中国药物临床试验安全性信息监测和报告体系分析  

Analysis of safety information monitoring and reporting system of drug clinical trial in China

作　　者：谢洁琼[1] 

机构地区：[1]国家食品药品监督管理总局高级研修学院,北京100073

出　　处：《中国新药与临床杂志》2015年第1期15-19,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：通过分析和解读药物临床试验不同参与方在安全性信息收集与处理中各自所扮演的角色和职责,将我国与欧美国家的药物临床试验安全性信息监测及报告体系进行比较,分析中国在此方面的特点与不足,为我国在加强和完善药物临床试验安全性信息监测和报告体系方面提出建议与期望。Through analyzing and clarifying the roles and responsibilities of different parties in safety information collection and process in clinical trials, the paper compared the safety information monitoring and reporting system between China and developed countries in order to analyze the characteristics and limitations of the safety information monitoring and reporting system of drug clinical trials in China, and provided some proposals and expectations on strengthening and improving the safety information monitoring and reporting system of drug clinical trials in China.

关 键 词：临床试验 安全 信息管理 

分 类 号：R951[医药卫生—药学]