Module 15 Presentations

10/04/2024

Data Protection

The Organisation for Professionals in Regulatory Affairs

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EU-GDPR – General Data Protection Regulation 2016/679

The GDPR covers the rights of EU citizens regarding Data Protection when being in- and outside of the EU, so all non-EU countries need to comply with the GDPR for EU citizens. For non-EU citizens: whilst in the EU, the GDPR also applies to handling their data. There will be made no difference for nationalities; the GDPR regulates data protection for all data collected in the EU. In addition the GDPR does also protect Site personnel, and other staff like Monitors (CVs, financial data, financial interest, etc.). It is recommended that a Declaration of Consent for Processing of Personal Data is collected from Site personnel and Monitors, etc. For study subjects, the rights outlined in Art. 12 ff, need to be addressed in the ICF

The Organisation for Professionals in Regulatory Affairs

44