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ARTICLE · 09 NOVEMBER 2018

Clinical Trials Regulation v. GDPR: How Data Protection Affects Research Under Italian Data Protection Rules

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The way clinical trials have been conducted in the European Union is actually undergoing two major challenges: the coming into effect of Regulation (EU) no. 536/2014 (so-called Clinical Trial Regulation) and the application of the General Data Protection Regulation or GDPR.

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The way clinical trials have been conducted in the European Union is actually undergoing two major challenges: the coming into effect of Regulation (EU) no. 536/2014 (so-called Clinical Trial Regulation) and the application of the General Data Protection Regulation or GDPR.

On the one hand, the Clinical Trial Regulation will create a consistent framework of rules applicable to clinical trials at the European level, which will then require implementation from all member states. On the other, GDPR is the much talked about piece of legislation concerning the protection and free movement of personal data in the EU, whose specific impact on clinical trials is yet to be seen.

The crossroad between GDPR and the Clinical Trial Regulation is an important one. This because the wide use of internet, electronic records and new technologies enabling the collection of massive amounts of data is becoming increasingly important in clinical, pharmaceutical and biomedical research.

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