摘要
目的为临床试验机构规范管理试验用药品提供参考。方法根据《药物临床试验质量管理规范》(GCP)的要求,建立符合我院实际情况的临床试验药房管理体系,药物管理员对试验用药品管理中出现的各种问题进行总结归纳,并积极解决工作中的各种问题。结果与结论目前我院试验药房的管理模式符合本机构的实情,药物管理员在试验用药品管理中发挥着重要作用,通过分析并解决存在的问题,减少了工作中的各种差错,为临床试验结果科学、可靠提供了保障,并保障了受试者用药安全。
OBJECTIVE To provide reference for clinical trial institutions,and to standardize the management of investigational products.METHODS According to the requirements of GCP,a management mode of clinical trial pharmacy had been established that conforms to the suitation for our hospital.Pharmacist summarized various problems that encountered in work and proposed them actively.RESULTS and CONCLUSION The management mode of clinical trial pharmacy is running well at present.Pharmacists play an important role in the management of experimental drugs,and provide a guarantee for scientific and reliable clinical results,and ensure the safety of the subjects.
作者
段舟萍
胡锦芳
白薇
程晓华
朱艳
曹端文
DUAN Zhou-ping;HU Jin-fang;BAI Wei;CHENG Xiao-hua;ZHU Yan;CAO Duan-wen(Drug clinical trial institution of the First Affiliated Hospital of Nanchang University,Nanchang,330006,China)
出处
《海峡药学》
2021年第4期220-222,共3页
Strait Pharmaceutical Journal
基金
国家十三五重大专项(课题编号:2020ZX09201027)。
关键词
试验用药品
标准化操作流程
临床试验
药品管理
Investigational product
Standardized Operation Process
Clinical trials
Drug management
