# Protocol Review and Monitoring System

> **NIH NIH P30** · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2024 · $74,793

## Abstract

PROJECT SUMMARY: PROTOCOL REVIEW AND MONITORING SYSTEM
The Sylvester Comprehensive Cancer Center (Sylvester) Protocol Review and Monitoring System (PRMS) is
the centralized authority which oversees and provides independent, peer review of the scientific merit, priority,
and progress of all prospective, hypothesis-driven clinical cancer research involving human subjects conducted
at the University of Miami (University). PRMS functions are accomplished by a rigorous two-stage review
process. The site disease groups (SDGs) and clinical research teams (CRTs) perform the initial, Stage 1
PRMS review of potential clinical impact, scientific importance, catchment area (CA)-relevance, and overall
prioritization within the existing portfolio of SDG/CRT studies, as well as assessing each study’s operational
and accrual feasibility. The Stage 2 PRMS review by the PRMC is the definitive, independent, centralized
authority for determining which studies proceed to activation, and which ongoing studies remain active, based
on scientific and clinical merit and accrual progress. The activities of the PRMC are independent and non-
overlapping with the University’s Institutional Review Board (IRB). Prioritization and approval by the SDG/CRT
are required before a study proceeds to the PRMC; however, only the PRMC has final and independent
authority to determine which studies will be activated and which underperforming studies will be closed. The
specific aims of the PRMC are to 1) assess the scientific merit of proposed cancer research studies through
robust scientific peer review; 2) prioritize all cancer studies according to Sylvester’s Strategic Plan, mission,
CA-relevance, and Research Programs; 3) confirm that appropriate subject recruitment plans are in place,
target accrual predictions are achievable, and adequate data and safety monitoring plans are defined; and 4)
monitor scientific progress with final authority to terminate cancer studies not meeting accrual goals. To
accomplish these aims, the PRMC ensures that all clinical cancer research studies involving human subjects
are scientifically robust, have appropriate biostatistics, and are prioritized within Sylvester’s research portfolio.
The PRMC also ensures that protocols are aligned with Sylvester’s Strategic Plan for clinical research, are
feasible for completion and meeting specified accrual goals within timeline, have an appropriate data and
safety monitoring plan, and are monitored regularly for accrual, clinical, and scientific progress. During the
reporting period (6/1/2018 to 5/31/2023), the Sylvester SDG/CRTs approved 691 protocols for PRMC review.
Once received by the PRMC, 244 of the 691 studies (35%) received an initial expedited review by the PRMC
Chair, while 447 of the 691 studies (65%), primarily Sylvester’s investigator-initiated and industry-sponsored
studies, were forwarded for full PRMC review. The PRMC closed 49 underperforming studies and facilitated
the closure of an additional 47...

## Key facts

- **NIH application ID:** 10933326
- **Project number:** 2P30CA240139-06
- **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:** 2024
- **Award amount:** $74,793
- **Award type:** 2
- **Project period:** 2019-07-10 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10933326

## Citation

> US National Institutes of Health, RePORTER application 10933326, Protocol Review and Monitoring System (2P30CA240139-06). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10933326. Licensed CC0.

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