Data Quality Issues in Electronic Data Capture

Electronic data capture (EDC) systems hold the potential for dramatically reducing the time and effort required to acquire and process clinical trials data. However, these systems raise a number of data quality issues. This paper presents some ancient history background for EDC systems; raises and discusses the question, “Is data quality important?”; presents a rigorous discussion of methodology for evaluating clinical trial data quality; and summarizes the use of this methodology for EDC systems.