我院临床试验用药品管理模式的建立.PDFVIP

我院临床试验用药品管理模式的建立 王彦荣＊，张丽娟，陈桂玲，戴欣雅（沧州市中心医院药物临床试验机构办公室，河北 沧州 061001） 中图分类号 R95 文献标志码 A 文章编号 1001-0408（2014）05-0408-03 DOI 10.6039/j.issn.1001-0408.2014.05.08 摘 要 目的：探讨临床试验用药品的管理模式。方法：按照《药物临床试验质量管理规范》（GCP）的规定，并结合我院实际情况 制订试验用药品管理机制。结果与结论：初步建立了药物临床试验机构办公室负责试验用药品的验收、回收、督导、培训，临床专 业组负责试验用药品的保管、分发和使用的试验用药品管理模式，保证试验用药品“专人、专柜、专锁”管理；同时将试验用药品的 管理纳入药物临床试验质量控制体系。但建立既符合法规要求又能适应本院实际情况的、较为完善的试验用药品管理模式需要 长期努力、多方协调才能达成。 关键词 临床试验用药品；医院；管理模式；质量控制 Establishment of Management Model of Clinical Trial Drugs in Our Hospital WANG Yan-rong，ZHANG Li-juan，CHEN Gui-ling，DAI Xin-ya（Drug Clinical Trial Institute Office，Cangzhou Municipal Central Hospital，Hebei Cangzhou 061001，China） ABSTRACT OBJECTIVE：To discuss the management model of clinical trial drugs in hospitals. METHODS：Based on the relat- ed regulations of Good Clinical Practice（GCP）and the actual situation of our hospital，the management mechanism of trial drugs had been developed. RESULTS CONCLUSIONS：Trial drug management model has been established initially，including the of- fice of drug clinical trial institution responsible for the acceptance，recovery，supervision and training of clinical trials drug；clini- cal section responsible for storage，distribution and use of clinical trials drugs. The clinical trials drug management of“special per- sonal，special counter and special lock”can be ensured. The management of trial drugs has been included in quality management system of drug clinical trials. More perfect management model of clinical trial drugs，which in line with the rules，regulation and the situation of the hospital，can be achieved by long-tem effort and multilateral coordination. KEYWORDS Clinical trial drug；Hospital；Management model；Quality control 我院是一所地市级综合性三级甲等医院，自 2011 年 6 月 2 合理安排试验用药品管理人员并进行培训[3] 正式启动了申请国家药物临床试验机构资格认定的工作后，