# Protocol Review and Monitoring System

> **NIH NIH P30** · UNIVERSITY OF CALIFORNIA AT DAVIS · 2023 · $92,395

## Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS)
PROJECT SUMMARY/ABSTRACT
The UC Davis Comprehensive Cancer Center (UCDCCC) Protocol Review and Monitoring System (PRMS)
provides a mechanism for ensuring internal oversight of the scientific and research aspects of cancer clinical
trials and for assuring that the UCDCCC's clinical resources are optimally engaged. The PRMS is intended to
cover clinical research activity meeting the NCI definition of a clinical trial, as defined in the Data and Safety
Monitoring Plan (DSMP). During the reporting period, the PRMS implemented several key processes to ensure
UCDCCC is maintaining a robust clinical research portfolio. The PRMS is comprised of two key committees
including the Disease Team Committees (DTCs) and the Scientific Review Committee (SRC). The DTCs and
SRC are responsible for the rigorous review of clinical protocols through a sequential two-stage process. At
UCDCCC, there are seven multidisciplinary, oncology focused DTCs including Breast, Gastrointestinal,
Genitourinary, Hematological malignancies, Phase I, Pediatrics, and Thoracic. Using standardized review
criteria, DTCs conduct the initial evaluation of a potential protocol for value, fit, and prioritization within the
UCDCCC trial portfolio. A protocol must be endorsed by the DTCs before heading to the SRC. The SRC is the
definitive independent authority that determines if a trial will be submitted to the Institutional Review Board
(IRB) for subsequent activation. The SRC provides essential review elements for scientific merit, prioritization,
resource allocation, and accrual monitoring. Once a trial is activated, an SRC sub-committee called the
Protocol Accrual Monitoring Committee (PAMC) is responsible for regularly reviewing trial accruals and
communicating with investigators. Based on PAMC findings, reminders are sent to investigators prior to SRC
intervention, in order to allow corrective actions or clarifications of issues. Once PAMC makes a
recommendation to close a trial due to poor or no accrual, the recommendation returns to SRC who has the
final authority to close that trial.

## Key facts

- **NIH application ID:** 10624401
- **Project number:** 5P30CA093373-21
- **Recipient organization:** UNIVERSITY OF CALIFORNIA AT DAVIS
- **Principal Investigator:** HELEN K CHEW
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $92,395
- **Award type:** 5
- **Project period:** 2002-07-01 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10624401

## Citation

> US National Institutes of Health, RePORTER application 10624401, Protocol Review and Monitoring System (5P30CA093373-21). Retrieved via AI Analytics 2026-06-10 from https://api.ai-analytics.org/grant/nih/10624401. Licensed CC0.

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