Clinical Protocol and Data Management/CTO/DSMB

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.