临床试验基于风险的管理研究进展

中国临床药理学与治疗学 ›› 2017, Vol. 22 ›› Issue (8): 955-960.

• 综述与讲座 • 上一篇

临床试验基于风险的管理研究进展

肖亮，郑高哲，黄瑜敏

嘉兴太美医疗科技有限公司，上海 200013

收稿日期:2017-02-23 修回日期:2017-03-18 出版日期:2017-08-26 发布日期:2017-08-18
作者简介:肖亮，男，博士，高级工程师，研究方向：临床研究及临床研究信息技术。 Tel: 021-68825798 E-mail: bryant.xiao@mobilemd.cn
基金资助:
浙江省嘉兴市政府精英引领计划领军人才A类基金

Research progress on risk-based management in clinical trials

XIAO Liang, ZHENG Gaozhe, HUANG Yumin

Jiaxing Taimei Medical Technology Co., Ltd., Shanghai 20013, China

Received:2017-02-23 Revised:2017-03-18 Online:2017-08-26 Published:2017-08-18

摘要/Abstract

摘要：

随着临床研究信息技术的普及，临床试验数据处理与统计方法的应用发展，以及通过远程的方法处理现场的工作和计算机自动化取代人工，临床研究行业逐步演变出了基于风险的管理模式。20年后的今天，人用药品注册技术要求国际协调会议（international conference on harmonization of technical requirements for registration of pharmaceuticals for human use，ICH）发布了新版药物临床试验质量管理规范（good clinical practice，GCP），欧美监管部门也颁发了临床试验监管新的指导原则，临床研究行业正在催生一个重大的变革。在临床试验基于风险的管理模式中，信息化技术和专业化的执行团队都将扮演重要的角色。

关键词: 临床研究, 信息化技术, 基于风险的管理, GCP

Abstract:

With the evolutions of information technology, the application and development of data management and statistical methods, and onsite tasks resolved by remote approaches, human work replaced by computer automation, a new project management model of risk based management gradually evolved out in clinical research industry. Now, twenty years later, ICH issued a new version of the GCP, and the European and American regulators also issued new guidelines for quality management in clinical trials. These policies and regulations will result in great changes in clinical research industry. In the risk based management model of clinical trials, information technology and professional implementation personnel will both play the important roles.

Key words: clinical research, information technology, risk based management, GCP

中图分类号:

R969

肖亮，郑高哲，黄瑜敏. 临床试验基于风险的管理研究进展[J]. 中国临床药理学与治疗学, 2017, 22(8): 955-960.

XIAO Liang, ZHENG Gaozhe, HUANG Yumin. Research progress on risk-based management in clinical trials[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2017, 22(8): 955-960.

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临床试验基于风险的管理研究进展

Research progress on risk-based management in clinical trials

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