Module 5 Presentations

19/07/2024

Summary

• In this presentation we have covered

– Consent and appropriate provision of information – Confidentiality, data privacy and limitations on use of clinical trial information – Enforcement and implications where rules not followed – Liability and compensation for injury to trial subjects – Clinical trial contracts, reflecting the parties and intended legal obligations

The Organisation for Professionals in Regulatory Affairs

47

Recommended references

• Regulation EU 536/2014 • UK Medicines for Human Use (Clinical Trials) Regulations 2004 • UK APBI/ BIA model clinical trial agreements • Guidelines on the practice of Ethics Committees in medical research with human participants (Royal College of Physicians) 2007 • ABPI Clinical Trial Compensation Guidelines 2014 • GDPR

The Organisation for Professionals in Regulatory Affairs

48

24