医疗器械临床试验项目启动前风险管理策略研究  

Research on Risk Management Strategy before the Start-up of Medical Device Clinical Trial Project

作　　者：王倩 郭晋敏 WANG Qian;GUO Jinmin(The 960th Hospital of the PLA Joint Logistics Support Force,Jinan,Shandong,250031,China;不详)

机构地区：[1]中国人民解放军联勤保障部队第九六〇医院,山东济南250031

出　　处：《中国卫生质量管理》2024年第10期91-95,共5页Chinese Health Quality Management

基　　金：山东省泰山学者青年专家项目(编号:tsqn202312385)。

摘　　要：目的探讨医疗器械临床试验项目启动前风险管理策略,以提高专业科室临床试验能力。方法基于机构规定的试验前流程,识别项目启动前各环节38项风险要素,对风险事件的影响程度和发生可能性进行评估及赋值,确定风险等级,并制订分级管控策略。结果针对中高风险事件、中风险事件、中低风险事件实施风险管控策略后,专业科室项目启动前风险评估由中风险降为低风险。结论通过构建项目启动前风险管理体系,使试验前各环节风险最小化,提升了专业科室临床试验质量。Objective To explore the risk management strategy before the start-up of medical device clinical trial project,so as to enhance the clinical trial ability of professional departments.Methods Based on the pre-test process specified by the organization,38 risk factors in all processes were identified,the influence degree and occurrence possibility of risk events were evaluated and assigned,the risk level was determined,and the hierarchical management and control strategies were formulated.Results After the implementation of risk management and control strategies for medium-high risk events,medium-risk events,and medium-low risk events,the overall risk assessment before the start-up of the professional departments project was reduced from medium risk to low risk.Conclusion Constructing the risk management system before project start-up can minimize the risk of each link before the test and improve the quality of clinical trial in professional departments.

关 键 词：医疗器械临床试验 风险管理 项目启动前管理 试验质量 

分 类 号：R197.39[医药卫生—卫生事业管理]