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Standardizing clinical trials workflow representation in UML for international site comparison.

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Date
2010-11-09
Authors
de Carvalho, Elias Cesar Araujo
Jayanti, Madhav Kishore
Batilana, Adelia Portero
Kozan, Andreia MO
Rodrigues, Maria J
Shah, Jatin
Loures, Marco R
Patil, Sunita
Payne, Philip
Pietrobon, Ricardo
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Abstract
BACKGROUND: With the globalization of clinical trials, a growing emphasis has been placed on the standardization of the workflow in order to ensure the reproducibility and reliability of the overall trial. Despite the importance of workflow evaluation, to our knowledge no previous studies have attempted to adapt existing modeling languages to standardize the representation of clinical trials. Unified Modeling Language (UML) is a computational language that can be used to model operational workflow, and a UML profile can be developed to standardize UML models within a given domain. This paper's objective is to develop a UML profile to extend the UML Activity Diagram schema into the clinical trials domain, defining a standard representation for clinical trial workflow diagrams in UML. METHODS: Two Brazilian clinical trial sites in rheumatology and oncology were examined to model their workflow and collect time-motion data. UML modeling was conducted in Eclipse, and a UML profile was developed to incorporate information used in discrete event simulation software. RESULTS: Ethnographic observation revealed bottlenecks in workflow: these included tasks requiring full commitment of CRCs, transferring notes from paper to computers, deviations from standard operating procedures, and conflicts between different IT systems. Time-motion analysis revealed that nurses' activities took up the most time in the workflow and contained a high frequency of shorter duration activities. Administrative assistants performed more activities near the beginning and end of the workflow. Overall, clinical trial tasks had a greater frequency than clinic routines or other general activities. CONCLUSIONS: This paper describes a method for modeling clinical trial workflow in UML and standardizing these workflow diagrams through a UML profile. In the increasingly global environment of clinical trials, the standardization of workflow modeling is a necessary precursor to conducting a comparative analysis of international clinical trials workflows.
Type
Journal article
Subject
Algorithms
Brazil
Clinical Trials as Topic
Computer Simulation
Humans
International Cooperation
Medical Oncology
Models, Theoretical
Programming Languages
Reference Standards
Rheumatology
Workflow
Permalink
https://hdl.handle.net/10161/4582
Published Version (Please cite this version)
10.1371/journal.pone.0013893
Publication Info
de Carvalho, Elias Cesar Araujo; Jayanti, Madhav Kishore; Batilana, Adelia Portero; Kozan, Andreia MO; Rodrigues, Maria J; Shah, Jatin; ... Pietrobon, Ricardo (2010). Standardizing clinical trials workflow representation in UML for international site comparison. PLoS One, 5(11). pp. e13893. 10.1371/journal.pone.0013893. Retrieved from https://hdl.handle.net/10161/4582.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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