The Biostatistics and Data Management Core (Core C) will provide integrated statistical and technical support to all projects under the Stroke Disparities Program (SDP). Core C is housed in the Department of Epidemiology and Statistics of the MedStar Research Institute, located in Washington, DC, and is in close proximity to the SDP investigative team and the hospitals involved in SDP studies. The aims of Core C are: 1) To provide consultation on study design, study logistics and integration of studies across the SDP program (Study Design); 2) To provide data management to all SDP projects (Data Management); 3) To coordinate review and approval of analytical plans (Statistical Planning and Review); and 4) To conduct statistical analysis, interpret study data, participate in writing of manuscripts and facilitate distribution of SDP data to the scientific community (Data Analysis and Distribution). Core C will engage in ongoing scientific discussions with SDP Core and Project Pis to ensure smooth and sound implementation of projects under the SDP umbrella. Core C's data collection and manageent plans involve designing, testing and deploying web-based data systems for each of the SDP projects. These systems will include numerous quality control features, as well as randomization functions for appropriate projects. Core C will produce study documentation such as codebooks, annotated data collection forms and data system users manuals, conduct regular audits of the clinical sites, and incorporate monitoring as part of a comprehensive quality control program. Core C will generate recruitment and retention reports for the projects as well as conduct interim analyses where appropriate. The Core will participate actively in the Publications Committee of SDP, providing statistical review and oversight during the review of proposals and completed manuscripts. Core C will provide centralized statistical analytic support for the entire SDP program by conducting data analysis in collaboration with SDP writing groups, and participate in manuscript preparation. To encourage data sharing and collaboration, Core C will produce public use data sets with accompanying documentation and deliver these materials to the NIH/NINDS data repository at the end of the study period. Core C will interact with Cores A and B in numerous ways, such as collaborative work on the Publications Committee and collaborative efforts on coding and derivation of stroke-specific variables and summary scales. Core C is experienced in provision of data management and statistical support for NIH-funded studies of diabetes and cardiovascular disease, with a particular emphasis on minority health, health disparities and clinical trials of cardiovascular disease. This experience will be applied to stroke disparities as part of a comprehensive program of technical and scientific support to the SDP program.
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