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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{{:Document:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021}} | {{:Document:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021}} | ||
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{| class=" | |||
|- | |- | ||
! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Scope | |||
| G | | G | ||
|- | |- | ||
! | ! Document part | ||
| 3.1 | | 3.1 | ||
|- | |- | ||
! | ! Language | ||
| EN | | EN | ||
|- | |- | ||
! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
|- | |- | ||
! | ! Contributors | ||
| | | | ||
|- | |- | ||
! | ! Tags (EN) | ||
| | | | ||
|- | |- | ||
! | ! Tags (original language) | ||
| | | | ||
|- | |- | ||
! | ! Tags (FR) | ||
| | | | ||
|- | |- | ||
! | ! Comment | ||
| Who should notify serious breaches and process | | Who should notify serious breaches and process | ||
|} | |} | ||
== | == Content == | ||
3. How to report a serious breach | 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. | ||
Revision as of 14:27, 29 June 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 | |
|---|---|
| Scope | G |
| Document part | 3.1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Who should notify serious breaches and process |
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.
