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Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - serious adverse event: Difference between revisions

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|HasDocument=Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
|has_document=Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
|RefScope=HM
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|RefDocPart=Glossary - serious adverse event
|unit=5.1.1
|RefLanguage=EN
|scope=HM
|RefTags=TAG-00046-Ser-sSc ++ TAG-00244-Def-ini ++ TAG-00043-Goo-tek ++ TAG-00258-Ser-nfΓΌ
|doc_part=Glossary - serious adverse event
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|entry_by=Florian Adragna
|contributors=
|tags=TAG-00046-Ser-sSc ++ TAG-00244-Def-ini ++ TAG-00043-Goo-tek ++ TAG-00258-Ser-nfΓΌ
|tags_display=[[Glossary:TAG-00046-Ser-sSc|Serious adverse event]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00258-Ser-nfΓΌ|Seriousness criteria]]
|comment=Definition of serious adverse event (GCP/ICH)
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An event that is associated with death, admission to hospital, prolongation of a hospital stay, persistent or significant disability or incapacity, or is otherwise life-threatening in connection with a clinical trial.
}}
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{{:Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995}}
{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 5 β€” Unit 5.1.1
|-
! Scope
| HM
|-
! Document part
| Glossary - serious adverse event
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags
| [[Glossary:TAG-00046-Ser-sSc|Serious adverse event]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00258-Ser-nfΓΌ|Seriousness criteria]]
|-
! Comment
| Definition of serious adverse event (GCP/ICH)
|}
== Content ==
serious adverse event
An event that is associated with death, admission to hospital, prolongation of a hospital stay, persistent or significant disability or incapacity, or is otherwise life-threatening in connection with a clinical trial.

Revision as of 12:56, 16 July 2026



Document information
Reference WHO WHO - Guidelines for GCP for trials on

pharmaceutical products* 1995

Validity area WHO
Scope(s) HM
Document name WHO - Guidelines for GCP for trials on

pharmaceutical products*

Version / Revision 1995
Status Current
Document type International guideline
Language(s) EN
Description World Health Organization

WHO Technical Report Series, No. 850, 1995, Annex 3 Guidelines for good clinical practice (GCP) for trials on pharmaceutical products*

Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Module Module 5 β€” Unit 5.1.1
Scope HM
Document part Glossary - serious adverse event
Language EN
Original entry by Florian Adragna
Contributors
Tags Serious adverse event, Definition, Good clinical practice, Seriousness criteria

Content

serious adverse event An event that is associated with death, admission to hospital, prolongation of a hospital stay, persistent or significant disability or incapacity, or is otherwise life-threatening in connection with a clinical trial.

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