Goodwin held a discussion about some of the challenges companies face when managing clinical trials and collaborations, particularly around the collection and use of personal data and the measures required to safeguard data and enable additional research activities.
Topics included:
- Interplay between the CTR and GDPR, including:
- Engagement with clinical sites/investigators and clinical research organisations
- Information notice requirements
- Explicit consent or reliance on other GDPR legal bases
- Use and generation of data in collaborations with third parties/medical research organisations/hospitals
- French governmental initiatives in connection with health data