摘要
本文针对在医疗器械临床试验全过程中存在的问题,从监管部门、申办者、研究者、受试者各方对其进行归纳分析,并不断探索解决这些问题的措施,为加快我国医疗器械临床试验研究与管理水平、提高医疗器械临床试验质量起到很好的促进作用。
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.
出处
《中国医疗设备》
2016年第8期126-128,共3页
China Medical Devices
关键词
医疗器械临床试验
知情同意
不良事件
数据溯源
medical device clinical trial
informed consent
adverse events
data traceability
