Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.1: Difference between revisions
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{{ | {{ReferenceData | ||
| | |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=3.1 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00049-Ser-Ver ++ TAG-00262-CTI-Kli ++ TAG-00017-Spo-die ++ TAG-00147-Ser-inD ++ TAG-00111-Agr-chr | |||
|tags_display=[[Glossary:TAG-00049-Ser-Ver|Serious breach]], [[Glossary:TAG-00262-CTI-Kli|CTIS]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00147-Ser-inD|Vendor]], [[Glossary:TAG-00111-Agr-chr|Written agreement]] | |||
|comment=Who should notify serious breaches and process | |||
|content=3. How to report a serious breach | |||
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3. How to report a serious breach | |||
3.1. Who should notify | 3.1. Who should notify | ||
The sponsor is responsible for the notification via the EU portal and EU database - part of the Clinical Trials Information System (CTIS). The sponsor may delegate this task to a service provider by means of a written agreement as described in Article 71 of the Regulation (EU) No 536/2014. | The sponsor is responsible for the notification via the EU portal and EU database - part of the Clinical Trials Information System (CTIS). The sponsor may delegate this task to a service provider by means of a written agreement as described in Article 71 of the Regulation (EU) No 536/2014. | ||
}} | |||
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 — Unit 4.1.4 |
| Scope | G |
| Document part | 3.1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Serious breach, CTIS, Sponsor, Vendor, Written agreement |
Content
3. How to report a serious breach
3.1. Who should notify The sponsor is responsible for the notification via the EU portal and EU database - part of the Clinical Trials Information System (CTIS). The sponsor may delegate this task to a service provider by means of a written agreement as described in Article 71 of the Regulation (EU) No 536/2014.
