# Protocol Review and Monitoring System

> **NIH NIH P30** · FRED HUTCHINSON CANCER RESEARCH CENTER · 2020 · $157,293

## Abstract

PROJECT SUMMARY: PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS)
A single Protocol Review and Monitoring System (PRMS) governs all oncology clinical trial protocols across
the Consortium partner institutions and assures that cancer-relevant human research is (1) scientifically
important and statistically sound; (2) designed appropriately without excluding special populations for non-
scientific reason; (3) feasible, with reasonably attainable accrual targets given the available patient population;
and (4) supportive of the research mission of the Consortium. The central feature of the PRMS is the Scientific
Review Committee (SRC). The PRMS committee structure is responsible for approving protocols that meet its
stringent and well-defined criteria. A Research Group Review is required prior to submission to the SRC as
part of a two-stage review process and assures that Consortium protocols are of high scientific merit and
feasible prior to investing additional institutional resources in development.
The SRC evaluates scientific merit, feasibility, prioritization, and progress of all Consortium clinical trial
protocols. As part of the Consortium’s trial activation process, SRC approval is required prior to IRB review.
Efficient operations and weekly SRC meetings have resulted in a median overall process time of 14 calendar
days (10 business days) which has remained consistent since 2015. The PRMS further ensures that during
accrual, the scientific rationale for the protocol has remained relevant and that accrual is sufficient to meet the
scientific aims of the trial. Since implementation of the updated Low Accrual Policy in FY 2015, the number of
reviews and closures increased from 25 trials reviewed and three closures, to 74 reviewed and 24 closed in FY
2018. All protocols approved by PRMS have access to CCSG-supported centralized resources, including
Clinical Protocol and Data Management (CPDM) and the Biostatistics Shared Resource (BSR). PRMS has the
ultimate authority to close trials that do not demonstrate scientific progress.

## Key facts

- **NIH application ID:** 9853671
- **Project number:** 2P30CA015704-45
- **Recipient organization:** FRED HUTCHINSON CANCER RESEARCH CENTER
- **Principal Investigator:** Ajay Gopal
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $157,293
- **Award type:** 2
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9853671

## Citation

> US National Institutes of Health, RePORTER application 9853671, Protocol Review and Monitoring System (2P30CA015704-45). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/9853671. Licensed CC0.

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