SAEs and SUSARs
Depending on the type of research, adverse events such as SAEs and SUSARs can occur during the research. On this page you will find the definitions of SAEs and SUSARs. In addition, for each type of research a flowchart is available in order to determine what procedures need to be followed.
Please note! 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) can be found on the following pages: CTR safety report, MDR safety report and IVDR safety report.
SAE is short for Serious Adverse Event. An SAE is any untoward medical occurrence in a patient or trial subject, 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.
An SAE that occurs during research with a medicinal product may be a SAR or a SUSAR. SAR is the abbreviation for Serious Adverse Reaction, and SUSAR for Suspected Unexpected 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.
Article 17(1)(d) of Directive 2001/20/EC provides that ‘the sponsor shall also inform all investigators’. According to the CT-3 – guidance, the information should be concise and practical. Therefore, whenever practicable the information on SUSARs should be aggregated in a periodic line listing as warranted by the nature of the research and the volume of SUSARs generated. This line listing should be accompanied by a concise summary of the evolving safety profile of the Investigational Medicinal Product (IMP) and shared with the investigators.
The following flowcharts (in Dutch) give for each type of research an overview of the reporting procedure with a more detailed explanation, as well as the exceptions that apply.