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Methodology elucidation of digital technology applications in direct data capture managements of clinical trials
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Chuan LIU1, Hua-long SUN1, Lin-juan SHEN2, Yi-qun TANG2
Chinese Journal of New Drugs | 2023, 32(3) : 255 - 263
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Chinese Journal of New Drugs | 2023, 32(3): 255-263
Methodology elucidation of digital technology applications in direct data capture managements of clinical trials
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Chuan LIU1, Hua-long SUN1, Lin-juan SHEN2, Yi-qun TANG2
Affiliations
  • 1Clinical Service Center, Beijing 100024, China
  • 2China Pharmaceutical University, Nanjing 210009, China
Published: 2023-02-15
Outline
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Direct data capture (DDC) by means of digital health technology (DHT) has been played a significant role in the evaluation of clinical benefits in either traditional centralized clinical trials or novel decentralized clinical trials of medicinal products. As a part of e-source data, a trial execution with the regulatory compliance of the DHT is one of the challenges in clinical data flow managements. In the views of developmental trends in GCP and global regulatory and supervisory requirements, DHT applications in clinical trials should meet the validation standards of an e-clinical system, conforming to the ALCOA principle regarding the trial data flow managements with roles and qualifications of relevant stakeholders, such as sponsors, investigators and subjects. In the standpoints of project management views, this paper discusses how the DHT application is complied with regulations, rational monitoring and supervisions on the DHT data flow, and responsibilities of relevant stakeholders, ensuring the approvability of clinical outcomes on DHT-based clinical data by regulatory authorities.

clinical trial  /  direct data capture  /  digital health technology  /  clinical study  /  data management  /  decentralized clinical trial  /  centralized clinical trial
Chuan LIU, Hua-long SUN, Lin-juan SHEN, Yi-qun TANG. Methodology elucidation of digital technology applications in direct data capture managements of clinical trials[J]. Chinese Journal of New Drugs, 2023 , 32 (3) : 255 -263 .
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Year 2023 volume 32 Issue 3
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  • Online Date：2026-03-05
  • Published：2023-02-15
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  • Accepted：2022-04-10
Affiliations
    1Clinical Service Center, Beijing 100024, China
    2China Pharmaceutical University, Nanjing 210009, China
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