完善中山市人民医院药物临床试验机构管理制度及标准操作规程的探讨

目的：探讨如何完善中山市人民医院（以下简称＂我院＂）药物临床试验机构管理制度及标准操作规程。方法：针对我院机构运行管理过程中存在的问题,对临床试验过程中的重要环节进行各项管理制度及标准操作规程（standard operation procedure,SOP）的细化、修订和完善,逐步提高可操作性。结果：机构办公室结合实际情况,在日常工作中逐步修订、细化、完善各项管理制度及SOP,并为其他机构提供了参考。结论：各机构应在运行管理过程中,结合我院实际情况,不定时对各项管理制度及SOP进行修订和完善,以保障药物临床试验工作的顺利开展。...

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Bibliographic Details
Published in中国医院用药评价与分析 Vol. 17; no. 5; pp. 684 - 685
Main Author 刘峰 邓贵新 李雪芹 王桂凤
Format Journal Article
LanguageChinese
Published 中山市人民医院药学部,广东 中山,528403 2017
Subjects
修订
完善
标准操作规程
管理制度
药物临床试验
标准操作规程
Improvement
完善
药物临床试验
Standard operating procedure
Revision
管理制度
Management system
Clinical drug trials
修订
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ISSN1672-2124
DOI10.14009/j.issn.1672-2124.2017.05.039

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Summary:目的：探讨如何完善中山市人民医院（以下简称＂我院＂）药物临床试验机构管理制度及标准操作规程。方法：针对我院机构运行管理过程中存在的问题,对临床试验过程中的重要环节进行各项管理制度及标准操作规程（standard operation procedure,SOP）的细化、修订和完善,逐步提高可操作性。结果：机构办公室结合实际情况,在日常工作中逐步修订、细化、完善各项管理制度及SOP,并为其他机构提供了参考。结论：各机构应在运行管理过程中,结合我院实际情况,不定时对各项管理制度及SOP进行修订和完善,以保障药物临床试验工作的顺利开展。
Bibliography:Clinical drug trials; Management system; Standard operating procedure; Revision; Improvement
OBJECTIVE： To probe into how to improve the organization management system and the standard operating procedure of clinical drug trials in Zhongshan People＇ s Hospital （ hereinafter referred to as ＂our hospital＂ ）. METHODS： According to the existed problems during management, refining, revising and improving on various management systems and standard operation procedures from important segment during clinical drug trials were conduct to gradually improve the operability. RESULTS： The organization office combined the existed problems in various management systems and standard operation procedures of our hospital, refining, revising and improving measures were conducted in daily work so as to improve the feasibility and operability, and provided reference for other organizations. CONCLUSIONS： Organizations should in reference to the actual conditions of our hospital, to untimely refine and improve the management system a
ISSN:1672-2124
DOI:10.14009/j.issn.1672-2124.2017.05.039