CASafetyReporting object

Sponsor must declare reportable events to

National CA
CA(s) of EU&EFTA Member States concerned

Reportable AEs

SAE (Serious Adverse Event)

SAE /SADE must be reported

Immediately
(Reportable events must be fully recorded)

Provision of Annual safety report mandatory

Yes

Applicable national legal framework/ Reference

Annex VII, Art 2 GDR 2009 (fr)

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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