A. History and Evolution of the Core The Digestive Disease Research Core Center at UNC has had a biostatistical core since the center was established in 1985. The name, the directors, and the mission of the core have changed over time in response to evolution in the needs and research interests of members. The Biostatistics and Data Management Core has been extensively used by basic science, epidemiology, clinical outcomes and clinical investigators who are CGIBD members and associate members. Furthermore, the Biostatistics and Data Management Core provides a unique national resource to Digestive Disease investigators outside our Center. The Biostatistics and Data Management Core provides state-of-the-art data services and consultation. As described in detail in the sections that follow, the core assists with the collection, analysis and integration of biological and epidemiological data using techniques of computer science and statistics. We provide assistance with database maintenance, web applications, data capture, quality control, data analysis, and statistics. The Core provides an interface between basic scientists and informatics specialists to support translational research. Importantly, the core provides essential services to the large group of clinical epidemiologists who are members of our center. The core is fully equipped and staffed with a suite of offices in the recently opened Bioinformatics Building. For the past decade the CGIBD Biostatistics and Data Management Core has served as the Data Management Center for the Crohn's and Colitis Foundation of America (CCFA) Clinical Alliance. The purpose of the Alliance is to conduct multi-center randomized trials of IBD therapy. As the Data Management Center it is our responsibility to assist in study design and protocol development. We create the case report forms, data entry routines, quality control measures, and analysis plans. Our biostatistician performs all data analyses. The Data Management Center is an excellent example of cooperation between a research university, a private foundation, and an NIH Digestive Disease Research Core Center. We were able to secure the contract with the CCFA because of the expertise and infrastructure that we developed through our Digestive Disease Research Core Center. In turn, our center members have benefited by the expertise and extra capacity that we have developed through CCFA funding. CGIBD members and associates derive the benefit of a full time biostatistician and data management team at their disposal. They also benefit from the equipment, tools and techniques that we have assembled. However, the CGIBD pays for only a small portion of the costs associated with the operation of the Data Management Center. The bulk of the costs are paid for by large research grants and contracts. B. Justification Our center places a strong emphasis on clinical and translational research. The Biostatistics and Data Management Core facilitates translation of research findings into practical treatments for patients. The core provides a repository for information on study volunteers and biological specimens. In that regard, the Biostatistics and Data Management serves as the Clinical Component for the CGIBD. The core provides the expertise and hardware for database design, maintenance, and analysis. We work with investigators to establish quality control systems, develop questionnaires and monitor research activities. We provide expert biostatistical consultation along with applications and statistical programming. In sum, the core provides a level of service that is not readily available on our campus, and does so in a cost-effective manner. The core also serves as a bridge between clinical and basic researchers. The core can increase the productivity and effectiveness of our members because it provides high quality and efficient support for the full range of data management needs. This is cost effective for members because fee-for-service statistical consultation on our campus is extremely expensive, and data management services are not readily available. As described in more detail below, we provide free consultation for pilot awardees, modest free consultation to Members and Associates, and fee-for-service or contract support for larger projects. The core use reports that are appended to this section document the benefits to investigators during the past 5 years. The services offered by the core are described below. We have a number of associate members who are formally trained in epidemiology who do not yet have independent funding. As they gain independence they will rely more heavily on the core. In the meantime, we are able to provide them support and biostatistical consultation necessary for the pilot work that will be necessary for them to secure funding.
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