基于风险管理策略的药物临床试验质量管理  

Analysis of Drug Clinical Trial Quality Management System based on Risk Management Strategy

作　　者：程晓华[1] 余路易 白薇[1] 温金华[1] 胡锦芳[1] CHENG Xiaohua;YU Luyi;BAI Wei;WEN Jinhua;HU Jinfang(Research Center of Clinical Trial,the First Affiliated Hospital of Nanchang University,Nanchang 330006,China)

机构地区：[1]南昌大学第一附属医院临床试验研究中心,南昌330006

出　　处：《医药导报》2022年第4期584-587,共4页Herald of Medicine

基　　金：“十三五”国家科技重大专项资助项目(2020ZX09201027)。

摘　　要：结合国内外发布的关于质量管理、风险管理、基于风险的质量管理等相关要求,依据现行版《药物临床试验质量管理规范》(GCP)的相关规定,以临床试验机构质量管理体系引入风险管理策略为切入点,通过对临床试验全过程中可能涉及的质量风险点进行识别、分析和评估,并提出针对不同风险等级制定相应的风险应对措施,充分发挥风险管理策略在临床试验机构质量管理中的作用,提高临床试验质量管理的效率,以期为其他医疗机构开展临床试验质量管理提供参考。In accordance with the relevant requirements of the current version of“Good Clinical Practice”(GCP),combined with the relevant requirements for quality management,risk management and risk-based quality management issued both domestic and international,taking the introduction of the risk management strategy to the quality management system of drug clinical trial institution as the entry point,the quality risk points that may be involved in the entire process of clinical trials were identified,analyzed and evaluated.Corresponding risk response measures for different risk levels were proposed.Given full play to the role of risk management strategies in the quality management of clinical trial institutions,the efficiency of clinical trial quality management was improved,and the study will provide a reference for drug clinical trial institutions to carry out quality management work.

关 键 词：临床试验 质量管理体系 风险管理 

分 类 号：R954[医药卫生—药学]