What is the GDPR?
The European Union’s (EU) General Data Protection Regulation (GDPR) goes into effect on May 25, 2018. The purpose of the GDPR is to protect the privacy and security of personal data and to strengthen the accountability to those using personal data.
What does this mean for clinical trials?
Personal data collected on subjects within the member states of the EU must comply with the GDPR, even if the study is not based in the EU. Interestingly, this would also include data collection on subjects who travel to the EU and are not residents. Data collection on EU residents who are outside the EU at the time of data collection are not covered under GDPR.
To learn more about how GDPR affects study subjects, click here. Thanks to Advarra for this great summary!
-The Clinical Pathways Team
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