Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. ; 3.: Difference between revisions
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| | |RefTags=TAG-00134-Eth-kom ++ TAG-00059-Reg-lat ++ TAG-00343-Doc-ten ++ TAG-00083-Enr-enr | ||
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| | | [[Glossary:TAG-00134-Eth-kom|Ethics committee]], [[Glossary:TAG-00059-Reg-lat|Regulatory submission]], [[Glossary:TAG-00343-Doc-ten|Documentation]], [[Glossary:TAG-00083-Enr-enr|Enrolment]] | ||
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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 — Unit 3.2.1 |
| Scope | HM |
| Document part | Schedule 3
Part 1 1. ; 3. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Ethics committee, Regulatory submission, Documentation, Enrolment |
| Comment | Documents required for ethics committee and authority applications |
Content
PARTICULARS AND DOCUMENTS THAT MUST ACCOMPANY AN APPLICATION FOR AN ETHICS COMMITTEE OPINION, A REQUEST FOR AUTHORISATION, A NOTICE OF AMENDMENT AND A NOTIFICATION OF THE CONCLUSION OF A TRIAL
PART 1 APPLICATION FOR ETHICS COMMITTEE OPINION
1. An application document including the following information or, in each case, an explanation of why that information is not being provided— [...] (h)arrangements for the recruitment of subjects, including the materials to be used; [...] 3. The following documents or, in each case, an explanation of why that document is not being provided— [...] (d)copies of the advertisement material for recruitment of research participants; [...]
