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Journal of Chinese Integrative Medicine ›› 2010, Vol. 8 ›› Issue (5): 406-409.doi: 10.3736/jcim20100502

Special Issue: Traditional Chinese Medicine

• Commentary • Previous Articles     Next Articles

Quality inspection of clinical research in traditional Chinese medicine

Rui Lia, Wei-liang Wenga(), Yuan-xiang Tianb,Qiu-yan Li a, Fang Lua   

  1. a GCP Clinical Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China
    b Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
  • Received:2009-12-23 Accepted:2010-03-12 Online:2010-05-20 Published:2010-05-15
  • Contact: Wei-liang Weng E-mail:ww6488@126.com

Beginning with 4-level quality control measures of clinical research in traditional Chinese medicine (TCM), we elaborated the implementation process and demands of quality control measures of each level, including quality control, monitoring, auditing, and inspection. On the basis of joint inspection experience of 41 projects of the “Prevention and Treatment of Difficult and Complicated Diseases of TCM” plan of the “11th Five-year National Key Technology R&D Program”, we analyzed the ensuring effect of 4-level quality control system and joint inspection model, and then pointed out the existing problems in the executing process of quality control system at different levels and joint inspection model. Finally we investigated what should be revised in the quality control system and joint inspection model, thus providing the theoretical support for quality inspection improvement of TCM clinical research.

Key words: Clinical study, Quality control, Traditional Chinese medicine

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