Module 5 Presentations

19/07/2024

Enforcement : Due Diligence

• No offence “if he took all reasonable precautions and exercised all due diligence to avoid the committing of that offence”

• Prosecuting authority must prove absence of claimed defence “beyond reasonable doubt”

• Effectively requirement to show proper efforts made to ensure obligations met

The Organisation for Professionals in Regulatory Affairs

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Liabilities arising from Clinical Trials

• Many potential sources of legal liability : – Breach of contract by sponsor – Failure by investigator to adhere to trial protocol – Costs incurred by investigator site as result of requirement to treat injured trial subject – Injuries suffered by trial subject due to effect of IMP • Most claims dealt with informally without recourse to court proceedings • Requirement for compensation systems “in the form of insurance, a guarantee, or a similar arrangement” appropriate to nature and extent of risk (Art 76 CTR)

The Organisation for Professionals in Regulatory Affairs

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