Adverse Events (SAEs, SUSARs, SADEs, etc.)

During the clinical trial a participant may experience so-called Adverse Events. The research protocol should describe how to deal with these types of events.
All Serious Adverse Events (SAEs) , Serious Adverse Reactions or Suspected Unsuspected Serious Adverse Reactions (SUSARs) must be reported to the reviewing MREC. Exceptions thereof can be described in the clinical trial protocol.
The reports may be comprised in a quarterly, semi-annual of annual line-listing. The line-listing mention events for which no immediate reporting is required.

Serious Adverse Event

SAE (Serious Adverse Event) is any untoward medical occurrence in a patient or trial participant, which does not have a causal relationship with the treatment, and:

is fatal, and/or
is life-threatening for 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, 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.

SUSAR

An SAE that occurs during research with a medicinal product may be a SAR or a SUSAR. SUSAR is short for Suspected Unexpected Serious Adverse Reaction. Sometimes also SAR is used. SAR stands for Serious Adverse Reaction.

An SAE that occurs during research with a medicinal product is a SAR if there is a certain degree of probability that the SAE is a harmful and undesired reaction to the investigational medicinal product, regardless of the administered dose. If the SAR is unexpected it is called a SUSAR. In this case ‘unexpected’ means that the nature and severity of the SAR do not match with the reference safety information (RSI) as included in the SPC text or Investigator’s Brochure.

SUSARs have to be reported to the reviewing MREC from the moment the dossier is submitted. This can be foreign SUSARs or SUSARs from the same medicinal product that occurred in a different study by the same sponsor if this information may have consequences for the safety of the research subjects in the study that is submitted for review.

SADE

An SAE that occurs during research with a medical device may be a SADE. SADE is the abbreviation for Serious Adverse Device Effect.

When and where must an event be reported?

A fatal SAE and/or life-threatening for the participant must be reported to the reviewing MREC and the CCMO within 7 days after the sponsor has been made aware.

SAEs that fall within the other categories must be reported within 15 days.

How must it be reported?

Investigator initiated research
SAEs can be reported via the portal in ToetsingOnline.
The MREC will be notified of a new report. The notification will be reviewed and saved in ToetsingOnline. The applicant receives a copy of the review via email.

Sponsored clinical trial
In case of a sponsor is a commercial profit-seeking party, SAEs can be submitted for review via email, CD-ROM or USB drive.

Flowcharts.

The CCMO has some flowcharts (in Dutch) which give for each type of research an overview of the reporting procedure with a more detailed explanation, as well as the exceptions that apply.