Let’s face it: privacy is paramount in the EU and the UK. As a trial sponsor, you must focus on safeguarding the personal data you collect on trial participants, as well as on-site staff, vendors and even your own EU - and UK -based employees. Failure to do so could lead to study delays and hefty fines.
EU and UK data protection laws have been around for decades. However, they’ve been significantly strengthened in recent years with implementation of the General Data Protection Regulation (GDPR). Most notably for sponsors in North America, the GDPR introduced the concept of ‘extraterritorial scope,’ which makes companies in any country responsible for compliance whenever EU and UK residents are involved.
In this playbook, we dive into ways to ensure your trial meets GDPR requirements and that you’re able to use the crucial personal data your trial generates. You’ll learn:
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