Clinical and Protocol Data Management: Provides centralized oversight and support for coordinating,facilitating and reporting on cancer clinical trials managed by the CFCCC?s Stern Center for Cancer ClinicalTrials & Research, which comprises the Regulatory Affairs Office (RAO) and Clinical Research Office (CRO).RAO and CRO services are provided for the lifecycle of a research study, which includes development andimplementation support, as well as quality control functions. CRO coordinates study management activitiesincluding screening subjects and collecting and recording study data. RAO manages the committeecoordination of the Protocol Review and Monitoring Committee (PRMC) and Data and Safety Monitoring Board(DSMB) and the submission of regulatory documents to all committees. Committee coordination is responsiblefor managing all Disease Oriented Team (DOT), PRMC, and DSMB meetings. The regulatory coordinatorssubmit all regulatory committee applications. RAO and CRO also work closely with the Clinical InformaticsDepartment of the UC Irvine Medical Center to manage the clinical trials management system, OnCore, whichhouses protocol data necessary for planning, reporting and internal oversight.Data and Safety Monitoring: Provides oversight and monitoring for the conduct of clinical trials to ensure thesafety of participants and the validity and integrity of data for all UC Irvine investigator-initiated trials (IITs). TheData and Safety Monitoring Board (DSMB) is responsible for reviewing data and safety monitoring plans andassigns risk levels to UC Irvine IITs, following its NCI-approved Data and Safety Monitoring Plan. Thefrequency of review of trials is commensurate with the level of risk for IITs. The DSMB reviews patient safetydata, efficacy related to protocol stopping rules, possible futility of protocols, data quality for all IIT protocols,monthly assessment of adverse events and serious adverse events, and protocol interim analyses.Inclusion of Women and Minorities: The CFCCC is the only NCI-designated comprehensive cancer center inOrange County (OC) and the majority of the participant base derives directly from OC residents for the accrualof women and minorities. The new Pacific Breast Care Center continues to increase clinical trialimplementation and recruitment efforts focusing on women. Additionally, the Gynecological DOT focuses onthe protocol portfolio and works to identify new protocols to open in breast, cervical, and ovarian cancers.Inclusion of Children: Pediatric oncology patient care and research of UC Irvine is carried out at the HyundaiCancer Institute at Children?s Hospital of Orange County (CHOC Children?s). A formal UC Irvine/CHOCAffiliation Agreement was approved by the University of California Regents in 2009, and CHOC Children?s isbeing included as a formal affiliate of the CFCCC in this competing renewal application.
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