Clinical Component

临床部分

• 批准号: 9312951
• 负责人: Heidi J Kalkwarf
• 金额: $ 5.73万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-08-01 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9312951
• 关键词: Age; Attention; Award; Basic Science; Biometry; Biopsy; Center for Translational Science Activities; Childhood; Clinical; Clinical Research; Clinical Trials; Consultations; Custom; Data; Databases; Development; Digestive System Disorders; Disease; Enrollment; Ensure; Evolution; Fostering; Genomics; Goals; Growth; Health; Laboratory Research; Medical center; Medicine; Monitor; Names; Online Systems; Patient Monitoring; Patients; Pediatric Hospitals; Population; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Sample Size; Sampling; Security; Services; Sex Distribution; Statistical Data Interpretation; Syndrome; Tissues; Training; Translational Research; Translations; Universities; algorithmic methodologies; base; bench to bedside; biobank; clinically relevant; college; data management; design; human tissue; validation studies

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.

项目摘要 消化健康中心（DHC）临床成分的总体目标是加速 将基础研究转化为临床研究和小儿消化疾病试验。组件 以三个完整的目标追求这个目标。在第一个目标中“提供有关研究设计的咨询和 DHC调查人员的生物统计服务：“临床组件向DHC调查人员提供了 基于Web的门户网站，用于与研究设计，统计分析和结果报告有关的服务。这条线 服务由临床组件主管和生物统计学家领导，并具有消化专家 疾病研究。补贴咨询可通过辛辛那提翻译中心提供 科学和培训和机构生物统计研究部门，由统计学家和数据组成 分析师。在第二个目标中“为实施和监视提供数据管理和基础架构 在基于患者的研究中，该组件向DHC调查人员提供了基础设施 REDCAP和其他大数据平台的全面数据管理服务。这些平台 依靠严格的安全性和临床和翻译研究的合规要求。在第三 旨在“为消化性疾病研究提供访问组织和基因组样本”，该组成部分 旨在促进小儿基于患者的研究的机构生物库的合作伙伴 人口。生物库使DHC研究人员有可能获得去识别的储存组织和 批准研究的相关疾病信息。它还促进了定制的开发 针对研究人员发起的项目的生物库，并有助于提交IRB提议的重点 消化疾病的研究。