CASafetyReporting object

Responsible for AE reporting to CA

Sponsor

Sponsor must declare reportable events to

National CA
CA(s) of EU&EFTA Member States concerned
Relevant EC(s)
All investigators

Reportable AEs

SAE (Serious Adverse Event)
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
Relevant EC(s)

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)

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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