Minnesota Clinic

明尼苏达诊所

基本信息

批准号：
8516965
负责人：
ARTHUR J MATAS
金额：
$ 18.58万
依托单位：
UNIVERSITY OF MINNESOTA
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-08-01 至 2016-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8516965
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

项目摘要

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.

项目摘要（请参阅说明）：临床核心将为患者入学和Follov \/ - UP提供帮助，数据管理（数据收集，计算机数据输入），数据分析（报告）以及赠款研究人员的生物统计学支持（研究设计，统计分析，统计分析）。临床核心将具有两个基本责任：1）将数据提取和输入到多中心数据库中，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。这还将包括维护数据库，数据的质量控制，示例跟踪和HIPPA合规性的保证。 2）第二个责任是为两个项目提供统计支持，包括项目1和2的报告。我们制定了良好的质量程序，用于数据传输，进入多中心数据库以及保护患者信息的机密性。迄今为止，我们已经招募了1010名捐助者和2864名接收者参加我们的基因组赠款（并预计截至8/1/11的入学人数约为1280名捐助者和3500名接收者），并收集了用于基因分型的样本。继续注册约800名接收者每年，我们预计我们的数据分析将包括有关6000多名接收者和2300名活捐赠者的信息。我们的数据管理计划和标本存储计划是在我们成功用于本研究的系统和生物统计学划分的先前研究的系统上。我们的数据管理系统是全面的，成熟的和完全开发的，现在正在非常成功地使用在几项国家和国际研究中。这是一种经济高效，有效的方法。核心具有所需的专业知识（包括生物信息学方面的专业知识），以及用于分析SNP数据的设施以及SNP与我们的终点的关联研究。由于数据将被收集并输入将用于两个项目的数据库，因此项目调查人员可以专注于其个人研究的独特方面。