Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 clinical trial: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 | ||
| | |module=1 | ||
| | |unit=1.2.2 | ||
|scope=HM | |||
|doc_part=Article 2 | |||
clinical trial | clinical trial | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
| | |tags=TAG-00008-Cli-ngK ++ TAG-00244-Def-ini ++ TAG-00001-Med-rzn ++ TAG-00003-Adv-cht | ||
|tags_display=[[Glossary:TAG-00008-Cli-ngK|Clinical trial]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00001-Med-rzn|Medicinal product]], [[Glossary:TAG-00003-Adv-cht|Adverse reaction]] | |||
|comment=Definition of clinical trial (medicinal products, directive) | |||
|content=[...] | |||
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| | |||
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[...] | |||
“clinical trial” means any investigation in human subjects, other than a non-interventional trial, intended— | “clinical trial” means any investigation in human subjects, other than a non-interventional trial, intended— | ||
(a)to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products, | (a)to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products, | ||
| Line 53: | Line 19: | ||
with the object of ascertaining the safety or efficacy of those products; | with the object of ascertaining the safety or efficacy of those products; | ||
[...] | [...] | ||
}} | |||
Latest revision as of 13:49, 16 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 — Unit 1.2.2 |
| Scope | HM |
| Document part | Article 2
clinical trial |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Clinical trial, Definition, Medicinal product, Adverse reaction |
Content
[...] “clinical trial” means any investigation in human subjects, other than a non-interventional trial, intended— (a)to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products, (b)to identify any adverse reactions to one or more such products, or (c)to study absorption, distribution, metabolism and excretion of one or more such products, with the object of ascertaining the safety or efficacy of those products; [...]
