CLINICAL PROTOCOL AND DATA MANAGEMENT

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DESCRIPTION (provided by applicant): The overall aims of the Clinical Protocol and Data Management Shared (CPDM) Facility are to: a) provide central management for the implementation, coordination, and conduct of clinical trials developed by the UAB Cancer Center faculty and by our extramural collaborators associated with SPOREs, other Cancer Centers, the NCI, industry and cooperative groups, b) provide for quality assurance of the operation including monitoring of toxicities, clinical care, data collection, and adherence to protocol-described procedures, c) provide a centralized database of protocol-specific data, and d) provide research pharmacy support for the acquisition, storage, dispensing, and tracking of all investigational agents administered to protocol patients as required by the protocol and regulatory agencies (local, state, and national). Major accomplishments since last submission have included: a) An increment of 28% in the 4 year accrual of patients in the CPDM Facility. This patient accrual includes a total of 1047 patients to investigator initiated trials (34% of the total accrual) and 1305 patients to Phase I and II trials (42% of the total accrual), b) Implementation of the Clinical Trials Monitoring Committee (CTMC) which meets weekly and monitors every active clinical trial in the Cancer Center, c) Development of specialized Protocol Management Teams consisting of nurse protocol coordinators and data managers to improve their disease specific expertise, enhance nurse-physician interaction and to increase the number of patients enrolled in the high priority studies, d) During this funding period, the Cancer Center played a central role in recruitment of 16 clinical investigators to UAB clinical Divisions and Departments. These recruitments ncluded the Deputy Director of the Cancer Center (Dr. Bland), Associate Director for Clinical Research (Dr. Rinehart) and Medical Director of the CPDM Facility (Dr. Forero). e) In 2002, we developed full ECOG membership under the leadership of Carla Falkson, M.D. In 2003, our first year of full membership we became the leading accrual site for ECOG with over 100 registrations.