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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2009, Vol. 14 ›› Issue (7): 837-840.

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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

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

CLC Number: