《中国卫生质量管理》[ISSN:1006-7515/CN:CN 61-1283/R]
卷:
第25卷
期数:
2018年04期
页码:
88-90
栏目:
质量案例
出版日期:
2018-07-28
- 作者:
-
王一 张庆瑜 郭丽敏
-
天津医科大学总医院
- 关键词:
-
药物临床试验; 受试者损害事件; 损害保险; 试验赔偿
- Keywords:
-
Pharmaceutical Clinical Trial; Injury Events of Subjects; Insurance Against Damage; Trial Compensation
- DOI:
-
10.13912/j.cnki.chqm.2018.25.4.28
- 摘要:
-
药物临床试验中，受试者损害事件不可避免。对药物临床试验中受试者损害案例进行分析，从药物临床试验立项与执行和损害事件后的发生与处理两方面，针对药物临床试验赔偿管理提出若干建议。
- Abstract:
-
In pharmaceutical clinical trials, the injury events of subjects are unavoidable. The subjects injury cases in pharmaceutical clinical trials were analyzed. From two aspects of the project and executing of pharmaceutical clinical trial,including the occurrence and processing of the damage incidents, then suggestions were put forward on compensation management in pharmaceutical clinical trials.
参考文献/References:
［1］单爱莲, 梁雁, 崔一民. 在新药与医疗器械临床试验中为受试者提供保险的调查与分析［J］.中国临床药理学杂志, 2013, 29(7): 483-487.
相似文献/References:
[1]董晶王雅琼朱娜周学锋.卫星药房建设提升临床试验质量[J].中国卫生质量管理,2022,29(09):72.[doi:10.13912/j.cnki.chqm.2022.29.9.16
]
DONG Jing,WANG Yaqiong,ZHU Na.Construction of Satellite Pharmacy for Promotion of the Quality of Clinical Trial[J].Chinese Health Quality Management,2022,29(04):72.[doi:10.13912/j.cnki.chqm.2022.29.9.16
]
[2]李浩王秀敏李芸芸林卡娜杨帆佘佳笑常国营孙心岩.一项儿童药物临床试验相关安全问题解析及改进[J].中国卫生质量管理,2023,30(11):60.[doi:10.13912/j.cnki.chqm.2023.30.11.13
]
LI Hao,WANG Xiumin,LI Yunyun.Analysis and Improvement of Safety Issues Related to a Pediatric Drug Clinical Trial[J].Chinese Health Quality Management,2023,30(04):60.[doi:10.13912/j.cnki.chqm.2023.30.11.13
]
更新日期/Last Update:
2018-07-28
