title: Data management in clinical research: Synthesizing stakeholder perspectives.
abstract: OBJECTIVE
  This study assesses data management needs in clinical research from the perspectives of researchers, software analysts and developers.
  
  
  METHODS
  This is a mixed-methods study that employs sublanguage analysis in an innovative manner to link the assessments. We performed content analysis using sublanguage theory on transcribed interviews conducted with researchers at four universities. A business analyst independently extracted potential software features from the transcriptions, which were translated into the sublanguage. This common sublanguage was then used to create survey questions for researchers, analysts and developers about the desirability and difficulty of features. Results were synthesized using the common sublanguage to compare stakeholder perceptions with the original content analysis.
  
  
  RESULTS
  Individual researchers exhibited significant diversity of perspectives that did not correlate by role or site. Researchers had mixed feelings about their technologies, and sought improvements in integration, interoperability and interaction as well as engaging with study participants. Researchers and analysts agreed that data integration has higher desirability and mobile technology has lower desirability but disagreed on the desirability of data validation rules. Developers agreed that data integration and validation are the most difficult to implement.
  
  
  CONCLUSIONS
  Researchers perceive tasks related to study execution, analysis and quality control as highly strategic, in contrast with tactical tasks related to data manipulation. Researchers have only partial technologic support for analysis and quality control, and poor support for study execution.
  
  
  CONCLUSIONS
  Software for data integration and validation appears critical to support clinical research, but may be expensive to implement. Features to support study workflow, collaboration and engagement have been underappreciated, but may prove to be easy successes. Software developers should consider the strategic goals of researchers with regard to the overall coordination of research projects and teams, workflow connecting data collection with analysis and processes for improving data quality.
authors.affiliation: Division of Health Informatics, Weill Cornell Medical College, 425 East 61st Street, DV-317, New York, NY 10065, United States. Electronic address: johnsos@med.cornell.edu.
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Johnson
authors.affiliation: Prometheus Research, LLC, New Haven, CT, United States.
authors.forename: Frank J
authors.initials: FJ
authors.lastname: Farach
authors.affiliation: Yale University, New Haven, CT, United States.
authors.forename: Kevin
authors.initials: K
authors.lastname: Pelphrey
authors.affiliation: Prometheus Research, LLC, New Haven, CT, United States.
authors.forename: Leon
authors.initials: L
authors.lastname: Rozenblit
mesh_terms: D000465:Algorithms; D035843:Biomedical Research / Q000379:methods* / Q000639:trends*; D003201:Computers; D006801:Humans; D058436:Knowledge Management; D008490:Medical Informatics / Q000379:methods*; D011381:Programming Languages; D011786:Quality Control; D012984:Software; D014584:User-Computer Interface
keywords: Biomedical research; Medical informatics; Needs assessment; Software design