CORE C: Clinical and Data Management

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) 摘要 临床和数据管理核心(核心C)将对P01计划的成功起到重要作用。 首先，该中心将继续在尼加拉瓜马那瓜进行儿童登革热队列研究。这一群人 这项研究是登革热持续时间最长的队列研究，因此是样本和 自然重复登革病毒(DENV)感染儿童的临床资料。既有追溯性又有 预期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 进行队列研究，包括登记、样本收集和存储、数据收集和 管理、质量控制、提供医疗护理和人类受试者文档。第二，核心C 将协调临床数据的汇编和P01计划可用样本的分发 尼加拉瓜和菲律宾的登革热研究，在那里对接种了登革热疫苗的儿童进行了队列研究 登革热疫苗正在进行中。为此，核心将设计、维护、更新和监督 P01计划数据库，其中将包括临床数据、样本特征和可用性。核心C将 提供量身定制的数据集，并协助选择特定于分析的生物样本，确保有效的数据 通过实施高水平的质量控制，实现共享和样品分发。这将包括 密歇根大学(UM)有一名数据经理，他将从临床现场收集数据，并 使用它来汇编数据集，包括为P01计划站点创建任何必要的变量。核心C 加州大学伯克利分校的工作人员将负责从尼加拉瓜接收样品，维护库存， 以及响应请求并与数据管理员协调，将样本分发给P01项目 在密歇根大学。第三，核心将保留通过项目1-3和核心产生的免疫学数据的副本 B，并将数据存入ImmPort。P01调查人员将能够提交数据以供上传和下载 来自数据库的数据，促进了所有P01计划合作伙伴之间的信息流。目标1是继续 在尼加拉瓜马那瓜进行基于社区的儿童登革热前瞻性队列研究。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 进行系统发育测序。目标3是管理通过P01生成的数据并存储 通过P01项目和核心产生的免疫学数据输入ImmPort。总而言之，临床 数据管理核心将通过提供数据和样本在P01计划中发挥重要作用 科学项目的最终目的是确定自然和疫苗诱导的免疫相关性 预防登革热。

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.