The Statistics and Data Management Core, as a centralized resource of the UCSD SPOTRIAS Center,provides expertise in study design and data management, quality control, and analysis for the entire Center'stranslational acute stroke research. The biostatistical responsibilities of the Core include collaborating on theexperimental design of every clinical trial protocol and research project; developing and generating therandomization sequence for each study; performing interim, preliminary, and final statistical analyses onstudy data; and assisting with the preparation of reports and publications.All UCSD SPOTRIAS Center study data are managed through Core A. Every aspect of the data captureprocess, including design of case report forms, maintenance of centralized patient data files, and productionof special purpose and routine statistical reports on accumulating data, is coordinated through the datamanagement operations of the Core. The Core's computing environment consists of approximately 9workstations connected in a client-server architecture, using TCP/IP local area network (LAN) with threeservers (web, data, and archive). The network is secured behind a firewall. Data management is conductedthrough the PostgreSQL and Mysql relational database management systems.The quality assurance (QA) program of the Statistics and Data Management Core is extensive andcomprehensive. While computerized, real-time monitoring of all study data is primary and fundamental, QAcoverage extends to study initiation, project investigator and support staff training in data entry, anddocument development and production (e.g., training manuals, manuals of procedures, newsletters). Dataentry is distributed with edit checking conducted both at the time of entry and longitudinally.
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