电子化时代临床数据管理现状和未来趋势

发布时间：2018-03-06 07:13

本文选题：电子化　切入点：临床数据管理　出处：《中国新药杂志》2014年08期 　论文类型：期刊论文

【摘要】：本文综述了电子化临床数据管理国内外现状,以及提高药物研究行业对药物临床试验电子化趋势的理解认知,并总结了数据管理的未来发展趋势:数据采集的电子化和智能化、数据审核的远程化、数据的标准化和透明化以及数据分析手段的交互可视化。我国还处于从纸质向电子化转换的初级阶段,可以借鉴国外的经验,完善临床关数据管理的配套技术指南和规范,提高数据管理的标准化、规范化,尤其是计算机系统和电子数据采集系统的技术标准,规范和鼓励国内EDC系统的开发,并开始逐步采用提交数据的格式标准。
[Abstract]:This paper summarizes the current situation of electronic clinical data management at home and abroad, and improves the understanding and cognition of the trend of electronic drug clinical trials in the pharmaceutical research industry, and summarizes the future development trend of data management: electronic and intelligent data collection. The remote data audit, the standardization and transparency of data and the interactive visualization of data analysis means. Our country is still in the primary stage of conversion from paper to electronic, so we can learn from the experience of foreign countries. To improve the supporting technical guidelines and specifications for clinical data management, to improve the standardization and standardization of data management, especially for computer systems and electronic data acquisition systems, to standardize and encourage the development of domestic EDC systems, And began gradually to submit data format standards.
【作者单位】：科文斯医药研发(北京)有限公司;医药数据解决方案公司;默沙东研发(中国)有限公司;
【分类号】：R197.39

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