Abstract
This chapter proposes a provenance model for the clinical research domain, focusing on the planning and conduct of randomized controlled trials, and the subsequent analysis and reporting of results from those trials. We look at the provenance requirements for clinical research and trial management of different stakeholders (researchers, clinicians, participants, IT staff) to identify elements needed at multiple levels and stages of the process. In order to address these challenges, a provenance model is defined by extending the Open Provenance Model with domain-specific additions that tie the representation closer to the expertise of medical users, and with the ultimate aim of creating the first OPM profile for randomized controlled clinical trials. As a starting point, we used the domain information model developed at University of Dusseldorf, which conforms to the ICH Guideline for Good Clinical Practice (GCP) standard, thereby ensuring the wider applicability of our work. The application of the model is demonstrated on several examples and queries based on the integrated trial data being captured as part of the TRANSFoRm EU FP7 project.
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Curcin, V., Danger, R., Kuchinke, W., Miles, S., Taweel, A., Ohmann, C. (2013). Provenance Model for Randomized Controlled Trials. In: Liu, Q., Bai, Q., Giugni, S., Williamson, D., Taylor, J. (eds) Data Provenance and Data Management in eScience. Studies in Computational Intelligence, vol 426. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-29931-5_1
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DOI: https://doi.org/10.1007/978-3-642-29931-5_1
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