Module 5 Presentations

19/07/2024

Negligence

• Examples of negligence in a clinical trial context (cont) – Investigator – Breach of protocol (selection of subjects, administration of IMP, monitoring) – Reaction to adverse event (failure to provide appropriate treatment or to discontinue subject from trial) – Inadequate consent procedures – Competent authority – Inadequate review of CTA dossier

The Organisation for Professionals in Regulatory Affairs

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Negligence

• Examples of negligence in a clinical trial context (cont) – Ethics Committee – Failure to confirm appropriate authorisations in place – Approval of trial with inappropriate design – Approval of inadequate patient information sheet – Approval of inexperienced/unqualified investigator or inadequate facilities

NB: Claims brought in strict liability may generally be brought in negligence as an alternative.

The Organisation for Professionals in Regulatory Affairs

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