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Visualising Data Models of Patient Registries and Clinical Studies – A Method for Quality Check of EDC Systems
Beatrice Coldewey, Philipp Honrath, Stefan Wolking, Anna Niemeyer, Rainer Röhrig, Yvonne Weber, Myriam Lipprandt
95 - 104
10.3233/SHTI240843
Research Article
Studies in Health Technology and Informatics
Volume 317: German Medical Data Sciences 2024
Abstract

Introduction:

The configuration of electronic data capture (EDC) systems has a relevant impact on data quality in studies and patient registries. The objective was to develop a method to visualise the configuration of an EDC system to check the completeness and correctness of the data definition and rules.

Methods:

Step 1: transformation of the EDC data model into a graphical model, step 2: Checking the completeness and consistency of the data model, step 3: correction of identified findings. This process model was evaluated on the patient registry EpiReg.

Results:

Using the graphical visualisation as a basis, 21 problems in the EDC configuration were identified, discussed with an interdisciplinary team, and corrected.

Conclusion:

The tested methodological approach enables an improvement in data quality by optimising the underlying EDC configuration.

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