How to Organise an International Register in Compliance with the European GDPR: Walking in the Footsteps of the PAMI Project (Paediatric ACL Monitoring Initiative)

  • Daniel TheisenEmail author
  • Håvard Moksnes
  • Cyrille Hardy
  • Lars Engebretsen
  • Romain Seil


The European Union General Data Protection Regulation (GDPR) has come into force in May 2018. It regulates the processing of personal data of data subjects residing in the European Union and concerns all organisations, independently of where they are located. The GDPR applies also to research organisations and concerns the vast majority of scientific activities. Researchers active in the field of clinical orthopaedics need to understand the principles underlying the GDPR when organising their research projects involving human data subjects residing in the European Union. This chapter presents the most important ones and should be considered as a mere introduction to the topic. In the framework of an international research project, the data controller and the data processor must be clearly identified and are responsible to ensure compliance to the GDPR when processing personal data of EU residents. Explicit consent must be obtained from study participants, who benefit from additional rights that must be guaranteed. The Paediatric ACL Monitoring Initiative (PAMI) is an international register recently implemented in Luxembourg, Europe, and is presented here to illustrate important aspects related to the GDPR. The reader is advised to seek help from a qualified data protection officer already at the planning stage of a new research project.


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Copyright information

© ISAKOS 2019

Authors and Affiliations

  • Daniel Theisen
    • 1
    Email author
  • Håvard Moksnes
    • 2
  • Cyrille Hardy
    • 1
  • Lars Engebretsen
    • 2
    • 3
  • Romain Seil
    • 1
    • 4
  1. 1.Sports Medicine Research LaboratoryLuxembourg Institute of HealthLuxembourgLuxembourg
  2. 2.Oslo Sports Trauma Research Center, Norwegian School of Sport SciencesOsloNorway
  3. 3.Division of OrthopedicsOslo University Hospital, University of OsloOsloNorway
  4. 4.Department of Orthopaedic SurgeryCentre Hospitalier LuxembourgLuxembourgLuxembourg

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