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Published on: September 20, 2019
On selecting a clinical trial management system for large scale, multi-centre, multi-modal clinical research study
Hugo Leroux1, Simon McBride, Simon Gibson
1The Australian E-Health Research Centre.
Studies in Health Technology and Informatics
|September 7, 2011
Summary
Open-source Clinical Trial Management Systems (CTMS) offer a viable, cost-effective solution for managing research studies. This paper provides guidelines and critiques systems, recommending OpenClinica for neurodegenerative disease research.
Area of Science:
- Neuroscience
- Medical Informatics
Background:
- Clinical research information systems face significant challenges.
- The Australian Imaging, Biomarkers and Lifestyle (AIBL) study involved 1112 participants for neurodegenerative disease research.
- The chosen clinical trial management system (CTMS) had notable shortcomings.
Purpose of the Study:
- To propose guidelines for evaluating CTMS solutions.
- To critique existing commercial and open-source CTMS.
- To address data migration challenges in clinical studies.
Main Methods:
- Developed a set of guidelines for CTMS selection.
- Critically evaluated five different CTMS options.
- Identified and discussed data migration issues.
Main Results:
- OpenClinica was identified as the most suitable CTMS.
- Open-source CTMS were found to be practical alternatives to commercial systems.
- Guidelines for CTMS selection were established.
Conclusions:
- Open-source CTMS are effective for conducting, recording, and managing clinical studies.
- The proposed guidelines aid in selecting appropriate CTMS.
- Addressing data migration is crucial for successful study management.
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