Data Privacy in the EU: A Guide for Clinical Trial Sponsors and Sites
U.S.-based companies routinely collect and process personal data of EU-based individuals as part of their operations.
Without a working knowledge of EU privacy laws and regulations, you run the risk of not being compliant.
The broad requirements of the EU’s General Data Protection Regulation (GDPR), which applies to all industries, must be reconciled with the specific provisions of the EU’s Clinical Trial Regulation (CTR).
Failure to comply with the GDPR comes with a heavy price tag — about $126 million in fines were collected in 2019. A single data breach could bankrupt your trial or even your entire organization.
Data Privacy in the EU: A Guide for Clinical Trial Sponsors and Sites explains how the GDPR and CTR overlap and how they compare to U.S. regulations, what data protection principles trials must follow to ensure compliance, and what requirements the EU rules place on the collection and processing of personal health information (PHI). The report also covers the rights of EU citizens under the GDPR, the need for a data protection officer (DPO) and what the DPO does, and how to conduct a privacy impact assessment.
- The difference in the way the EU and the U.S. regulate privacy
- Introduction, historical and legal context of the GDPR
- Application of the GDPR to clinical trials data
- Data protection principles that must be followed by trials
- Transparency requirements under the GDPR vs. the CTR
- The roles of sponsors, sites and CROs in handling personal data
- The responsibilities of the data protection officer
- Nine principles of data protection
- Requirements of consent under the GDPR
- Reporting data breaches
If your clinical trials involve the personal data of EU-based individuals, you need to understand the rules that apply to data collection. Place your order today.
Add to Cart