Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix I
From GxPlex
| 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 â 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. [...]
