Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. (i): Difference between revisions
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| Β | | [[Glossary:TAG-00077-Inc-gsk|Inclusion criteria]], [[Glossary:TAG-00078-Exc-ssk|Exclusion criteria]], [[Glossary:TAG-00154-Vul-eil|Vulnerable participants]], [[Glossary:TAG-00134-Eth-kom|Ethics committee]], [[Glossary:TAG-00343-Doc-ten|Documentation]] | ||
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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 3 β Unit 3.2.2 |
| Scope | HM |
| Document part | Schedule 3
Part 1 1. (i) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Inclusion criteria, Exclusion criteria, Vulnerable participants, Ethics committee, Documentation |
| Comment | Documentation required for ethics committee application |
Content
1. An application document including the following information or, in each case, an explanation of why that information is not being providedβ [β¦] (i)the criteria for inclusion and exclusion of patients, including justification for recruiting from vulnerable groups;
