Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 serious adverse event: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 | ||
| | |module=5 | ||
| | |unit=5.1.1 | ||
|scope=HM | |||
|doc_part=Article 2 | |||
serious adverse event | serious adverse event | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
|tags=TAG-00046-Ser-sSc ++ TAG-00004-Ser-ege ++ TAG-00047-Une-ete ++ TAG-00244-Def-ini ++ TAG-00258-Ser-nfü | |||
|tags_display=[[Glossary:TAG-00046-Ser-sSc|Serious adverse event]], [[Glossary:TAG-00004-Ser-ege|Serious adverse reaction]], [[Glossary:TAG-00047-Une-ete|Unexpected SAR]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00258-Ser-nfü|Seriousness criteria]] | |||
|comment=Definitions of SAE, SAR and USAR (UK) | |||
|content=“serious adverse event”, “serious adverse reaction” or “unexpected serious adverse reaction” means any adverse event, adverse reaction or unexpected adverse reaction, respectively, that— | |||
| | |||
| | |||
= | |||
“serious adverse event”, “serious adverse reaction” or “unexpected serious adverse reaction” means any adverse event, adverse reaction or unexpected adverse reaction, respectively, that— | |||
(a)results in death, | (a)results in death, | ||
(b)is life-threatening, | (b)is life-threatening, | ||
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(d)results in persistent or significant disability or incapacity, or | (d)results in persistent or significant disability or incapacity, or | ||
(e)consists of a congenital anomaly or birth defect; | (e)consists of a congenital anomaly or birth defect; | ||
}} | |||
Latest revision as of 13:50, 16 July 2026
| Document information | |
|---|---|
| Reference | GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 |
| Validity area | GBR |
| Scope(s) | HM |
| Document name | The Medicines for Human Use (Clinical Trials) Regulations 2004 |
| Version / Revision | 01-May-2004 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | The Medicines for Human Use (Clinical Trials) Regulations 2004 |
| 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 | Article 2
serious adverse event |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Serious adverse event, Serious adverse reaction, Unexpected SAR, Definition, Seriousness criteria |
Content
“serious adverse event”, “serious adverse reaction” or “unexpected serious adverse reaction” means any adverse event, adverse reaction or unexpected adverse reaction, respectively, that— (a)results in death, (b)is life-threatening, (c)requires hospitalisation or prolongation of existing hospitalisation, (d)results in persistent or significant disability or incapacity, or (e)consists of a congenital anomaly or birth defect;
