ECSafetyReporting object
Reportable AEs
SAE (Serious Adverse Event)
SUSAR (Suspected Unexpected Serious Adverse Reaction)
Investigator shall report SAE to
Sponsor
Reporting timeline
Immediately (without delay)
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
Guidance on AE reporting procedure
A detailed guideline on AE reporting obligations published by SUKL is available on the website:
“KLH-21 -Reporting Adverse Reactions to Medicinal Products for Human Use in a Clinical Trial and to Medicinal Products without Marketing Authorisation”
National legal framework in place
Yes
Additional Information
ad Annual Safety Report: A summary of the Annual Safety Report provided to the CA has to be submitted to the local EC or the MEC only.
