1. 2011/C 172/01, Communication from the Commission — Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clini- cal trials on medicinal products for human use (2011). Brussels: European Commission.
2. Bernard Marr & Co.(2020). Data Use Case Template. Accessed on 4 July 2020. URL: https://www.bernardmarr.com/img/PDF%20Templates-2.pdf
3. Cavanillas, J. M., Curry, E. & Wahlster, W. (2016). New horizons for a data-driven economy: A roadmap for usage and exploitation of Big Data in Europe. Cham: Springer International Publishing. p. 4.
4. COM(2017) 135 final, Report from the Commission to the European Parliament and the Council in accordance with Article 59
5. (4) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (2017). Brussels: European Commission.