Chinese Journal of Pharmacovigilance ›› 2019, Vol. 16 ›› Issue (10): 608-613.
DOI: 10.19803/j.1672-8629.2019.10.08

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Application of Electronic Information-and-network-based Technology in Clinical Trial Management

FAN Yi   

  1. Center for Drug Evaluation, NMPA, Beijing 100022,China
  • Received:2019-10-24 Revised:2019-10-24 Online:2019-10-20 Published:2019-10-24

Abstract: Objective To improve the efficiency and quality of clinical trial research and to provide reference for more effective information supervision of drug life cycles. Methods By focusing on the construction of information systems for clinical trial research management, CNKI and official websites of drug regulatory agencies in various countries were searched to collect papers, literature and guidelines.The advantages, characteristics, functions and processes of commonly-used clinical trial research management information systems were analyzed comprehensively in combination with our actual work. Results & Conclusion The advantages of clinical trial research management systems over the original methods or modes of management have been illuminated, the possible impact of popularization of electronic information technology discussed, and solutions to problems to be solved offered.

Key words: clinical trial, electronic information-and-network-based technology, drugs clinical trail management system.

CLC Number: