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Management of data from clinical trials using the ArchiMed system
Georg Duftschmid1, Walter Gall, Ernst Eigenbauer
1University of Vienna, Department of Medical Computer Sciences, Spitalgasse 23, A-1090 Vienna, Austria. georg.duftschmid@akh-wien.ac.at
Medical Informatics and the Internet in Medicine
|January 1, 2003
Summary
The ArchiMed system efficiently supports clinical trial data management, including database design and patient recruitment. This tool empowers clinical users to manage trials autonomously, reducing reliance on IT experts.
Area of Science:
- Clinical research methodology
- Health informatics
Background:
- Clinical trials are essential for medical research and frequently conducted at university hospitals.
- Efficient data management is crucial for the successful execution of clinical trials.
Purpose of the Study:
- To report how the ArchiMed system supports key data management tasks in clinical trials.
- To evaluate the usability of ArchiMed for clinical end users at the University of Vienna and Graz Medical Schools.
Main Methods:
- The ArchiMed system was implemented to support tasks such as trial database design, electronic case report form design, patient recruitment, data collection, and statistical analysis.
- The system was customized for clinical end users to enable autonomous trial management.
Main Results:
- An evaluation of ArchiMed in 12 trials at the University of Vienna Medical School demonstrated its utility.
- Individual system functions were found to be beneficially applicable for clinical trial data management.
Conclusions:
- The ArchiMed system effectively supports various aspects of clinical trial data management.
- ArchiMed facilitates autonomous management of clinical trials by end users, enhancing efficiency.