Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
European Medicines Agency published a new Guideline on the reporting of Serious Breaches, that will come into effect on January 31, 2022.
Find out:
✔ how to report serious breach
✔ responsibilities of the different parties involved in the notification
✔ examples of serious breaches
✔ template form for reporting
Read more.
Regulation (EU) Nº 536/214 CTR defines ”Serious Breach” as any deviation of the approved protocol version or the clinical trial regulation that is likely to affect the safety, rights of trial participants and/or data reliability and robustness to a significant degree in a clinical trial.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
