# Protocol Review and Monitoring System

> **NIH NIH P30** · UNIVERSITY OF MARYLAND BALTIMORE · 2020 · $41,709

## Abstract

13.0 Abstract: Protocol Review and Monitoring System 
The Protocol Review and Monitoring System (PRMS) of UMGCC is embodied in the UMGCC Clinical 
Research Committee (CRC). The CRC reviews all new cancer-related protocols for scientific merit, 
methodology, competing studies in the portfolio, and reasonability of accrual goals before submission to the 
UMB Institutional Review Board (IRB). The CRC ensures that expert biostatistical review of clinical trial design 
and calculation of sample size occurs for each institutional protocol and selected noninstitutional protocols. The 
CRC provides initial review of the intended data safety monitoring plan and, as needed, verifies PI 
determinations of research versus standard-of-care procedures. The CRC receives input from Disease Group 
leaders and the UMGCC Protocol Feasibility Committee to ensure proper prioritization of new and existing 
protocols. The CRC reviews accrual to all studies supported by UMGCC on a continuous basis and oversees 
the development of corrective action plans or closes poorly accruing trials. Finally, the CRC provides scientific 
review as needed for issues that may arise relating to accrual, for safety or adverse events noted by the Data 
Safety Monitoring/Quality Assurance Committee, or for specific questions referred from the IRB. As of January 
2015, with the coalescence of the UMGCC PS Program, individuals with expertise in population science have 
been recruited as members of the CRC and a process for review of interventional trials from PS members at 
UMCP and UMB developed. 
During CY2014, the CRC reviewed at full committee level 63 protocols; 29 were approved as written, 23 were 
approved with minor modifications, 10 were approved with major modifications requiring re-review, and 1 was 
deferred. An expedited review process exists for minimal risk studies, and it was utilized to approve 45 studies 
in CY2014. During CY2014, 83 trials were monitored for accrual, targeting for corrective action any protocols 
that were not accruing at a rate suggesting successful completion within a 3- to 5-year timeframe. Twenty- 
three warning letters were issued, resulting in closure of 12 protocols by August 26, 2015.

## Key facts

- **NIH application ID:** 9984997
- **Project number:** 5P30CA134274-13
- **Recipient organization:** UNIVERSITY OF MARYLAND BALTIMORE
- **Principal Investigator:** Vu H. Duong
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $41,709
- **Award type:** 5
- **Project period:** 2008-08-08 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9984997

## Citation

> US National Institutes of Health, RePORTER application 9984997, Protocol Review and Monitoring System (5P30CA134274-13). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/9984997. Licensed CC0.

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