Clinical Component

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PROJECT SUMMARY The overall goal of the Clinical Component of the Digestive Health Center (DHC) is to accelerate the translation of basic research into clinical studies and trials for pediatric digestive diseases. The Component pursues this goal with three complementary aims. In the first aim “to provide consultation on study design and biostatistical services for DHC investigators,” the Clinical component makes available to DHC investigators a web-based portal for services related to study design, statistical analysis, and result reporting. This line of services is led by the Director of the Clinical Component and a biostatistician with expertise on digestive disease studies. Subsidized consultation is made available through the Cincinnati Center for Translational Science and Training and institutional Biostastistical Research Unit, which is staffed by statisticians and data analysts. In the second aim “to provide data management and infrastructure for implementation and monitoring of patient based research, the Component makes available to DHC investigators the infrastructure for comprehensive data management services with REDcap and other large-data platforms. These platforms count on rigorous security and compliance requirements for clinical and translational research. And in the third aim “to provide access to tissues and genomic samples for digestive disease research,” the Component partners with the institutional biobank that is designed to facilitate patient-based research in the pediatric population. The biobank makes it possible for DHC investigators to obtain de-identified stored tissues and relevant disease information for approved studies. It also facilitates the development of customized biorepositories for investigator-initiated projects, and helps with submission of IRB proposals focused on studies of digestive diseases.