# Protocol Review and Monitoring System

> **NIH CA P30** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2026 · $161,625

## Abstract

PROJECTSUMMARY/ABSTRACT – PROTOCOL REVIEW AND MONITORING SYSTEM
The Moores Cancer Center (MCC) Protocol Review and Monitoring System (PRMS) oversees and provides
independent, peer review of the scientific merit, priority, and progress of all cancer relevant studies involving
human subjects conducted at the University of California, San Diego, its affiliated Rady Children's Hospital as
well as cancer-related population sciences research conducted at MCC's consortium partner, San Diego State
University. PRMS functions are accomplished by rigorous review in a two-stage process: Stage 1) MCC
multidisciplinary Disease Teams (DTs) perform initial assessment of value, portfolio fit, alignment with catchment
area priority cancers, prioritization within the existing portfolio of studies, as well as an assessment of each
study's operational and accrual feasibility; and Stage 2) the Protocol Review and Monitoring Committee (PRMC)
makes the definitive independent determination of which studies proceed to activation. Stage 1 DT input and
approval are required before proceeding to Stage 2 review by PRMC. The PRMC has final and independent
authority to determine which studies will be activated and which underperforming studies will be closed. In 2024,
the MCC DT reviewed 249 studies and advanced 116 to Stage 2 PRMC review. Once received by the PRMC, 27
studies moved on to an initial expedited review by the PRMC Chair, Vice Chair, or a designee, and 89, primarily
representing MCC's investigator-initiated and industry-sponsored trials, were forwarded for full PRMC review. Of
all new studies reviewed by PRMC, 96 were approved, 13 were approved with contingencies, 6 were deferred,
and one was disapproved. Also in 2024, the PRMC reviewed 169 protocol amendments and 256 continuations,
and closed nine underperforming studies. The MCC PRMS, including Stage 1 (DT) and Stage 2 (PRMC), serves
a critical function to ensure the conduct of high-quality research. Improvements to the MCC protocol

## Key facts

- **NIH application ID:** 11335321
- **Project number:** 2P30CA023100-38
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** Lyudmila  Bazhenova
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** CA
- **Fiscal year:** 2026
- **Award amount:** $161,625
- **Award type:** 2
- **Project period:** 1996-07-01T00:00:00 → 2031-04-30T00:00:00

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11335321

## Citation

> US National Institutes of Health, RePORTER application 11335321, Protocol Review and Monitoring System (2P30CA023100-38). Retrieved via AI Analytics 2026-07-11 from https://api.ai-analytics.org/grant/nih/11335321. Licensed CC0.

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