ECSafetyReporting object

Reportable AEs

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

Investigator shall report SAE to

Sponsor (if AE is fatal, IMA and the EC concerned must also be notified)

Reporting timeline

Immediately (without delay)

Responsible for AE reporting to relevant EC(s)

Principal Investigator (if no sponsor related to study)

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

Within a max of 7d upon first knowledge

All other SUSAR must be reported

Within a max of 15d upon first knowledge

Provision of Annual safety report mandatory


National legal framework in place


Applicable national legal framework/ Reference

Art 29,30,33 Regulation no 443/2004

Additional Information

Annual safety report is mandatory to be submitted to IMA and the NBC (Art 33 Regulation no 433/2004)