European Medicines Agency published a new Guideline on the reporting of Serious Breaches, that will come into effect on January 31, 2022.
✔ how to report serious breach
✔ responsibilities of the different parties involved in the notification
✔ examples of serious breaches
✔ template form for reporting
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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