摘要
针对新修订的医疗器械和体外诊断试剂法规与指导原则在临床试验实施阶段的主要变化,总结研究者、医疗器械临床试验机构和申办者需要关注的重要问题,通过对盲法、医疗器械/体外诊断试剂和生物样本管理的典型案例分析,加强对临床试验实施环节中风险及质控要点的理解,通过多方合作不断提高医疗器械和体外诊断试剂临床试验的质量。
In view of the main changes in the newly revised regulations and guiding principles of medical devices and in vitro diagnostic reagents in the implementation of clinical trials,the important issues that investigators,medical device clinical trial institutions,and sponsors must pay attention to were summarized.Through typical case analysis of the management of blinding,medical devices/in vitro diagnostic reagents,and biological sample,the understanding of the risks and quality control points of clinical trial implementation was strengthened,so as to continuously improve the clinical trial quality of medical devices and in vitro diagnostic reagents through multi-party cooperation.
作者
洪璐
张晓燕
曾涛
张炜
何高丽
袁兰芳
徐丛剑
HONG Lu;ZHANG Xiao-yan;ZENG Tao;ZHANG Wei;HE Gao-li;YUAN Lan-fang;XU Cong-jian(National Drug Clinical Trial Institution,Obstetrics and Gynecology Hospital,Fudan University,SHANGHAI 2000ll,China)
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2023年第4期229-232,共4页
Chinese Journal of New Drugs and Clinical Remedies
基金
上海市级医院医企协同临床试验管理项目(20CR4004B)。
关键词
医疗器械
试剂盒
诊断
临床试验
质量控制
medical device
reagent kits,diagnostic
clinical trial
quality control
