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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{{:Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004}} | {{:Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004}} | ||
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{| class=" | |||
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! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Scope | |||
| HM | | HM | ||
|- | |- | ||
! | ! Document part | ||
| Article 2 | | Article 2 | ||
serious adverse event | serious adverse event | ||
|- | |- | ||
! | ! Language | ||
| EN | | EN | ||
|- | |- | ||
! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
|- | |- | ||
! | ! Contributors | ||
| | | | ||
|- | |- | ||
! | ! Tags (EN) | ||
| | | | ||
|- | |- | ||
! | ! Tags (original language) | ||
| | | | ||
|- | |- | ||
! | ! Tags (FR) | ||
| | | | ||
|- | |- | ||
! | ! Comment | ||
| Definitions of SAE, SAR and USAR (UK) | | 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, | ||
Revision as of 14:27, 29 June 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 | |
|---|---|
| Scope | HM |
| Document part | Article 2
serious adverse event |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| 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— (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;
