Clinical Core

临床核心

• 批准号: 10491675
• 负责人: Kari C. Nadeau
• 金额: $ 53.79万
• 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/10491675
• 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; 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; Time; Training; Translational Research; United States National Institutes of Health; Update; Whole Blood; Work; base; biobank; 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.

项目摘要 p01的临床核心，高分辨率的纵向免疫监测，以阐明免疫老化 动态，将为所有P01人类研究项目和 内核以及实施和管理的人员，程序和流程 拟议的临床项目。临床核心将策划P01的临床研究工作，包括： 开发（使用NIAID/NIA）以及策划临床方案和文件；提供和更新培训 临床研究人员和工作人员；组织，实施，监测和努力改善临床项目 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，项目绩效期望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的生物测量。这两个项目将无法访问任何受保护的健康信息（PHI）。 2）建立和维护P01用来提供核心临床的人员，程序和过程 支持。 3）建立和维护协议里程碑，绩效指南，合规性，参与者 招募和临床研究和样本收集的保留率。临床核心将接触到最先进的 生物循环服务以支持P01研究，并将在成功中运用数十年的一流经验 临床项目管理，以进行出色和严格的研究，以对 为P01获得的结果。