摘要
论述了医疗器械药物临床试验管理规范的主要内容,阐述了各个相关部门在操作医疗器械临床试验时容易发生的各种不符合规范的现象及其可能导致的严重后果,同时深入分析了这些现象背后的本质问题,提出了应该通过完善质量管理体制、强化人员培训、完善知情同意制度、建立监管机制等措施,使医疗器械临床试验的最终结论更具真实性、科学性,更好地为广大人民群众的健康事业服务。
The contents of medical equipment GCP are discussed,and the nonstandard operations and their results during medical equipment clinical trial are described.Some measures are put forward,including improving quality management system,strengthening personnel training,completing informed consent regulation,establishing supervision mechanism and etc.
出处
《医疗卫生装备》
CAS
2013年第9期93-95,共3页
Chinese Medical Equipment Journal
关键词
医疗器械
临床试验
规范化
medical equipment
clinical trial
standardization
