【摘要】：目的:探討建立科學和規(guī)范化的臨床試驗用藥品管理方法。方法:采用理論分析與實證分析相結(jié)合的方法,從臨床試驗藥房的軟硬件建設(shè)、藥品管理制度和標準操作規(guī)程的制訂、定期質(zhì)控和藥品信息化管理平臺建設(shè)等方面,介紹我院臨床試驗用藥品的管理模式。結(jié)果:從我院實踐情況來看,建立專門的臨床試驗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,由專職藥學專業(yè)人員依據(jù)國家的法律法規(guī)、管理制度和標準操作規(guī)程集中管理試驗用藥品,并由質(zhì)控小組定期對藥品管理進行質(zhì)控監(jiān)督檢查,可有效保障受試者用藥安全,保證藥物臨床試驗結(jié)果嚴謹科學。結(jié)論:藥物臨床試驗機構(gòu)嚴格遵照《藥物臨床試驗質(zhì)量管理規(guī)范》的要求,加強對試驗用藥品的管理,并不斷提升信息化管理水平,對于構(gòu)建規(guī)范化、精細化、高效能的臨床試驗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】： 華南腫瘤學國家重點實驗室/腫瘤醫(yī)學協(xié)同創(chuàng)新中心/中山大學腫瘤防治中心;
【分類號】：R95

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相關(guān)期刊論文 前5條

1 陳燕鑾;林忠曉;蔣發(fā)燁;陳文戈;趙樹進;余細勇;;我院臨床試驗用藥品信息化管理平臺的構(gòu)建與應(yīng)用[J];中國藥房;2014年29期

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本文編號：2429025