Module 5 Presentations

05/07/2024

Definitions (1)

Serious adverse event (SAE): ‘Any adverse event that results in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect’. [SI 2004, N.1031, 2]

Adverse event (AE): ‘any untoward medical occurrence in a subject to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product’. [SI 2004 n.1031, 2(1)]

Adverse reaction (AR): ‘any untoward and unintended

response in a subject to an investigational

medicinal product which is related to any dose administered to that subject’. [SI 2004 n.1031, 2 (1)]

The Organisation for Professionals in Regulatory Affairs

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Definitions (2)

SUSARs = Suspected Unexpected Serious Adverse Reactions= serious events at least possibly related to the study drug (causality) which are not expected

Seriousness and causality are assessed by the investigator.

Expectedness is assessed by the Sponsor.

Causality assessment : it cannot be downgraded. Upgrading is possible. Both Sponsor’s and investigator’s causality assessments can be provided in case of disagreement.

Unexpected : ‘an adverse reaction, the nature or severity of which is not consistent with the Reference Safety Information (RSI)

The Organisation for Professionals in Regulatory Affairs

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