# Clinical Protocol and Data Management

> **NIH NIH P30** · UT SOUTHWESTERN MEDICAL CENTER · 2022 · $540,954

## Abstract

The Simmons Comprehensive Cancer Center (SCCC) Clinical Protocol and Data Management (CPDM)
section reports information related to the (1) Clinical Research Office (CRO), (2) Data and Safety Monitoring
Committee, (3) Inclusion of Women and Minorities in Clinical Research, and (4) Inclusion of Individuals
Across the Lifespan in Clinical Research. These efforts, along with the Protocol Review and Monitoring
System (PRMS), are closely monitored by the SCCC Clinical Cancer Research Committee, which is led by
David E. Gerber, MD (Associate Director of Clinical Research). The CRO, under the leadership of M.
Shaalan Beg, MD (CRO Medical Director) and Erin Williams, MBA (CRO Administrative Director), provides
comprehensive, centralized services for the implementation and management of all oncology clinical
research studies conducted at UT Southwestern Medical Center (UTSW) and its affiliated healthcare
systems, Parkland Health and Hospital System and Children’s Medical Center. The CRO serves as the
central repository for all cancer studies, maintains real-time reporting on research activities, and provides
training and a library of standard operating procedures (SOPs) for all clinical research personnel. The Data
and Safety Monitoring Committee (DSMC), led by Jonathan Dowell, MD, operates independently of the
PRMS and CRO and conducts risk-based monitoring for adverse events and protocol compliance for all
SCCC interventional trials. The DSMC is supported by a three-person Quality Assurance Unit that ensures
the highest level of protocol compliance according to the SCCC’s National Cancer Institute–approved DSM
Plan. SCCC also promotes and monitors the inclusion of women and underrepresented minorities in
clinical research. Key to promoting underrepresented minority participation in clinical research is
SCCC’s provision and support for clinical trials within its affiliate Parkland Health and Hospital System—the
safety-net provider for Dallas County. The CRO also partners with the SCCC Office of Community
Outreach, Engagement, and Equity to implement tailored strategies to support enrollment of
underrepresented minorities. Inclusion of individuals across the lifespan is demonstrated most poignantly
by the CRO’s activities at Children’s Medical Center, the largest pediatric oncology program in North
Texas, as well as SCCC’s special attention to minimizing age restrictions in all clinical trials. In the current
Cancer Center Support Grant funding period, SCCC has made notable clinical research progress.
Highlights include (1) a 28% increase in interventional treatment accruals since 2014 (48% increase for
SCCC-led investigator-initiated treatment trials), (2) a 17% reduction in time to study activation, (3)
consistent enrollment of racial/ethnic minorities to trials proportional to SCCC catchment demographics
(currently 34% of interventional accrual), and (4) a commitment to enrollment across the lifespan, with SCCC
among the top 7% in accrual for all NCI Ch...

## Key facts

- **NIH application ID:** 10478011
- **Project number:** 5P30CA142543-12
- **Recipient organization:** UT SOUTHWESTERN MEDICAL CENTER
- **Principal Investigator:** Shaalan Beg
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $540,954
- **Award type:** 5
- **Project period:** 2010-09-01 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10478011

## Citation

> US National Institutes of Health, RePORTER application 10478011, Clinical Protocol and Data Management (5P30CA142543-12). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10478011. Licensed CC0.

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