Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 6.: Difference between revisions
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| | | [[Glossary:TAG-00328-Com-egu|Compliance]], [[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00134-Eth-kom|Ethics committee]] | ||
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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 4 — Unit 4.1.1 |
| Scope | HM |
| Document part | Schedule 1
Part 2 6. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Compliance, Protocol, Good clinical practice, Ethics committee |
| Comment | GCP principle: protocol compliance by sponsor and investigator |
Content
CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS Principles based on International Conference on Harmonisation GCP Guideline [...] 6. A trial shall be conducted in compliance with the protocol that has a favourable opinion from an ethics committee.
