Minnesota Clinic

明尼苏达诊所

• 批准号: 8224747
• 负责人: ARTHUR J MATAS
• 金额: $ 12.4万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-01 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8224747
• 关键词: Acute; Bioinformatics; Biometry; Blood; Calcineurin; Calcineurin inhibitor; Chronic; Clinic; Clinical; Clinical Data; Computers; Confidentiality of Patient Information; Creatinine; DNA; Data; Data Analyses; Data Collection; Data Quality; Databases; Diabetes Mellitus; Drug toxicity; Enrollment; Functional disorder; Genetic; Genetic Variation; Genomics; Genotype; Goals; Graft Survival; Grant; Immune; Immune response; Immunosuppressive Agents; Individual; Inosine; Instruction; International; Kidney Transplantation; Living Donors; Maintenance; Minnesota; Mycophenolate; Outcome; Pathway interactions; Patients; Pharmaceutical Preparations; Procedures; Protocols documentation; Quality Control; Reporting; Research Design; Research Infrastructure; Research Personnel; Sampling; Services; Single Nucleotide Polymorphism; Site; Specimen; System; Tacrolimus; Techniques; Testing; Therapeutic immunosuppression; Time; Toxic effect; Transplant Recipients; Transplantation; Validation; Writing; base; cohort; cost effective; data exchange; data management; design; drug efficacy; enzyme activity; follow-up; genetic variant; genome wide association study; graft failure; improved; kidney allograft; mRNA Expression; nephrotoxicity

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.

项目总结（见说明）： 临床中心将在患者入组和随访、数据管理（数据收集、计算机数据录入）、数据分析（报告）和生物统计支持（研究设计、统计分析）方面为研究者提供帮助。临床核心将有两项基本职责：1）提取数据并将其输入多中心数据库，包括来自研究中心的临床数据和基因分型 基因分型核心的结果这也将包括数据库的维护、数据的质量控制、样品跟踪和HIPPA合规性的保证。2)第二项责任是为这两个项目提供统计支助，包括项目1和项目2的报告。 我们有完善的数据传输质量程序，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资助中招募了1010名捐赠者和2864名接受者（预计截至2011年8月1日的招募人数约为1280名捐赠者和3500名接受者），并收集了基因分型样本。随着约800名受助人的继续登记， 每年，我们预计我们的数据分析将包括超过6000名接受者和2300名活体捐赠者的信息。我们的数据管理和标本储存计划是建立在我们成功用于本研究和生物统计学部门先前研究的系统基础上。我们的数据管理系统是全面的、成熟的和充分开发的，现在正在非常成功地使用 在一些国家和国际研究中。这是一种成本效益高、效率高的方法。 该中心拥有所需的专业知识（包括生物信息学方面的专业知识），以及分析SNP数据和研究SNP与我们终点之间关联的设施。 由于数据将被收集并输入到两个项目都将使用的数据库中，因此项目研究人员可以专注于他们各自研究的独特方面。