Challenges of GDPR compliance for clinical trials spanning multiple international borders – a case study
Clinical trials often occur cross-border, involving sites under different regulatory authorities across multiple countries and continents. In our experience, it can be challenging to understand and comply with the data protection and privacy requirements for clinical trials. There are often differences in local laws and their interpretation relating to the interplay between these regulations and those specific to clinical trials.
The Role and Responsibilities of the GDPR Data Protection Officer
The EU GDPR and UK GDPR require organisations to appoint a Data Protection Officer (DPO) if their data processing activities meet specific criteria. The DPO is mandatory for pharma or biotech companies processing health-related information on data subjects in the EU or UK. The DPO’s role and responsibilities are distinct from those of the Data Protection Representative (for companies not established in the EU or UK). The role should not be confused with other roles, such as the legal representative under the Clinical Trials Regulation.
What is a Data Protection Impact Assessment, and why is it a requirement of GDPR?
This article explains when to conduct a DPIA, provides an overview of the steps undertaken during a DPIA and how a GDPR compliance consultancy can support you through the process.