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dc.contributor.author de Carvalho, EC
dc.contributor.author Jayanti, MK
dc.contributor.author Batilana, AP
dc.contributor.author Kozan, AM
dc.contributor.author Rodrigues, MJ
dc.contributor.author Shah, J
dc.contributor.author Loures, MR
dc.contributor.author Patil, S
dc.contributor.author Payne, P
dc.contributor.author Pietrobon, R
dc.coverage.spatial United States
dc.date.accessioned 2011-06-21T17:32:20Z
dc.date.issued 2010-11-09
dc.identifier http://www.ncbi.nlm.nih.gov/pubmed/21085484
dc.identifier.citation PLoS One, 2010, 5 (11), pp. e13893 - ?
dc.identifier.uri http://hdl.handle.net/10161/4582
dc.description.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.
dc.format.extent e13893 - ?
dc.language eng
dc.language.iso en_US en_US
dc.relation.ispartof PLoS One
dc.relation.isversionof 10.1371/journal.pone.0013893
dc.subject Algorithms
dc.subject Brazil
dc.subject Clinical Trials as Topic
dc.subject Computer Simulation
dc.subject Humans
dc.subject International Cooperation
dc.subject Medical Oncology
dc.subject Models, Theoretical
dc.subject Programming Languages
dc.subject Reference Standards
dc.subject Rheumatology
dc.subject Workflow
dc.title Standardizing clinical trials workflow representation in UML for international site comparison.
dc.title.alternative en_US
dc.type Journal Article
dc.description.version Version of Record en_US
duke.date.pubdate 2010-11-9 en_US
duke.description.endpage e13893 en_US
duke.description.issue 11 en_US
duke.description.startpage e13893 en_US
duke.description.volume 5 en_US
dc.relation.journal Plos One en_US
pubs.author-url http://www.ncbi.nlm.nih.gov/pubmed/21085484
pubs.issue 11
pubs.organisational-group /Duke
pubs.organisational-group /Duke/Faculty
pubs.publication-status Published online
pubs.volume 5
dc.identifier.eissn 1932-6203

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