Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - serious adverse event: Difference between revisions
From GxPlex
Gxplex admin (talk | contribs) m 1 revision imported |
imported>GxPlexBot Import from GxPlex Excel |
||
| Line 4: | Line 4: | ||
|RefDocPart=Glossary - serious adverse event | |RefDocPart=Glossary - serious adverse event | ||
|RefLanguage=EN | |RefLanguage=EN | ||
| | |RefTags=TAG-00046-Ser-sSc ++ TAG-00244-Def-ini ++ TAG-00043-Goo-tek ++ TAG-00258-Ser-nfü | ||
| | |RefModule=5 | ||
| | |RefUnit=5.1.1 | ||
}} | }} | ||
| Line 14: | Line 14: | ||
|- | |- | ||
! colspan="2" class="gplx-infobox-header" | Reference Details | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Module | |||
| Module 5 — Unit 5.1.1 | |||
|- | |- | ||
! Scope | ! Scope | ||
| Line 30: | Line 33: | ||
| Â | | Â | ||
|- | |- | ||
! Tags | ! 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-nfü|Seriousness criteria]] | ||
|- | |||
| Â | |||
|- | |||
| Â | |||
|- | |- | ||
! Comment | ! Comment | ||
Revision as of 17:29, 15 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 - serious adverse event |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Serious adverse event, Definition, Good clinical practice, 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.
