中国中药杂志

2015, v.40(24) 4766-4769

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中药注射剂临床安全性监测质量控制指标的构建与实现
Construction and implementation of quality control index for clinical safety of Chinese medicine injection

姜俊杰;谢雁鸣;
JIANG Jun-jie;XIE Yan-ming;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences;

摘要(Abstract):

为保证中药注射剂安全性监测数据的真实准确,基于临床研究过程的质控和管理构建了中药注射剂安全性监测质量控制指标,包括监测中心、监测人员、硬件条件、监测进度与入组病例数、原始文件与档案管理、电子数据、不良事件、质量管理。将其应用于重大新药创制"科技重大专项"——10种中药注射剂临床安全性监测的质量控制工作中,发现了遗漏监测病例、未上报不良事件、仅上报不良反应、电子数据上报滞后、一级质量控制力度不足的问题,并予以整改,实现了中药注射剂安全性监测质量控制与质量保证,并为后续中药安全性监测质量控制工作提供参考。
In order to ensure the authenticity and accuracy of traditional Chinese medicine injection safety monitoring data,Chinese medicine injection safety monitoring quality control indicators,including the monitoring center,monitoring personnel,hardware conditions,monitoring progress and the number of patients into the group,original documents and archives management,electronic data,adverse events,quality management were constructed. Its application in the creation of major new drugs technology major projects,10 kinds of traditional Chinese medicine injections clinical safety monitoring quality control work,found the missing case surveillance,not reported adverse events,only reported adverse reactions,electronic data reporting lag,lack of level of efforts to control the problem,and corrected,the traditional Chinese medicine injection safety monitoring of quality control and quality assurance,and subsequent Chinese medicine safety monitoring quality control to provide the reference.

关键词(KeyWords): 质量控制;中药注射剂;安全性监测;医院集中监测
quality control;traditional Chinese medicine injection;safety monitoring;hospital centralized monitoring

Abstract:

Keywords:

基金项目(Foundation): 国家“重大新药创制”科技重大专项(2009ZX09502-030);; 中央级公益性科研院所基本业务费项目(Z0406)

作者(Author): 姜俊杰;谢雁鸣;
JIANG Jun-jie;XIE Yan-ming;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences;

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