Document:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021: Difference between revisions
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Revision as of 15:07, 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 | |
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| 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 | G | 3.1 | EN | 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 ... |
| 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 | G | 6.4 | EN | 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 ... |
| Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.2 | G | 3.2 | EN | 3.2. When should the notification be made? Without undue delay and at the latest within 7 calendar days of the sponsor becoming aware of a serious breach. If the sponsor has reasonable grounds based ... |
| 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 | G | 5.1 | EN | 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 ... |
| Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 4 | G | 4 | EN | 4. Clarification on reporting requirements • Serious breaches which occurred outside the EU/EEA while the application for a clinical trial authorisation (CTA) is submitted but not yet authorised in ... |
| Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 Appendix I | G | Appendix I | EN | Appendix I – Examples of serious breaches |
