Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 non-interventional trial

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 1 — Unit 1.2.2
Scope	HM
Document part	Article 2 non-interventional trial
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Non-interventional study, Definition, Medicinal product, Marketing authorisation holder

Content

[...] “non-interventional trial” means a study of one or more medicinal products which have a marketing authorization, where the following conditions are met— (a)the products are prescribed in the usual manner in accordance with the terms of that authorization, (b)the assignment of any patient involved in the study to a particular therapeutic strategy is not decided in advance by a protocol but falls within current practice, (c)the decision to prescribe a particular medicinal product is clearly separated from the decision to include the patient in the study, (d)no diagnostic or monitoring procedures are applied to the patients included in the study, other than those which are ordinarily applied in the course of the particular therapeutic strategy in question, and (e)epidemiological methods are to be used for the analysis of the data arising from the study; [...]