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Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial
Robert Fleischmann1,2, Anne-Marie Decker1, Antje Kraft1
1Clinical Research Unit, Charité Campus Mitte, Berlin Institute of Health (BIH), Charitéplatz 1, 10117, Berlin, Germany.
BMC Medical Research Methodology
|December 2, 2017
Summary
Electronic case report forms (eCRFs) significantly improve data collection efficiency and quality in clinical trials compared to paper case report forms (pCRFs). This study demonstrates time savings and enhanced data integrity with eCRFs.
Area of Science:
- Clinical research methodology
- Health informatics
Background:
- Clinical trial data management faces challenges due to complex regulations and large datasets.
- Electronic data capture (EDC) systems are proposed solutions, but empirical evidence is limited.
- This study addresses the need for evidence on the efficiency and data integrity of EDC.
Purpose of the Study:
- To compare the time efficiency of electronic case report forms (eCRFs) versus paper case report forms (pCRFs) for clinical trial data collection.
- To identify predictors of time-saving effects associated with eCRF use.
- To evaluate the impact of eCRFs on data integrity.
Main Methods:
- A randomized controlled parallel group study was conducted within a six-month clinical weight loss trial.
- Study nurses and patients were randomized to use either eCRFs or pCRFs for data entry during routine visits.
- Time required for data entry and data integrity were assessed using statistical analyses, including t-tests and ANOVA.
Main Results:
- eCRF data collection was significantly faster than pCRF (8.29 min vs. 10.54 min, p=.047).
- Time savings were not influenced by participant type, CRF length, or patient age.
- eCRFs demonstrated superior data integrity with zero errors compared to three errors in the pCRF group, with additional time savings from reduced transcription.
Conclusions:
- This study provides direct comparative evidence that eCRFs enhance time efficiency in clinical trial data collection.
- eCRF implementation leads to improved data quality and integrity.
- The benefits of eCRFs are consistent across various data collection scenarios in clinical trials.
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