# Protocol Review and Monitoring System

> **NIH NIH P30** · UNIVERSITY OF FLORIDA · 2023 · $55,684

## Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM: ABSTRACT
The University of Florida Health Cancer Center (UFHCC) Protocol Review and Monitoring System (PRMS) is
responsible for scientific evaluation, prioritization, and monitoring of all cancer-relevant clinical research
conducted by the UFHCC. The overall goal of the PRMS is to ensure that the clinical research portfolio consists
of impactful and scientifically sound studies aligned with the UFHCC strategic vision. All PRMS activities are
coordinated by the UFHCC Clinical Research Office. UFHCC uses a 2-stage process consisting of Disease Site
Group (DSG) and Scientific Review and Monitoring Committee (SRMC) reviews. The DSGs provide an
integrated, multidisciplinary approach to guide the selection and endorsement of high-quality cancer clinical
trials, while the SRMC reviews research studies for scientific merit, including study design, methodology,
statistical analysis plan, accrual goal expectations, procedures to ensure participant safety, and institutional
priority. A feasibility assessment is performed for all interventional studies to confirm there are a sufficient number
of potential participants and adequate clinical resources. To facilitate mission alignment, the University of Florida
mandates that all cancer-relevant research protocols must be reviewed and approved by the SRMC prior to
Institutional Review Board (IRB) approval. Prior to SRMC submission, all interventional trials are reviewed by
the appropriate DSG for scientific and clinical interest and relevance to the UFHCC catchment area. The latter
is verified by the Director of the Office of Community Outreach and Engagement, who serves as a member of
the SRMC. The SRMC focuses on scientific merit and study progress, and its function does not overlap with that
of the IRB, whose jurisdiction is primarily participant safety. SRMC prioritizes trials competing for UFHCC
resources or participants and has final authority on study approval/termination, without appeal. The SRMC
conducts ongoing reviews of all active interventional clinical trials to ensure they are making sufficient scientific
progress. The SRMC closes trials for inadequate accrual, loss of scientific merit, or protocol violations that
compromise participant safety or the scientific integrity of a study. SRMC members are multidisciplinary to ensure
a fair, critical review of proposed cancer clinical studies. Membership includes faculty and staff with expertise in
clinical investigation, biostatistics, research pharmacy, clinical care, nursing, laboratory, biobehavioral and
population science, and Citizen Scientists. In 2021, DSGs considered 238 new clinical research studies,
ultimately bringing 86 (36%) to the SRMC, of which 53 were approved, 29 were approved with stipulations, and
4 were tabled. None were disapproved, due largely to rigor of the DSG review process. In 2021, the SRMC also
completed 66 protocol amendment reviews and 131 continuation reviews. The continuation review...

## Key facts

- **NIH application ID:** 10625764
- **Project number:** 1P30CA247796-01A1
- **Recipient organization:** UNIVERSITY OF FLORIDA
- **Principal Investigator:** Ryan M. Thomas
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $55,684
- **Award type:** 1
- **Project period:** 2023-06-01 → 2027-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10625764

## Citation

> US National Institutes of Health, RePORTER application 10625764, Protocol Review and Monitoring System (1P30CA247796-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10625764. Licensed CC0.

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