title: Standardizing clinical trials workflow representation in UML for international site comparison.
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.
authors.affiliation: Research on Research Group, Department of Surgery, Duke University, Durham, North Carolina, United States of America.
authors.forename: Elias Cesar Araujo
authors.initials: EC
authors.lastname: de Carvalho
authors.forename: Madhav Kishore
authors.initials: MK
authors.lastname: Jayanti
authors.forename: Adelia Portero
authors.initials: AP
authors.lastname: Batilana
authors.forename: Andreia M O
authors.initials: AM
authors.lastname: Kozan
authors.forename: Maria J
authors.initials: MJ
authors.lastname: Rodrigues
authors.forename: Jatin
authors.initials: J
authors.lastname: Shah
authors.forename: Marco R
authors.initials: MR
authors.lastname: Loures
authors.forename: Sunita
authors.initials: S
authors.lastname: Patil
authors.forename: Philip
authors.initials: P
authors.lastname: Payne
authors.forename: Ricardo
authors.initials: R
authors.lastname: Pietrobon
mesh_terms: D000465:Algorithms; D001938:Brazil; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D003198:Computer Simulation; D006801:Humans; D007391:International Cooperation; D008495:Medical Oncology / Q000379:methods / Q000592:standards; D008962:Models, Theoretical; D011381:Programming Languages; D012015:Reference Standards; D012219:Rheumatology / Q000379:methods / Q000592:standards; D057188:Workflow