The Data Management and Statistics Core provides the database management and statistical support for research conducted within the Massachusetts ADRC (MADRC), including local research projects such as Projects 1, 2 &3 in this grant renewal submission, and collaborative efforts with other ADCs and with national AD research initiatives. The Core aims to catalyze basic science, clinical and translational research in AD by participating in collaborations with subject-matter researchers, in which we develop efficient study designs, and implement and develop optimal analytic methods;as well as through collaborative software development, data management and web-based collaboration and communication methods. The Core aims to innovate in study design and analytic methods, aiming for validity, unbiasedness, and optimal use of time, subjects, and other resources in clinical trials and observational studies. In data management, we have already transitioned from the Center's CBASE system to the multi-center LAVA Clinical Research Management System, for all UDS data management tasks. LAVA will be customized in the coming period to handle the entirety of data collected in the Clinical and Neuropathology Cores, as well as summary descriptive and indexing data from the Neuroimaging Cores. We will continue to collaborate in and support an innovative move across several centers to implement shared software development based on LAVA. The Core aims to educate researchers at all levels, including undergraduates, doctoral students, and post-doctoral fellows in Biostatistics and Epidemiology, MD fellows in Neurology and allied fields, and faculty level clinician scientists. This education encompasses informal instruction on statistical principles of experimental design and data analysis, formal mentoring on research projects, and close collaboration with the Outreach and Admin Cores on Web based programs. Statistics provides consultation for MADRC and MADRC-affiliated Research and Pilot Projects, from the initial conception of the study goals, endpoints and designs, to their monitoring and final analyses. Data Management interacts with each component of the Center. The collaboration is particularly close with the Clinical Core, which enters, verifies and maintains systematic data collected regularly on all LC subjects into the LAVA database, including the UDS set of test results. We then submit the UDS data to NACC. We also assist MADRC investigators with database queries, data extraction and statistical analyses. There is a similar relation with the Neuropathology Core, which submits biomarker and autopsy data;we forward autopsy findings to NACC. We plan to receive, manage and store information from the new Neuroimaging Core. The Data and Statistics Core functions as the glue that binds other Cores together, and fulfills the Administrative Core's mandate of ensuring a smooth functioning research center. It is our overall aim to serve both as a resource for ongoing activities in Alzheimer's disease and other neurodegenerative diseases and as a leader in both research and technical development activities.
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