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
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
NoMA only requires that SUSARs originated in patients in Norway are reported.
Reporting format - Options
Other
SUSARs should be reported electonically through the EMEA EudraVigilance database. If electronical reporting is not possible, the CIOMS-form should be used.
Provision of Annual safety report mandatory
Yes
Annual safety report shall be provided by sponsor to
National CA
CA(s) of EU&EFTA Member States concerned
Additional Information
Investigator shall report SEA to sponsor
Investigator shall report SAE to
Sponsor
Sponsor
Reporting timeline
Immediately