Multicentre Clinical Trials’ data management: A hybrid solution to exploit the strengths of Electronic Data Capture and Electronic Health Records systems

Background: Clinical Trials (CTs) are indispensable instruments for evidence-based medicine and frequently necessitate the management, sharing and analysis of large amounts of data amongst partners in different locations. Methods: To effectively satisfy these requirements, the proposed solution combines a web platform and a Clinical Data Management System (CDMS) to exploit the strengths of Electronic Health Records (EHR) and Electronic Data Capture (EDC) systems. The core of the proposal is a relational database which has high data structuring characteristics and utilises biomedical controlled vocabularies (e.g. LOINC and ICD). In addition, units and normality ranges were collected for data comparison through the application of the Z-score transformation. Results: The obtained CDMS preserves the EDC’s flexibility and user autonomy and permits the creation of patient cohorts, as in the EHR. Accordingly, clinical information, after the initial recording, is available for different simultaneous multicentre CTs. Furthermore, interface runtime controls guarantee high data quality during data entering processes. Currently, the proposed system has been developed in the HIV and eye diseases fields in Italy. Conclusions: The proposed solution is flexible and suitable to perform multicentre research within a varying range of medical domains. In the future, the automatic importation of information from hospitals has been planned through an HL7 standard interface which would improve both data quantity and quality.