# Protocol Review and Monitoring System

> **NIH NIH P30** · UNIVERSITY OF HAWAII AT MANOA · 2024 · $39,080

## Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM - ABSTRACT
 The Protocol Review and Monitoring System (PRMS) serves a critical role in ensuring the execution of
high-quality cancer-related clinical research within the University of Hawai‘i Cancer Center (UHCC) and its
extensive network of community-based hospitals, health systems, and oncology providers, all operating within
the UHCC-led clinical trials infrastructure. The PRMS review process has been designed in compliance with
Cancer Center Support Grant (CCSG) guidelines to ensure all studies undergo rigorous review and monitoring.
 The PRMS review process consists of two distinct stages. The first-stage review is now done by Disease
Site Working Groups (DSWGs) and before March 2023 by the Clinical Trials Office (CTO) Operations
Committee. They conduct a comprehensive assessment of studies, focusing on scientific merit and alignment
with UHCC’s portfolio requirements and priorities. Before the initiation of DSWGs, the CTO Operations
Committee conducted the initial review and prioritization of studies. This committee then forwarded their
recommendation to the PRMC for second-stage review. Between January 2018 and March 2023, the CTO
Operations Committee reviewed 279 new studies, with 164 receiving recommendations for a second-stage
review. The DSWG, initiated in March 2023, consists of ten discipline groups. They conduct the initial review
and prioritize studies. Priority is assigned first to funded Investigator Initiated Trials (IITs), followed by national
and industrial studies. Studies recommended for approval are subsequently routed for PRMC review. Since the
introduction of DSWGs in March 2023 and through August 2023, 57 new protocols have been reviewed, with
20 already receiving recommendations for second-stage review. Some of the others are in progress. The CTO
acts as the crucial communication channel between DSWGs and the PRMC. Additionally, it provides essential
administrative support and logistical expertise.
 The Protocol Review and Monitoring Committee (PRMC), chaired by Jeffrey Berenberg, MD (reports to
Naoto Ueno, MD, PhD, UHCC Director), conducts the second-stage review. The PRMC is responsible for an
independent scientific evaluation and holds the exclusive authority to approve studies for activation. The
PRMC serves as an independent scientific review committee with the ultimate authority to approve trials for
activation and terminate studies that fail to demonstrate scientific progress. They conduct annual reviews of
active protocols to monitor scientific progress and accruals, terminating studies when necessary. The PRMC’s
functions are distinct from those of the Institutional Review Board (IRB) and do not duplicate their
responsibilities. Between January 1, 2018, and December 31, 2022, the PRMC reviewed 164 new studies,
approving 155 for activation. In addition, the PRMC conducted 305 annual reviews, resulting in the termination
of 41 studies due to slow accrual. All PRMS activities ...

## Key facts

- **NIH application ID:** 10935920
- **Project number:** 2P30CA071789-23
- **Recipient organization:** UNIVERSITY OF HAWAII AT MANOA
- **Principal Investigator:** Jeffrey Lee Berenberg
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $39,080
- **Award type:** 2
- **Project period:** 1997-07-01 → 2029-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10935920

## Citation

> US National Institutes of Health, RePORTER application 10935920, Protocol Review and Monitoring System (2P30CA071789-23). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10935920. Licensed CC0.

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