# Protocol Review and Monitoring System

> **NIH NIH P30** · UNIVERSITY OF MARYLAND BALTIMORE · 2022 · $58,943

## Abstract

8.0 Abstract: Protocol Review and Monitoring System (PRMS)
The Protocol Review and Monitoring System (PRMS) of the University of Maryland Marlene and Stewart
Greenebaum Comprehensive Cancer Center (UMGCCC) is a two-step system. Step 1 occurs at
Disease/Modality Focused Group (DFG) meetings, where faculty and staff involved in specific disease teams
discuss current and proposed clinical trials. Step 2 involves the Clinical Research Committee (CRC) which
reviews all new cancer-related protocols for scientific merit, methodology, competing studies in the portfolio, and
reasonability of accrual goals before submission to the Institutional Review Board (IRB). The CRC ensures an
expert biostatistics review of clinical trial design and calculation of sample size for each institutional and selected
non-institutional protocols. CRC reviews the Data Safety Monitoring plan to ensure sufficiency and receives DFG
and UMGCCC Protocol Feasibility Committee input to ensure proper prioritization and utilization of resources.
CRC continually reviews accrual to studies supported by UMGCCC and closes poorly accruing trials. Finally,
CRC provides scientific review for issues that arise relating to accrual, safety or adverse events noted by the
Data Safety Monitoring/Quality Assurance Committee, and addresses IRB questions. During the 2019 calendar
year, the CRC performed full committee level reviews of 123 protocols; 71 were approved as written, 31 were
approved with minor modifications, 15 were approved with major modifications requiring re-review, and 6 were
deferred. An expedited review process exists for research that is deemed to pose minimal risk, based on
University of Maryland–Baltimore IRB guidelines, and that involves chart reviews, interviews or surveys, studies
of archived biospecimens, collection/banking of biospecimens during routine clinical procedures, Phase III
industry-sponsored trials, or any Phase IV postmarketing study seeking more information on safety and efficacy.
During CY2019, expedited review approved 21 studies. To further refine the use of CRC resources, a new
category of review (Acknowledgment Review) was created in 2019 to allow for UMGCCC CRC acknowledgment
of research approved by the National Cancer Institute (NCI) Central Institutional Review Board (CIRB) or of
studies that have undergone external peer review (e.g., approved by the PRMS of another NCI-designated
cancer center or consortium trial). During CY2019, 172 trials were monitored for accrual and any protocols not
accruing at a rate suggesting successful completion of targeted enrollment within three to five years were
targeted for corrective action. In CY2019, UMGCCC received the “Most Improved” award, granted by Forte
Research for achieving a 90-day reduction in overall trial activation including a 9-day reduction in CRC approval.
Sixty-five warning letters were issued, resulting in closure of 11 protocols in CY2020. During FY2019, costs to
support PRMS exceeded $800,000, of...

## Key facts

- **NIH application ID:** 10492065
- **Project number:** 5P30CA134274-15
- **Recipient organization:** UNIVERSITY OF MARYLAND BALTIMORE
- **Principal Investigator:** Vu H. Duong
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $58,943
- **Award type:** 5
- **Project period:** 2008-08-08 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10492065

## Citation

> US National Institutes of Health, RePORTER application 10492065, Protocol Review and Monitoring System (5P30CA134274-15). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10492065. Licensed CC0.

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