摘要
目的:促进药物临床试验管理水平,保证临床试验质量。方法:参照《药物临床试验质量管理规范》(GCP)和《药物临床试验机构资格认定复核检查标准》对试验药品的管理要求,检查我院临床试验药品在贮存保管硬件设施、管理人员资质及接收、贮存、发放、回收资料记录等管理中存在的问题,并提出改进措施及相关建议。结果与结论:我院临床试验药品在硬件设施和人员资质方面基本符合要求,但在接收、贮存、发放、回收等记录管理中存在缺陷,为此制订了改善药品管理流程、完善记录等措施,并提出建立电子化药品管理系统、药师积极参与药物临床试验的全过程干预、临床试验机构办设立专职药师管理试验用药品的建议等。
OBJECTIVE：To promote the management of clinical trial drugs and to guarantee the quality of clinical trials. METHODS：According to the management regulatory requirements,in Good Clinical Practice（GCP）and Drug Clinical Trial In-stitution Qualification Review Inspection Standard for clinical trial drug the problems including hardware facilities,personnel and re-cording documents such as receiving,storing,dispensing and recycling for surplus drugs were reviewed,meanwhile,countermea-sures and relative suggestions were put forward. RESULTS ＆amp; CONCLUSIONS：The hardware facilities and personnel meet the re-quirements of GCP,but many recording documents such as receiving,storing,dispensing and surplus drug recycling are incom-plete and should be improved in our hospital. Therefore,the improvement of the process of experimental drug flow management and the complement of record of the documents are established. And suggestions about the establishment of electronic drug manage-ment system,pharmacists to take an active part in the whole process of drug clinical trials intervention,the establishment of full-time pharmacist to manage the clinical trial drugs in the clinical trial institution pharmacy are put forward.
出处
《中国药房》
CAS
北大核心
2015年第28期3909-3911,共3页
China Pharmacy
关键词
药物临床试验机构
药品管理
检查
专职药师
Drug clinical trial institution
Drug management
Inspect
Full-time pharmacist
