CASafetyReporting object
Responsible for AE reporting to CA
Sponsor
Sponsor must declare reportable events to
Competent Authority
All investigators
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
National standard reporting form available
No
Preferred format
Online portal
Online Safety Reporting Portal
Sponsors, or delegated Contract Research Organizations (CROs), are required to send SUSARs only to the EudraVigilance Clinical Trial Module (EVCTM)., following the
"Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’) (2011/C 172/01)"
Provision of Annual safety report mandatory
Yes
Annual safety report shall be provided by sponsor to
National CA
