Clinical Core

临床核心将提供生物标本，数据管理和统计专业知识，以支持U19内的研究。临床核心将建立在一套丰富和高效的现有NIH支持的队列和基础设施的基础上，以确保符合每个项目中概述的标准的特征良好的参与者可用于拟议的研究。使用已经到位且可操作的基础设施，收集和表征临床 生物样本将由中心提供，包括静脉切开术、白细胞分离术、肠道活检、淋巴结活检和/或骨髓活检。临床核心还将包括一个分析子核心，该子核心将提供跨项目的集中数据管理和生物统计分析支持。临床核心有四个具体目标：（1）招募和跟踪研究参与者，以执行U19计划研究项目中概述的科学;（2）提供来自特征良好的参与者的生物标本，以支持所有在人类中进行研究的项目;（3）提供数据管理服务，包括为U19网络开发中央数据库和数据共享计划;（4）为所有项目的每个阶段提供统计支持。临床核心的总体目标是整合U19中的研究，加强项目之间的互动，实现真正的多学科 翻译研究的方法。为实现这些目标，核心将：（1）确保每个项目中概述的分子、细胞和临床测量在可能的情况下在相同的受试者和相同的时间点进行;（2）提供数据库支持，以便每个项目和核心的合作实验室生成的数据以集成方式集中管理，以促进跨项目研究;（3）为每个项目提供生物统计支持，以确保 一致和严格的分析方法;和（4）提供跨学科的专业知识，整合临床和生物学数据与团队，这是在这个过程中经验丰富。

The Clinical Core will provide biological specimens, data management and statistical expertise to support research within this U19. The Clinical Core will build upon a rich and highly productive set of existing, NIH supported cohorts and infrastructure to ensure that well-characterized participants who meet the criteria outlined in each of the projects are available for proposed investigations. Using an infrastructure that is already in place and operational, all of the procedures necessary to collect and characterize clinical biological specimens will be provided by the Core, including phlebotomy, leukapheresis, gut biopsy, lymph node biopsy and/or bone marrow biopsy. The Clinical Core will also encompass an Analysis sub-core, which will provide centralized data management and biostatistical analysis support across projects. The Clinical Core has four specific aims: (1) to recruit and follow study participants required to perform the science outlined in the research projects of this U19 program; (2) to provide biological specimens from well characterized participants to support all projects performing studies in humans; (3) to provide data management services, including developing a central database for the U19 network and a data sharing plan, and; (4) to provide statistical support for every stage of all projects. The Clinical Core has overall goals of integrating investigations in this U19, enhancing interactions between projects and achieving a true multidisciplinary approach to translational investigation. To achieve these goals, the Core will: (1) insure that the molecular, cellular, and clinical measurements outlined in each of the projects are performed on the same subjects and at the same time points, when possible; (2) provide database support so that the data generated in the Collaboratory in each of the projects and cores are managed centrally in an integrated fashion that facilitates cross-project investigations; (3) provide biostatistical support to each project to ensure consistent and rigorous analysis approaches; and (4) provide cross-disciplinary expertise integrating clinical and biological data with a team that is highly experienced in this process.