Data Quality Issues in Electronic Data Capture
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0092-8615/2001 Copyright 0 2001 Drug Information Association Inc.
F’rinted in the USA. All rights reserved.
DATA QUALITY ISSUES IN ELECTRONIC DATA CAPTURE RONALDW. HELMS,PHD Chairman, Rho, lnc., and Professor Emeritus, Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina
Electronic data capture (EDC) systems hold the potential for dramatically reducing the time and effort required to acquire andprocess clinical trials data. However; these systems raise a number of data quality issues. Thispaper 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. Key Words: Electronic data capture; Data quality assessment; Error rate estimate; Initial data record; Correct data value; Data quality issues in electronic data capture
INTRODUCTION
to a mainframe computer in the Research Triangle Park. The system used custom-writELECTRONIC DATA CAPTURE has beten EDC software that ran under IBM’s TSO come a very popular topic in the general area “time sharing” operating system. TWO EDC of clinical trials data management (CTDM). clinical sites were initiated, one in Dallas Many feel that EDC holds the potential for and one in Houston. Another 25 sites used dramatically reducing the time required for traditional paper forms. CTDM, and possibly for reducing the costs That first system produced a number of as well. Another important factor in the curconclusions about EDC, many of which are rent popularity of the topic of EDC is that relevant almost 30 years later. A primary some EDC systems use the Internet as a conclusion was that most clinical personnel means of transmitting data from clinical sites (physicians and nurses) do not enjoy serving to a central facility. The Internet is currently as data entry operators, generally feeling that a very popular topic and EDC appears to the work is at a secretarial or clerical level. inherit some of the excitement. This is despite the fact that the EDC system EDC has a long history, having been used closely mimicked the paper forms that were (under other names) long before the Internet completed by clinical personnel at the study’s became popular. The first use of EDC in a other sites. The statisticians at the Statistics multicenter study apparently was in the Naand Data Management Center and the EDC tional Institutes of Health (N1H)-sponsored sites’ principal investigators all felt that sigKidney Transplant Histocompatibility Study nificant training would have been required in 1973 (1). The study used teleprinter termifor clerical level personnel to enter data using nals connected via dial-up telephone lines the EDC system. (Budgetary limitations prevented hiring of study coordinators for this purpose.) Reprint address: Ronald W. Helms, PhD, Rho, Inc., 100 A second major conclusion was that a notEastowne Drive, Chapel Hill, NC 27514. E-mail: ver
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