## 5 Conclusions  
The pilots undertaken to date have confirmed that the use of a standardised but semantically agnostic clinical modelling tool offers multiple benefits in representing the c4c CCPDD items, compared with the more traditional Microsoft Excel-style resource. Tools such as Direcht, which can render the c4c CCPDD easier to use in clinical trials, carry significant added value for clinicians and researchers who are typically time-short and require assets which simplify processes and aid understanding. Beyond this, however, the tool offers major potential to address the current lack of standardisation--and, by extension, interoperability--of the data most often collected in a typical paediatric study. A greater volume of more easily pooled data should support more streamlining of future research, for instance in terms of adapted trial design--potentially reducing the use of placebo arms, for example. The potential to map the c4c CCPDD items to real world data, such as EHRs, is also powerful, and could facilitate activities such as extracting data from EHRs to populate eCRFs for a study, as well as using EHR or registry data to support post-marketing surveillance studies. The c4c consortium will continue to pilot use of this tool, to ascertain its added value for different stakeholders and, simultaneously, continue to build synergies between standards development organisations, stimulating adaptations which should benefit the wider paediatric health and research data communities.  
Conceptualisation, V.S., C.A., R.L., A.P., V.H., R.Q.S. and D.K.; data curation, C.A., R.L., A.P., R.Q.S. and D.K.; formal analysis, C.A., R.L., A.P., A.S., R.Q.S. and D.K.; funding acquisition, R.L.; investigation, C.A., R.L., A.P., R.Q.S. and D.K.; methodology, V.S., C.A., R.L., A.P., R.Q.S. and D.K.; project administration, R.L. and V.H.; resources, C.A., R.L., A.P., R.Q.S. and D.K.; software, R.Q.S.; supervision, R.L. and V.H.; validation, C.A., R.L., A.P., A.S., R.Q.S. and D.K.; visualisation, V.S., C.A., R.L., A.P., V.H., A.S., R.Q.S. and D.K.; writing--original draft, C.A., R.L., A.P., V.H., R.Q.S. and D.K.; writing--review and editing, V.S., C.A., R.L., A.P., V.H., A.S., R.Q.S. and D.K. All authors have read and agreed to the published version of the manuscript.  
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement no. 777389. The Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA.  
Data sharing not applicable. No new data were created or analysed in this study. Data sharing is not applicable to this article.  
[PERSON], co-founder of Sidqam Ltd., which has developed the Direcht Modelling Tool used as part of the modelling work performed by the conect4 children (c4c) Cross Cutting Paediatric Data Dictionary (CCPDD) team.  
\begin{table}
\begin{tabular}{p{142.3 pt} p{142.3 pt}} \hline \hline
**Feature** & **Practical Implication** \\ \hline Interoperability between standards & Creates a bridge between the clinical and research worlds. Potential to combine standardised data from different sources. \\ \hline User friendliness & Heightened understanding of the representation of clinical paediatric data items. Personnel less familiar with data standards can use the models, resulting in a wider pool of standardised data. This could be of particular importance to academic studies. \\ \hline Automated eCRF creation potential & Researchers can export models into their EDC systems. This avoids any human error in applying standards and makes it easier for personnel, particularly those new to implementing data standards at the CRF level. \\ \hline \hline \end{tabular}
\end{table}
Table 2: Implications of the clinical modelling pilot.  
**Disclaimer:** The publication reflects the authors' view and neither IMI nor the European Union, EFPIA, or any associated partners are responsible for any use that may be made of the information contained therein.