[1]朱 淼.药物临床试验档案管理现状与对策[J].医学信息,2018,31(05):29-30.[doi:10.3969/j.issn.1006-1959.2018.05.011]
　ZHU Miao.Current Situation and Countermeasures of Archives Management of Drug Clinical Trial[J].Journal of Medical Information,2018,31(05):29-30.[doi:10.3969/j.issn.1006-1959.2018.05.011]
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药物临床试验档案管理现状与对策()
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医学信息[ISSN:1006-1959/CN:61-1278/R]

卷:
31卷
期数:
2018年05期
页码:
29-30
栏目:
出版日期:
2018-03-01

文章信息/Info

Title:
Current Situation and Countermeasures of Archives Management of Drug Clinical Trial
文章编号:
1006-1959（2018）05-0029-02
作者:
朱 淼
首都医科大学附属北京安定医院药物临床试验机构，北京 100088
Author(s):
ZHU Miao
Institute of Clinical Trial of Drugs,Beijing Anding Hospital,Capital Medical University,Beijing 100088,China
关键词:
药物临床试验; 档案管理; 现状; 问题; 对策
Keywords:
Key words：Drug clinical trial; File management; Current situation; Problems; Countermeasures
分类号:
R95
DOI:
10.3969/j.issn.1006-1959.2018.05.011
文献标志码:
A
摘要:
2015年，党中央、国务院提出了“最严谨的标准、最严格的监管、最严厉的处罚、最严肃的问责，确保广大人民群众饮食用药安全”，将药物临床试验管理工作提高到一个新的高度。本文从药物临床试验档案管理的重要性及特点入手，对药物临床试验档案管理的现状、存在的问题及管理对策进行探讨。
Abstract:
Abstract：In 2015,the CPC Central Committee and the State Council put forward"the most stringent standards,the strictest supervision, the most severe punishment,the most serious accountability,to ensure the safety of food and drug use among the masses of the people ",the management of clinical trial of drugs is raised to a new height.This paper begins with the importance and characteristics of the archives management of clinical trials of drugs,and gives an account of the present situation of the archives management of clinical trials of drugs.The existing problems and management countermeasures are discussed.

参考文献/References:

[1]国家食品药品监督管理局.药物临床试验质量管理规范[S].2003-09-01. [2]王玲,王燕.对药物临床试验档案资料规范化管理的探讨[J].中国社会医学,2014,31(2):84-85. [3]刘勇.关于当前药物临床试验的几点思考[J].中国医院,2010,14(5):18-19. [4]胡薏慧,元唯安,彭朋,等.浅谈药物临床试验档案管理[J].解放军医院管理杂志,2014,21(2):199-200. [5]徐莉娅,陈燕溪,杨林芬,等.浅析药物临床试验档案管理现状及对策[J].中国中医药现代远程教育,2016,14(13):35-37.

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更新日期/Last Update: 2018-03-01