View source for Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 serious adverse event

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serious adverse event
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{{:Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004}}

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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Scope
| HM
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! Document part
| Article 2
serious adverse event
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! Language
| EN
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! Original entry by
| Florian Adragna
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! Contributors
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! Tags (EN)
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! Tags (original language)
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! Tags (FR)
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! Comment
| Definitions of SAE, SAR and USAR (UK)
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== 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;