Human Subjects Core

高质量的结核病临床和流行病学研究需要在高负担的情况下运营良好的现场 可招募和留住结核病患者、暴露的接触者和控制者的结核病环境；确保安全和 完成数据收集和管理；确保参与者获得高质量的合适临床 护理；进行适当的实验室测试，并与当地诊所和国家结核病进行建设性的互动 程序。在过去的4年里，哈佛大学的一个团队建立了一个高效和组织良好的研究基础设施，已经招募和留住了16000多名参与者。 核心是通过招募和跟踪秘鲁利马的结核病患者和家庭接触者队列来支持TBRU的科学项目，获得相关数据和样本，并确保将数据和样本有效地传输到波士顿的数据管理中心。为此，我们提议识别并重新同意3000名具有明确结核病结果的初始队列成员进行人类基因分型，并登记300例新的结核病病例及其350名家庭接触者，他们将接受相关结果的跟踪，并将提供血液和尿样用于跨界剖析和生物标记物评估。

High quality clinical and epidemiologic research on tuberculosis requires well-run field sites in high burden TB settings that can recruit and retain TB patients, exposed contacts and controls; ensure secure and complete data collection and management; ensure that participant receive high quality appropriate clinical care; conduct appropriate laboratory testing and interact constructively with local clinics and National TB programs. Over the past 4 years, a Harvard- Socios-en-Salud team has built a highly efficient and well-organized research infrastructure that has recruited and retained over 16000 participants.The aim of the Core is to support the TBRU's scientific project by recruiting and following TB patient and household contact cohorts in Lima, Peru, obtaining relevant data and samples and ensuring the efficient transfer of data and samples to the Data Management Center in Boston To that end, we propose to identify and reconsent 3000 of our initial cohort members with well defined TB outcomes for human genotyping and to enroll 300 new TB cases and 350 of their household contacts who will be followed for relevant outcomes and who will provide blood and urine samples for transciptional profiling and biomarker assessment.