# Protocol Review and Monitoring System

> **NIH NIH P30** · MEDICAL UNIVERSITY OF SOUTH CAROLINA · 2021 · $80,153

## Abstract

PROTOCOL REVIEW & MONITORING SYSTEM: SUMMARY
The Hollings Cancer Center (HCC) Protocol Review & Monitoring System (PRMS) oversees and provides in-
dependent, peer review of the scientific merit, priority, and progress of all prospective, hypothesis-driven, can-
cer studies involving human subjects conducted at the Medical University of South Carolina (MUSC). PRMS
functions are accomplished by rigorous review in a two-stage process conducted by: 1) HCC Clinical Disease
Focus Groups (DFG), where initial assessment of value, fit, and prioritization within the existing portfolio of
studies is performed, as well as regular assessments of each study’s overall performance in terms of accrual;
and 2) the Protocol Review Committee (PRC), which is the final definitive authority for determining which stud-
ies proceed to activation and which studies remain activated based on scientific and accrual progress. The
PRC is charged with ensuring that all prospective, hypothesis-driven, cancer research studies involving human
subjects are: 1) scientifically sound; 2) effectively designed, specifically from a biostatistics perspective; 3) ap-
propriately prioritized within each DFG’s research portfolio to avoid competing trials, as well as aligned with the
HCC’s overall institutional priorities for clinical research; 4) feasible for completion or in meeting institutional
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 scientific and accrual progress. In 2017, the HCC DFGs vetted in ag-
gregate 136 new studies and forwarded 102 (75%) of these studies to PRC review. Among the 102 studies
received by the PRC, 37 studies (36%) received an initial expedited review by the PRC chair or co-chairs, as
they had already received an appropriate external scientific peer-review, and 65 studies (64%), primarily repre-
senting HCC’s investigator-initiated and industry-sponsored trials, were forwarded for full PRC review. Thirty-
six of the 65 studies (55%) reviewed by the full PRC required modifications prior to being approved, and one
study was disapproved and not allowed to proceed through the activation process. In addition, the PRC also
conducted scientific and accrual progress reviews for all actively accruing HCC studies (330 studies) for which
27 underperforming studies were closed by the PRC in 2017. The HCC PRMS, inclusive of the DFGs and PRC
review processes, is one of the most critical functions that the HCC performs to ensure the highest quality of
research is being conducted at the HCC.

## Key facts

- **NIH application ID:** 10134286
- **Project number:** 5P30CA138313-13
- **Recipient organization:** MEDICAL UNIVERSITY OF SOUTH CAROLINA
- **Principal Investigator:** James Ravenel
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $80,153
- **Award type:** 5
- **Project period:** 2009-04-01 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10134286

## Citation

> US National Institutes of Health, RePORTER application 10134286, Protocol Review and Monitoring System (5P30CA138313-13). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10134286. Licensed CC0.

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