Clinical Core

项目摘要 P01的临床核心，高分辨率纵向免疫监测以阐明免疫老化 Dynamic，将为所有P01人类研究项目提供最先进的生物质学支持，以及 核心，以及执行和管理 建议的临床项目。临床核心将协调P01的临床研究工作，包括： (与NIAID/NIA)制定和管理临床方案和文件；提供和更新培训 临床研究人员和工作人员；组织、实施、监测和改进临床项目 性能；以及进行质量控制和纠正措施(如果需要)，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2的生物制品。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)建立和维护协议里程碑、绩效指南、合规性、参与者 招募和保留，用于临床研究和样本采集。临床核心将采用最先进的技术 Biosecimen服务支持P01研究，并将应用数十年的一流经验在成功 临床项目管理，以产生杰出和严格的研究，以产生变革性的影响 为P01获得的结果。

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.