Reference:ICH ICH E2A Guideline 1994 II A. 3.
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Document Information
| 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
| Scope | G |
|---|---|
| Document part | II A. 3. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Definition of unexpected adverse drug reaction |
Text
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.)
