# Protocol Review and Monitoring System

> **NIH NIH P30** · UT SOUTHWESTERN MEDICAL CENTER · 2021 · $200,703

## Abstract

The Simmons Comprehensive Cancer Center (SCCC) Protocol Review and Monitoring System (PRMS) provides 
independent peer review for scientific merit, prioritization, and monitoring for all cancer-related clinical and 
population science studies conducted at the UT Southwestern Medical Center (UTSW) and its affiliated 
healthcare systems, Parkland Health and Hospital System and Children’s Medical Center. PRMS functions are 
accomplished by a rigorous review in a two-stage process conducted by: 1) SCCC Disease-Oriented Teams 
(DOTs), where initial assessment of value, fit, and prioritization within the existing portfolio of studies is 
performed, as well as an assessment of each study’s operational and accrual feasibility; and 2) the Protocol 
Review and Monitoring Committee (PRMC), which is the definitive independent authority for determining which 
studies proceed to activation. The PRMC ensures that all SCCC-aligned cancer research studies involving 
human subjects are (1) scientifically sound, (2) effectively designed, (3) appropriately prioritized within DOT 
research portfolios, (4) aligned with SCCC institutional clinical research priorities, (5) feasible for completion, (6) 
inclusive of appropriate data and safety monitoring plans, and (7) monitored regularly for accrual and scientific 
progress. Utilizing standard operating policies and procedures, the PRMS is conducted by 13 DOTs and three 
PRMCs (two for clinical studies and one for population studies), under the leadership of Hans Hammers, MD, 
PhD (PRMC1), Robert Timmerman, MD (PRMC2), and Simon Craddock Lee, PhD, MPH (Population Science 
PRMC). During the current project period, the PRMS made substantial progress in key areas, including 
implementing parallel review with the Institutional Review Board (IRB) while still requiring PRMC approval before 
IRB approval, increasing PRMC meeting frequency, expanding PRMC membership, and transitioning to a fully 
electronic review process, all of which have contributed to decreased review timelines while maintaining the 
highest scientific standards. In 2019, the SCCC DOTs vetted 197 studies for potential submission and forwarded 
162 studies for PRMC review. Of these, 50 had undergone an appropriate external scientific peer review and 
therefore received an expedited review by the PRMC Chair and/or Vice Chair. The remaining 112 studies, 
primarily representing SCCC investigator-initiated and industry-sponsored trials, were forwarded for full PRMC 
review. More than 70% of the studies reviewed by PRMC required modifications prior to being approved. No 
studies were disapproved. Ten underperforming studies were closed. In the next CCSG cycle, the PRMS will 
focus on further reduction in review timelines and enhancing information provided to investigators during the 
review process.

## Key facts

- **NIH application ID:** 10170622
- **Project number:** 2P30CA142543-11
- **Recipient organization:** UT SOUTHWESTERN MEDICAL CENTER
- **Principal Investigator:** Kevin D Courtney
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $200,703
- **Award type:** 2
- **Project period:** 2010-09-01 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10170622

## Citation

> US National Institutes of Health, RePORTER application 10170622, Protocol Review and Monitoring System (2P30CA142543-11). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10170622. Licensed CC0.

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