Biostatistics, Bioinformatics and Environmental Sampling Core

摘要 生物统计学、生物信息学和暴露采样（BBES）核心将提供一种综合方法， 关于1）研究设计，2）吸入接触评估工具和测量，3） 表型、吸入暴露和分子数据的整合和管理，以及4）生物统计学和 生物信息学分析通过集中这些活动，我们预计这一多学科核心将增加 项目之间以及项目与核心之间的互动水平。这一战略将使我们能够 协调研究设计和数据管理问题，从而形成更一致的暴露方法 评估和数据分析以及显著的成本节约。核心主管（芬格林）沿着 吸入暴露评估负责人（Thornburg）将监督一个在以下方面经验丰富的小组： 涉及多学科研究团队协调的研究。团队拥有所需的技能， 管理研究设计、流行病学、基因组学、广泛的定量方法、数据等复杂问题 管理和吸入暴露评估。与项目和核心的互动：BBES核心 将服务于所有四个项目。项目将获得核心研究设计的帮助，包括 在研究开始时就方法问题与项目主要参与者进行磋商， 研究进展。在Thornburg博士的指导下， 核心小组的职责是：1）为项目1提供个人照射监测器; 2）量化 基于从所有项目将使用的个人监视器中获取的过滤器的暴露，以及3） 维护全面的暴露数据集，并将这些数据传输给NJH。核心的数据集成和 管理职责将服务于所有项目以及行政核心，包括：1） 数据采集和传输的管理，2）研究数据库的开发和维护，以及3） 确保数据备份、存储和安全。核心的生物统计学和生物信息学分析 职责包括：1）与项目负责人开会，确定分析需求，2）进行 生物统计学分析，以及3）进行生物信息学分析，以总结和询问生物统计学 从生物学的角度来看。每个项目都将受益于向其他项目提供的服务; 同样的专家将在所有三个项目上工作，这将确保思想的相互交流和分享， 信息.此外，BBES核心将与临床核心密切互动，以协调双方的接触 评估和获取临床表型数据。最后，这一核心将与行政部门协调， 核心，因为它提供了行政和组织结构，以支持这一计划，并将获得 行政核心和执行委员会的指导。这个核心将与 行政核心每月与项目负责人举行会议，并根据需要提供其活动报告 否则核心成员将参加每月的计划会议，并将有个人每月 会议与每个项目;这些会议将错开，这样每周博士芬格林和 适当的核心研究人员将与单个项目团队或整个项目团队会面。的 从Core到Program的产品包括：1）数据集成和分析脚本，全面的去中心化， 已确定的数据集、暴露监测数据、数据分析总结和文件，以及参与 传播的各个方面。这些产品将协助所有项目和行政核心， 履行其研究、报告和资源共享的目标和义务。

Abstract The Biostatistics, Bioinformatics and Exposure Sampling (BBES) Core will provide an integrated approach to all projects with regard to 1) study design, 2) inhalation exposure assessment tools and measurement, 3) integration and management of phenotype, inhalation exposure and molecular data, and 4) biostatistical and bioinformatics analysis. By centralizing these activities, we expect that this multidisciplinary Core will increase the level of interaction among the projects and between projects and the Core. This strategy will allow us to coordinate study design and data management issues, leading to a more coherent approach to exposure assessment and data analysis as well as significant cost savings. The Core Director (Fingerlin) along with the inhalation exposure assessment lead (Thornburg) will supervise a team that is experienced in the conduct of studies involving the coordination of multidisciplinary teams in research. The team has the skill set required to manage complex issues of study design, epidemiology, genomics, broad quantitative methods, data management and inhalation exposure assessment. Interaction with Projects and Cores: The BBES Core will serve all four projects. Projects will receive assistance with Study Design from the Core including consultation with project PIs on methodological issues, at the initiation of a study, and ongoing consultation as the study progresses. Under the direction of Dr. Thornburg, the Inhalation Exposure Assessment responsibilities of the Core will be to 1) provide personal exposure monitors to Project 1, and 2) quantify exposures based on the filters taken from the personal monitors that will be utilized by all projects and 3) maintain comprehensive exposure data sets and transfer these data to NJH. The Core's Data Integration and Management responsibilities will serve all projects as well as the Administrative Core including: 1) management of data acquisition and transfer, 2) development and maintenance of research databases, and 3) ensuring data backup, storage, and security. The Core's Biostatistical and Bioinformatics Analysis responsibilities will include: 1) meeting with Project Directors to determine analysis needs, 2) conducting the biostatistical analyses, and 3) conducting bioinformatic analyses to summarize and interrogate the biostatistical results in terms of biologic pathways. Each project will benefit from the services provided to the other projects; the same experts will work on all three projects, which will ensure cross-fertilization of ideas and sharing of information. In addition, The BBES Core will interact closely with the Clinical Core to coordinate both exposure assessment and capture of clinical phenotype data. Finally, this Core will coordinate with the Administrative Core, as it provides the administrative and organizational structure to support this Program, and will receive direction from the Administrative Core and the Executive Committee. This Core will interact with the Administrative Core at monthly meetings with Project Leaders, and provide reports on its activities as needed otherwise. Members of the Core will attend the monthly Program meetings and will have individual monthly meetings with each project; these meetings will be staggered such that each week Dr. Fingerlin and appropriate Core investigators will meet with either an individual Project team or the entire Program. The products from the Core to the Program include 1) data integration and analysis scripts, comprehensive de- identified data sets, exposure monitor data, data analysis summaries with documentation, and participation in all aspects of dissemination. These products will assist all of the Projects and the Administrative Core in fulfilling their research, reporting and resource sharing goals and obligations.