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 Con-structing the risk management system before project start-up can minimize the risk of each link before the test and im-prove 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
Key words
Medical Device Clinical Trial/Risk Management/Management before Project Start-Up/Test Quality
维普
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