从监督抽查结果解析医疗器械临床试验准备阶段的常见问题  

Analysis of common problems in preparation stage of medical device clinical trials from results of supervision and random inspection

作　　者：李佳[1] 梁新华[1] 王琪[1] 李灏来[1] 韩祺 Ll Jia;LIANG Xin-hua;WANG Qi;LI Hao-lai;HAN Qi(State Insitute of Medical Device Clinical Trial/National Clinical Research Center for Orul Diseases,West China Hospital ofStomatology,Sichuan University,Chengdu SICHUAN 610041,China)

机构地区：[1]四川大学华西口腔医院,国家医疗器械临床试验机构/国家口腔疾病临床研究中心,四川成都610041

出　　处：《中国新药与临床杂志》2021年第12期822-826,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：以医疗器械临床管理相关法规为依据,梳理2016年9月—2021年1月国家药品监督管理局及各省级药监局公布的77次医疗器械临床试验监督抽查结果,共计825条问题中属于准备阶段的问题有323条。主要涉及基础条件的准备(90条)、试验资料的设计(83条)、试验器械的入库管理(81条)及培训与授权(53条)。申办方、临床试验机构和研究者应从不同角度定位临床试验准备阶段的职责,从源头提升医疗器械临床试验的质量。According to the relevant management regulations of medical device clinical trials, the results of 77 times of supervision and inspection of medical device clinical trials published by the National Medical Products Administration and provincial medical products administrations from September 2016 to January 2021 were untangled, and it was found that 323 of total 825 problems were in the preparation stage. It mainly involves the preparation of basic condition(90), design of documents(83), deposit management of testing devices(81), and training and authorization(53). The sponsor, clinical trial institution and investigators should assume the responsibilities in the preparation stage of clinical trial from different angles, so as to improve the quality of medical device clinical trials from the source.

关 键 词：医疗器械 临床试验 研究资料 

分 类 号：R197.39[医药卫生—卫生事业管理] R969.4[医药卫生—公共卫生与预防医学]