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Clinical trial management and remote data entry on the Internet based on XML case report forms.

P Wübbelt1, G Fernandez, J Heymer

  • 1Department of Biometry, Hannover Medical School, Carl Neuberg Str. 1, D-30625 Hannover, Germany.

Studies in Health Technology and Informatics
|February 24, 2001
PubMed
Summary

The Internet enhances clinical trial management through remote data entry and progress tracking. This study introduces Extensible Markup Language (XML) as a more flexible alternative to HTML for electronic Case Report Forms (eCRFs).

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Area of Science:

  • Clinical trial management
  • Health informatics
  • Medical data science

Background:

  • The Internet and World Wide Web are increasingly used in clinical trial management.
  • Current applications include remote randomization, data entry, and progress information distribution.
  • Some large trials utilize HTML-based electronic Case Report Forms (eCRFs).

Purpose of the Study:

  • To describe a more flexible approach to managing clinical trial data.
  • To introduce Extensible Markup Language (XML) as a superior alternative for electronic Case Report Forms (eCRFs).

Main Methods:

  • Utilizing Extensible Markup Language (XML) for clinical trial data management.
  • Developing flexible electronic Case Report Forms (eCRFs) using XML.

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Main Results:

  • XML offers greater flexibility compared to HTML for eCRFs.
  • The proposed XML approach facilitates efficient clinical trial data handling.

Conclusions:

  • Extensible Markup Language (XML) provides a more adaptable framework for electronic Case Report Forms (eCRFs) in clinical trials.
  • This approach enhances the management and data handling capabilities in clinical research.