Major Overhaul of EU Clinical Trial Rules Kicks In
On 31 January 2022, the EU Clinical Trial Regulation (CTR) came into application, almost 8 years after its adoption by the European Parliament and he Council of the EU. The CTR will radically change the regulatory framework for conducting clinical trials.
From a privacy and data protection perspective, the CTR provides that all clinical trial information must be recorded, processed, handled, and stored in accordance with the applicable law on personal data protection, which includes the EU General Data Protection Regulation (GDPR).
It is noteworthy that, since the CTR was adopted prior to GDPR, some of the CTR’s provisions relating to privacy and data protection are not fully aligned with the provisions of the GDPR and, in particular, the data protection authorities’ interpretation of how those provisions should be applied in practice.
