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Inicio  /  Applied Sciences  /  Vol: 12 Par: 3 (2022)  /  Artículo
ARTÍCULO
TITULO

How Can a Clinical Data Modelling Tool Be Used to Represent Data Items of Relevance to Paediatric Clinical Trials? Learning from the Conect4children (c4c) Consortium

Chima Amadi    
Rebecca Leary    
Avril Palmeri    
Victoria Hedley    
Anando Sen    
Rahil Qamar Siddiqui    
Dipak Kalra and Volker Straub    

Resumen

To demonstrate the advantages of using a modelling tool to define and structure the clinical data items represented in the conect4children (c4c) Cross Cutting Paediatric Data Dictionary (CCPDD). By facilitating the unambiguous definition of data items, we show how a modelling tool can improve the interoperability of data collected in paediatric clinical trials. We demonstrate how the clinical application of a modelling approach to semantic interoperability can be used to represent the c4c CCPDD. We highlight how modelling via tooling of terminology is a better means of data dictionary representation compared to an implicit model captured in Microsoft Excel. We report on how the Direcht tool facilitates the export of data models into electronic capture (EDC) systems, such as REDCap and Castor. Finally, we illustrate how the Direcht tool formalises the modelling of data items to improve the content of the CCPDD and makes it semantically and contextually complete.

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