Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (5) (k)-(l): Difference between revisions
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| | |RefTags=TAG-00134-Eth-kom ++ TAG-00280-Fin-anT ++ TAG-00111-Agr-chr ++ TAG-00329-Saf-lne | ||
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| Β | | [[Glossary:TAG-00134-Eth-kom|Ethics committee]], [[Glossary:TAG-00280-Fin-anT|Participant compensation]], [[Glossary:TAG-00111-Agr-chr|Written agreement]], [[Glossary:TAG-00329-Saf-lne|Safety]] | ||
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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 2 β Unit 2.3.4 |
| Scope | HM |
| Document part | Article 15
(5) (k)-(l) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Ethics committee, Participant compensation, Written agreement, Safety |
| Comment | Ethics committee considerations for subject safety and rights |
Content
Ethics committee opinion 15.β [...] (5) In preparing its opinion, the committee shall consider, in particular, the following mattersβ (k)the amounts, and, where appropriate, the arrangements, for rewarding or compensating investigators and subjects; (l)the terms of any agreement between the sponsor and the owner or occupier of the trial site which are relevant to the arrangements referred to in sub-paragraph (k)
