Cognitive evaluation of user interface for phase i clinical trials

Bhanu Bahl, Sonja Coull, Louise Doll, Vimla L. Patel

Research output: Contribution to journalArticlepeer-review


In the pharmaceutical industry, there is a growing emphasis on applying cognitive techniques and methods to improve and validate clinical trial data capture interfaces like data entry tools and paper case report forms (CRFs), to ensure compliance, ease of use and minimal errors by investigator sites when recording the data. Earlier error detection typically results in lower final error rates, lower error detection/error correction costs and also improves site satisfaction. For the study purposes, usability of Merck & Co, Inc.'s clinical pharmacology data entry system, CPC 2000, is evaluated for first-time or infrequent users with special attention to how well the interface supports 'exploratory learning', i.e., first-time use without formal training. The cognitive method used is cognitive walkthrough (CW). Sessions were videotaped and analysed for reactions, responses, errors and for the cues generated by the interface. The findings are sorted into 20 key areas to allow for semantic grouping. The objective of the usability testing is to evaluate the tool on cognitive standards and make recommendations to revise/enhance the interface or future interfaces, making them more user-friendly, logical and thus less prone to data entry errors.

Original languageEnglish (US)
Pages (from-to)490-503
Number of pages14
JournalInternational Journal of Medical Engineering and Informatics
Issue number4
StatePublished - Jun 2009


  • CW
  • Clinical trials
  • Cognitive evaluation
  • Cognitive walkthrough
  • Pharmaceutical technology
  • Remote data capture
  • Technology assessment
  • Usability testing
  • User-computer interface

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Biomaterials
  • Biomedical Engineering
  • Health Informatics


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