The UT-H Data Core will provide support with research design, data entry and management of 3 Research Projects, the Stroke Registry, additional Research Projects as they are developed, and statistical analyses. In addition, the UT-H Data Core will provide support in collaborative projects between the UT-H Stroke Center and other Stroke Centers in SPOTRIAS. Finally, the UT-H Data Core will serve as an educational resource for stroke trainees in clinical trial methodology. Our Data Core will be directed by Professor M. H. Rahbar, Director of the Biostatistics, Epidemiology, and Research Design (BERD) Core of the UT-H Center for Clinical and Translational Sciences (CCTS). He is an experienced biostatistician with significant expertise in managing data coordinating centers for a national study of autism and international clinical trials. Dr. Rahbar will oversee the work conducted by Miriam Morales, Rick Sline and other members of Data Core. We are fortunate to have Dr. Donald Berry, MD Anderson Chair of Biostatistics as a consultant, and a commitment from Dr. Joseph Lucke, Bayesian Biostatistician at our UT-H Medical School to support our PPARy Project (SHRINC Project 2) and the team in our Data Core. The UT-H Data Core represents an integrated team of statisticians, programmers, and clinicians across The University of Texas Medical School, The University of Texas Center for Clinical and Translational Sciences, The University of Texas School of Bioinformatics, and MD Anderson Department of Biostatistics. The team works together to follow clinical research design and methodology, streamline data entry and management, monitor and evaluate data quality, and to develop innovative solutions regarding data management and trial design The specific aims of the Data Core encompass statistical and clinical trial methodological support, trial design, data coordination, data management, data assurance, quality control, reporting, and education of stroke trainees in biostatistics. The Data Core will provide the following: 1. Clinical research design and methodological support in the planning, conduct, and analysis of collaborative projects, center specific projects, and in the development of new research hypotheses, in particular multicenter trials of acute stroke therapy. 2. Statistical analysis support for clinicians and researchers at our site as well as develop innovative study design solutions for complex trial designs, encourage collaboration across SPOTRIAS sites, facilitate publications, and data sharing. 3. Establish and monitor systems for data collection, management, processing, quality control, data assurance, security, communication, and documentation. 4. Maintain a registry on all stroke patients seen by the Stroke Team, and transmit this data to the shared SPOTRIAS database. 5. Serve as an educational resource for stroke trainees in clinical trial methodology and biostatistics. Statistical analyses support will include concordant trial design and conduct including biostatistics, epidemiology, medicine, trial management, database management, study forms design, data editing, quality control, safety and efficacy analyses. The data core will provide statistical support to facilitate abstracts and manuscripts for publications and presentations. In addition, the data core will continue to develop our educational component for our stroke trainees in clinical trial methodology and statistical reasoning in medicine. Furthermore, the faculty in the Data Core will have an excellent opportunity to implement methodological improvements for conducting clinical trials and coordinating multisite/multicenter clinical trials. The data collection and storage is an upgrade to a SQL Server 2005 database with an ASP. NET front end. Appropriate measures will continue to be used to insure the accuracy and confidentially of the data. Database design and computer program development are conducted in accordance with accepted best practices. The structure provided by the Data Core in this application will ensure that the clinical research enterprise of our SPOTRIAS site will maintain our high standards in research development, conduct and reporting, while at the same time maintain the flexibility necessary for our continued growth as we collaborate with other centers and train new investigators in translational research..
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