Clinical Component

项目摘要 消化健康中心（DHC）临床部分的总体目标是加速 将基础研究转化为儿科消化系统疾病的临床研究和试验。组件 为实现这一目标，我们有三个相辅相成的目标。第一个目标是“为研究设计提供咨询， DHC研究者的生物统计服务，”临床部分为DHC研究者提供了 研究设计、统计分析和结果报告相关服务的基于网络的门户网站。这行 服务由临床部分主任和一名具有消化系统专业知识的生物统计学家领导。 疾病研究。通过辛辛那提翻译中心， 科学和培训以及机构生物统计研究股，由统计人员和数据提供者组成 分析机构的第二个目标是“为执行和监测提供数据管理和基础设施 在基于患者的研究中，该组件为DHC研究人员提供了基础设施， 通过REDcap等大数据平台提供全面的数据管理服务。这些平台 在临床和转化研究中，我们始终遵循严格的安全和合规要求。和第三 该组件旨在“为消化系统疾病研究提供组织和基因组样本”， 与机构生物库合作，旨在促进儿科以患者为基础的研究 人口生物库使DHC研究人员能够获得去识别的储存组织， 已批准研究的相关疾病信息。它还促进了定制的 生物储存库为制药厂发起的项目，并帮助提交IRB的建议，重点是 消化系统疾病的研究。

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.