ECSafetyReporting object

Reportable AEs

Not specified

Investigator shall report SAE to

Sponsor
Sponsor

Reporting timeline

Immediately

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

Not specified

All other SUSAR must be reported

Not specified

Provision of Annual safety report mandatory

No

Applicable national legal framework/ Reference

Chapter 7 of Regulation 2009 for clinical trials

Additional Information

No reports on side effects and SUSARs (as a matter of routine) shall be sent to REC
(furhter details provided on REK website in section Rules and Procedures > Procedures for Project Reports)

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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