One case of clinical trial subjects damage compensation
10.13699/j.cnki.1001-6821.2018.02.024
- VernacularTitle:1例临床试验受试者损害的赔偿
- Author:
Shuang MU
1
;
Zhen FAN
Author Information
1. 北京大学人民医院科研处
- Keywords:
clinical trial;
drug-induced injury;
cause of action;
identification;
no-fault compensation
- From:
The Chinese Journal of Clinical Pharmacology
2018;34(2):181-183
- CountryChina
- Language:Chinese
-
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.
