Data Treatment in Complex Research Studies in Light of the GDPR Rules. A Critical Analysis

Abstract

The introduction of the new GDPR regulation had strong impact on clinical research and also in EU funded international research program involving several partners. This chapter is presenting the practice designed and implemented in the NESTORE project (as relevant case study which is used to build procedures and documentation to be exploited in the following research projects) in relation to privacy, data management issues including data sharing, sharing this perspective as good practice for next actions in the same framework. This was the first case study to develop a proper GDPR compliant approach and DPIA so that it was adopted ad best practice among all projects in this Politecnico di Milano university and shared among other consortia. This chapter discusses regulation, obligations, adopted measures and procedures for properly implementing the GDPR.