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Reference:ICH ICH E2A Guideline 1994 III A. 1.: Difference between revisions

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{{#set:
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|HasDocument=Document:ICH ICH E2A Guideline 1994
|has_document=Document:ICH ICH E2A Guideline 1994
|RefScope=G
|module=5
|RefDocPart=III A. 1.
|unit=5.1.4
|RefLanguage=EN
|scope=G
|RefTags=TAG-00066-Cau-enh ++ TAG-00003-Adv-cht ++ TAG-00297-Ind-erh ++ TAG-00201-Cli-eSt ++ TAG-00017-Spo-die
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|tags=TAG-00066-Cau-enh ++ TAG-00003-Adv-cht ++ TAG-00297-Ind-erh ++ TAG-00201-Cli-eSt ++ TAG-00017-Spo-die
{{:Document:ICH ICH E2A Guideline 1994}}
|tags_display=[[Glossary:TAG-00066-Cau-enh|Causality]], [[Glossary:TAG-00003-Adv-cht|Adverse reaction]], [[Glossary:TAG-00297-Ind-erh|ICSR]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00017-Spo-die|Sponsor]]
 
|comment=Causality assessment in clinical investigation cases
{| class="wikitable gplx-infobox"
|content=[...]
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 5 — Unit 5.1.4
|-
! Scope
| G
|-
! Document part
| III A. 1.
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags
| [[Glossary:TAG-00066-Cau-enh|Causality]], [[Glossary:TAG-00003-Adv-cht|Adverse reaction]], [[Glossary:TAG-00297-Ind-erh|ICSR]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00017-Spo-die|Sponsor]]
|-
! Comment
| Causality assessment in clinical investigation cases
|}
 
== Content ==
[...]
Causality assessment is required for clinical investigation cases. All cases judged by either the reporting health care professional or the sponsor as having a reasonable suspected causal relationship to the medicinal product qualify as ADRs. For purposes of reporting, adverse event reports associated with marketed drugs (spontaneous reports) usually imply causality.
Causality assessment is required for clinical investigation cases. All cases judged by either the reporting health care professional or the sponsor as having a reasonable suspected causal relationship to the medicinal product qualify as ADRs. For purposes of reporting, adverse event reports associated with marketed drugs (spontaneous reports) usually imply causality.
[...]
[...]
}}

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 III A. 1.
Language EN
Original entry by Florian Adragna
Contributors
Tags Causality, Adverse reaction, ICSR, Clinical investigation, Sponsor

Content

[...] Causality assessment is required for clinical investigation cases. All cases judged by either the reporting health care professional or the sponsor as having a reasonable suspected causal relationship to the medicinal product qualify as ADRs. For purposes of reporting, adverse event reports associated with marketed drugs (spontaneous reports) usually imply causality. [...]

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