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概念:电子数据采集 [2022/02/08 07:24] 老T |
概念:电子数据采集 [2022/02/25 04:05] (当前版本) 老T |
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| - | ====== 电子数据采集（EDC） ====== | + | ====== 电子数据采集 EDC ====== |
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| + | **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。(([[法规: | ||
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| + | 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. | ||
| - | ===== 一、定 义 ===== | ||
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| - | **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。(([[法规: | ||
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| - | 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. | ||