Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix II: Difference between revisions
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| | | [[Glossary:TAG-00049-Ser-Ver|Serious breach]], [[Glossary:TAG-00327-Exa-spi|Examples]], [[Glossary:TAG-00324-Med-Age|MHRA]] | ||
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Revision as of 17:29, 15 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 II |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Serious breach, Examples, MHRA |
| Comment | Examples of serious breaches notified to MHRA |
Content
Appendix II Examples of Serious Breaches Notified to MHRA (this is not an exhaustive list)
