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.
The Clinical Core is critical in supporting the research projects in this proposal that study human subjects. It will provide a central resource for enrolling study participants, and carrying out all the procedures to provide blood and other tissues for the research projects. It will also provide data management and statistical expertise that will integrate data across projects as well as supporting data analysis work for each project.
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