# Protocol Review and Monitoring System

> **NIH NIH P30** · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 2024 · $141,652

## Abstract

ABSTRACT – PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS)
The protocol review and monitoring system (PRMS) for the O’Neal Comprehensive Cancer Center (O’Neal)
ensures that clinical cancer research performed at the University of Alabama at Birmingham (UAB) has scientific
merit, is aligned with the priorities of the center, and progresses timely to yield relevant results. Fifteen disease
working groups (DWGs) form the foundation of PRMS and serve as the primary setting for interface with the
center research programs and the first step of scientific review of protocols. DWGs facilitate protocol
development and perform scientific and feasibility review for internally and externally sourced clinical protocols.
During the current project period, the DWGs reviewed 857 and approved 643 (75%) clinical protocols. Clinical
protocols approved by the DWGs proceed for review by the Protocol Review and Monitoring Committee (PRMC),
the second step of scientific review. The PRMC is composed of two co-chairs, administrative staff, and 17 core
members representing several disciplines relevant to clinical cancer research. Following strict criteria, protocols
undergo expedited review by co-chairs or full board review. The PRMC has final authority on protocol approval
or rejection. While the PRMC and UAB’s Institutional Review Board (IRB) are independent with no overlapping
membership, PRMC scientific approval is required for IRB approval. During the current project period, the PRMC
reviewed 694 protocols, including 410 protocols that underwent full committee review. The PRMC oversees the
progress of approved protocols towards their accrual goals. Following a well-established set of criteria, PRMC
flags protocols for remediation when not meeting accrual goals and, in the event of inadequate improvement,
determines the closure of protocols. In the current CCSG cycle, 300 protocols required PI action due to
insufficient accrual. In 250 protocols, an adequate correction action plan was implemented while 50 were
eventually closed by determination of the PRMC. The PRMS is supported by administrative staff that ensures
uniform and consistent operation of DWGs and the PRMC, documentation of activities, and communication with
investigators and research teams. Several important changes were implemented in the PRMS during the current
period, including standardization of DWG activities, transition to fully electronic protocol management,
implementation of virtual meetings, and establishment of dedicated administrative support. Operational
improvements can be exemplified by the reduction in time from PRMC submission to determination (from median
of 47 to 26 days). Future plans include increasing the interaction between DWGs and O’Neal research programs
and aligning the DWGs with the Cancer Service Line to ensure synchrony between research priorities and clinical
operations.

## Key facts

- **NIH application ID:** 10817212
- **Project number:** 5P30CA013148-51
- **Recipient organization:** UNIVERSITY OF ALABAMA AT BIRMINGHAM
- **Principal Investigator:** Charles A. Leath
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $141,652
- **Award type:** 5
- **Project period:** 1997-03-28 → 2027-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10817212

## Citation

> US National Institutes of Health, RePORTER application 10817212, Protocol Review and Monitoring System (5P30CA013148-51). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10817212. Licensed CC0.

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