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

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 adverse event adverse reaction
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Adverse event, Adverse reaction, Definition, Medicinal product

Content

“adverse event” means any untoward medical occurrence in a subject to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product;

“adverse reaction” means any untoward and unintended response in a subject to an investigational medicinal product which is related to any dose administered to that subject;