Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 5.1: 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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! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
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! Scope | |||
| G | | G | ||
|- | |- | ||
! | ! Document part | ||
| 5.1 | | 5.1 | ||
|- | |- | ||
! | ! Language | ||
| EN | | EN | ||
|- | |- | ||
! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
|- | |- | ||
! | ! Contributors | ||
| | | | ||
|- | |- | ||
! | ! Tags (EN) | ||
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! | ! Tags (original language) | ||
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! | ! Tags (FR) | ||
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|- | |- | ||
! | ! Comment | ||
| Definition of what needs to be reported as serious breach | | Definition of what needs to be reported as serious breach | ||
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== | == Content == | ||
5.1. What needs to be reported? | 5.1. What needs to be reported? | ||
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 | 5.1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Definition of what needs to be reported as serious breach |
Content
5.1. What needs to be reported?
Any breach of: • The Regulation (EU) No 536/2014. or • The clinical trial protocol version applicable at the time of the breach. which is likely to affect to a significant degree: • The safety of a trial participant. and/or • The rights of a trial participant. and/or • The reliability and robustness of the data generated in the clinical trial. is serious and should be notified.
