# Mays Cancer Center at UT Health SA

> **NIH NIH P30** · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · 2024 · $122,148

## Abstract

Project Summary—Protocol Review and Monitoring System
The Protocol Review and Monitoring System (PRMS) oversees and ensures the prioritization, feasibility,
scientific merit and progress of all clinical studies at the Mays Cancer Center (MCC). The PRMS consists of two
stages of review, as well as a logistics and feasibility review. Each of these components work in collaboration
with one another to ensure that the right trials for the right population with the right resources open and accrue.
Initial review of protocols and prioritization is performed by the nine Clinical Disease Site Teams (CDSTs),
physician-led groups focused on a particular disease site or area of interest. Scientific rigor and progress are
evaluated by the Protocol Review Committee (PRC). The PRC evaluates statistical accuracy of the protocol,
drug dosages and reviews the rational, innovation, preclinical data, impact and significance of the cancer-related
trials. Though not part of the PRMS, the Clinical Trial Operations Committee (CTOC) reviews protocols for
feasibility, safety and logistics. The PRMS evaluation process occurs prior to submission to the UT Health SA
Institutional Review Board (IRB) and is required for IRB approval. Importantly, the PRMS process is
complementary to the IRB review, occurs in tandem, and does not overlap or duplicate their responsibilities. The
IRB will not approve a protocol without the PRC's approval. After a study has opened to accrual, the PRC
provides ongoing review to ensure adequate accrual and scientific progress. The PRC has the authority to close
studies that have not progressed toward their intended scientific objectives. In 2018, the MCC PRMS Committee
reviewed 78 trials. Of those, 77 were approved and opened to accrual, 1 was not approved, and 2 studies were
closed for lack of progress/accrual.

## Key facts

- **NIH application ID:** 10891446
- **Project number:** 5P30CA054174-29
- **Recipient organization:** UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
- **Principal Investigator:** Chul Soo Ha
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $122,148
- **Award type:** 5
- **Project period:** 1997-08-01 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10891446

## Citation

> US National Institutes of Health, RePORTER application 10891446, Mays Cancer Center at UT Health SA (5P30CA054174-29). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10891446. Licensed CC0.

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