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药物临床试验机构专业科室建设与规范管理的探索

陆明莹 张田香 张彩霞 袁祖贻

中国临床药理学杂志Issue(23):2360-2361,2.
中国临床药理学杂志Issue(23):2360-2361,2.DOI:10.13699/j.cnki.1001-6821.2015.23.027

药物临床试验机构专业科室建设与规范管理的探索

Discussion on the development and standardized management of professional department in drug clinical trial institutions

陆明莹 1张田香 1张彩霞 1袁祖贻1

作者信息

  • 1. 西安交通大学 第一附属医院 临床药理机构办公室,西安 710061
  • 折叠

摘要

Abstract

The development and standardized management of professional department is the core of the national drug clinical trial institution development and quality control. Combined with the practice and exploration of the development of drug clinical trial institution in large comprehensive hospitals, this paper states main elements and basic ideas of standardized management of professional department in detailed from the following several aspects: the basic hardware, the formation of good clinical practice ( GCP ) team, the system construction of professional department and the training of investigator.

关键词

临床试验机构/专业科室/规范管理

Key words

drug clinical trial institution/professional department/standardized management

分类

医药卫生

引用本文复制引用

陆明莹,张田香,张彩霞,袁祖贻..药物临床试验机构专业科室建设与规范管理的探索[J].中国临床药理学杂志,2015,(23):2360-2361,2.

基金项目

陕西省科技攻关基金资助项目 ()

中国临床药理学杂志

OA北大核心CSCDCSTPCD

1001-6821

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