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's translational acute stroke research. The biostatistical responsibilities of the Core include collaborating on the experimental design of every clinical trial protocol and research project;developing and generating the randomization sequence for each study;performing interim, preliminary, and final statistical analyses on study 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 capture process, including design of case report forms, maintenance of centralized patient data files, and production of special purpose and routine statistical reports on accumulating data, is coordinated through the data management operations of the Core. The Core's computing environment consists of approximately 9 workstations connected in a client-server architecture, using TCP/IP local area network (LAN) with three servers (web, data, and archive). The network is secured behind a firewall. Data management is conducted through the PostgreSQL and Mysql relational database management systems. The quality assurance (QA) program of the Statistics and Data Management Core is extensive and comprehensive. While computerized, real-time monitoring of all study data is primary and fundamental, QA coverage extends to study initiation, project investigator and support staff training in data entry, and document development and production (e.g., training manuals, manuals of procedures, newsletters). Data entry is distributed with edit checking conducted both at the time of entry and longitudinally.
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