An Exploratory Evaluation Framework for e-Clinical Data Management Performance

Abstract

Electronic data management is becoming important to reduce the overall cost and run-time of clinical trials with enhanced data quality. It is also imperative to meet regulated guidelines for the overall quality and safety of electronic clinical trials. The purpose of this paper is to develop an exploratory performance evaluation framework for e-clinical data management. This study performs a Delphi survey for 3 iterative rounds to develop an exploratory framework based on key informants’ knowledge. Four key metrics in the areas of infrastructure, intellectual preparation, study implementation, and study completion covering major aspects of clinical trial processes are proposed. Performance measures evaluate the extent of regulation compliance, data quality, cost, and efficiency of the electronic data management process. They also provide measurement indicators for each evaluation item. Based on the key metrics, the performance evaluation framework is developed in three major areas involved in clinical data management—clinical site, monitoring, and data coordinating center. From this initial attempt to evaluate the extent of electronic data management in clinical trials by a Delphi survey, further empirical studies are planned and recommended.

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Correspondence to HyunJu Lee PhD.

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Lee, H., Lee, S. An Exploratory Evaluation Framework for e-Clinical Data Management Performance. Ther Innov Regul Sci 46, 555–564 (2012). https://doi.org/10.1177/0092861512452119

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Keywords

  • clinical trials
  • data management
  • electronic data capture system
  • performance metrics