中国药物警戒 ›› 2019, Vol. 16 ›› Issue (10): 608-613.
DOI: 10.19803/j.1672-8629.2019.10.08

• 法规与管理研究 • 上一篇    下一篇

电子信息化技术在临床试验研究管理中的应用研究

范乙   

  1. 国家药品监督管理局药品审评中心,北京 100022
  • 收稿日期:2019-10-24 修回日期:2019-10-24 出版日期:2019-10-20 发布日期:2019-10-24
  • 作者简介:范乙,男,硕士,工程师,软件工程。

Application of Electronic Information-and-network-based Technology in Clinical Trial Management

FAN Yi   

  1. Center for Drug Evaluation, NMPA, Beijing 100022,China
  • Received:2019-10-24 Revised:2019-10-24 Online:2019-10-20 Published:2019-10-24

摘要: 目的 为提高临床试验研究的效率和质量,加强药品全生命周期信息化监管提供参考。方法 围绕临床试验研究管理的信息化系统建设,在中国知网和各国药品监管机构官网收集文献和政策资料,结合实际工作,综合分析几种常见的临床试验研究管理信息化系统的优势、特点、功能、流程等情况。结果结论 阐明临床试验研究管理系统相对于原始管理方法/模式的优势,讨论电子信息技术普及可能带来的影响,探索了有待改进的问题,提出了相关建议。

关键词: 临床试验研究信息化, 电子信息技术, 药物警戒管理

Abstract: Objective To improve the efficiency and quality of clinical trial research and to provide reference for more effective information supervision of drug life cycles. Methods By focusing on the construction of information systems for clinical trial research management, CNKI and official websites of drug regulatory agencies in various countries were searched to collect papers, literature and guidelines.The advantages, characteristics, functions and processes of commonly-used clinical trial research management information systems were analyzed comprehensively in combination with our actual work. Results & Conclusion The advantages of clinical trial research management systems over the original methods or modes of management have been illuminated, the possible impact of popularization of electronic information technology discussed, and solutions to problems to be solved offered.

Key words: clinical trial, electronic information-and-network-based technology, drugs clinical trail management system.

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