Analysis on Legal Relationship Based on a Typical Case of Medical Device Clinical Trial
10.12026/j.issn.1001-8565.2023.03.08
- VernacularTitle:基于医疗器械临床试验典型案例的法律关系探析
- Author:
Xiaoyang YU
1
;
Yan’gang TIAN
2
;
Mingjie ZI
1
Author Information
1. Xiyuan Hospital, China Academy of Chinese Medical Sciences/National Clinical Medical Research Center for Cardiovascular Diseases of Chinese Medicine, Beijing 100091, China
2. Beijing Lyuli Law Firm, Beijing 100091, China
- Publication Type:Journal Article
- Keywords:
Medical Device Clinical Trial;
Serious Adverse Event;
Litigation Subject Qualification
- From:
Chinese Medical Ethics
2023;36(3):284-287
- CountryChina
- Language:Chinese
-
Abstract:
Guaranteeing the rights and safety of subjects is an important responsibility of all participants in the medical devices clinical trial, including medical institutions, sponsors and researchers. The legal disputes caused by serious adverse events in the clinical trial of medical devices are characterized by complex legal relationships, great difficulty in handling, and many points of dispute. Based on a typical case of medical device clinical trials, this paper discussed the litigation subject qualification, the treatment of contract breach and tort in medical device clinical trial, analyzed the responsibility of different subjects, and provided constructive suggestions on the risk management of medical device clinical trial.
