriented Team (DOT) or a corresponding 
multidisciplinary tumor board. These groups are charged with determining their level of interest in and 
commitment to the trial, whether the scientific question addressed is of sufficient importance to their field, the 
appropriateness of the trial design, the potential to accrue to the trial, any conflicts with existing studies and 
prioritization, and possible correlative translation science that could be captured. The principal charge of the 
Protocol Review and Monitoring Committee (PRMC) is evaluation of scientific quality and progress. For 
scientific quality, the PRMC will evaluate only institutional, investigator-initiated trials (IITs) that have not 
undergone this process elsewhere. Cooperative group and pharmaceutical industry trials, which have been 
vetted on a national level, are exempt from this review. In addition to scientific quality, the PRMC assesses 
whether the clinical trials office has the appropriate resources (e.g. data management, pharmacy, nursing, etc.) 
to support the trial, how the trial fits into the broad interests of the Cancer Center (e.g. portfolio balance across 
disease areas, potential for accrual of women and minorities, whether the trial is an IIT), and the track record of 
the principal investigator in accruing to previous trials. The PRMC will continue to routinely review scientific 
progress for all open trials and also consider data timeliness and quality. The PRMC may disapprove a trial, 
approve a trial, or request additional information from the PI. The record of deliberations of the PRMC and 
correspondence with the PI is documented in the clinical trials management system, OnCore.

## Key facts

- **NIH application ID:** 9851366
- **Project number:** 5P30CA062203-23
- **Recipient organization:** UNIVERSITY OF CALIFORNIA-IRVINE
- **Principal Investigator:** Krishnansu Sujata Tewari
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $83,908
- **Award type:** 5
- **Project period:** — → 2022-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9851366

## Citation

> US National Institutes of Health, RePORTER application 9851366, Protocol Review and Monitoring System (PRMS) (5P30CA062203-23). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9851366. Licensed CC0.

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