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Reference:ICH ICH E2A Guideline 1994 II A. 3.: Difference between revisions

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{{#set:
{{ReferenceData
|HasDocument=Document:ICH ICH E2A Guideline 1994
|has_document=Document:ICH ICH E2A Guideline 1994
|RefScope=G
|module=5
|RefDocPart=II A. 3.
|unit=5.1.4
|RefLanguage=EN
|scope=G
|RefTagsEN=
|doc_part=II A. 3.
|RefTagsOriginal=
|language=EN
|RefTagsFR=
|entry_by=Florian Adragna
|contributors=
|tags=TAG-00331-Une-irk ++ TAG-00003-Adv-cht ++ TAG-00244-Def-ini ++ TAG-00034-Inv-Bro
|tags_display=[[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]]
|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.)
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}}
== Document Information ==
{{:Document:ICH ICH E2A Guideline 1994}}
== Reference Details ==
{| class="wikitable" style="width:100%;"
|-
! scope="row" style="width:200px;" | Scope
| G
|-
! scope="row" style="width:200px;" | Document part
| II A. 3.
|-
! scope="row" style="width:200px;" | Language
| EN
|-
! scope="row" style="width:200px;" | Original entry by
| Florian Adragna
|-
! scope="row" style="width:200px;" | Contributors
|
|-
! scope="row" style="width:200px;" | Tags (EN)
|
|-
! scope="row" style="width:200px;" | Tags (original language)
|
|-
! scope="row" style="width:200px;" | Tags (FR)
|
|-
! scope="row" | 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.)

Latest revision as of 13:50, 16 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

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.)

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