Improving Data Collection and Quality with Online Clinical Data Management
Author Information
Author(s): Maarten A Wildeman, Jeroen Zandbergen, Andrew Vincent, Camelia Herdini, Jaap M Middeldorp, Renske Fles, Otilia Dalesio, Emile van der Donk, I Bing Tan
Primary Institution: The Netherlands Cancer Institute- Antoni van Leeuwenhoek Hospital
Hypothesis
Can an online clinical data management service help in improving data collection and data quality in a developing country setting?
Conclusion
The study shows that the introduction of a Clinical Trial Data Management service can lead to acceptable levels of data quality and a decrease in error rates over time.
Supporting Evidence
- 51 patients were entered into the study over the first five months.
- The Primary data error rate was 1.6%, while the Secondary data error rate was 2.7%.
- Error rates were decreasing over time, indicating improved data quality.
- The CTDMS allows for real-time data monitoring and immediate correction of errors.
Takeaway
Using an online system to collect patient data helps doctors make fewer mistakes and improves the quality of the information they gather.
Methodology
Data items were checked for inconsistencies automatically when submitted online, and error rates were analyzed over the first five months of the trial.
Limitations
The study only covers the first five months of a three-year trial, and the error rates were not yet at levels appropriate for final analysis.
Participant Demographics
Patients with Nasopharyngeal Carcinoma in Indonesia.
Digital Object Identifier (DOI)
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