Provenance model for randomized controlled trials

Vasa Curcin; Roxana Danger; Wolfgang Kuchinke; Simon Miles; Adel Taweel; Christian Ohmann

doi:10.1007/978-3-642-29931-5-1

Provenance model for randomized controlled trials

Vasa Curcin^*, Roxana Danger, Wolfgang Kuchinke, Simon Miles, Adel Taweel, Christian Ohmann

^*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceeding › Chapter › peer-review

5 Citations (Scopus)

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.

Original language	English
Title of host publication	Data Provenance and Data Management in eScience
Editors	Qing Liu, Quan Bai, Stephen Giugni, Darrell Williamson, John Taylor
Publisher	Springer Berlin Heidelberg
Pages	3-33
Number of pages	31
ISBN (Print)	9783642299308
DOIs	https://doi.org/10.1007/978-3-642-29931-5-1
Publication status	Published - 1 Jan 2013

Publication series

Name	Studies in Computational Intelligence
Volume	426
ISSN (Print)	1860-949X

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10.1007/978-3-642-29931-5-1

Cite this

Curcin, V., Danger, R., Kuchinke, W., Miles, S., Taweel, A., & Ohmann, C. (2013). Provenance model for randomized controlled trials. In Q. Liu, Q. Bai, S. Giugni, D. Williamson, & J. Taylor (Eds.), Data Provenance and Data Management in eScience (pp. 3-33). (Studies in Computational Intelligence; Vol. 426). Springer Berlin Heidelberg. https://doi.org/10.1007/978-3-642-29931-5-1

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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.",

author = "Vasa Curcin and Roxana Danger and Wolfgang Kuchinke and Simon Miles and Adel Taweel and Christian Ohmann",

year = "2013",

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doi = "10.1007/978-3-642-29931-5-1",

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series = "Studies in Computational Intelligence",

publisher = "Springer Berlin Heidelberg",

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Provenance model for randomized controlled trials. / Curcin, Vasa; Danger, Roxana; Kuchinke, Wolfgang et al.
Data Provenance and Data Management in eScience. ed. / Qing Liu; Quan Bai; Stephen Giugni; Darrell Williamson; John Taylor. Springer Berlin Heidelberg, 2013. p. 3-33 (Studies in Computational Intelligence; Vol. 426).

Research output: Chapter in Book/Report/Conference proceeding › Chapter › peer-review

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AU - Taweel, Adel

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PY - 2013/1/1

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N2 - 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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PB - Springer Berlin Heidelberg

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Provenance model for randomized controlled trials

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