Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix I: Difference between revisions
From GxPlex
Gxplex admin (talk | contribs) m 1 revision imported |
gxplex>GxPlexBot Import from GxPlex Excel |
||
| Line 9: | Line 9: | ||
}} | }} | ||
{{:Document:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020}} | {{:Document:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020}} | ||
{| class="gplx-infobox" | |||
{| class=" | |||
|- | |- | ||
! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Scope | |||
| HM | | HM | ||
|- | |- | ||
! | ! Document part | ||
| Appendix I | | Appendix I | ||
|- | |- | ||
! | ! Language | ||
| EN | | EN | ||
|- | |- | ||
! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
|- | |- | ||
! | ! Contributors | ||
| | | | ||
|- | |- | ||
! | ! Tags (EN) | ||
| | | | ||
|- | |- | ||
! | ! Tags (original language) | ||
| | | | ||
|- | |- | ||
! | ! Tags (FR) | ||
| | | | ||
|- | |- | ||
! | ! Comment | ||
| Reporting serious breaches at non-UK sites for UK trials | | 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. | ||
[...] | [...] | ||
Revision as of 14:27, 29 June 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 | |
|---|---|
| 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? 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. [...]
