Clinical Studies

临床研究

• 批准号: 10595536
• 负责人: MEGAN B MURRAY
• 金额: $ 140.94万
• 依托单位: HARVARD MEDICAL SCHOOL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-18 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10595536
• 关键词: Algorithms; Area; Basic Science; Case Report Form; Clinical; Clinical Research; Data; Data Analyses; Data Collection; Data Security; Development; Drug resistance in tuberculosis; Early Diagnosis; Enrollment; Ensure; Goals; Human Subject Research; Informed Consent; Institutional Review Boards; Laboratories; Laboratory Procedures; Monitor; Multidrug-Resistant Tuberculosis; Mycobacterium tuberculosis; Peru; Pharmaceutical Preparations; Procedures; Process; Protocols documentation; Quality Control; Research; Research Personnel; Services; Site; Specimen; Standardization; System; Testing; Training; Translational Research; United States National Institutes of Health; Work; data cleaning; data management; data quality; database structure; design; diagnostic tool; experience; human subject; molecular diagnostics; participant enrollment; protocol development; recruit; response; sample collection; treatment response

PROJECT SUMMARY: CORE B The proposed Center for Excellence in Translational Research combines four projects focused on developing a rapid molecular diagnostic to detect altered drug responses to Mycobacteria tuberculosis (Mtb). Core B, our proposed clinical research core, will support projects involving human subjects. We will build on systems and expertise that we have developed in previous work to provide services that include developing protocols to ensure all aspects of human subjects research meet NIH requirements; that all procedures and materials are in place for data management, quality control, storage and analysis; that data collection protocols are being implemented; that staff are trained in the research and understand its goals; and that specimen collection and clinical procedures are standard across sites.

项目摘要：核心B 拟议的翻译研究卓越中心结合了四个项目，重点是开发 快速分子诊断以检测对结核分枝杆菌(Mtb)改变的药物反应。核心B，我们的 拟议的临床研究核心，将支持涉及人类受试者的项目。我们将建立在系统和 我们在以前的工作中开发的提供服务的专业知识，包括开发协议以 确保人体受试者研究的所有方面都符合NIH的要求；所有程序和材料都符合 用于数据管理、质量控制、存储和分析；数据收集协议正在 实施；工作人员接受研究方面的培训并了解其目标；以及标本收集和 临床程序在各个地点都是标准的。