Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 6.4: Difference between revisions
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| | |has_document=Document:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 | ||
| | |module=4 | ||
| | |unit=4.1.4 | ||
| | |scope=G | ||
| | |doc_part=6.4 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
Β | |tags=TAG-00049-Ser-Ver ++ TAG-00019-Pri-PrΓΌ ++ TAG-00257-Sit-zen ++ TAG-00246-Inv-hte | ||
|tags_display=[[Glossary:TAG-00049-Ser-Ver|Serious breach]], [[Glossary:TAG-00019-Pri-PrΓΌ|Principal investigator]], [[Glossary:TAG-00257-Sit-zen|Site staff]], [[Glossary:TAG-00246-Inv-hte|Investigator responsibilities]] | |||
Β | |comment=Principal investigator obligations for breach detection | ||
|content=6.4. Principal Investigator | |||
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6.4. Principal Investigator | |||
The principal investigator should have a process in place to ensure that: Β | The principal investigator should have a process in place to ensure that: Β | ||
β’ the site staff or service providers delegated by the principal investigator/institution are able to identify the occurrence of a (suspected) serious breach; | β’ the site staff or service providers delegated by the principal investigator/institution are able to identify the occurrence of a (suspected) serious breach; | ||
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This may be a formal standard operating procedure or a study-specific guidance. | This may be a formal standard operating procedure or a study-specific guidance. | ||
}} | |||
Latest revision as of 13:50, 16 July 2026
| Document information | |
|---|---|
| Reference | EU EMA/698382/2021
- Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 |
| Validity area | EU |
| Scope(s) | G |
| Document name | EMA/698382/2021
- Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol |
| Version / Revision | 2021 |
| Status | Current |
| Document type | Official guideline |
| Language(s) | EN |
| Description | EMA/698382/2021
Quality and Safety of Medicines Department Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 β Unit 4.1.4 |
| Scope | G |
| Document part | 6.4 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Serious breach, Principal investigator, Site staff, Investigator responsibilities |
Content
6.4. Principal Investigator The principal investigator should have a process in place to ensure that: β’ the site staff or service providers delegated by the principal investigator/institution are able to identify the occurrence of a (suspected) serious breach; β’ a (suspected) serious breach is promptly reported to the sponsor or delegated party, through the contacts (e-mail address or telephone number) provided by the sponsor or delegated party;
This may be a formal standard operating procedure or a study-specific guidance.
