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中国临床药理学与治疗学 ›› 2009, Vol. 14 ›› Issue (7): 837-840.

• 综述与讲座 • 上一篇    

浅谈运用ISO9001 质量管理体系基本理论指导药物临床试验的实施

孔小红, 戚建伟, 李萍, 殷晓红   

  1. 南京医科大学附属南京第一医院, 南京210006, 江苏
  • 收稿日期:2009-04-11 修回日期:2009-05-14 出版日期:2009-07-26 发布日期:2020-10-30
  • 作者简介:孔小红, 女, 医学学士, 副主任医师, 副教授, 主要研究方向:医院科教管理。Tel:025-52271039-81  E-mail:kfhnfh@sina.com

Using the basic theory of ISO9001 quality management system to guide the implementation of drug clinical trial

KONG Xiao-hong, QI Jian-wei, LI Ping, YIN Xiao-hong   

  1. Nanjing Medical University, Affiliated Nanjing First Hospital, Nanjing 210006, Jiangsu, China
  • Received:2009-04-11 Revised:2009-05-14 Online:2009-07-26 Published:2020-10-30

摘要: 药物临床试验全过程必须严格遵循三大原则——伦理原则、科学原则、法律原则进行。在此基础上, 本院还将ISO9001 质量管理体系的管理理念贯穿于药物临床试验全程质控中, 从而进一步巩固并完善了临床试验机构内部的质保体系。

关键词: ISO9001 质量管理体系, 药物临床试验, 过程管理

Abstract: The whole process of drug clinical trial must be strictly followed by three major principles:ethical, scientific and legal.On this basis, the hospital will also use the management concepts of ISO9001 quality management system throughout the entire process of quality control in drug clinical trial to further consolidate and improve the quality assurance system of the clinical trial.

Key words: ISO9001 quality management system, drug clinical test, process administration

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