CORE C: Clinical and Data Management

核心 C：临床和数据管理

• 批准号: 10458127
• 负责人: AUBREE L GORDON
• 金额: $ 63.54万
• 依托单位: UNIVERSITY OF CALIFORNIA BERKELEY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-29 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10458127
• 关键词: Address; B-Lymphocytes; Biological; Caring; Characteristics; Child; Child Support; Childhood; Clinical; Clinical Data; Clinical Management; Clinical Research; Cohort Studies; Communication; Communities; Data; Data Collection; Data Set; Databases; Dengue; Dengue Infection; Dengue Vaccine; Dengue Virus; Dengvaxia; Deposition; Disease; Documentation; Enrollment; Ensure; Equipment and supply inventories; Funding Agency; Health; Hospitals; Human; Human Resources; Immune; Immunity; Immunologics; Infection; Institutes; Laboratories; Medical; Michigan; Nicaragua; Nicaraguan; Participant; Persons; Philippines; Phylogenetic Analysis; Play; Predisposition; Procedures; Process; Program Research Project Grants; Prospective cohort study; Protocols documentation; Quality Control; Research Personnel; Role; Running; Sampling; Science; Serotyping; Ships; Site; Source; Specimen; Statistical Models; Study Subject; T cell response; Universities; Update; Vaccinated; Vaccination; Vaccines; Viral; base; clinical research site; cohort; cross reactivity; data dictionary; data exchange; data harmonization; data management; data sharing; design; epidemiologic data; human subject; improved; instrument; programs; prospective; response; sample collection; success; unvaccinated

CORE C: Clinical and Data Management Core (UC Berkeley, University of Michigan, Sustainable Sciences Institute) SUMMARY The Clinical and Data Management Core (Core C) will be instrumental for the success of the P01 Program. First, the Core will continue to conduct the Pediatric Dengue Cohort Study in Managua, Nicaragua. This cohort study is the longest continuous cohort study of dengue and as such is an invaluable source of samples and clinical data from children with natural repeat dengue virus (DENV) infections. Both retrospectively and prospectively collected samples and data will be available to the P01 Projects. Core C will oversee all aspects of running the Cohort Study including enrollment, sample collection and storage, data collection and management, quality control, provision of medical care, and human subjects documentation. Second, Core C will coordinate the compilation of clinical data and the distribution of samples available from the P01 Program dengue studies in Nicaragua and the Philippines, where a cohort study of children vaccinated with the Dengvaxia® dengue vaccine is ongoing. To this end, the Core will design, maintain, update and oversee the P01 Program databases, which will include clinical data, sample characteristics and availability. Core C will provide tailored data sets and assist in selection of analysis-specific biological specimens, ensuring efficient data sharing and sample distribution through the implementation of high levels of quality control. This will include having a data manager at the University of Michigan (UM) who will compile the data from the clinical sites and use it to assemble data sets, including the creation of any necessary variables for P01 Program sites. Core C personnel at UC Berkeley will be responsible for receiving samples from Nicaragua, maintaining an inventory, and distributing the samples to P01 Projects in response to requests and in coordination with the data manager at UM. Third, the Core will maintain a copy of immunological data generated through the Projects 1-3 and Core B and will deposit data into ImmPort. P01 investigators will be able to submit data for upload to and download data from the database, facilitating the flow of information across all P01 Program partners. Aim 1 is to continue conducting the community-based prospective Pediatric Dengue Cohort Study in Managua, Nicaragua. Aim 2 is to coordinate clinical data compilation, integration and distribution, and shipment of clinical samples, and to perform phylogenetic sequencing. Aim 3 is to manage data generated through the P01 and to deposit immunological data generated through the P01 Projects and Cores into ImmPort. Taken together, the Clinical and Data Management Core will play an essential role in the P01 Program by providing data and samples to scientific Projects for the ultimate purpose of identifying both natural and vaccine-induced immune correlates of protection against dengue disease.

核心 C：临床和数据管理核心 （加州大学伯克利分校、密歇根大学、可持续科学研究所） 概括 临床和数据管理核心（核心 C）将有助于 P01 计划的成功。 首先，核心将继续在尼加拉瓜马那瓜开展儿童登革热队列研究。 该研究是最长的登革热连续队列研究，因此是宝贵的样本来源和 自然重复登革热病毒 (DENV) 感染儿童的临床数据。 前瞻性收集的样本和数据将提供给 P01 项目，核心 C 将监督所有方面。 开展队列研究，包括登记、样本收集和存储、数据收集和 第二，核心 C。 将协调临床数据的汇编和 P01 计划提供的样本的分发 尼加拉瓜和菲律宾进行了登革热研究，其中对接种了登革热疫苗的儿童进行了队列研究 为此，核心将设计、维护、更新和监督 Dengvaxia® 登革热疫苗。 P01 计划数据库，其中包括临床数据、样本特征和可用性。 提供量身定制的数据集并协助选择分析专用的生物样本，确保数据高效 通过实施高水平的质量控制来共享和分发样品。 在密歇根大学 (UM) 配备一名数据经理，负责整理临床站点的数据并 使用它来组装数据集，包括为 P01 程序核心 C 站点创建任何必要的变量。 加州大学伯克利分校的人员将负责从尼加拉瓜接收样本，维护库存， 并根据请求并与数据经理协调将样本分发给 P01 项目 第三，核心将保留通过项目 1-3 和核心生成的免疫学数据的副本。 B 并将数据存入 ImmPort，调查人员将能够提交数据以供上传和下载。 目标 1 是继续推进所有 P01 计划合作伙伴之间的信息流动。 在尼加拉瓜马那瓜开展基于社区的前瞻性儿科登革热队列研究，目标 2 是。 协调临床数据的汇编、整合和分发以及临床样本的运输，并 目标 3 是管理通过 P01 生成的数据并存储。 通过 P01 项目和 ImmPort 核心生成的免疫学数据合起来就是临床。 数据管理核心将在 P01 计划中发挥重要作用，为 科学项目的最终目的是识别自然和疫苗诱导的免疫相关性 预防登革热疾病。