Clinical Studies

项目总结：核心B 拟议中的卓越中心在转化研究结合四个项目，重点是开发一个 快速分子诊断，以检测对结核分枝杆菌（Mtb）的药物反应改变。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。我们将建立系统， 我们在以前的工作中开发的专业知识，以提供服务，包括开发协议， 确保人类受试者研究的各个方面符合NIH的要求;所有程序和材料都符合NIH的要求。 数据管理、质量控制、存储和分析的场所;数据收集协议正在 实施;工作人员接受研究培训并了解其目标;标本收集和 临床程序是各研究中心的标准程序。

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.