# Clinical Protocol and Data Management/CTO/DSMB

> **NIH NIH P30** · UNIVERSITY OF CALIFORNIA-IRVINE · 2022 · $243,878

## Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT
 PROJECT SUMMARY/ABSTRACT
Clinical Protocol and Data Management (CPDM) fulfills a vital function within the Chao Family Comprehensive
Cancer Center (CFCCC), directing and supporting effective clinical research operations. The CPDM function is
conducted by the Sue and Ralph Stern Center for Cancer Clinical Trials & Research (Stern Center), the
centralized office for clinical trial operations at the CFCCC. Stern Center leadership has both the clinical and
administrative expertise to nurture a culture of outstanding clinical research.
The Stern Center (~80 FTEs) provides a centralized resource for high quality, cost-effective and efficient
assistance to investigators in developing, activating and completing scientifically impactful clinical trials. The
Stern Center manages the largest portfolio of clinical trials at UCI, with a reputation as a visionary and best-
practice leader in clinical research operations across the institution.
The CFCCC Data and Safety Monitoring Board (DSMB) oversees institutional cancer clinical trials that are
interventional, as defined by the NCI's P30 Cancer Center Support Grant Data Table Guide. The DSMB is the
focal point of the Cancer Center's strategy to ensure the safety of subjects and the validity and integrity of data.
The NCI-approved Institutional Data and Safety Monitoring Plan requires that the DSMB review new Investigator
Initiated Trials, and monitor and audit trials via a risk-based approach. Audits are conducting by the Stern
Center's Quality Assurance Unit according to the Quality Assurance Monitoring and Auditing Plan. Results are
reported to the DSMB. The Quality Assurance Unit maintains a culture of excellence, safety, and compliance in
order to provide audit-ready operations at all times.
The CFCCC-defined Catchment Area is Orange County, which is the third-largest and second-most densely
populated county in California, the sixth-most populated county in the United States, and covers nearly 950
square miles. There are 3.2 million people living in 44 cities and towns in the CFCCC Catchment Area, and the
population is racially and ethnically diverse. The CFCCC is committed to recruiting women, minorities and
individuals across the lifespan to clinical trials. The CFCCC demonstrates equitable and proportionate inclusion
in clinical trials of all genders, races, ethnicities, and ages relative to the Catchment Area demographics and
patient population of the Center.

## Key facts

- **NIH application ID:** 10334388
- **Project number:** 2P30CA062203-24
- **Recipient organization:** UNIVERSITY OF CALIFORNIA-IRVINE
- **Principal Investigator:** SUSAN M O'BRIEN
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $243,878
- **Award type:** 2
- **Project period:** 1997-09-11 → 2027-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10334388

## Citation

> US National Institutes of Health, RePORTER application 10334388, Clinical Protocol and Data Management/CTO/DSMB (2P30CA062203-24). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10334388. Licensed CC0.

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