FAIRification of CRFs (conect4children)

The FAIR data principles aim to improve the Findability, Accessibility, Interoperability, and Reuse of digital assets1 . The c4c FAIR Data Working Group was formed to ascertain the relevance of the FAIR principles to the domain of paediatric clinical trial data. The working group is exploring the potential of each FAIR principle - theoretically - for interoperable data sharing and (metadata-level) data querying between Electronic Case Report Forms (eCRFs) from different studies. The emphasis of this work is to focus on enabling FAIR data collection from the planning stages of a trial. The working group will also consider the potential for greater interoperability between eCRFs and the broader field of electronic health records (EHRs) and real-world clinical data. This deliverable, in its current form, sets out the rationale for this work and the process needed to FAIRify a CRF. To this end of creating eCRFs from the start, the FAIR Data Working Group is analysing CRFs from the KD-CAAP Proof of Viability (PoV) Study as a pilot study to develop a practical guide for all stakeholders interested in paediatric research data, which will be elaborated as part of a future update to the deliverable. The working group will use data items from the CRFs as examples to identify how and where the FAIR data principles could be applied. For instance, recommending that certain types of data collected through the eCRF - e.g. lab data - could benefit from being captured using particular international nomenclatures. This deliverable sets out the added value of applying the FAIR principles to paediatric data and sets out a plan for developing practical recommendations. The deliverable also describes how existing resources, developed both within c4c and external to the consortium can also be used to make the data collected within c4c more FAIR.