医疗器械临床试验立项审查环节质量分析及防范策略  

Quality Analysis and Preventive Measures in the Project Approval Review Link of Medical Device Clinical Trials

作　　者：赵同香[1] 马丽萍[1] 庞华 蒋向明[1] ZHAO Tongxiang;MA Liping;PANG Hua(Peking University,Shougang Hospital,Beijing,100144,China;不详)

机构地区：[1]北京大学首钢医院,北京100144 [2]北京核工业医院,北京100840

出　　处：《中国卫生质量管理》2024年第2期76-79,共4页Chinese Health Quality Management

摘　　要：立项审查是提高医疗器械临床试验质量的关键环节。通过对立项阶段发现的典型问题以案例的形式进行综合分析。提出,国家药监部门需进一步完善规章制度,申办者应承担临床试验质量管理责任,临床试验机构应建立完善的立项审查机制,研究者应提高规范意识,以保证试验质量和受试者权益。Project approval review is the key link to improve the quality of medical device clinical trials.Through a comprehensive analysis of typical problems found in the project initialization stage in the form of cases,it is suggested that the state drug regulatory authorities should further improve the regulations,that the applicants should assume the responsibility of clinical trial quality management,that the clinical trial institutions should establish a sound mechanism for project approval review,and that the researchers should enhance their normative awareness,so as to ensure the quality of the trial and the interests of the subjects.

关 键 词：医疗器械 临床试验 立项审查 环节质量 

分 类 号：R197.39[医药卫生—卫生事业管理]