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用于临床试验的电子数据捕获技术:一项全球上市后研究的经验

Electronic data-capturing technology for clinical trials: experience with a global postmarketing study.

作者信息

Lu Zengwu

机构信息

Anhui Medical University China.

出版信息

IEEE Eng Med Biol Mag. 2010 Mar-Apr;29(2):95-102. doi: 10.1109/MEMB.2009.935726.

Abstract

The purpose of this article was to address three questions: What were the electronic data-capturing (EDC) technologies employed in a typical industry-sponsored clinical study? How is the developed system meeting the clinical research need? What would we want more from this EDC technology? This article is prepared from industry perspectives to present and analyze the advantages, benefits, and challenges in applying EDC technologies to address industry's clinical trial operational needs based on a systematic overview.

摘要

本文旨在探讨三个问题

在典型的行业资助临床研究中采用了哪些电子数据捕获(EDC)技术?所开发的系统如何满足临床研究需求?我们对这种EDC技术还期望有更多什么?本文从行业角度撰写,基于系统概述来呈现和分析应用EDC技术以满足行业临床试验运营需求方面的优势、益处及挑战。

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