我院药物临床试验机构药房药品管理实践体会

发布时间：2018-08-08 11:17

【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。
[Abstract]:Objective: to promote the management of clinical trials and ensure the quality of clinical trials. Methods: according to the management requirements of (GCP) and qualification check Standard for Drug Clinical trial, we examined the storage and storage hardware facilities of clinical trial drugs in our hospital. Management personnel qualification and management of receiving, storage, distribution, recovery of data records and other management problems, and put forward improvement measures and related recommendations. Results & conclusion: the clinical trial drugs in our hospital basically meet the requirements in terms of hardware facilities and personnel qualifications, but there are some defects in the record management of receiving, storage, distribution and recovery. Some measures such as perfecting records, establishing electronic drug management system, actively participating in the whole process intervention of drug clinical trials, and setting up full-time pharmacists to manage drugs used in clinical trials were put forward.
【作者单位】：四川省医学科学院·四川省人民医院药学部;
【分类号】：R95

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