中国医疗设备2016，Vol.31Issue(8)：126-128,3.DOI:10.3969/j.issn.1674-1633.2016.08.041
医疗器械临床试验中存在的问题与对策探讨
Discussion on Problems in Medical Device Clinical Trials and Relevant Solutions
杨春梅 1袁丹江 1徐珍1
作者信息
- 1. 华中科技大学同济医学院附属荆州医院 药物临床试验机构，湖北 荆州434020
- 折叠
摘要
Abstract
In view of the problems in the full process of medical device clinical trials, the paper summarized the problems from four aspects, including regulators, sponsors, investigators and subjects. Additionally, relevant solutions were explored so as to play a positive role in accelerating the medical device clinical trial and improving its management level and quality.关键词
医疗器械临床试验/知情同意/不良事件/数据溯源Key words
medical device clinical trial/informed consent/adverse events/data traceability分类
医药卫生引用本文复制引用
杨春梅,袁丹江,徐珍..医疗器械临床试验中存在的问题与对策探讨[J].中国医疗设备,2016,31(8):126-128,3.
