ECSafetyReporting object

Reportable AEs

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

Investigator shall report SAE to

Sponsor

Reporting timeline

Immediately (without delay)

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

Chapter 6 (11-18) LVFS 2003:6

Additional Information

In case of acute danger or risk to the study participants, the sponsor is obliged to inform the CA and the EC without delay of the measure taken (Chapter 6 (4) LVFS 2003:6)

NB: In practice, ECs do NOT want undigested SAE or SUSARS. They accept national reports, but prefer a report with a statement if the event affects the risk-benefit evaluation]

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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