Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Investigator/Institution: Difference between revisions
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| | | [[Glossary:TAG-00049-Ser-Ver|Serious breach]], [[Glossary:TAG-00246-Inv-hte|Investigator responsibilities]], [[Glossary:TAG-00148-Con-rsc|CRO]], [[Glossary:TAG-00151-Sta-rat|SOP]], [[Glossary:TAG-00017-Spo-die|Sponsor]] | ||
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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 | D
Investigator/Institution |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Serious breach, Investigator responsibilities, CRO, SOP, Sponsor |
| Comment | Investigator/institution obligations to report serious breaches |
Content
[...] Investigator/Institution: The investigator/institution (for example, vendor, CRO or investigator site) should also have a process in place to identify and notify the sponsor of serious breaches. This may be a formal SOP or detailed in the protocol or study-specific guidance. Consideration should be given to what actions to take if the Sponsor does not report the breach to the MHRA (due diligence is required – for example, should you continue with the trial? Should you report to the authorities?) [...]
