Clinical Core

项目摘要 P01的临床核心，阐明免疫老化的高分辨率纵向免疫监测 动力学，将为所有P01人类研究项目提供最先进的生物标本支持， 核心，以及实施和管理的人员、程序和流程， 临床项目推荐临床核心将协调P01的临床研究工作，包括： 制定（与NIAID/NIA）和策划临床协议和文件;提供和更新培训， 临床研究者和工作人员;组织、实施、监督和努力改进临床项目 执行质量控制和纠正措施（如需要），包括确保遵守 里程碑、项目绩效预期和临床良好实践指南。我们的具体任务是： 1)获取项目1和项目2的生物标本。这两个项目都不会访问任何受保护的健康信息（PHI）。 2)建立和维护P01将用于提供核心临床的人员、程序和流程 支持. 3)建立和维护方案里程碑、性能指南、合规性、参与者 临床研究和样本采集的招募和保留。临床中心将采用最先进的 生物标本服务，以支持P01研究，并将应用数十年的一流经验，成功地 临床项目管理，以产生杰出和严格的研究，使变革性的影响， P01的结果。

Project Summary The Clinical Core of the P01, High resolution longitudinal immune monitoring for elucidating immune aging dynamics, will provide state-of-the-art biospecimen support for both all the P01 human research projects, and cores, as well as the personnel, procedures and processes for the implementation and management of the proposed clinical project. The Clinical Core will orchestrate the clinical research effort of the P01, including: co- developing (with NIAID/NIA) and curating clinical protocols and documents; providing and updating training for clinical investigators and staff; organizing, implementing, monitoring and working to improve clinical project performance; and conducting quality control and corrective action (if needed), including assuring adherence to milestones, project performance expectations, and clinical Good Practice Guidelines. Our Specific Tasks are: 1) Obtain biospecimens for Projects 1 and 2. Both projects will not access any protected health information (PHI). 2) Establish and maintain the personnel, procedures and processes that the P01 will use to provide core clinical support. 3) Establish and maintain protocol milestones, performance guidelines, compliance, participant recruitment, and retention for clinical study and sample collection. The Clinical Core will engage state-of-the-art biospecimen services to support P01 research and will apply decades of first-rate experience in successful clinical project management to produce outstanding and rigorous research to make a transformative impact in results obtained for the P01.