ECSafetyReporting object

Reportable AEs

SAE (Serious Adverse Event)

Additional Information

All SAEs must be fully recorded and immediately notified to all CAs of the Member States in which the clinical investigation is being performed.
(Annex X, Art 2 Regulation no. 934/2010)

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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