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Comparison of electronic data capture (EDC) with the standard data capture method for clinical trial data
Brigitte Walther1, Safayet Hossin, John Townend
1Statistics and Data Management Department, Medical Research Council, Fajara, The Gambia. waltherbrigitte@t-online.de
Plos One
|October 4, 2011
Summary
Electronic data capture (EDC) methods show promise for reducing clinical trial costs and improving efficiency. While some EDC tools achieved similar accuracy to paper records, successful implementation requires process adjustments.
Area of Science:
- Clinical research methodology
- Health informatics
Background:
- Traditional clinical research relies on paper case report forms, which are time-consuming and prone to errors.
- This study addresses data collection challenges in West African clinical trials, often involving remote locations.
Purpose of the Study:
- To compare the duration and accuracy of four electronic data capture (EDC) methods against conventional paper-based data collection.
- To evaluate EDC tools in diverse settings, including urban, rural, and remote areas.
Main Methods:
- A Graeco Latin square design compared netbooks, PDAs, tablet PCs, and mobile phones for telephone interviews against paper forms with double data entry.
- The study controlled for factors like interview order, interviewer, and interviewee.
Main Results:
- Error rates decreased across all EDC methods over three weeks.
- Netbook and tablet PC accuracy approached paper-based accuracy by the study's end, unlike PDAs and mobile phones.
- Free text and date fields had higher error rates than numerical or select fields.
Conclusions:
- EDC methods can achieve data accuracy comparable to traditional paper-based approaches.
- EDC significantly reduces the time from data collection to database lock, potentially lowering research costs.
- Successful EDC implementation necessitates adapting work processes and reallocating resources.
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