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Expert consensus on key points of the Beijing DCT project management system documents
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Ruo-wei TANG1, Xin WANG2, Yu-ying YIN2, Yan CUI3, Min JIANG4, Xiao-yuan CHEN5, Shu-min WANG6, Ying GAO7, Zhen-wei XIE8, Xiao-hong HAN9, Ping DU10, Yu TANG11, Hong FANG11, Zhi-xia ZHAO12, Tong GUO13, Ya-dong ZHANG1, Yi-min CUI14
Chinese Journal of Clinical Pharmacology | 2026, 42(10) : 1485 - 1500
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Chinese Journal of Clinical Pharmacology | 2026, 42(10): 1485-1500
• Expert Consensus •
Expert consensus on key points of the Beijing DCT project management system documents
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Ruo-wei TANG1, Xin WANG2, Yu-ying YIN2, Yan CUI3, Min JIANG4, Xiao-yuan CHEN5, Shu-min WANG6, Ying GAO7, Zhen-wei XIE8, Xiao-hong HAN9, Ping DU10, Yu TANG11, Hong FANG11, Zhi-xia ZHAO12, Tong GUO13, Ya-dong ZHANG1, Yi-min CUI14
Affiliations
  • 1.Drug Registration Administration Department, Beijing Municipal Medical Products Administration, Beijing 101117, China
  • 2.Clinical Trial Research Center, Beijing Hospital/National Center of Gerontology, Beijing 100730, China
  • 3.Office of Drug Clinical Trial Institution, Beijing Friendship Hospital Affiliated of Capital Medical University, Beijing 100050, China
  • 4.National Drug Clinical Trial Institution, Peking University Cancer Hospital & Beijing Institute for Cancer Research, Beijing 100142, China
  • 5.Office of Drug Clinical Trial Institution, Beijing Tsinghua Changgung Hospital, Beijing 102218, China
  • 6.Office of Drug Clinical Trial Institution, Beijing Chaoyang Hospital Affiliated of Capital Medical University, Beijing 100013, China
  • 7.Drug Clinical Trial Center, Peking University First Hospital, Beijing 100034, China
  • 8.Clinical Trial Institution, Peking University People’s Hospital, Beijing 100044, China
  • 9.Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100005, China
  • 10.National Drug Clinical Trial Institution, Beijing Youan Hospital Affiliated of Capital Medical University, Beijing 100069, China
  • 11.Drug Clinical Trial Research Center (GCP Center), Cancer Hospital Chinese Academy of Medical Sciences?, Beijing 100021, China
  • 12.Drug Clinical Trial Research Center (GCP Center), China-Japan Friendship Hospital, Beijing 100029, China
  • 13.Clinical Research Center, GoBroad Healthcare Group, Beijing 102206, China
  • 14.Institute of Clinical Pharmacology, Peking University First Hospital, Beijing 100034, China
Published: 2026-05-28 doi: 10.13699/j.cnki.1001-6821.2026.10.022
Outline
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Currently, decentralized clinical trials (DCT) are in a period of rapid development, with new technologies and methods such as remote intelligent technologies, wearable devices, and electronic data capture systems continuously emerging, profoundly reshaping the traditional clinical trial landscape. To adapt to this transformative trend and promote the scientific and orderly implementation of DCT in Beijing, the "Beijing Municipal Medical Products Administration", in collaboration with ten pilot institutions, has developed the "Beijing DCT Project Management System Document Consensus" through in-depth practice and multiple rounds of discussion. This consensus, consisting of 15 management documents, establishes a standardized management framework characterized by clear roles and responsibilities, operational feasibility, and controllable quality. It represents a significant milestone in the modernization of clinical trial governance in Beijing and has formed a replicable "Beijing Experience".

decentralized clinical trials  /  project management system  /  operational guidelines
Ruo-wei TANG, Xin WANG, Yu-ying YIN, Yan CUI, Min JIANG, Xiao-yuan CHEN, Shu-min WANG, Ying GAO, Zhen-wei XIE, Xiao-hong HAN, Ping DU, Yu TANG, Hong FANG, Zhi-xia ZHAO, Tong GUO, Ya-dong ZHANG, Yi-min CUI. Expert consensus on key points of the Beijing DCT project management system documents[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (10) : 1485 -1500 . DOI: 10.13699/j.cnki.1001-6821.2026.10.022
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Article Info
doi: 10.13699/j.cnki.1001-6821.2026.10.022
  • Receive Date：2026-03-31
  • Online Date：2026-08-06
  • Published：2026-05-28
Article Data
Affiliations
History
  • Received：2026-03-31
Affiliations
    1.Drug Registration Administration Department, Beijing Municipal Medical Products Administration, Beijing 101117, China
    2.Clinical Trial Research Center, Beijing Hospital/National Center of Gerontology, Beijing 100730, China
    3.Office of Drug Clinical Trial Institution, Beijing Friendship Hospital Affiliated of Capital Medical University, Beijing 100050, China
    4.National Drug Clinical Trial Institution, Peking University Cancer Hospital & Beijing Institute for Cancer Research, Beijing 100142, China
    5.Office of Drug Clinical Trial Institution, Beijing Tsinghua Changgung Hospital, Beijing 102218, China
    6.Office of Drug Clinical Trial Institution, Beijing Chaoyang Hospital Affiliated of Capital Medical University, Beijing 100013, China
    7.Drug Clinical Trial Center, Peking University First Hospital, Beijing 100034, China
    8.Clinical Trial Institution, Peking University People’s Hospital, Beijing 100044, China
    9.Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100005, China
    10.National Drug Clinical Trial Institution, Beijing Youan Hospital Affiliated of Capital Medical University, Beijing 100069, China
    11.Drug Clinical Trial Research Center (GCP Center), Cancer Hospital Chinese Academy of Medical Sciences?, Beijing 100021, China
    12.Drug Clinical Trial Research Center (GCP Center), China-Japan Friendship Hospital, Beijing 100029, China
    13.Clinical Research Center, GoBroad Healthcare Group, Beijing 102206, China
    14.Institute of Clinical Pharmacology, Peking University First Hospital, Beijing 100034, China
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