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Tytuł:
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[Construction of data remote monitoring and auditing system for clinical trials].
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Autorzy:
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Shen L; Department of Information, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
Huang Q; Research Center for Clinical Pharmacy, Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
Zhai Y; Research Center for Clinical Pharmacy, Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
Qiu Y; Research Center for Clinical Pharmacy, Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
Zhao Q; Research Center for Clinical Pharmacy, Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
Wu L; Research Center for Clinical Pharmacy, Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
Zhou M; Department of Information, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
Liu J; Research Center for Clinical Pharmacy, Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
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Źródło:
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Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences [Zhejiang Da Xue Xue Bao Yi Xue Ban] 2020 Aug 25; Vol. 49 (4), pp. 531-536.
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Typ publikacji:
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Journal Article
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Język:
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Chinese
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Imprint Name(s):
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Original Publication: Hangzhou : Zhejiang da xue xue bao bian ji bu, [1999]-
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MeSH Terms:
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Clinical Trials as Topic*/methods
Clinical Trials as Topic*/standards
Management Audit*
Remote Consultation*
Computer Security
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Contributed Indexing:
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Keywords: Clinical trial; Clinical trial management system; Remote auditing; Remote monitoring
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Entry Date(s):
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Date Created: 20200928 Date Completed: 20201020 Latest Revision: 20220402
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Update Code:
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20240105
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PubMed Central ID:
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PMC8800691
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DOI:
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10.3785/j.issn.1008-9292.2020.07.01
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PMID:
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32985168
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Clinical trial management system is independently developed by our hospital, which basically realized the whole process management and data collection of clinical trials. Based on the platform, the functional architecture of data remote monitoring and auditing was established. By desensitizing and encrypting of data, the project and subject hologram were visualized to facilitate to review of data. The data remote monitoring and auditing cloud platform adopts the B/S architecture pattern. Users register to apply for an account through the cloud platform, and access to the account via HTTPS security protocol. The authorized users were able to view the relevant items online to ensure the secure data transmission and easy operating. The electronic management of data is the direction of future efforts. By compliance with laws and regulations, the remote monitoring/auditing can be realized, and the data security and personal privacy can be ensured with the application of information technology. In this paper, the feasibility of remote monitoring/auditing mode is explored, specific technical schemes and system functions are suggested, and the realization scenarios are conceived in case of major public health emergencies.