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SAEs

SAEs may occur during research. The information on this page is only applicable to research with a medicinal product that is subject to the Dutch WMO Act (under previous legislation). Information on reporting adverse events during research with medicinal products under CTR, medical devices (MDR) and in-vitro diagnostics (IVDR) is available on the following pages: CTR safety report, MDR safety report and IVDR safety report.

SAE

SAE is short for Serious Adverse Event. An SAE is any untoward medical occurrence in a patient or research participant, which does not have a causal relationship with the treatment, and:

  • is fatal, and/or
  • is life-threatening for the particpant, and/or
  • makes hospital admission or an extension of the admission necessary, and/or
  • causes persistent or significant invalidity or work disability, and/or
  • manifests itself in a congenital abnormality or malformation, and/or
  • could, according to the person that carries out the research, have developed to a serious undesired medical event, but was however prevented due to premature interference.

Flowcharts

The following flowchart (in Dutch) offers an overview of the reporting procedure with a more detailed explanation, also pointing out the exceptions.

Download Flowchart adverse events observational and other research subject to the WMO (in Dutch)

A sample form is available, showcasing the questions to be answered.

Attention: This form is only a sample template of the questionnaire that must be completed online. It cannot be filled in or submitted in this format.

Research with a medicinal product that is subject to the Dutch WMO Act (under previous legislation), not having been migrated to CTR

SUSARs (Suspected Unexpected Serious Adverse Reactions) must be submitted until the termination of the study in the Netherlands. After that submitting SUSARs is no longer required, unless in the long run information becomes available that can also be relevant for research participants in the Netherlands.