There is inconsistency across the EU in terms of how Data Protection Supervisory Authorities (SA), medicines and healthcare regulators and agencies, ethics committees, and other stakeholders involved in clinical trials view the roles of sponsors and investigators/sites with respect to participant personal data. With the increasing use of new and innovative technologies in clinical studies and the associated complexity in contracting models, the case for a unified EU approach has never been clearer.
As part of its advocacy program, ACRO submits feedback to foster alignment across industry bodies and regulators. A white paper proposing what could be a truly harmonized position that could be adopted at an EU level can be found below. The analysis in this document factors in engagement with leading CROs, and representative bodies of the pharma industry and the existing guidelines and positions that exist across the EU.