ECSafetyReporting object

Reportable AEs

SAE (Serious Adverse Event)
SUSAR (Suspected Unexpected Serious Adverse Reaction)

Investigator shall report SAE to

Sponsor

Reporting timeline

Immediately

Responsible for AE reporting to relevant EC(s)

Sponsor

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 SUSAR must be reported

Within a max of 15d upon first knowledge

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

Yes

Provision of Annual safety report mandatory

Yes

Applicable national legal framework/ Reference

Art 58-62 Ordin nr 904/2006

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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