CASafetyReporting object
Responsible for AE reporting to CA
Sponsor
Other
Sponsor or other organization designated by sponsor
Sponsor must declare reportable events to
Competent Authority
CA(s) of EU&EFTA Member States concerned
Relevant EC(s)
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
Reporting format - Options
Online portal
Provision of Annual safety report mandatory
Yes
Annual safety report shall be provided by sponsor to
National CA
Relevant EC(s)
Investigator shall report SAE to
Sponsor
Reporting timeline
Immediately (not later than 24h)
Followed by detailed written report within 5d