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Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix I: Difference between revisions

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{{#set:
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|HasDocument=Document:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020
|has_document=Document:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020
|RefScope=HM
|module=4
|RefDocPart=Appendix I
|unit=4.1.4
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|doc_part=Appendix I
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|language=EN
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|entry_by=Florian Adragna
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|contributors=
 
|tags=TAG-00049-Ser-Ver ++ TAG-00135-Inv-ntr ++ TAG-00324-Med-Age ++ TAG-00142-Mul-ent
{{:Document:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020}}
|tags_display=[[Glossary:TAG-00049-Ser-Ver|Serious breach]], [[Glossary:TAG-00135-Inv-ntr|Trial site]], [[Glossary:TAG-00324-Med-Age|MHRA]], [[Glossary:TAG-00142-Mul-ent|Multicentre trial]]
 
|comment=Reporting serious breaches at non-UK sites for UK trials
{| class="wikitable gplx-infobox"
|content=[...]
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| HM
|-
! Document part
| Appendix I
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags (EN)
|
|-
! Tags (original language)
|
|-
! Tags (FR)
|  
|-
! Comment
| Reporting serious breaches at non-UK sites for UK trials
|}
 
== Content ==
[...]
6. For trials that are on-going in the UK, should serious breaches that occur at non-UK sites be reported?
6. For trials that are on-going in the UK, should serious breaches that occur at non-UK sites be reported?
If a serious breach is identified at an investigator site outside the UK that has a significant impact on the integrity of trial subjects at that non-UK site and is likely to have a significant impact on the integrity of trial subjects in the UK, then this will require notification to the MHRA.
If a serious breach is identified at an investigator site outside the UK that has a significant impact on the integrity of trial subjects at that non-UK site and is likely to have a significant impact on the integrity of trial subjects in the UK, then this will require notification to the MHRA.
[...]
[...]
}}

Latest revision as of 13:50, 16 July 2026



Document information
Reference GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020
Validity area GBR
Scope(s) HM
Document name GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL
Version / Revision 08-Jul-2020
Status Current
Document type Official guideline
Language(s) EN
Description GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL
Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Module Module 4 — Unit 4.1.4
Scope HM
Document part Appendix I
Language EN
Original entry by Florian Adragna
Contributors
Tags Serious breach, Trial site, MHRA, Multicentre trial

Content

[...] 6. For trials that are on-going in the UK, should serious breaches that occur at non-UK sites be reported? If a serious breach is identified at an investigator site outside the UK that has a significant impact on the integrity of trial subjects at that non-UK site and is likely to have a significant impact on the integrity of trial subjects in the UK, then this will require notification to the MHRA. [...]

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