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Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Suspected Unexpected Serious Adverse Reaction (SUSAR): Difference between revisions

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Revision as of 17:29, 15 July 2026



Document information
Reference ICH ICH E6 Guideline R3 (2025)
Validity area ICH
Scope(s) HM
Document name ICH E6 Guideline
Version / Revision R3 (2025)
Status Current
Document type International guideline
Language(s) EN
Description GUIDELINE FOR GOOD CLINICAL PRACTICE
Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Module Module 5 — Unit 5.1.4
Scope G
Document part GLOSSARY - Suspected Unexpected Serious Adverse Reaction (SUSAR)
Language EN
Original entry by Florian Adragna
Contributors
Tags SUSAR, Unexpected SAR, Definition, Causality, Unexpected adverse reaction
Comment Definition of SUSAR

Content

Suspected Unexpected Serious Adverse Reaction (SUSAR): an adverse reaction that meets three criteria: suspected, unexpected and serious.

• Suspected: There is a reasonable possibility that the drug caused the adverse drug reaction.

• Unexpected: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator’s Brochure or alternative documents according to applicable regulatory requirements; see RSI).

•Serious: See above for SAE.

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