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.
; The Clinical Core is essential to our goals: to determine if genetic variation is associated with kidney transplant outcome and /or immunosuppressive drug disposition and toxicity. Both projects will use Core services. Both projects rely on the Core for data collection and management, quality control, and biostatistical support. The Core provides the expertise of a biostatistical group composed of statistical geneticists and analysts specialized in bioinformatics analytical techniques.
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