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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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{{#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=3
|RefDocPart=Schedule 3
|unit=3.2.2
|scope=HM
|doc_part=Schedule 3
Part 1
Part 1
1. (i)
1. (i)
|RefLanguage=EN
|language=EN
|RefTagsEN=
|entry_by=Florian Adragna
|RefTagsOriginal=
|contributors=
|RefTagsFR=
|tags=TAG-00077-Inc-gsk ++ TAG-00078-Exc-ssk ++ TAG-00154-Vul-eil ++ TAG-00134-Eth-kom ++ TAG-00343-Doc-ten
}}
|tags_display=[[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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|comment=Documentation required for ethics committee application
== Document Information ==
|content=1.Β  An application document including the following information or, in each case, an explanation of why that information is not being providedβ€”
{{:Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004}}
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== Reference Details ==
{| class="wikitable" style="width:100%;"
|-
! scope="row" style="width:200px;" | Scope
| HM
|-
! scope="row" style="width:200px;" | Document part
| Schedule 3
Part 1
1. (i)
|-
! scope="row" style="width:200px;" | Language
| EN
|-
! scope="row" style="width:200px;" | Original entry by
| Florian Adragna
|-
! scope="row" style="width:200px;" | Contributors
|
|-
! scope="row" style="width:200px;" | Tags (EN)
|
|-
! scope="row" style="width:200px;" | Tags (original language)
|
|-
! scope="row" style="width:200px;" | Tags (FR)
| Β 
|-
! scope="row" | Comment
| Documentation required for ethics committee application
|}
Β 
== Text ==
1.Β  An application document including the following information or, in each case, an explanation of why that information is not being providedβ€”
[…]
[…]
(i)the criteria for inclusion and exclusion of patients, including justification for recruiting from vulnerable groups;
(i)the criteria for inclusion and exclusion of patients, including justification for recruiting from vulnerable groups;
}}

Latest revision as of 13:49, 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 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

Content

1. An application document including the following information or, in each case, an explanation of why that information is not being providedβ€” […] (i)the criteria for inclusion and exclusion of patients, including justification for recruiting from vulnerable groups;

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