CASafetyReporting object

Responsible for AE reporting to CA

Sponsor

Sponsor must declare reportable events to

National CA

Reportable AEs

SUSAR (Suspected Unexpected Serious Adverse Reaction)

SUSAR being life-thereatening or leading to death must be reported

Within a max of 7d upon first knowledge (+ 8d for additional information)

All other SUSARs

Within a max of 15d upon first knowledge

Provision of Annual safety report mandatory

Yes

Annual safety report shall be provided by sponsor to

National CA

Applicable national legal framework/ Reference

Art 58-63 Ordin nr. 904/2006

Investigator shall report SAE to

Sponsor

Reporting timeline

Immediately

Sponsor is obliged to notify all investigators of SAE/ SADE occurrence

Yes

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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