The General Data Protection Regulation 2016/679 or GDPR came into effect in 2018 and sets out a new regulatory framework for companies who process personal data pertaining to European citizens and / or process personal data within the European area. This new framework imposes sets of measures to be taken by those companies before processing any personal data. This Privacy by Design intends to empower citizens in order for them to keep the control over their personal data while allowing companies to pursue their activities. Clinical trial are impacted by this regulation even though the impact can be moderate for sponsors as some of the obligations of the GDPR were already mentioned under regulations ( Clinical trial Directive, GCP etc ..).
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