Module 5 Presentations

05/07/2024

Risk-adapted approach PV: examples

1. Trial of licensed IMP with known-safety profile in off-label indications which is standard clinical practice.  AEs not recorded.  All SAEs recorded from first administration to end of follow-up. No invasive trial-related procedure during screening . 2. Trial of licensed IMP with known-safety profile in population prone to SAEs due to their disease.  Only specified AEs are collected at all CTCAE grades. All others are recorded only if the event is CTCAE grade 3 and above.  Rationale: A large number of low grade AEs is unlikely to alter the risk-benefit of the IMP.

The Organisation for Professionals in Regulatory Affairs

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The Organisation for Professionals in Regulatory Affairs

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