【摘要】：目的:探討建立科學(xué)和規(guī)范化的臨床試驗(yàn)用藥品管理方法。方法:采用理論分析與實(shí)證分析相結(jié)合的方法,從臨床試驗(yàn)藥房的軟硬件建設(shè)、藥品管理制度和標(biāo)準(zhǔn)操作規(guī)程的制訂、定期質(zhì)控和藥品信息化管理平臺(tái)建設(shè)等方面,介紹我院臨床試驗(yàn)用藥品的管理模式。結(jié)果:從我院實(shí)踐情況來(lái)看,建立專(zhuān)門(mén)的臨床試驗(yàn)用藥品中心化管理藥房,配置齊備的藥品管理設(shè)施設(shè)備,由專(zhuān)職藥學(xué)專(zhuān)業(yè)人員依據(jù)國(guó)家的法律法規(guī)、管理制度和標(biāo)準(zhǔn)操作規(guī)程集中管理試驗(yàn)用藥品,并由質(zhì)控小組定期對(duì)藥品管理進(jìn)行質(zhì)控監(jiān)督檢查,可有效保障受試者用藥安全,保證藥物臨床試驗(yàn)結(jié)果嚴(yán)謹(jǐn)科學(xué)。結(jié)論:藥物臨床試驗(yàn)機(jī)構(gòu)嚴(yán)格遵照《藥物臨床試驗(yàn)質(zhì)量管理規(guī)范》的要求,加強(qiáng)對(duì)試驗(yàn)用藥品的管理,并不斷提升信息化管理水平,對(duì)于構(gòu)建規(guī)范化、精細(xì)化、高效能的臨床試驗(yàn)用藥品中心化管理藥房具有重要意義。
[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.
【作者單位】： 華南腫瘤學(xué)國(guó)家重點(diǎn)實(shí)驗(yàn)室/腫瘤醫(yī)學(xué)協(xié)同創(chuàng)新中心/中山大學(xué)腫瘤防治中心;
【分類(lèi)號(hào)】：R95

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相關(guān)期刊論文 前5條

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