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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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{{#set:
{{ReferenceData
|HasDocument=Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
|has_document=Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
|RefScope=HM
|module=6
|RefDocPart=Schedule 3
|unit=6.1.2
|scope=HM
|doc_part=Schedule 3
Part 1
Part 1
1. (p)
1. (p)
|RefLanguage=EN
|language=EN
|RefTagsEN=
|entry_by=Florian Adragna
|RefTagsOriginal=
|contributors=
|RefTagsFR=
|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)
{{:Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004}}
|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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{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| HM
|-
! Document part
| Schedule 3
Part 1
1. (p)
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags (EN)
|
|-
! Tags (original language)
|
|-
! Tags (FR)
| Β 
|-
! Comment
| Documentation required for ethics committee and authority applications (end of trial)
|}
Β 
== Content ==
1.Β  An application document including the following information or, in each case, an explanation of why that information is not being providedβ€”
[…]
[…]
(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€” […] (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;

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