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
All other SUSAR must be reported
Within a max of 15d upon first knowledge
National Standard Reporting form available
Yes, electronic form of online portal 'Toetsing Online'
Reporting format - Options
Online portal
Preferred reporting format
Online portal
Online Safety Reporting Portal
Toetsing Online. SUSAR is then sent automatically to all involved parties
Guidance on AE reporting procedure available
Yes
Guidance on AE reporting procedure
Related information and examples of completed SAE and SUSAR form fromToetsing Online are provided on the CCMO website in section: Home>Investigators>During and after the research>SAEs/SUSARs
National legal framework in place
Yes
Applicable national legal framework/ Reference
SAE reporting requirements on medicinal products are regulated by section o-q WMO (en).
