View source for 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: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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! Document part
| 5.1
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! Language
| EN
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! Original entry by
| Florian Adragna
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! Tags (original language)
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! Comment
| Definition of what needs to be reported as serious breach
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== 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.