摘要
Abstract
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 & 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.关键词
药物临床试验机构/药品管理/检查/专职药师Key words
Drug clinical trial institution/Drug management/Inspect/Full-time pharmacist分类
医药卫生
