我国新药临床试验参与主体的风险管理  

Risk Management of Each Actor Involved in Drug Clinical Trials in China

作　　者：谢洁琼[1] Xie Jieqiong(China Food and Drug Administration Institute of Executive Development, Beijing 100073, China)

机构地区：[1]国家食品药品监督管理总局高级研修学院,北京100073

出　　处：《中国药师》2017年第6期1100-1103,共4页China Pharmacist

摘　　要：从风险管理的角度出发,剖析现阶段我国新药临床试验各参与主体包括申办者、研究者、受试者、伦理委员会及医疗机构可能面临的各类风险,并对如何管控和最小化风险提出建议和思考,期望采用正确、有效的管控策略最大程度地优化试验各方资源和降低风险,以达到保护受试者安全和获得高质量试验数据的目的。From the perspective of risk management, all kinds of risks potentially encountered by each actor involved in the clini- cal trials in China, including the sponsors, investigators, subjects ethics committee and medical institutions, were analyzed, and some suggestions and expectations on how to minimize the risks were accordingly proposed. Appropriate and effective strategies of risk control and management should be performed to optimize the resource of each actor involved and reduce risks, and eventually to guanrantee the safety of subjects and obtain high quality of study data.

关 键 词：临床试验 风险管理 质量 

分 类 号：R951[医药卫生—药学]