ECSafetyReporting object
Reportable AEs
SAE (Serious Adverse Event)
SUSAR (Suspected Unexpected Serious Adverse Reaction) occurring in the respective country
Investigator shall report SAE to
Sponsor
Reporting timeline
Immediately
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
Provision of Annual safety report mandatory
Yes