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Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 29A: Difference between revisions

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|has_document=Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
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|tags=TAG-00049-Ser-Ver ++ TAG-00017-Spo-die ++ TAG-00057-Com-deR ++ TAG-00043-Goo-tek ++ TAG-00033-Pro-oto
{{:Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004}}
|tags_display=[[Glossary:TAG-00049-Ser-Ver|Serious breach]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00057-Com-deR|Competent authority]], [[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00033-Pro-oto|Protocol]]
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|comment=Sponsor obligation to notify licensing authority of serious breaches
{| class="wikitable gplx-infobox"
|content=29A. (1) The sponsor of a clinical trial shall notify the licensing authority in writing of any serious breach of -
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 4 β€” Unit 4.1.4
|-
! Scope
| HM
|-
! Document part
| Article 29A
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags
| [[Glossary:TAG-00049-Ser-Ver|Serious breach]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00057-Com-deR|Competent authority]], [[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00033-Pro-oto|Protocol]]
|-
! Comment
| Sponsor obligation to notify licensing authority of serious breaches
|}
Β 
== Content ==
29A. (1) The sponsor of a clinical trial shall notify the licensing authority in writing of any serious breach of -
(a) the conditions and principles of GCP in connection with that trial; or
(a) the conditions and principles of GCP in connection with that trial; or
(b) the protocol relating to that trial, as amended from time to time in accordance with regulations 22 to 25, within 7 days of becoming aware of that breach.
(b) the protocol relating to that trial, as amended from time to time in accordance with regulations 22 to 25, within 7 days of becoming aware of that breach.
Line 47: Line 17:
(a) the safety or physical or mental integrity of the subjects of the trial; or
(a) the safety or physical or mental integrity of the subjects of the trial; or
(b) the scientific value of the trial
(b) the scientific value of the trial
}}

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 4 β€” Unit 4.1.4
Scope HM
Document part Article 29A
Language EN
Original entry by Florian Adragna
Contributors
Tags Serious breach, Sponsor, Competent authority, Good clinical practice, Protocol

Content

29A. (1) The sponsor of a clinical trial shall notify the licensing authority in writing of any serious breach of - (a) the conditions and principles of GCP in connection with that trial; or (b) the protocol relating to that trial, as amended from time to time in accordance with regulations 22 to 25, within 7 days of becoming aware of that breach. (2) For the purposes of this regulation, a β€œserious breach” is a breach which is likely to effect to a significant degree – (a) the safety or physical or mental integrity of the subjects of the trial; or (b) the scientific value of the trial

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