The Clinical Database and Data Management Core (CDDMC) will provide the necessary data collection and management activities for the current and future SPORE projects. The purposes of the CDDMC are: 1) To develop the data collection forms and the data management system for the current and future SPORE projects, 2) To collect a dataset of specialized and follow-up clinical data on patients at participating SPORE institutions who are enrolled in the prospective melanoma and cutaneous T cell lymphoma studies (Projects 2 and 3). 3) To collect the same data fields described above (1) in patients at participating SPORE institutions who are enrolled in clinical trials (Projects 4 and 5) as well as in developmental projects that may require data management. 4) To process the data with quality control mechanisms for final data analysis. 5) To maintain a database information storage system on specimens processed by the tissue pathology and immunology core lab. The CDDMC can provide efficient and consistent quality control and management of the clinical data from the multiple projects over time through a centralized core facility. Special attention will be paid specifically to information systems, file management, data entry, interaction between the CDDMC and clinical sites, and the preparation of the clinical data for statistical analysis. The CDDMC will manage data on the baseline demographics, clinical characteristics, treatment and outcomes of patients diagnosed with melanoma and cutaneous T-cell lymphoma, using the Domain Clintrial v4.3, an ORACLE-based clinical database management system for Projects 2, 3, 4, 5, and 6. Data will be remotely entered at the participating SPORE institutions through a web- interface via Domain Clintrial Connect. The CDDMC will also be interfaced with the Tissue Tracking System for integration of data from the Pathology Core and Tissue/Blood Repository. The longitudinal integration of tissue tracking and clinical data will allow correlation of histopathological, genetic, and phenotypical data over time from patients at different stages of melanoma and cutaneous T-cell lymphoma.
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