摘要
Abstract
Clinical trial of medical device is the key link to verify the safety and effectiveness of medical device products to be listed and registered under normal conditions of use,Clinical trials of medical devices shall be carried out in registered medical institutions,The medical device clinical trial institution is the medical device clinical trial management department responsible for communication and coor-dination,organization and implementation,supervision and training,and development planning,based on the clinical trial process of med-ical devices,It is necessary to assist in project acceptance and recommendation,project evaluation,project contract review,project start-up and implementation,medical device management,sample management,project quality control management,project fund management,project closure management,project file management,and project related inspection and other work.This article summarizes management practices,and analyzes the key points of process management for the above-mentioned clinical trial projects of medical device.It can be known that medical device clinical trial institutions need to actively adopt fine,professional and efficient management processes,through effective integration of resources,active communication and coordination,rapid response to needs,optimization of service processes,and strict risk management,in order to ensure that the medical device clinical trial process is real and standardized,and the results are scien-tific and reliable.To support the high-quality development of medical device clinical trial,and effectively safeguard and implement the rights and demands of all relevant parties,including sponsors,institutions,researchers,and subjects.Effectively safeguard and implement the rights and demands of all relevant parties involved in medical device clinical trials,including sponsors,institutions,researchers,and subjects.关键词
医疗器械临床试验/临床试验机构/项目流程管理/规范化Key words
Clinical trials of medical device/Clinical trial institution/Project process management分类
医药卫生
