Clinical Research Core

PROJECT SUMMARY - CLINICAL RESEARCH CORE The mission of the Center for Gastrointestinal Biology and Disease is to catalyze multidisciplinary research on various aspects of clinically relevant gastrointestinal biology, pathophysiology, and epidemiology to reduce the burden associated with digestive disease. The Clinical Research Core is fundamental to accomplishing that mission. The 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 assists 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 methodology during the design, conduct and analysis phases of research. 2) To offer data collection and data management services including forms development, enrollment tracking, data capture, data validation, data security and confidentiality, database closure, statistical programming, and application development. 3) To allow access to large claims databases such as IQVIA Pharmetrics, IBM MarketScan and Medicare. 4) To support clinical and translational research through regulatory support, contract negotiations, and data and specimen collection and cataloguing provided by a team of experienced study coordinators. 5) To deliver training and education about sample size and power calculations, study design and analysis.