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Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - 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 - adverse event
|unit=5.1.1
|RefLanguage=EN
|scope=HM
|RefTags=TAG-00045-Adv-hte ++ TAG-00244-Def-ini ++ TAG-00043-Goo-tek ++ TAG-00066-Cau-enh
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|entry_by=Florian Adragna
|contributors=
|tags=TAG-00045-Adv-hte ++ TAG-00244-Def-ini ++ TAG-00043-Goo-tek ++ TAG-00066-Cau-enh
|tags_display=[[Glossary:TAG-00045-Adv-hte|Adverse event]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00066-Cau-enh|Causality]]
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Any untoward medical occurrence in a clinical trial subject administered a pharmaceutical product; it does not necessarily have a causal relationship with the treatment.
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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 — Unit 5.1.1
|-
! Scope
| HM
|-
! Document part
| Glossary - adverse event
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags
| [[Glossary:TAG-00045-Adv-hte|Adverse event]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00066-Cau-enh|Causality]]
|-
! Comment
| Definition of adverse event (GCP/ICH)
|}
== Content ==
adverse event
Any untoward medical occurrence in a clinical trial subject administered a pharmaceutical product; it does not necessarily have a causal relationship with the treatment.

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 — Unit 5.1.1
Scope HM
Document part Glossary - adverse event
Language EN
Original entry by Florian Adragna
Contributors
Tags Adverse event, Definition, Good clinical practice, Causality

Content

adverse event Any untoward medical occurrence in a clinical trial subject administered a pharmaceutical product; it does not necessarily have a causal relationship with the treatment.

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