Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Suspected Unexpected Serious Adverse Reaction (SUSAR): Difference between revisions
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| 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 ā 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 |
Content
Suspected Unexpected Serious Adverse Reaction (SUSAR): an adverse reaction that meets three criteria: suspected, unexpected and serious.
ā¢ Suspected: There is a reasonable possibility that the drug caused the adverse drug reaction.
ā¢ Unexpected: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigatorās Brochure or alternative documents according to applicable regulatory requirements; see RSI).
ā¢Serious: See above for SAE.
