Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. (p): Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 | ||
| | |module=6 | ||
| | |unit=6.1.2 | ||
|scope=HM | |||
|doc_part=Schedule 3 | |||
Part 1 | Part 1 | ||
1. (p) | 1. (p) | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
|tags=TAG-00037-End-ung ++ TAG-00287-Sto-pre ++ TAG-00134-Eth-kom ++ TAG-00343-Doc-ten ++ TAG-00033-Pro-oto | |||
|tags_display=[[Glossary:TAG-00037-End-ung|Trial end]], [[Glossary:TAG-00287-Sto-pre|Stopping rules]], [[Glossary:TAG-00134-Eth-kom|Ethics committee]], [[Glossary:TAG-00343-Doc-ten|Documentation]], [[Glossary:TAG-00033-Pro-oto|Protocol]] | |||
Β | |comment=Documentation required for ethics committee and authority applications (end of trial) | ||
|content=1.Β An application document including the following information or, in each case, an explanation of why that information is not being providedβ | |||
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1.Β An application document including the following information or, in each case, an explanation of why that information is not being providedβ | |||
[β¦] | [β¦] | ||
(p)the rules for terminating or concluding the trial beforeβ | (p)the rules for terminating or concluding the trial beforeβ | ||
(i)the date for the conclusion of the trial specified in the protocol, or | (i)the date for the conclusion of the trial specified in the protocol, or | ||
(ii)the event specified in the protocol as the event which indicates that the end of the trial has occurred; | (ii)the event specified in the protocol as the event which indicates that the end of the trial has occurred; | ||
}} | |||
Latest revision as of 13:50, 16 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 6 β Unit 6.1.2 |
| Scope | HM |
| Document part | Schedule 3
Part 1 1. (p) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Trial end, Stopping rules, Ethics committee, Documentation, Protocol |
Content
1. An application document including the following information or, in each case, an explanation of why that information is not being providedβ [β¦] (p)the rules for terminating or concluding the trial beforeβ (i)the date for the conclusion of the trial specified in the protocol, or (ii)the event specified in the protocol as the event which indicates that the end of the trial has occurred;
