Project 1 - Beryllium Antigen: HLA Peptide, Metal Interactions

临床实验室中心将负责提供研究招募、时间安排、入组和 保留支持，沿着生物标本的所有项目。核心将负责 维护人类受试者的权利，并将处理和提供临床生物标本 需要个别项目。通过协调所有临床生物样本处理活动， 核心，该项目将实现大幅节省成本。重要的是，通过集中样本 处理，它成为可能，以优化使用人类标本尽可能多的实验， 尽可能，并[协调项目1同时进行的实验的样本共享 和3]。临床实验室中心将提供以下五项服务：1）研究受试者招募， 时间安排、入组和保留支持，包括从这些活动中获得的结果的数据录入; 2） 确保对人类受试者的保护; 3）标准化样本处理和分发; 4）最大限度地 利用生物标本，确保节约成本; 5）提供标准化实验室 血液和支气管肺泡灌洗细胞的程序。沿着内核将确保实验室 将通过核心数据库生成的临床数据输入适当的数据库， 项目领导人如有需要。与项目和核心的互动：临床实验室核心将与 与行政核心，因为它提供了行政和组织结构，以支持这一点 赠款机制以及项目与核心项目之间的协同作用。该核心将向 在执行委员会的每月会议上提供关于其活动的报告， 否则需要。临床实验室核心将与生物统计学和暴露核心合作， 建立和维护数据库，生成研究识别号并进行常规数据质量检查 检查.临床实验室核心将向生物统计学和暴露核心报告受试者的情况 这样他们就可以从临床和人口统计学队列数据库中获得数据， 为个别项目进行数据分析。此通知将触发曝光重建 通过生物统计学和暴露核心工作人员开始，适用于入组项目2的受试者 和3.这些措施将适用于所有项目，并为赠款节省大量成本。 相关性（参见说明）： 有些工人在接触铍后会产生过敏或疾病，而其他人则不会，原因是 可能是由于免疫、遗传和暴露因素。临床实验室核心将确保招募 实验室程序的标准化和保证人 本POI中所有项目的主题保护。这些项目的成果将对公众健康产生重要影响。 对生物标志物、潜在治疗剂和适用于工业的安全接触限值的影响。

The Clinical Laboratory Core will be responsible for providing study recruitment, scheduling, enrollment and retention support, along with biological specimens to all of the projects. The Core will be responsible for maintaining the rights of human subjects and will process and provide the clinical biological specimens needed for the individual projects. By coordinating all clinical biological specimen processing activities in this Core, the Projects will realize a substantial cost savings. Importantly, by centralizing the specimen processing, it becomes possible to optimize the use of human specimens for as many experiments as possible and, [coordinate the sharing of specimens for simultaneous experiments conducted in Projects 1 and 3]. The Clinical Laboratory Core will provide the following five services: 1) study subject recruitment, scheduling, enrollment and retention support, including data entry of results obtained from these activities; 2) ensure protection of human subjects; 3) standardize specimen handling and distribution; 4) maximize utilization of biological specimens and ensure cost savings; and 5) provide standardized laboratory procedures for blood and bronchoalveolar lavage cells. Along with this, the Core will ensure that laboratory and clinical data generated through the Core are entered into the appropriate databases and are available to Project Leaders as needed. Interaction with Projects and Cores: The Clinical Laboratory Core will interact with the Administrative Core, as it provides the administrative and organizational structure to support this grant mechanism and the synergy between the Projects and Cores. This Core will report to the Administrative Core at monthly meetings of the Executive Committee and provide reports on its activities as needed otherwise. The Clinical Laboratory Core will work with the Biostatistics and Exposure Core which will set up and maintain databases, generate study identification numbers and perform routine data quality checks. The Clinical Laboratory Core will report to the Biostatistics and Exposure Core as to the subjects that are enrolled, so that they may obtain data from the clinical and demographic cohort databases as needed for data analysis for the individual Projects. This notification will trigger an exposure reconstruction to begin through the Biostatistics and Exposure Core staff, as appropriate for subjects enrolled in Projects 2 and 3. These measures will serve all Projects and result in considerable cost savings to the grant. RELEVANCE (See instructions): The reason some workers develop sensitization or disease when exposed to beryllium and others do not, is likely due to immune, genetic and exposure factors. The Clinical Laboratory Core will ensure the recruitment of subjects from a number of workforces, standardization of laboratory procedures and assurance of Human Subjects protection for all Projects in this POI. The Projects' results derived will have important public health implications regarding biomarkers, potential therapeutics and safe exposure limits applicable to industry.