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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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{{#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
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|scope=HM
|doc_part=Schedule 3
Part 1
Part 1
1. ; 3.
1. ; 3.
|RefLanguage=EN
|language=EN
|RefTagsEN=
|entry_by=Florian Adragna
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|contributors=
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|tags=TAG-00134-Eth-kom ++ TAG-00059-Reg-lat ++ TAG-00343-Doc-ten ++ TAG-00083-Enr-enr
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|tags_display=[[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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|comment=Documents required for ethics committee and authority applications
== Document Information ==
|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
{{: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. ; 3.
|-
! 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
| Documents required for ethics committee and authority applications
|}
Β 
== Text ==
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
PART 1
Line 61: Line 26:
(d)copies of the advertisement material for recruitment of research participants;
(d)copies of the advertisement material for recruitment of research participants;
[...]
[...]
}}

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 3.2.1
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

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 providedβ€” [...] (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 providedβ€” [...] (d)copies of the advertisement material for recruitment of research participants; [...]

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