# Protocol Review and Monitoring System

> **NIH NIH P30** · WAKE FOREST UNIVERSITY HEALTH SCIENCES · 2024 · $72,738

## Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS): PROJECT SUMMARY
The goal of the Protocol Review and Monitoring System (PRMS) is to provide independent peer review of the
scientific merit, priority, feasibility, and progress of all clinical cancer research studies conducted within the Wake
Forest Baptist Comprehensive Cancer Center (WFBCCC). The PRMS functions are accomplished by rigorous
evaluations through a multi-stage review process conducted by: (1) WFBCCC’s multidisciplinary Disease-
Oriented Teams (DOTs), where initial assessment of value, fit, and prioritization within the existing portfolio of
studies is performed; (2) a Clinical Protocol and Data Management Feasibility Group (CPDM-FG), which reviews
all operational considerations and/or logistical aspects of studies to ensure timely activation and completion; and
(3) the Protocol Review Committee (PRC), which is the definitive independent authority for determining which
studies proceed to activation based on scientific merit. The DOT approval and CPDM-FG’s review are required
before proceeding to the PRC; however, only the PRC has final authority with regards to determining which
studies will be activated. The PRMS process ensures that all WFBCCC clinical cancer research studies are: (1)
scientifically sound; (2) effectively designed, specifically from a biostatistics perspective; (3) appropriately
prioritized within the DOT’s research portfolio to avoid competing trials as well as align with WFBCCC’s overall
institutional priorities for clinical research; (4) feasible for activation and completion (or in meeting institutional
target accrual goals); (5) assessed for the adequacy of the data and safety monitoring plans based on the risk
level of the study; and (6) monitored regularly for accrual and scientific progress. In 2020, the WFBCCC DOTs
vetted in aggregate 185 studies and forwarded 112 of these studies to the CPDM-FG. Eighty-seven of these
studies proceeded to PRC review. Once received by the PRC, 29 studies received an initial expedited review by
a PRC Chair as they had already received an appropriate external scientific peer review, and 58 studies, primarily
representing WFBCCC’s investigator-initiated and industry-sponsored trials, were forwarded for full PRC review.
More than 28% (24/87) of the studies fully reviewed by the PRC required modifications prior to approval. None
of the studies were disapproved. In addition, all studies were monitored for scientific and accrual progress, and
10 underperforming studies were closed in 2020. The PRMS, inclusive of the DOTs, CPDM-FG, and PRC review
processes, is one of the most critical functions that the WFBCCC performs to ensure the highest quality of
research is being conducted.

## Key facts

- **NIH application ID:** 10813807
- **Project number:** 5P30CA012197-49
- **Recipient organization:** WAKE FOREST UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** Boris Pasche
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $72,738
- **Award type:** 5
- **Project period:** 1997-02-01 → 2027-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10813807

## Citation

> US National Institutes of Health, RePORTER application 10813807, Protocol Review and Monitoring System (5P30CA012197-49). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10813807. Licensed CC0.

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