Clinical and Data Management Core

摘要(核心C) 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 将协调临床数据的汇编和P01计划可用样本的分发 尼加拉瓜和武田疫苗试验地点的登革热研究。为此，核心将设计、维护、更新 并监督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将提供定制的数据集和选择特定于分析的生物样本，以确保 通过实施高水平的质量控制，实现高效的数据共享和样本分发。这 将包括在加州大学伯克利分校有一名专门的数据管理员，他将汇编临床站点的数据 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。 第三，核心将设计和维护一个以网络为基础的数据库系统，用于进入和管理 通过项目1-3和核心B产生的免疫学数据P01调查人员将能够上传 数据到数据库和从数据库下载数据，促进所有P01计划之间的信息流 合伙人。最后，核心将向各个项目提供统计专门知识，并使用先进的 综合所有项目数据的统计方法。基本建模方法和高级建模方法将 用于检查免疫反应、协变量和结果之间的关系。这将包括一个 专职的研究统计员以及核心领导和生物统计顾问的支持。目标1 继续在马那瓜开展以社区为基础的儿童登革热前瞻性队列研究， 尼加拉瓜。目标2是协调临床数据的汇编、集成和分发，以及临床数据的运输 样本。目标3是创建和管理一个数据库系统，用于通过 P01项目和核心使用最先进的、开源的、基于网络的信息系统进行数据收集 和分享。目标4是向项目提供统计支助，并将所有项目的成果整合到 统计模型。总而言之，临床和数据管理核心将在 P01计划，通过向科学项目提供数据和样本，最终确定两者 预防登革热疾病的天然和疫苗诱导的免疫相关性。

SUMMARY (CORE C) The Clinical and Data Management Core (Core C) will be instrumental in 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, the Core will coordinate the compilation of clinical data and the distribution of samples available from the P01 Program dengue studies in Nicaragua and Takeda vaccine trial sites. 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 select 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 dedicated data manager at UC Berkeley 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. Third, the Core will design and maintain a web-based database system for the entry and management of immunological data generated through the Projects 1-3 and Core B. P01 investigators will be able to upload data to and download data from the database, facilitating the flow of information across all P01 Program partners. Finally, the Core will provide statistical expertise to the individual projects and use advanced statistical methods to integrate data from all Projects. Basic as well as advanced modeling methods will be used to examine relationships between immune response, covariates, and outcomes. This will include a dedicated study statistician as well as support from both the Core Leader and biostatistics consultants. 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. Aim 3 is to create and manage a database system for immunological data generated through the P01 Projects and Cores using state-of-the-art, open source, web-based information systems for data collection and sharing. Aim 4 is to provide statistical support to the Projects and integrate results from all Projects into statistical models. 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.