L4. SAEs

SAE is short for Serious Adverse Event. An SAE is an undesired medical event involving a patient or test subject, which is not necessarily associated with the treatment, that:

• is fatal, and/or
• threatens the life of the subject, 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.
• 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.

Like SUSARs, SAEs can be reported through ToetsingOnline. In principle all individual SAEs must be reported. However, it can be indicated in the research protocol that certain SAEs will not be reported immediately, but instead will be sent periodically as an SAE overview to the reviewing committee. This approach does however require prior approval from the reviewing committee.