SUSARs trigger expedited reporting to regulators (e.g., 7 or 15 calendar days under FDA and EMA rules) and to IRBs as required by the protocol and local policy.
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Glossary Term
SUSAR
Data & Safety
Also known as: suspected unexpected serious adverse reaction
Suspected Unexpected Serious Adverse Reaction — a serious adverse reaction whose nature or severity is not consistent with the reference safety information.
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