亚洲社会药学
亚洲社会药学

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›› 2014, Vol. 9 ›› Issue (3): 128-131.doi:

• Drug R&D • 上一篇    下一篇

The Safety Monitoring System for Drug Clinical Trials

BIAN Lei, YANG Yue   

  1. School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
  • 收稿日期:1900-01-01 修回日期:1900-01-01 出版日期:2014-09-20 发布日期:2014-09-20

The Safety Monitoring System for Drug Clinical Trials

BIAN Lei, YANG Yue   

  1. School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
  • Received:1900-01-01 Revised:1900-01-01 Online:2014-09-20 Published:2014-09-20
  • Contact: YANG Yue

摘要： Objective To provide an important theoretical guidance and a practical base for standardizing timely and effectively the safety
monitoring system of drug clinical trials by learning experiences from foreign mature practices under the trend of globalization for
drug clinical research. Methods Framework of foreign drug safety monitoring system was systematically expounded by analyzing
the safety reports, assessment reviews and risk control regulations in clinical trials in the ICH, the United States and the EU. Results
and Conclusion At present, drug clinical safety monitoring system in China is still at initial stage, yet it can be perfected constantly
by learning experiences from foreign countries to guarantee people’s safety in drug use.

关键词: drug clinical trial, safety report, monitoring system

Abstract: Objective To provide an important theoretical guidance and a practical base for standardizing timely and effectively the safety
monitoring system of drug clinical trials by learning experiences from foreign mature practices under the trend of globalization for
drug clinical research. Methods Framework of foreign drug safety monitoring system was systematically expounded by analyzing
the safety reports, assessment reviews and risk control regulations in clinical trials in the ICH, the United States and the EU. Results
and Conclusion At present, drug clinical safety monitoring system in China is still at initial stage, yet it can be perfected constantly
by learning experiences from foreign countries to guarantee people’s safety in drug use.

Key words: drug clinical trial, safety report, monitoring system

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