# Protocol Review and Monitoring System

> **NIH NIH P30** · UNIVERSITY OF HAWAII AT MANOA · 2020 · $43,954

## Abstract

ABSTRACT
 The overall purpose of the Protocol Review and Monitoring System (PRMS) is to ensure that clinical
research of the highest scientific caliber is conducted at the University of Hawai‘i Cancer Center (UHCC) and
throughout the large community-based network of hospitals, health systems and oncology providers within the
UHCC-led clinical trials infrastructure.
 The PRMS consists of the Protocol Review and Monitoring Committee (PRMC). The PRMC review
process ensures that all research is safe and scientifically sound with entry criteria that reflect the catchment
area patient population, have a high probability of full accrual, do not compete with each other, have adequate
resources to answer the question being asked, and is consistent with the priorities of the UHCC. Pre-PRMS
evaluations are completed by the Translational and Clinical Research (TCR) Steering Committee, the
Community Research Advocacy Board (CRAB) and review of data safety and monitoring plans by the Data
Safety and Monitoring Committee (DSMC). The outcome from each of these evaluations is submitted to the
PRMC for reference, ensuring that each protocol receives a thorough, high quality peer review. The PRMC
review occurs prior to the submission to the Institutional Review Board (IRB). PRMS functions are
independent of the IRB, and do not duplicate or overlap with the responsibilities of the IRB. The PRMS has the
authority to open protocols that meet the scientific merit and priorities of the UHCC and to terminate protocols
that do not demonstrate scientific progress.
 The PRMC is comprised of senior clinical oncology investigators from a wide range of disciplines.
Members receive training and evaluate all cancer protocols. Special emphasis is placed on the review of
investigator-initiated trials (IITs) that have not had other external scientific review. From January 1, 2012
through June 30, 2017, the PRMC reviewed 218 new protocols, of which 191 were approved and 27 were not
approved. During this period, 275 were reviewed by the PRMC for annual monitoring. Of these, 25 were
disapproved for continuation, primarily due to low or slow accrual that would prevent achievement of the
scientific goals. PRMC efficiency is monitored through ePRMS tracking within OnCore and includes volume
tracking and tracking of time frames from submission to approval.

## Key facts

- **NIH application ID:** 9968066
- **Project number:** 5P30CA071789-20
- **Recipient organization:** UNIVERSITY OF HAWAII AT MANOA
- **Principal Investigator:** Charles J Rosser
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $43,954
- **Award type:** 5
- **Project period:** — → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9968066

## Citation

> US National Institutes of Health, RePORTER application 9968066, Protocol Review and Monitoring System (5P30CA071789-20). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/9968066. Licensed CC0.

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