In April 2016, the European Parliament adopted the General Data Protection Regulation (GDPR) to modernize its data protection legislation. As of May 25, 2018, the Data Protection Directive was thus repealed and replaced by the GDPR, while all member states legislation became subject to review to be aligned with the GDPR, leading to major modifications of the rules that prevailed prior to the GDPR coming into force.
For research trials, enacting the GDPR had a number of implications, both for sponsors, contract research organizations (CROs) and trial sites located in the European Union (EU), and for some foreign CROs and sponsors, which now need to comply with various obligations failing which they may be exposed to heavy fines and other legal recourses.
Click here to read about the various obligations that must be complied with.
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