The Biostatistics and Informatics Core (BSIC) will gather data from OIAC cores and studies, provide and manage a centralized data system for the storage of study data, and perform analyses that combine data across Cores and studies. The BSIC will be a focal point for all OAIC research and will promote synergy among studies and Cores producing a Pepper Center that is more than the sum of its parts. The strong statistical expertise and unique facilities for data storage and study management provided by the BSIC that will help the OAIC achieve its goal of increasing the independence of older Americans. The BSIC has three complementary roles. The first is to support OAIC investigators from the inception of an idea for a research project to the analysis and publication of research data. The second is to educate researchers in the statistical methods and interpretation of the results of statistical analyses. The third is to perform research into statistical methods that addresses important problems that arise in clinical research. The Core will support researchers by helping them design and execute their studies and by managing and helping them analyze study data. The Core will perform power calculations (including allowance for subjects lost to follow-up), and randomize subjects. The Core will provide a centralized, user-friendly, secure, regularly backed-up, data management system, GERI, that will be used to store, review, and access data generated by OAIC researchers, and cores. The Tracking, Adjudication, Medication databases and the Adverse Event Reporting System will assist researchers and leadership manage OAIC studies. A series of bi-weekly reports will (1) document completeness of the data and identify missing data elements, (2) facilitate data verification by listing new subjects and data added to the database since the last report, (3) examine study data looking for extreme, and possibly erroneous values using exploratory data analysis and bivariate correlations of related data, and (4) review entry of subjects into each research protocol to determine if entry keeps up with recruiting goals. The Core will assist the Safety Monitoring Board oversee Pepper Center studies. The Core is strongly committed to the training of junior faculty to help them become independent investigators contributing to research on aging.
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