电子数据采集 EDC
电子数据采集:是一种基于计算机网络的用于临床试验数据采集的技术,通过软件、硬件、SOP和人员配置的有机结合,以电子化的形式直接采集和传递临床数据。1)
An Electronic Data Capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices.
1)
临床试验数据管理工作技术指南. 国家药品监督管理局. 2016