| 摘要: |
| 目的 建立药物临床试验药房的建设和管理的标准。方法 参照已有规范及检查标准，并结合龙华医院药物信息化管理系统的相关实践，总结归纳医院药物临床试验中心药房的标准化建设和规范化管理的经验。结果 从药物临床试验中心药房的管理模式、管理流程、硬件设施、文件资料的管理和信息化系统的应用等多方面综合阐述更为规范化、科学化、系统化的医院药物临床试验中心药房的标准化建设和规范化管理的实践策略及思考。结论 试验用药物的规范化管理是整个临床试验的重要组成部分。为了稳步提高国内药物临床试验研究质量，需要针对试验用药物管理存在的问题，不断完善制度建设和软硬件条件的配备，切实保障受试者用药安全。 |
| 关键词: 药物临床试验 中心药房 标准化建设 规范化管理 |
| DOI：10.13748/j.cnki.issn1007-7693.2019.23.019 |
| 分类号:R952 |
| 基金项目:上海市临床药学重点专科建设项目（沪卫计药政[2017]5号） |
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| Standardized Construction and Management of Clinical Trial Centralized Pharmacy in the Hospital |
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XU Jiaqi
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Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
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| Abstract: |
| OBJECTIVE To establish unified standards for the construction and management of clinical pharmacies. METHODS According to the current specifications and the practical experience of clinical trial drug information management system in Longhua hospital, this paper summarized the valuable experience of standardized construction and management of clinical trial centralized pharmacy in the hospital. RESULTS From the aspects of the management mode, management process, hardware facilities, document and data management and the application of information system in the clinical trial centralized pharmacy. This paper comprehensively expounded the practical strategies and considerations of standardization construction and standardization management of pharmacies in clinical drug trial centers of hospitals, which were more standardized, scientific and systematic. CONCLUSION Standardized management of experimental drugs is an important part of the whole clinical trial. In order to steadily improve the quality of clinical drug trial research in China, need to improve the system construction, the allocation of hardware and software conditions for the safety of patients based on the problems in management of experimental drugs. |
| Key words: drug clinical trial centralized pharmacy standardized construction standardized management |
