New requirements and reflections on ethics review in the 2022 version of Good Clinical Practice for Medical Devices
10.12026/j.issn.1001-8565.2024.08.08
- VernacularTitle:2022版《医疗器械临床试验质量管理规范》对伦理审查的新要求及思考
- Author:
Qiansu YANG
1
;
Nan BAI
;
Jiyin ZHOU
Author Information
1. 中国人民解放军总医院医疗保障中心,北京 100853
- Keywords:
Good Clinical Practice for Medical Devices;
ethics committee;
initial review;
follow-up review
- From:
Chinese Medical Ethics
2024;37(8):919-925
- CountryChina
- Language:Chinese
-
Abstract:
The National Medical Products Administration issued a new version of the"Good Clinical Practice for Medical Devices(GCP)"in March 2022,which deleted specific requirements for the constitution and operation of the ethics committee and simplified the processes of submitting initial review documents and reporting serious adverse events in clinical trials.Firstly,the new requirements for ethics committees were sorted out and analyzed,including responsibilities,compositions,qualifications and training of members and secretaries,as well as the management of archives.Secondly,it elaborated on the new requirements for ethical initial reviews,including submission of materials,contents,methods,and conclusions of the review,as well as the learning curve risk management of drug-device combination medical devices and medical devices during use.It emphasized the compliance and validity of informed consent,strictly limited the conditions for exemption from informed consent,and redefined the organizations and individuals allowed to access trial data.Finally,it elaborated on the new requirements for follow-up review of serious adverse events,device defects,and new requirements for the correction clinical trial data after project the completion.The new version of the GCP is more operational and puts forward higher requirements for the review quality and efficiency of the ethics committee.The ethics committee should improve the review efficiency on the premise of ensuring the quality of the review,to effectively protect the safety,rights and interests of the subjects.
