Clinical Core

临床核心

• 批准号: 10665020
• 负责人: Christopher C. Whalen
• 金额: $ 29.33万
• 依托单位: RUTGERS BIOMEDICAL AND HEALTH SCIENCES
• 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/10665020
• 关键词: Biological; Brazil; Clinical; Clinical Protocols; Clinical Research; Collaborations; 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; Site; Specimen; Statistical Data Interpretation; Study Subject; Systems Biology; Uganda; United States National Institutes of Health; Universities; Work; biobank; clinical epidemiology; 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 临床核心将全面负责拟议 TBRU 中的所有人类受试者研究 协议，并将与数据和运营管理中心（DOMC）密切合作 行政核心协调批准的协议和全单位范围的科学活动 TBRU的科学决策。临床核心的主要目标是确保实施和 临床研究的进行符合 TBRU 项目的科学和转化目标， 科学核心，通过提供支持； 1. 协议制定，2. 实施和运营，3. 质量 保证和控制，4. 样本银行和库存； 5. 数据收集，以及 6. 流行病学和 统计分析。临床核心将监控临床操作、样本收集和处理，以及 从研究启动到结束的数据收集，以确保所有活动均合规进行 符合当地和国际法规以及道德标准。临床研究将在 乌干达坎帕拉的麦克雷雷大学和巴西维多利亚的 Núcleo de Doenças Infecciosas (NDI)。这 核心领导 Whalen 博士和 Douglass 女士将与每个地点的首席研究员密切合作，以确保 按时完成所有项目里程碑。在乌干达结核病患者 HHC 的前瞻性队列中， 在巴西（项目 1 和 2）和乌干达（项目 1）的回顾性队列研究中，我们将描述 重点关注细菌和宿主异质性的直接和长期后果以及相互作用影响 我们假设潜在的免疫机制是自然史的关键决定因素 结核病。这些涉及人类参与者的研究必须经过精心设计和我们的监督 巴西和乌干达合作伙伴保证所有参与者、研究团队和人员的安全和保护 数据的完整性。临床核心将与行政和系统生物学核心协调，并且 在主要研究者的指导下，为了实现这些目标，实施临床方案 巴西和乌干达合作地点的项目 1 和 2，并建立人体临床清单 项目 1、2、3 和 4 使用的 Mtb 标本、分离株和临床流行病学数据。