中国临床药理学杂志2018，Vol.34Issue(2)：181-183,3.DOI:10.13699/j.cnki.1001-6821.2018.02.024
1例临床试验受试者损害的赔偿
One case of clinical trial subjects damage compensation
母双 1范贞2
作者信息
- 1. 北京大学人民医院科研处,北京100044
- 2. 北京市百瑞律师事务所,北京100097
- 折叠
摘要
Abstract
Article 43 of good clinical practice (GCP) stipulates that the sponsor shall insure the subject participates in clinical trial and shall compensate the medical charges and economic loss for injury or death associated with trial.The injured research subject should be compensated on a no fault basis.It remains necessary for the research subject to demonstrate that his injuries were caused by participation in the trial.If the injured research subject should be compensated on a fault basis,there is heavy risk for both sponsors and hospital.关键词
临床试验/药物损害/案由/鉴定/无过错赔偿Key words
clinical trial/drug-induced injury/cause of action/identification/no-fault compensation分类
医药卫生引用本文复制引用
母双,范贞..1例临床试验受试者损害的赔偿[J].中国临床药理学杂志,2018,34(2):181-183,3.
