中国医疗设备Issue(11)：157-158,175,3.DOI:10.3969/j.issn.1674-1633.2015.11.053
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
许静 1李昂 1尹赛赛 1郭辉1
作者信息
- 1. 南京军区南京总医院 医学影像科，江苏 南京 210002
- 折叠
摘要
Abstract
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 scientiifc, 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Key words
clinical trial equipment/analog-site inspection/equipment administrator/clinical trials of drugs分类
医药卫生引用本文复制引用
许静,李昂,尹赛赛,郭辉..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[J].中国医疗设备,2015,(11):157-158,175,3.
