Coordinating data management for multiple ongoing clinical trials and registries.

Topics in health record management Pub Date : 1990-12-01
M A Carr
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引用次数: 0

Abstract

The Epidemiology Data Center at the University of Pittsburgh has developed a standard set of data management procedures, reports, and computing configurations for use on multicenter research projects. Based on budget restrictions and study design considerations, a project-specific data management system can be quickly constructed by utilizing appropriate components from the EDC tool kit: the PoP software system for the computerization of the database from paper forms to data entry screens; program shells for telecommunication and backup procedures; and procedural documents for providing the necessary training materials for centralized or decentralized processing environments. The EDC data flow specification provides quality control assurances from entry through statistical analysis.

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协调多个正在进行的临床试验和注册的数据管理。
匹兹堡大学的流行病学数据中心开发了一套标准的数据管理程序、报告和计算配置,用于多中心研究项目。基于预算限制和研究设计方面的考虑,可以利用EDC工具包中的适当组成部分,迅速建立一个特定项目的数据管理系统:用于将数据库从纸质表格电脑化到数据输入屏幕的PoP软件系统;程序外壳用于通讯和备份程序;以及为集中或分散处理环境提供必要培训材料的程序性文件。EDC数据流规范提供了从入口到统计分析的质量控制保证。
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