加强对医疗器械临床试验项目的质量管理  

Strengthen the management of quality in medical device clinical trials

作　　者：范华莹[1] 王瓅珏[1] 谢振伟[1] 郭丹杰[1] 张华[1] 王豪[1] FAN Huaying;WANG Lijue;XIE Zhenwei;GUO Danjie;ZHANG Hua;WANG Hao(Drug Clinical Trial Institution,Peking University People's Hospital,Bejing 100044,China)

机构地区：[1]北京大学人民医院药物临床试验机构,北京100044

出　　处：《沈阳药科大学学报》2021年第4期428-432,共5页Journal of Shenyang Pharmaceutical University

基　　金：北京国际医药临床研发(CRO)平台。

摘　　要：目的分析我院在医疗器械临床试验管理中发现的常见问题,提出相应的解决对策和建议。方法总结我院承接的数百项医疗器械临床试验项目在管理中存在的问题,从伦理审评、质量控制、研究人员资质和试验器械管理等方面,深度剖析目前管理中存在的薄弱环节,并提出相应解决方案和对策。结果与结论医疗器械临床试验机构应当完善相关的管理制度,切实履行受试者的合法权益,提高研究团队的试验水平,加强信息化建设,以进一步规范医疗器械临床试验行为,保证试验结果科学、可靠。Objective To analyze the common problems found in the management of medical device clinical trials,and puts forward the corresponding countermeasures and suggestions.Methods Based on summarizing the problems in the management of hundreds of medical device clinical trials undertaken by our hospital,this paper systematically analyzed the weaknesses from four aspects,including ethic review,quality control,investigators and device management,and relevant solutions were explored.Results and conclusions The clinical trial institutions of medical devices should improve the relevant management system and the abilities of investigators,protect the interests of the subjects,and strengthen the supervision of the trial process,thus ensuring the scientificalness and reliability of clinical trials.

关 键 词：医疗器械 临床试验 质量管理 

分 类 号：R955[医药卫生—药学]