ECSafetyReporting object
Reportable AEs
SAE (Serious Adverse Event)
SUSAR (Suspected Unexpected Serious Adverse Reaction)
Investigator shall report SAE to
Sponsor
Reporting timeline
Immediately
Sponsor is obliged to notify all investigators of SAE/ SADE occurrence
Yes
Provision of Annual safety report mandatory
Yes
Additional Information
The investigator must communicate to the sponsor and the relevant EC any information requested by them about deaths of research subjects (pursuant to Section 10e of Act No. 488/1999).
Ad Annual Safety Report: The sponsor must compile and submit a list of SUSARS identified in connection with the trial must be submitted to the relevant EC according to Section 10g of Act No. 488/1999. The lists must be accompanied by reports on the safety of subjects and the investigator’s opinion on the impacts of the reported cases.
