Visualising Data Models of Patient Registries and Clinical Studies – A Method for Quality Check of EDC Systems

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.