GDPR in EU clinical trials
GDPR applied to clinical data in the EU.
GDPR framework
GDPR (EU 2016/679) is directly applicable in 27 Member States + EEA. Each country adds nuances via national legislation, but principles are uniform.
In clinical trials GDPR coexists with CTR (EU) 536/2014 which harmonizes execution but doesn't replace data protection obligations.
Key obligations
- •Documented legal basis (Art. 6 + Art. 9)
- •DPA with processor (Art. 28)
- •DPIA for large-scale health data (Art. 35)
- •<72h breach notification (Art. 33)
- •Subject rights with Art. 89 safeguards
EU controls
- ✓Signable DPA on all paid plans
- ✓EU residency on Institutional
- ✓Internal RoPA documentation
- ✓Subject rights workflow integration
FAQ
Does Art. 89 exempt from all subject rights?
No — allows proportionate restrictions when exercising the right would render impossible or seriously affect research objectives. Each restriction must be justified.
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