Clinical Core

临床核心

• 批准号: 10687221
• 负责人: Kari C. Nadeau
• 金额: $ 77.09万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-21 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10687221
• 关键词: Address; Adherence; Aging; Biological Assay; Budgets; Cataloging; Cells; Clinical; Clinical Immunology; Clinical Investigator; Clinical Protocols; Clinical Research; Collection; Core Facility; DNA; Data; Ensure; Goals; Good Clinical Practice; Guidelines; Health protection; Human; Human Resources; Immune; Immunologic Monitoring; Informatics; Infrastructure; Institutional Review Boards; Laboratories; Lead; Longitudinal Studies; Monitor; National Institute of Allergy and Infectious Disease; Patient Recruitments; Performance; Peripheral Blood Mononuclear Cell; Plasma; Practice Guidelines; Procedures; Process; Protocols documentation; Quality Control; RNA; Registries; Research; Research Project Grants; Resolution; Sampling; Sampling Studies; Services; Specimen; Technology; Translational Research; United States National Institutes of Health; Update; Whole Blood; Work; biobank; clinical training; data management; expectation; experience; improved; operation; participant enrollment; participant retention; recruit; research study; retention rate; sample collection; screening; search engine; success

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.

项目概要 P01 的临床核心，高分辨率纵向免疫监测阐明免疫衰老 动力学，将为所有 P01 人类研究项目提供最先进的生物样本支持，以及 核心，以及实施和管理的人员、程序和流程 拟议的临床项目。临床核心将协调 P01 的临床研究工作，包括： 开发（与 NIAID/NIA）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、监督和努力改进临床项目 表现;并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 的生物样本。这两个项目都不会访问任何受保护的健康信息 (PHI)。 2) 建立并维护 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 临床研究和样本收集的招募和保留。临床核心将采用最先进的技术 生物样本服务支持 P01 研究，并将应用数十年的一流经验成功 临床项目管理产生杰出而严谨的研究，以产生变革性的影响 P01 获得的结果。