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Abstract:
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As a recipient of the Cancer Center Support Grant from the National Cancer Institute, the University of Wisconsin Comprehensive Cancer Center (UWCCC) is required to maintain a protocol review and monitoring system to evaluate scientific merit of all UWCCC clinical trials and to assure that clinical resources of the center are maximally utilized to achieve scientific goals of the clinical trials program. A system is required to prioritize competing protocols and assess the scientific progress of each clinical trial. These as well as other federal regulations, external audits, and core grant submissions necessitates a database management system (DBMS) for tracking protocol development, review, status change, and scientific progress. It is also necessary to provide the capability for patient registrations and monitoring of accrual and patient status. Quality control for reliability of research data and validity of results requires a validated data management system with edit checks and audit trails. The UWCCC in partnership with an IT vendor named e2Go Technology, Inc. developed such a DBMS in order to fulfill these obligations and responsibilities. The system is intended for use by clinical investigators, clinical research associates and staff at the UWCCC and its affiliate institutions. The system's interface is Web-based, making it platform-independent. Its database back-end is the Oracle relational database management system. This exhibit will give a general introduction to the UWCCC's database management system for protocol tracking and patient registration and demonstrate its use.
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