Module 5 Presentations

19/07/2024

Negligence

• Formulation of claim will be based on local law

Under English law – A breach of the duty of care owed to a trial subject – Standard of care is that of a reasonable man skilled in the particular art, as determined by his peers – The breach of duty resulted in the injury suffered by the Claimant

•

The Organisation for Professionals in Regulatory Affairs

27

• Examples of negligence in a clinical trial context – Sponsor • Inadequate pre-clinical testing • Inappropriate trial design • Selection of CRO/Investigator without adequate experience • Selection of trial site without adequate facilities • Inadequate monitoring of trial site Negligence

The Organisation for Professionals in Regulatory Affairs

28

14