BIOSTATISTICS AND CLINICAL RESEARCH CORE PROJECT SUMMARY The Biostatistics and Clinical Research Core assists with study design and logistics, as well as the collection, analysis and integration of biological and epidemiological data using techniques of computer science and statistics. Under the direction of Evan Dellon, MD, MPH, an experienced clinical, epidemiologic, and translational researcher, the core provides assistance with database implementation and maintenance, web applications, validated and secure data capture, quality control, data analysis, and statistical analysis. The core offers full collaboration on sound statistical study design, study process engineering, data model development, system design and implementation. This leads to secure and accurate data capture and management, linking of various data types and sources, and data extraction and reporting for analytics. The Core provides an interface between basic scientists and informatics specialists to support translational research. The Core provides essential services to the large group of clinical epidemiologists who are members of our center. The clinical research component of the core includes assistance with study start-up, IRB approval, IND, regulatory issues, contracting, clinical coordinator staffing, data and specimen collection, specimen processing, quality control and monitoring. The specific aims of the core are: 1) To provide consultation on biostatistics and study design during the design, conduct and analysis phases of research. 2) To offer data collection and data management services including forms development, enrolment tracking, data capture, data validation, data security and confidentiality, database closure, statistical programming, application development. 3) To enable members and trainees access to large claims databases such as IMS Pharmetrics, MarketScan and Medicare. 4) To support clinical research through consultation, regulatory support, contract negotiations, and data and specimen collection provided by a team of experienced study coordinators. 5) To deliver training and education about sample size and power calculations, study design and analysis.