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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|  | | [[Glossary:TAG-00049-Ser-Ver|Serious breach]], [[Glossary:TAG-00019-Pri-Prü|Principal investigator]], [[Glossary:TAG-00257-Sit-zen|Site staff]], [[Glossary:TAG-00246-Inv-hte|Investigator responsibilities]] | ||
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Revision as of 17:29, 15 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 — 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 |
| Comment | Principal investigator obligations for breach detection |
Content
6.4. Principal Investigator The principal investigator should have a process in place to ensure that: • the site staff or service providers delegated by the principal investigator/institution are able to identify the occurrence of a (suspected) serious breach; • 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.
