Reference:ICH ICH E2A Guideline 1994 II A. 3.: Difference between revisions
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| | | [[Glossary:TAG-00331-Une-irk|Unexpected adverse reaction]], [[Glossary:TAG-00003-Adv-cht|Adverse reaction]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00034-Inv-Bro|Investigator's brochure]] | ||
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Revision as of 17:29, 15 July 2026
| Document information | |
|---|---|
| Reference | ICH ICH E2A Guideline 1994 |
| Validity area | ICH |
| Scope(s) | G |
| Document name | ICH E2A Guideline |
| Version / Revision | 1994 |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING
E2A |
| 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 | II A. 3. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Unexpected adverse reaction, Adverse reaction, Definition, Investigator's brochure |
| Comment | Definition of unexpected adverse drug reaction |
Content
Unexpected Adverse Drug Reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational medicinal product). (See section III.C.)
