Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 non-interventional trial: Difference between revisions
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| Β | | [[Glossary:TAG-00010-Non-Stu|Non-interventional study]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00001-Med-rzn|Medicinal product]], [[Glossary:TAG-00276-Mar-inh|Marketing authorisation holder]] | ||
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Revision as of 17:29, 15 July 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 | |
|---|---|
| Module | Module 1 β 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 |
| Comment | Definition of non-interventional trial (medicinal products) |
Content
[...] βnon-interventional trialβ means a study of one or more medicinal products which have a marketing authorization, where the following conditions are metβ (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; [...]
