Project 2 - Immunogenetic and Exposure Factors in Berylliosis

生物统计和暴露核心将为有关1）的所有项目提供综合方法 研究设计，2）生物统计分析，3）数据管理和信息学，以及4）暴露评估。 通过集中这些活动，这一多学科核心将提高各组织之间的互动水平。 项目与核心之间。它将使我们能够协调研究设计和数据 管理问题，导致对暴露评估和数据分析采取更加一致的方法， 以及显著的成本节约。核心主任（Fingeriin）和接触评估联络联席主任 （Martyny）将监督一个在开展研究和协调多学科小组方面经验丰富的小组 在临床研究中。该团队具有管理研究设计的复杂问题所需的技能， 流行病学、遗传学、定量方法、数据管理和接触评估。相互作用 项目和核心：生物统计和暴露核心将服务于所有三个项目。所有项目 将从核心获得研究设计方面的帮助，包括与项目Pis进行咨询， 方法问题，在研究开始时，随着研究的进展不断进行协商。所有 三个项目也将由核心的生物统计分析职责提供服务：1）与 项目负责人确定分析需求，2）通过核心统计团队进行分析， Drs. Fingeriin和Strand以及Silveira女士，负责所有三个项目，并指导对 项目2的遗传关联研究，以及3）协助开发数据的专门模型 在项目3中。核心的数据管理和信息学职责将扩展到所有三个项目 以及行政和临床实验室核心，包括：1）数据采集管理， 转让，2）开发和维护研究数据库，3）确保数据备份，存储， 安全核心小组的风险评估职责主要为项目2和项目3服务 包括：1）对新成员的接触访谈，2）获取，分析和管理 NJH队列雇主的工业卫生监测数据，3）与负责调查的调查人员合作 4）制定统一的暴露评估方法 所有队列的指标，以用于此POI。生物统计和暴露核心将与 行政核心，因为它提供了行政和组织结构，以支持这一赠款。这 核心将接受行政、执行委员会和临床实验室核心的指导 在PI、Co-PI和项目负责人的月度会议上，并根据需要提供其活动报告。 相关性（参见说明）： 为什么有些工人在接触铍时会产生过敏或疾病，而另一些人则会 不，可能与遗传和暴露因素有关，共同决定疾病风险。这一核心 提供必要的生物统计和暴露资源，以分析遗传，暴露， 免疫因素对本POI中的所有三个项目都很重要。这些分析和暴露评估 将阐明免疫学和免疫与疾病的关系，并将对公共卫生产生影响， 对这种疾病和其他环境疾病的理解。

The Biostatistics and Exposure Core will provide an integrated approach to all projects with regard to 1) study design, 2) biostatistical analysis, 3) data management and informatics, and 4) exposure assessment. By centralizing these activities, this multidisciplinary Core will boost the level of interaction among the projects and between projects and the Core. It 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 (Fingeriin) and Co-Director, exposure assessment liaison (Martyny) will supervise a team experienced in conducting studies and coordinating multidisciplinary teams in clinical research. The team has the skill set required to manage complex issues of study design, epidemiology, genetics, quantitative methods, data management and exposure assessment. Interaction with Projects and Cores: The Biostatistics and Exposure Core will service all three projects. All 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. All three projects will also be served by the Core's biostatistical analysis responsibilities by: 1) meeting with Project Leaders to determine analysis needs, 2) conducting the analysis through the Core statistics team, Drs. Fingeriin and Strand and Ms. Silveira, for all three Projects, and directing the statistical analysis of genetic association studies for Project 2, and 3) assisting in the development of specialized models for data in Project 3. The Core's Data Management and Informatics responsibilities will extend to all three projects as well as the Administrative and Clinical Laboratory Cores including: 1) management of data acquisition and transfer, 2) development and maintenance of research databases, 3) ensuring data backup, storage, and security. The Exposure Assessment responsibilities of the Core will primarily serve Projects 2 and 3 including: 1) exposure interviews for new cohort members, 2) acquisition, analysis, and management of industrial hygiene monitoring data for NJH cohort employers, 3) collaboration with investigators responsible for other cohorts to develop consistent exposure assessment methods 4) development of uniform exposure metric across all cohorts to be used in this POI. The Biostatistics and Exposure Core will interact with the Administrative Core, as it provides the administrative and organizational structure to support this grant. This Core will receive direction from the Administrative, the Executive Committee, and Clinical Laboratory Cores at monthly meetings ofthe PI, Co-PI and Project Leaders, and provide reports on its activities as needed. RELEVANCE (See instructions): The reason why some workers develop sensitization or disease when exposed to beryllium while others do not, is likely related to genetic and exposure factors, acting in concert to determine disease risk. This core provides the biostatistical and exposure resources necessary to analyze the genetic, exposure, and immunological factors important for all three projects in this POI. These analyses and exposure assessments will clarify the immunologic and exposure-disease relationships, and will have public health implications in the understanding of this and other environmental diseases.