Comparison of Electronic Data Capture (EDC) with the Standard Data Capture Method for Clinical Trial Data
2011

Comparing Electronic Data Capture Methods in Clinical Trials

Sample size: 75 publication 10 minutes Evidence: moderate

Author Information

Author(s): Walther Brigitte, Hossin Safayet, Townend John, Abernethy Neil, Parker David, Jeffries David

Primary Institution: Medical Research Council, Fajara, The Gambia

Hypothesis

This study compares four electronic data capture (EDC) methods with the conventional approach regarding data capture duration and accuracy.

Conclusion

EDC solutions can achieve similar data accuracy to paper-based methods while reducing the time from data collection to database lock.

Supporting Evidence

  • Error rates for EDC methods decreased significantly over time.
  • Data accuracy for netbook and tablet PC was comparable to the conventional method.
  • EDC methods took longer to conduct interviews than the standard method.

Takeaway

This study looked at different ways to collect data for health research. It found that using electronic tools can be just as good as paper, but it takes a bit longer.

Methodology

The study used a Graeco Latin square design to compare error rates and interview durations across four EDC methods and a standard paper-based method.

Potential Biases

Selection bias may exist as interviewers were randomly selected from a pool of candidates nominated by MRC programs.

Limitations

The study was limited to a short duration and may not reflect long-term performance of EDC methods in the field.

Participant Demographics

Five interviewers, one female and four male, aged 29 to 46, with varying experience in fieldwork.

Statistical Information

P-Value

p<0.05

Confidence Interval

CI95%: 3.5–7.2%

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1371/journal.pone.0025348

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