Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 adverse event adverse reaction: Difference between revisions
From GxPlex
Gxplex admin (talk | contribs) m 1 revision imported |
imported>GxPlexBot Import from GxPlex Excel |
||
| Line 6: | Line 6: | ||
adverse reaction | adverse reaction | ||
|RefLanguage=EN | |RefLanguage=EN | ||
| | |RefTags=TAG-00045-Adv-hte ++ TAG-00003-Adv-cht ++ TAG-00244-Def-ini ++ TAG-00001-Med-rzn | ||
| | |RefModule=5 | ||
| | |RefUnit=5.1.1 | ||
}} | }} | ||
| Line 16: | Line 16: | ||
|- | |- | ||
! colspan="2" class="gplx-infobox-header" | Reference Details | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Module | |||
| Module 5 — Unit 5.1.1 | |||
|- | |- | ||
! Scope | ! Scope | ||
| Line 34: | Line 37: | ||
| | | | ||
|- | |- | ||
! Tags | ! Tags | ||
| | | [[Glossary:TAG-00045-Adv-hte|Adverse event]], [[Glossary:TAG-00003-Adv-cht|Adverse reaction]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00001-Med-rzn|Medicinal product]] | ||
|- | |||
| | |||
|- | |||
| | |||
|- | |- | ||
! Comment | ! Comment | ||
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 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 |
| Comment | Definition of adverse event (UK clinical trials) |
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;
