_applied sciences_  
_Article_  
**How Can a Clinical Data Modelling Tool Be Used to Represent Data Items of Relevance to Paediatric Clinical Trials? Learning from the Conect4 children (c4c) Consortium**  
[PERSON] 1, [PERSON] 1, [PERSON] 1, [PERSON] 1, [PERSON] 1, [PERSON] 2, [PERSON] 3 and [PERSON] 1,*  
John Walton Muscularly Prostearch Centre, Newcastle University and Newcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne NE1 3 BZ, UK; [EMAIL_ADDRESS] (C.A.); [EMAIL_ADDRESS] (R.L.); [EMAIL_ADDRESS] (A.P.); [EMAIL_ADDRESS] (V.H.); [EMAIL_ADDRESS] (A.S.)  
Sidqam Ltd., Altrincham WA14 3 NB, UK; [EMAIL_ADDRESS]  
Department of Medical Informatics & Statistics, The European Institute for Innovation through Health Data, Ghent University Hospital, 9000 Gent, Belgium; [EMAIL_ADDRESS]  
Correspondence: [EMAIL_ADDRESS]  
**Featured Application: To demonstrate the advantages of using a modelling tool to define and structure the clinical data items represented in the conect4 children (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 Directhot tool facilitates the export of data models into electronic capture (EDC) systems, such as REDCap and Castor. Finally, we illustrate how the Directhot tool formalises the modelling of data items to improve the content of the CCPDD and makes it semantically and contextually complete.**  
Data dictionaries for clinical trials are often created manually, with data structures and controlled vocabularies specific for a trial or family of trials within a sponsor's portfolio. Microsoft Excel is commonly used to capture the representation of data dictionary items but has limited functionality for this purpose. The conect4 children (c4c) network is piloting the Directh clinical data modelling tool to model their Cross Cutting Paediatric Data Dictionary (CCPDD) in a more formalised way. The first pilot had the key objective of testing whether a clinical data modelling tool could be used to represent data items from the CCPDD. The key objective of the second pilot is to establish whether a small team with little or no experience of clinical data modelling can use Direcht to expand the CCPDD. Clinical modelling is the process of structuring clinical data so it can be understood by computer systems and humans. The model contains all of the elements that are needed to define the data item. Results from the pilots show that Direcht creates a structured environment to build data items into models that fit into the larger CCPDD. Models can be represented as an HTML document, mind map, or exported in various formats for import into a computer system. Challenges identified over the course of both pilots are being addressed with c4c partners and external stakeholders.  
connect4 children; clinical modelling; data dictionary; paediatric clinical trials; electronic data capture; Direcht; Castor; REDCap; CDISC