药物临床试验质量管理资格认定中设备管理员职责的探讨  

Discussion on the Role of the Equipment Administrator in Clinical Trials of Drug Quality Management Accreditation

作　　者：许静[1] 李昂[1] 尹赛赛 郭辉[1] 

机构地区：[1]南京军区南京总医院医学影像科,江苏南京210002

出　　处：《中国医疗设备》2015年第11期157-158,175,共3页China Medical Devices

摘　　要：目的探讨在申请药物临床试验质量管理资格认定中影像设备管理员的职责及准备工作。方法进行《药物临床试验质量管理规范》(GCP)培训,按照《药物临床试验机构资格认定办法》要求起草仪器设备类标准操作规程(SOP)及临床试验用仪器设备使用、维护保养记录表。结果有效保障了临床试验期间仪器设备的正常运转,顺利通过了由国家食品药品监督管理局会同卫生部组成检查组实施的模拟现场检查。结论在临床试验中设立专门的设备管理员,制订并认真执行相关的SOP,可以使药物临床试验更加规范化、科学化,也对学科的建设发展和科室医疗水平的提高起到了积极的促进作用。Objective To investigate the role of imaging equipment administrator and relevant preparations in clinical trials of drug quality management application accreditation.Methods A training of Good Clinical Practice（GCP） was organized.And the standard operating procedures（SOP） and the record sheets for the use and maintenance of the equipment were drafted according to the Drug Clinical Trial Institution Accreditation Approach.Results The normal operation of the equipment during clinical trials was guaranteed so as to successfully pass the analog-site inspection implemented by the inspection team consisting of the State Food and Drug Administration and the Ministry of Health.Conclusion Establishment of a dedicated facility manager in clinical trials together with development and strict implementation of the relevant SOP could make drug clinical trials more standardized and scientific,which also promoted the construction and development of medical discipline for departments in the hospital.

关 键 词：临床试验设备 模拟现场检查 设备管理员 药物临床试验 

分 类 号：R197.3[医药卫生—卫生事业管理] R197.39[医药卫生—公共卫生与预防医学]