Personal tools

Sponsorname

Your company could advertise here

www.fla-consulting.eu

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

From GxPlex

Jump to: navigation, search
← Older editNewer edit →
m 1 revision imported
gxplex>GxPlexBot
Import from GxPlex Excel
Line 9: Line 9:
}}
}}


== Document Information ==
{{:Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004}}
{{:Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004}}


== Reference Details ==
{| class="gplx-infobox"
{| class="wikitable" style="width:100%;"
|-
|-
! scope="row" style="width:200px;" | Scope
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| HM
| HM
|-
|-
! scope="row" style="width:200px;" | Document part
! Document part
| Article 29A
| Article 29A
|-
|-
! scope="row" style="width:200px;" | Language
! Language
| EN
| EN
|-
|-
! scope="row" style="width:200px;" | Original entry by
! Original entry by
| Florian Adragna
| Florian Adragna
|-
|-
! scope="row" style="width:200px;" | Contributors
! Contributors
|  
|  
|-
|-
! scope="row" style="width:200px;" | Tags (EN)
! Tags (EN)
|  
|  
|-
|-
! scope="row" style="width:200px;" | Tags (original language)
! Tags (original language)
|  
|  
|-
|-
! scope="row" style="width:200px;" | Tags (FR)
! Tags (FR)
|  
|  
|-
|-
! scope="row" | Comment
! Comment
| Sponsor obligation to notify licensing authority of serious breaches
| Sponsor obligation to notify licensing authority of serious breaches
|}
|}


== Text ==
== Content ==
29A. (1) The sponsor of a clinical trial shall notify the licensing authority in writing of any serious breach of -
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

Revision as of 14:27, 29 June 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
Scope HM
Document part Article 29A
Language EN
Original entry by Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment Sponsor obligation to notify licensing authority of serious breaches

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 “serious 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

Retrieved from "https://gxplex.org/index.php?title=Reference:GBR_The_Medicines_for_Human_Use_(Clinical_Trials)_Regulations_2004_01-May-2004_Article_29A&oldid=7888"