Module 5 Presentations

19/07/2024

Contractual claims

• Where a subject has entered a contract with investigator/sponsor, this is likely to provide for payment of compensation where the subject suffers injury

The Organisation for Professionals in Regulatory Affairs

31

No fault compensation arrangements

• The EU Clinical Trial Reguation provides that EU Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation in a clinical trial conducted on their territory are in place in the form of insurance, a guarantee, or a similar arrangement” • Such protection includes both the provision of adequate treatment and financial compensation in the case of injury to a trial subject • Ethics committees will generally refuse to approve a clinical trial unless the sponsor has agreed to provide compensation on a no fault basis

The Organisation for Professionals in Regulatory Affairs

32

16