我院临床试验用药品管理模式的构建
发布时间：2019-02-23 16:50
【摘要】：目的:探讨建立科学和规范化的临床试验用药品管理方法。方法:采用理论分析与实证分析相结合的方法,从临床试验药房的软硬件建设、药品管理制度和标准操作规程的制订、定期质控和药品信息化管理平台建设等方面,介绍我院临床试验用药品的管理模式。结果:从我院实践情况来看,建立专门的临床试验用药品中心化管理药房,配置齐备的药品管理设施设备,由专职药学专业人员依据国家的法律法规、管理制度和标准操作规程集中管理试验用药品,并由质控小组定期对药品管理进行质控监督检查,可有效保障受试者用药安全,保证药物临床试验结果严谨科学。结论:药物临床试验机构严格遵照《药物临床试验质量管理规范》的要求,加强对试验用药品的管理,并不断提升信息化管理水平,对于构建规范化、精细化、高效能的临床试验用药品中心化管理药房具有重要意义。
[Abstract]:Objective: to establish a scientific and standardized method for drug management in clinical trials. Methods: the method of combining theoretical analysis with empirical analysis was used to construct the hardware and software of clinical trial pharmacy, the establishment of drug management system and standard operating procedure, the construction of regular quality control and information management platform of drugs, and so on. This paper introduces the management mode of clinical trial drugs in our hospital. Results: according to the actual situation of our hospital, we set up a special drug center management pharmacy for clinical trial, equipped with complete facilities for drug management, and the full-time pharmaceutical professionals were in accordance with the laws and regulations of the country. The centralized management system and standard operating procedures of experimental drugs, and the quality control supervision and inspection of drug management by quality control team on a regular basis, can effectively ensure the safety of drug use by the subjects and ensure the rigorous and scientific results of the clinical trials of drugs. Conclusion: in accordance with the requirements of the quality Management Standard of Drug Clinical trial, the drug clinical trial organization should strengthen the management of the drug used in the experiment, and continuously improve the level of information management, which can be standardized and meticulous for the construction of the drug. It is of great significance to centralize drug management for clinical trials.
【作者单位】： 华南肿瘤学国家重点实验室/肿瘤医学协同创新中心/中山大学肿瘤防治中心;
【分类号】：R95
[Abstract]:Objective: to establish a scientific and standardized method for drug management in clinical trials. Methods: the method of combining theoretical analysis with empirical analysis was used to construct the hardware and software of clinical trial pharmacy, the establishment of drug management system and standard operating procedure, the construction of regular quality control and information management platform of drugs, and so on. This paper introduces the management mode of clinical trial drugs in our hospital. Results: according to the actual situation of our hospital, we set up a special drug center management pharmacy for clinical trial, equipped with complete facilities for drug management, and the full-time pharmaceutical professionals were in accordance with the laws and regulations of the country. The centralized management system and standard operating procedures of experimental drugs, and the quality control supervision and inspection of drug management by quality control team on a regular basis, can effectively ensure the safety of drug use by the subjects and ensure the rigorous and scientific results of the clinical trials of drugs. Conclusion: in accordance with the requirements of the quality Management Standard of Drug Clinical trial, the drug clinical trial organization should strengthen the management of the drug used in the experiment, and continuously improve the level of information management, which can be standardized and meticulous for the construction of the drug. It is of great significance to centralize drug management for clinical trials.
【作者单位】： 华南肿瘤学国家重点实验室/肿瘤医学协同创新中心/中山大学肿瘤防治中心;
【分类号】：R95
【参考文献】
相关期刊论文 前5条
1 陈燕銮;林忠晓;蒋发烨;陈文戈;赵树进;余细勇;;我院临床试验用药品信息化管理平台的构建与应用[J];中国药房;2014年29期
2 赵淑华;江e，
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