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Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (5) (k)-(l): 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=2
|RefDocPart=Article 15
|unit=2.3.4
|scope=HM
|doc_part=Article 15
(5) (k)-(l)
(5) (k)-(l)
|RefLanguage=EN
|language=EN
|RefTagsEN=
|entry_by=Florian Adragna
|RefTagsOriginal=
|contributors=
|RefTagsFR=
|tags=TAG-00134-Eth-kom ++ TAG-00280-Fin-anT ++ TAG-00111-Agr-chr ++ TAG-00329-Saf-lne
}}
|tags_display=[[Glossary:TAG-00134-Eth-kom|Ethics committee]], [[Glossary:TAG-00280-Fin-anT|Participant compensation]], [[Glossary:TAG-00111-Agr-chr|Written agreement]], [[Glossary:TAG-00329-Saf-lne|Safety]]
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|comment=Ethics committee considerations for subject safety and rights
== Document Information ==
|content=Ethics committee opinion
{{:Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004}}
Β 
== Reference Details ==
{| class="wikitable" style="width:100%;"
|-
! scope="row" style="width:200px;" | Scope
| HM
|-
! scope="row" style="width:200px;" | Document part
| Article 15
(5) (k)-(l)
|-
! 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
| Ethics committee considerations for subject safety and rights
|}
Β 
== Text ==
Ethics committee opinion
15.β€” [...] Β 
15.β€” [...] Β 
(5) In preparing its opinion, the committee shall consider, in particular, the following mattersβ€”
(5) In preparing its opinion, the committee shall consider, in particular, the following mattersβ€”
(k)the amounts, and, where appropriate, the arrangements, for rewarding or compensating investigators and subjects;
(k)the amounts, and, where appropriate, the arrangements, for rewarding or compensating investigators and subjects;
(l)the terms of any agreement between the sponsor and the owner or occupier of the trial site which are relevant to the arrangements referred to in sub-paragraph (k)
(l)the terms of any agreement between the sponsor and the owner or occupier of the trial site which are relevant to the arrangements referred to in sub-paragraph (k)
}}

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 2 β€” Unit 2.3.4
Scope HM
Document part Article 15

(5) (k)-(l)

Language EN
Original entry by Florian Adragna
Contributors
Tags Ethics committee, Participant compensation, Written agreement, Safety

Content

Ethics committee opinion 15.β€” [...] (5) In preparing its opinion, the committee shall consider, in particular, the following mattersβ€” (k)the amounts, and, where appropriate, the arrangements, for rewarding or compensating investigators and subjects; (l)the terms of any agreement between the sponsor and the owner or occupier of the trial site which are relevant to the arrangements referred to in sub-paragraph (k)

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