Module 5 Presentations

19/07/2024

• Confidentiality – Obligations owed to participants, sponsor, investigator – Tension with move towards heightened transparency – e.g. EudraCT • UK Common Law (judge-made) • Basic rule : information provided in circumstances of confidence may not be disclosed without consent. • Exceptions: – Statute, e.g. Freedom of Information, Pharmacovigilance obligations – Court Order, – Public interest, e.g. W v Egdell & Ors 1989 • Sanctions: action for breach of confidence; professional Confidentiality

The Organisation for Professionals in Regulatory Affairs

11

Data Privacy

• General Data Protection Regulation • UK implementation - Data Protection Act 2018 and UK GDPR

The Organisation for Professionals in Regulatory Affairs

12

6