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-HData Core will provide support in collaborative projects between the UT-H Stroke Center and other Stroke Centers inSPOTRIAS. Finally, the UT-H Data Core will serve as an educational resource for stroke trainees in clinical trialmethodology. 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 anexperienced biostatistician with significant expertise in managing data coordinating centers for a national study ofautism and international clinical trials. Dr. Rahbar will oversee the work conducted by Miriam Morales, Rick Sline andother members of Data Core. We are fortunate to have Dr. Donald Berry, MD Anderson Chair of Biostatistics as aconsultant, and a commitment from Dr. Joseph Lucke, Bayesian Biostatistician at our UT-H Medical School to supportour PPARy Project (SHRINC Project 2) and the team in our Data Core. The UT-H Data Core represents an integratedteam of statisticians, programmers, and clinicians across The University of Texas Medical School, The University ofTexas Center for Clinical and Translational Sciences, The University of Texas School of Bioinformatics, and MDAnderson 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 solutionsregarding data management and trial designThe specific aims of the Data Core encompass statistical and clinical trial methodological support, trial design, datacoordination, data management, data assurance, quality control, reporting, and education of stroke trainees inbiostatistics. The Data Core will provide the following:1. Clinical research design and methodological support in the planning, conduct, and analysis of collaborativeprojects, center specific projects, and in the development of new research hypotheses, in particular multicentertrials of acute stroke therapy.2. Statistical analysis support for clinicians and researchers at our site as well as develop innovative study designsolutions for complex trial designs, encourage collaboration across SPOTRIAS sites, facilitate publications, anddata 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 sharedSPOTRIAS 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 andefficacy analyses. The data core will provide statistical support to facilitate abstracts and manuscripts for publicationsand presentations. In addition, the data core will continue to develop our educational component for our stroketrainees in clinical trial methodology and statistical reasoning in medicine. Furthermore, the faculty in the Data Core willhave an excellent opportunity to implement methodological improvements for conducting clinical trials and coordinatingmultisite/multicenter clinical trials. The data collection and storage is an upgrade to a SQL Server 2005 database withan ASP. NET front end. Appropriate measures will continue to be used to insure the accuracy and confidentially of thedata. Database design and computer program development are conducted in accordance with accepted bestpractices.The structure provided by the Data Core in this application will ensure that the clinical research enterprise of ourSPOTRIAS site will maintain our high standards in research development, conduct and reporting, while at the sametime maintain the flexibility necessary for our continued growth as we collaborate with other centers and train newinvestigators in translational research..
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