GDPR

The General Data Protection Regulation (GDPR), officially known as Regulation (EU) 2016/679, was enacted in 2018, introducing a comprehensive regulatory structure for organizations engaged in processing personal data of European citizens or operating within the European region. This regulation entails a fresh paradigm for companies, mandating specific measures to be undertaken prior to the processing of any personal data. A core tenet of GDPR, known as Privacy by Design, seeks to empower individuals, enabling them to retain control over their personal information while enabling businesses to continue their operations.

Even within the context of clinical trials, the influence of GDPR is palpable. Although the impact on sponsors might be moderate due to certain obligations of GDPR being reiterated in existing regulations like the Clinical Trial Directive and Good Clinical Practice (GCP), clinical trials are still within the ambit of this regulation. GDPR establishes a heightened level of data protection and privacy, ensuring that participants’ personal data is treated with the utmost care and security throughout the clinical trial process. This balance aims to safeguard individual rights while facilitating scientific progress and medical research.