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)
Sponsor
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
Yes
National legal framework in place
Yes
Additional Information
Annual safety report is mandatory to be submitted to IMA and the NBC (Art 33 Regulation no 433/2004)
