Minnesota Clinic

项目总结(见说明)： 临床核心中心将在患者登记和后续行动、数据管理(数据收集、计算机数据输入)、数据分析(报告)和生物统计支持(研究设计、统计分析)方面为赠款调查人员提供协助。临床核心将承担两项基本职责：1)提取数据并将其输入多中心数据库，包括研究地点的临床数据和基因分型 基因分型核心的结果。这还将包括数据库的维护、数据的质量控制、样本跟踪和HIPPA遵守情况的保证。2)第二项责任是为两个项目提供统计支助，包括项目1和2的报告。 我们有完善的、高质量的数据传输程序，进入我们的多中心数据库，并保护患者信息的机密性。到目前为止，我们已经在我们的基因组基金中招募了1010名捐赠者和2864名受赠者(预计截至2011年8月1日的登记人数约为1280名捐赠者和3500名受赠者)，并收集了样本进行基因分型。继续招收约800名收件人 每年，我们预计我们的数据分析将包括6000多名受助者和2300名在世捐赠者的信息。我们的数据管理和标本存储计划是建立在我们在生物统计司内成功用于这项研究和以前的研究的系统的基础上。我们的数据管理系统是全面、成熟和充分发展的，目前正在非常成功地使用 在几项国内和国际研究中。这是一种成本效益高、效率高的方法。 核心拥有所需的专门知识(包括生物信息学方面的专门知识)，并拥有分析SNP数据和研究SNP与我们的终点的关联的设施。 由于数据将被收集并输入将用于这两个项目的数据库，因此项目调查人员可以专注于他们各自研究的独特方面。

PROJECT SUMMARY (See instructions): The Clinical Core will provide assistance in patient enrollment and follov\/-up, data management (data collection, computer data entry), data analyses (reports), and biostatistical support (study design, statistical analyses) for grant investigators. The Clinical Core will have two basic responsibilities: 1) the extraction and inputting of data into the multicenter database, including clinical data from the study sites and genotyping results from the Genotyping Core. This will also include maintenance ofthe database, quality control of the data, sample tracking and assurance of HIPPA compliance. 2) The second responsibility will be to provide statistical support to the two projects, including reports for Projects 1 and 2. We have well-established, quality procedures for data transmission, entry into our multicenter database, and protection ofthe confidentiality of information of patients. To date, we have enrolled 1010 donors and 2864 recipients in our genomic grant (and expect enrollment as of 8/1/11 to be about 1280 donors and 3500 recipients) and have collected samples for genotyping. With continued enrollment of about 800 recipients per year, we anticipate that our data analyses will include information on over 6000 recipients and 2300 living donors. Our plan for data management and specimen storage is to build upon the system we have used successfully for this study and in previous studies within the Division of Biostatistics. Our data management system is comprehensive, mature and fully developed and is being used now very successfully in several national and international studies. It is a cost-effective, efficient approach. The Core has the required expertise (including expertise in bioinformatics), and facilities for the analyses of the SNP data and the studies of associations of SNPs with our endpoints. Because data will be collected and entered into a database that will be used for both projects, the project investigators can focus on the unique aspects of their individual studies.