CORE--CLINICAL PROTOCOLS AND DATA MANAGEMENT

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The Clinical Protocol and Data Management Shared Resource (CPDM) is a component of the Center's Clinical Trials Unit that provides central management and oversight of all clinical trials activities of the Center. The Shared Resource provides a range of management and quality control functions that are essential for conducting clinical trials research in Hawaii's decentralized community practice setting. It includes a central location for all cancer protocols, a centralized database of protocol-specific data, an updated list of currently active protocols for the use of Center investigators, and status reports of protocols, It provides a centralized organization for activating and monitoring protocols throughout Hawaii's multiple community offices and medical centers involving several Institutional Review Boards (IRBs). Quality control functions include: insuring subject safety and compliance with federal requirements through the Data and Safety Monitoring plan, insuring staff competency through training for research nurses, CRAs, clinical trials assistants and community office, clinic, and hospital staff engaged in Hawaii's cancer clinical trials enterprise, and insuring recruitment of underserved minorities through focused outreach activities.