Clinical Core

临床核心

• 批准号: 10271646
• 负责人: Christopher C. Whalen
• 金额: $ 15.35万
• 依托单位: RBHS-NEW JERSEY MEDICAL SCHOOL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-23 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10271646
• 关键词: Biological; Brazil; Clinical; Clinical Protocols; Clinical Research; Collection; Data; Data Analyses; Data Collection; Development; Ensure; Epidemiology; Equipment and supply inventories; Ethics; Heterogeneity; Human; Immune; International; Investigation; Laboratories; Lead; Manuscripts; Monitor; Mycobacterium tuberculosis; Natural History; Participant; Patients; Principal Investigator; Prospective cohort; Protocols documentation; Quality Control; Regulation; Reporting; Research Design; Research Personnel; Retrospective cohort; Retrospective cohort study; Safety; Sampling; Ships; Site; Specimen; Statistical Data Interpretation; Study Subject; Systems Biology; Time; Uganda; United States National Institutes of Health; Universities; Work; biobank; data integrity; design; epidemiologic data; human subject; operation; programs; protocol development; quality assurance; recruit; research study; sample collection

The TBRU Clinical Core will take overall responsibility for all human subjects’ studies in the proposed TBRU protocols, and will work closely with the Data and Operations Management Center (DOMC) in the Administrative Core to coordinate approved protocols and unit-wide scientific activities in concert with scientific decisions of the TBRU. The primary objective of the Clinical Core is to ensure the implementation and conduct of the clinical research studies align with the scientific and translational aims of the TBRU projects and scientific cores by providing support for; 1. Protocol development, 2. Implementation and operations, 3. Quality assurance and control, 4. Sample banking and inventory; 5. Data collection, and 6. Epidemiological and statistical analysis. The Clinical Core will monitor the clinical operations, sample collection and processing, and data collection from study initiation through close out, to ensure that all activities are conducted in compliance with local and international regulations and ethical standards. The clinical studies will be conducted at Makerere University in Kampala, Uganda and the Núcleo de Doenças Infecciosas (NDI) in Vitória, Brazil. The Core leads Dr. Whalen and Ms. Douglass will work closely with the Lead Investigators at each site to ensure timely completion of all project milestones. In a prospective cohort of HHC of TB patients in Uganda and a retrospective cohort study in Brazil (Projects 1 and 2) and one in Uganda (Project 1) we will characterize the immediate and long-term consequences and interactive effects of bacterial and host heterogeneity with a focus on the underlying immune mechanisms that we hypothesize to be critical determinants of the natural history of TB. These studies involving human participants must be conducted with careful design and oversight with our Brazilian and Ugandan partners to guarantee the safety and protection of all participants, the study team, and the integrity of the data. The Clinical Core will coordinate with the Administrative and Systems Biology Core, and under the direction of the Principal Investigators, to accomplish these objectives, implement the clinical protocols for projects 1 and 2 at the collaborating sites in Brazil and Uganda, and to establish an inventory of human clinical specimens, isolates of Mtb and clinical epidemiological data to be utilized across projects 1, 2, 3 and 4.

TBRU临床核心将对拟议的TBRU中所有人类受试者的研究承担总体责任 协议，并将与数据和操作管理中心（DOMC）紧密合作 行政核心协调批准的协议和单位范围的科学活动 TBRU的科学决定。临床核心的主要目的是确保实施和 临床研究的进行与TBRU项目的科学和翻译目标保持一致 科学核心通过提供支持； 1。协议开发，2。实施和操作，3。质量 保证和控制，4。样本银行和库存； 5。数据收集，6。流行病学和 统计分析。临床核心将监视临床操作，样本收集和处理，以及 从研究计划到关闭的数据收集，以确保所有活动均合规 与地方和国际法规以及道德标准。临床研究将在 位于乌干达的坎帕拉的Makerere University和巴西Vitória的NúcleoDoençasInfesccios（NDI）。 核心领导沃伦博士和道格拉斯女士将与每个站点的主要调查员紧密合作，以确保 及时完成所有项目里程碑。在乌干达的结核病患者和A的前瞻性HHC中 巴西的回顾性队列研究（项目1和2）和乌干达的一项（项目1），我们将表征 细菌和宿主异质性的直接和长期后果以及重点 关于我们假设的基本免疫机制是对自然历史的关键决定者 TB。这些涉及人参与者的研究必须通过我们的仔细设计和监督进行 巴西和乌干达的合作伙伴保证所有参与者，学习团队以及 数据的完整性。临床核心将与行政和系统生物学核心协调，以及 在主要研究人员的指导下，实现这些目标，实施临床方案 对于巴西和乌干达的协作网站的项目1和2，并建立人类临床清单 在项目1、2、3和4中将使用标本，MTB的分离株和临床流行病学数据。