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

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
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;