# Protocol Review and Monitoring System (PRMS)

> **NIH NIH P30** · VIRGINIA COMMONWEALTH UNIVERSITY · 2024 · $91,955

## Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM: 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
Virginia Commonwealth University (VCU) Massey Cancer Center (MCC). PRMS functions are accomplished by
rigorous evaluations through a multi-stage review process conducted by 1) MCC’s multidisciplinary Disease
Working Groups (DWGs) that perform initial assessments of the value, fit, operational feasibility, and prioritization
within the existing portfolio of studies; and 2) the Protocol Review and Monitoring Committee (PRMC), the
definitive, independent authority for determining which studies proceed to activation based on scientific merit.
DWG approval is required before proceeding to the PRMC; however, only the PRMC has final authority with
regards to determining which studies will be activated. The PRMS process ensures that all MCC cancer-relevant
research studies are 1) scientifically sound; 2) effectively designed, specifically from a biostatistics perspective;
3) appropriately prioritized within the DWG research portfolio to avoid competing trials and ensure alignment with
MCC’s overall institutional priorities for clinical research; 4) feasible for activation and completion (or in meeting
institutional target accrual goals); 5) assessed for data and safety monitoring adequacy based on the study risk
level; and 6) monitored regularly for accrual and scientific progress. In 2021, the MCC DWGs vetted in aggregate
113 studies and forwarded 77 to the PRMC. Once received by the PRMC, 42 studies received an initial expedited
review by the PRMC as they had already received an appropriate external scientific peer review, and 35 studies,
primarily representing MCC’s investigator-initiated and industry-sponsored trials, were forwarded for full PRMC
review. More than 20% (7/35) of the studies reviewed by the full committee required modifications prior to
approval. None of the studies were disapproved, reflecting the effectiveness of the DWG vetting process and
the attentive support investigators receive from the MCC Clinical Trials Office and MCC leadership in developing
their investigator-initiated studies prior to PRMC submission. In addition, in CY2021 the PRMC performed
scientific and accrual monitoring reviews for 152 studies. Of those, 59 studies received low accrual notifications
requiring Principal Investigator response. This resulted in the closure of 14 studies. The PRMS, inclusive of the
DWG and PRMC review processes, is one of the most critical functions that the MCC performs to ensure the
highest quality clinical research is being conducted.

## Key facts

- **NIH application ID:** 10850951
- **Project number:** 5P30CA016059-42
- **Recipient organization:** VIRGINIA COMMONWEALTH UNIVERSITY
- **Principal Investigator:** Renato Martins
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $91,955
- **Award type:** 5
- **Project period:** 1995-12-01 → 2028-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10850951

## Citation

> US National Institutes of Health, RePORTER application 10850951, Protocol Review and Monitoring System (PRMS) (5P30CA016059-42). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10850951. Licensed CC0.

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