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| <noinclude>{{#set:
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| |DocReference=EU EMA/698382/2021
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| -
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| Guideline for the notification of serious breaches of
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| Regulation (EU) No 536/2014 or the clinical trial protocol 2021
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| |DocValidityArea=EU
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| |DocScopes=G
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| |DocName=EMA/698382/2021
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| -
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| Guideline for the notification of serious breaches of
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| Regulation (EU) No 536/2014 or the clinical trial protocol
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| |DocVersion=2021
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| |DocStatus=Current
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| |DocType=Official guideline
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| |DocLanguage=EN
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| |DocDescription=EMA/698382/2021
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| Quality and Safety of Medicines Department
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| Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
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| |DocRestricted=No
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| |DocSubmittedBy=Florian Adragna
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| |DocContributors=
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| }}</noinclude>
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| {{DocumentBox
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| |reference=EU EMA/698382/2021 | | |reference=EU EMA/698382/2021 |
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| <noinclude>
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| == References ==
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| {| class="wikitable"
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| ! Reference !! Scope !! Document part !! Language !! Preview
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| | [[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 ...
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| | [[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 ...
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| | [[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 ...
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| | [[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 ...
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| | [[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 ...
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| | [[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
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| |}
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| </noinclude>
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