? Clinical Protocol and Data Management 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 Clinical Trials & 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 and implementation support, as well as quality control functions. CRO coordinates study management activities including screening subjects and collecting and recording study data. RAO manages the committee coordination 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 responsible for managing all Disease Oriented Team (DOT), PRMC, and DSMB meetings. The regulatory coordinators submit all regulatory committee applications. RAO and CRO also work closely with the Clinical Informatics Department of the UC Irvine Medical Center to manage the clinical trials management system, OnCore, which houses 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 the safety of participants and the validity and integrity of data for all UC Irvine investigator-initiated trials (IITs). The Data and Safety Monitoring Board (DSMB) is responsible for reviewing data and safety monitoring plans and assigns risk levels to UC Irvine IITs, following its NCI-approved Data and Safety Monitoring Plan. The frequency of review of trials is commensurate with the level of risk for IITs. The DSMB reviews patient safety data, 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 in Orange County (OC) and the majority of the participant base derives directly from OC residents for the accrual of women and minorities. The new Pacific Breast Care Center continues to increase clinical trial implementation and recruitment efforts focusing on women. Additionally, the Gynecological DOT focuses on the 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 Hyundai Cancer Institute at Children's Hospital of Orange County (CHOC Children's). A formal UC Irvine/CHOC Affiliation Agreement was approved by the University of California Regents in 2009, and CHOC Children's is being included as a formal affiliate of the CFCCC in this competing renewal application.
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