The study of disability and response to intervention requires a comprehensive analysis of physiology, comorbid conditions and neurophysiologic and psychosocial factors. Data describing these factors will be collected by the IDS-I, IDS-2, OAIC cores, clinical laboratory and pilot studies. The Biostatistics Core (ICRC-D) will be responsible for gathering data from all OAIC cores and studies, will provide and manage a centralized data system for the storage of the data, and will perform analyses that combine data across cores and studies. RRC-D will be a focal point for all OAIC research and will promote synergy among studies and cores, producing an OAIC that is more than the sum of its parts. The RRC-D has three complementary roles. The first role is to support Pepper Center investigators in all phases of their work, from the inception of an idea for a research project to the analysis and publication of research data. The second role is to develop new techniques that can be used to collect, store, manipulate, display and analyze data. The third is to educate researchers in the use and interpretation of statistical analysis. The core will support researchers by helping them design and execute their studies and by managing and analyzing study data. The Core will perform power calculations (including corrections for subjects lost to follow-up) and will randomize subjects. The core will be responsible for the analysis of data from all studies and will provide a centralized, user-friendly, secure, regularly backed-up, data management system that can be used to store, manipulate, review, and access research data. Centralization of data storage will promote sharing of data among Pepper Center researchers and will increase the range of analyses that can be performed. The core will oversee all aspects of data management. A series of 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. Finally, the ore will assist the safety monitoring board in overseeing OAIC studies.
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