Cognitive evaluation of user interface for Phase I clinical trials
by Bhanu Bahl, Sonja Coull, Louise Doll, Vimla L. Patel
International Journal of Medical Engineering and Informatics (IJMEI), Vol. 1, No. 4, 2009

Abstract: 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 make recommendations to revise/enhance the interface or future interfaces, making them more user-friendly, logical and thus less prone to data entry errors.

Online publication date: Fri, 26-Jun-2009

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