CASafetyReporting object

Sponsor
Legal representative domiciled in the EU/EEA

No

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

(1) Online Portal for investigator initiated research: As of the 1st of January 2010 investigators are required to report serious effects and events (SUSARs and SAEs) via ToetsingOnline. (2) Other: by e-mail (maximum 8 MB) or by cd-rom

Toetsing Online (for investigator initiated research)

Yes

National CA

Yes

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

Yes

SAE reporting requirements on medicinal products are regulated by section o-q WMO (en)

General reporting obligations in the Netherlands:
SUSARs have to be reported to:
• the reviewing committee (MREC/METC or CCMO)
• the CA (CCMO or VWS)
• the Medicines Evaluation Board (MEB)

NB! Specific reporting obligations:
• Multi-national trials: SUSARs must be reported to the CA in other involved EU member states (depending on the country-specific reporting regulations). If the SUSAR has already been reported in the EudraVigilance database, then declaration to the national CA is not required. Note: SUSARs shall not be reported twice!
• Gene Therapy: SAEs and SUSARs which occur during a research on gene therapy must also be reported to the Gene Therapy Office.

Note: any reports to the CA must be submitted digitally. The CA does not send a confirmation of receipt.