ECSafetyReporting object
Reportable AEs
SAE (Serious Adverse Event)
SUSAR (Suspected Unexpected Serious Adverse Reaction)
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
National Standard Reporting form available
No
Standard Reporting Form
Only standard 'Safety Report Cover form' (Form 5) for Annual safety report (available on the website of the Department of Health in section: Policy A-Z>C>Clinical Trials Involving Medicinal Products>Application Forms.
Provision of Annual safety report mandatory
Yes
Guidance on AE reporting procedure
Details on AE reporting procedures (expedited and annual safety reports) is provided in the Guidance booklet on applications to Recognised Ethics Committees (RECs), are available on the website of the Department of Health in section: Policy A-Z>C>Clinical Trials Involving Medicinal Products
