CASafetyReporting object
Sponsor
Principal Investigator (if no sponsor related to study)
National CA
EMA Eudravigilance CT Module (EVCTM)
Relevant EC(s)
SAE (Serious Adverse Event)
SUSAR (Suspected Unexpected Serious Adverse Reaction)
Within a max of 7d upon first knowledge (+ 8d for additional information)
Within a max of 15d upon first knowledge
No, European standard SUSAR reporting form CIOMS-I recommended
Online portal
Electronically
Sponsors shall report SUSARs to EMA´s database, EudraVigilance (IMA has access to information in the database and does not require copies of these reports). If the sponsor does not have access to the EudraVigilance, SUSARs should be reported to IMA electronically on CIOMS forms.
Yes
National CA
Relevant EC(s)
Yes
Related information is provided on the IMA website in section Home > Licences > Clinical Trials > SUSAR reporting (OR Home > Licences > Clinical Trials > Notification and Reports)
Yes
Art 29 Regulation no 443/2004
Art 33 Regulation no 433/2004
Sponsor (if AE is fatal, IMA and the EC concerned must also be notified)
Immediately (without delay)