# Protocol Review and Monitoring System

> **NIH NIH P30** · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2020 · $37,035

## Abstract

PROJECT SUMMARY: PROTOCOL REVIEW AND MONITORING SYSTEM
The Protocol Review and Monitoring System (PRMS) at the Sylvester Comprehensive Cancer Center
(Sylvester) oversees all cancer-related clinical and population science research conducted at the University of
Miami. The main aims of the PRMS are to 1) provide timely review of the scientific merit of all cancer research
studies; 2) ensure prioritization of cancer research studies according to Sylvester’s strategic plan, mission, and
vision, including programmatic alignment and catchment area relevance; and 3) monitor the scientific progress
of all cancer research studies. PRMS functions are accomplished by a two-stage rigorous review process.
First, the Site Disease Groups (SDG) assess scientific and clinical value, patient availability, and priority within
the existing research portfolio. Second, studies are reviewed by the Protocol Review and Monitoring
Committee (PRMC) composed of reviewers with the depth and breadth of expertise necessary to conduct a
critical and fair review of all protocols. In 2017, Sylvester subdivided the PRMC, creating a subcommittee for
population science studies (PRMC-PS), composed of faculty with expertise in population science,
biobehavioral, and epidemiologic studies and a subcommittee for medical studies (PRMC-M), composed of
faculty experienced in clinical, translational, and biological studies. Both subcommittees include members from
the Biostatistics and Bioinformatics Shared Resource and members with basic science expertise, and they
operate under the same standard operating procedures. PRMC scientific review takes into account the specific
rationale, study design, availability of adequate numbers of patients or subjects, presence of any competing
studies, and robustness of biostatistical design, assuring internal oversight of the scientific merit of all cancer
studies. The functions of PRMC complement, rather than overlap or duplicate, the Institutional Review Board
(IRB), which is responsible for the protection of human subjects. Further, the PRMC does not perform any
auditing or data and safety monitoring functions. The PRMC does not duplicate traditional peer review for
studies supported by various NIH mechanisms (e.g., R01s, U01s, P01s, U10s, and P50s) or approved by the
NCI’s Cancer Therapy Evaluation Program. These protocols receive an expedited review for the purposes of
prioritization. All studies are reviewed annually to evaluate scientific progress and continuing clinical and
scientific relevance and importance; accruals are monitored every six months to ensure the study’s scientific
design and that accrual is proceeding sufficiently to support the overall objectives of the study. Sylvester’s
PRMC is administrated by the Research Committees Support Unit staff within Clinical Research Services. The
PRMC has the final authority to close cancer studies not meeting scientific or accrual goals. Having a robust
PRMS, which includes both the SDG and the PR...

## Key facts

- **NIH application ID:** 9975835
- **Project number:** 5P30CA240139-02
- **Recipient organization:** UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
- **Principal Investigator:** JONATHAN C TRENT
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $37,035
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9975835

## Citation

> US National Institutes of Health, RePORTER application 9975835, Protocol Review and Monitoring System (5P30CA240139-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9975835. Licensed CC0.

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