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
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Document Information
| 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 |
Text
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.
