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药物临床试验管理系统中质量控制体系的设计与应用

徐帆 徐贵丽 徐昕明 寇苏

中国药房2012,Vol.23Issue(1):16-18,3.
中国药房2012,Vol.23Issue(1):16-18,3.DOI:10.6039/j.issn.1001-0408.2012.01.05

药物临床试验管理系统中质量控制体系的设计与应用

Design and Application of Quality Control System in Clinical Trial Management System

徐帆 1徐贵丽 1徐昕明 1寇苏2

作者信息

  • 1. 成都军区昆明总医院,昆明650032
  • 2. 贵阳医学院,贵阳550004
  • 折叠

摘要

Abstract

OBJECTIVE: To provide reference for the standard information management for clinical trial. METHODS: The importance of the module design of quality control system and application of it in clinical trial management system were discussed. RESULTS & CONCLUSIONS: The system has been designed on the basis of module, with functions of electronic signature, user rights management, audition management, checking and monitoring and inspection mark. It contributes to ensuring the quality of clinical drug trials and it is a necessary part of clinical trial management system.

关键词

药物临床试验管理系统/质量控制体系/设计/应用

Key words

Clinical trial management system/ Quality control system/ Design/ Application

分类

医药卫生

引用本文复制引用

徐帆,徐贵丽,徐昕明,寇苏..药物临床试验管理系统中质量控制体系的设计与应用[J].中国药房,2012,23(1):16-18,3.

中国药房

OACSCDCSTPCD

1001-0408

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