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Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 3: Difference between revisions

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{{#set:
{{ReferenceData
|HasDocument=Document:GBR Directive 2001/20/EC 04-Apr-2001
|has_document=Document:GBR Directive 2001/20/EC 04-Apr-2001
|RefScope=HM
|module=5
|RefDocPart=Article 3
|unit=5.5.0
|RefLanguage=EN
|scope=HM
|RefTags=TAG-00072-Ins-her ++ TAG-00025-Sub-mer ++ TAG-00017-Spo-die ++ TAG-00018-Inv-die
|doc_part=Article 3
|RefModule=5
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|entry_by=Florian Adragna
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|contributors=
 
|tags=TAG-00072-Ins-her ++ TAG-00025-Sub-mer ++ TAG-00017-Spo-die ++ TAG-00018-Inv-die
{{:Document:GBR Directive 2001/20/EC 04-Apr-2001}}
|tags_display=[[Glossary:TAG-00072-Ins-her|Insurance]], [[Glossary:TAG-00025-Sub-mer|Trial participant]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00018-Inv-die|Investigator]]
 
|comment=Insurance requirement for clinical trial participation
{| class="wikitable gplx-infobox"
|content=Protection of clinical trial subjects
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 5 — Unit 5.5.0
|-
! Scope
| HM
|-
! Document part
| Article 3
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags
| [[Glossary:TAG-00072-Ins-her|Insurance]], [[Glossary:TAG-00025-Sub-mer|Trial participant]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00018-Inv-die|Investigator]]
|-
! Comment
| Insurance requirement for clinical trial participation
|}
 
== Content ==
Protection of clinical trial subjects
[…]
[…]
2. A clinical trial may be undertaken only if, in particular:
2. A clinical trial may be undertaken only if, in particular:
[…]
[…]
(f) provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor.
(f) provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor.
}}

Latest revision as of 13:50, 16 July 2026



Document information
Reference GBR Directive 2001/20/EC 04-Apr-2001
Validity area GBR
Scope(s) HM
Document name Directive 2001/20/EC
Version / Revision 04-Apr-2001
Status Current
Document type Legal act
Language(s) EN
Description DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL - of 4 April 2001

on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use

The European Directive (2001/20/EC) no longer applies in the UK. The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations amend the Medicines for Human Use (Clinical Trials) Regulations 2004 to enable the MHRA to operate as a regulator outside the EU.

Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Module Module 5 — Unit 5.5.0
Scope HM
Document part Article 3
Language EN
Original entry by Florian Adragna
Contributors
Tags Insurance, Trial participant, Sponsor, Investigator

Content

Protection of clinical trial subjects […] 2. A clinical trial may be undertaken only if, in particular: […] (f) provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor.

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