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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2020, Vol. 25 ›› Issue (5): 550-554.doi: 10.12092/j.issn.1009-2501.2020.05.011

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Characteristic and development of standard operating procedure of electronic data management in traditional Chinese medicine clinical research

LI Qingna1, HUANG Ke2, LU Fang1, ZHAO Yang1, QIU Panbo1, WANG Shuge1,GAO Rui1   

  1. 1Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091;
    2Department of Endocrinology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091
  • Published:2020-07-06

Abstract: Electronic data management has the advantages of saving cost and research time and improving the data quality, which has gradually been the mainstream form of clinical data collection and management. It is important to improve the quality of Traditional Chinese Medicine (TCM) clinical researches. This paper introduces the function, general style, developing principles and processes, management and training of Standard Operating Procedure (SOP) for electronic clinical data management. The characteristics and difficulties of electronic data management of TCM clinical researches are discussed and suggested solutions are proposed in the end.

Key words: clinical research, electronic data management, standard operating procedure

CLC Number: