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L1. SUSARs

SUSAR is the abbreviation of Suspected Unexpected Serious Adverse Reaction.

Criteria

If an adverse reaction arises during a study in the patient/subject, then this is deemed to be a SUSAR if the following three criteria are met:

1. The event must be serious, that is to say, the event (regardless of the dose):

  • 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.

2. There must be a certain degree of probability that the event is a harmful and undesirable reaction to the medicinal product under investigation, regardless of the administered dose (in other words, there is an adverse reaction).

3. The adverse reaction must be unexpected, that is to say, the nature and severity of the adverse reaction are not in agreement with the product information as recorded in:

  • for an authorised medicine: the SPC text (Summary of Product Characteristics; in the Netherlands this is the IB1 text). In the case of an international multicentre research with an authorised product, the sponsor may choose an SPC. If there is, in comparison to the authorisation, a different dosage form, indication, patient group or dose, then the summary of the product information must be supplemented with the relevant information for the concerned study.
  • for a non-authorised medicine: the Investigator’s Brochure.

When to send (accelerated) reports and to which authority/authorities?

SUSARs must be reported to the reviewing committee (accredited MREC or CCMO), to the competent authority (CCMO or Ministry of Health, Welfare and Sport), the Medicines Evaluation Board (MEB) and the accredited institutions in other involved member states. The reviewing committee only receives accelerated reports, i.e. within the legally defined term of 7 or 15 days, for the following SUSARs:

  • SUSARs that have arisen in the study that was reviewed by the review committee;
  • SUSARs that have arisen in other studies of the same sponsor and with the same medicinal product and that could have consequences for the safety of the subjects involved in the study reviewed by the review committee.

None of the remaining SUSARs need to undergo accelerated reporting to the reviewing committee. These are included in an overview line listing that must be submitted to the reviewing committee once every six months. This line listing provides an overview of all SUSARs of the research medicinal product.

The competent authority and the MEB must receive accelerated reports of all SUSARs. SUSARs that have already been reported to the EMA Eudravigilance database do not need to be reported again to the competent authority and the MEB, as both have direct access to the Eudravigilance database. A sponsor can request a waiver for this at the MEB 

Reporting in ToetsingOnline

For studies with an NL-number (all studies submitted after 1st of March 2006) all SUSARs have to be reported through the webportal ToetsingOnline. When submitted via ToetsingOnline, the SUSAR will automatically be forwarded to all organisations involved in SUSAR reporting in the Netherlands: the reviewing committee (MREC or CCMO), the competent authority (CCMO or Ministry of Health, Welfare and Sport) and the Medicine Evaluation Board (CBG-MEB).

Reporting outwith of ToetsingOnline

If you report your SUSAR outwith of ToetsingOnline you can use one of the following templates. A SUSAR report form is available on this website. Other examples can be found on the websites of CIOMS, the Council for International Organizations of Medical Sciences, and Medwatch, the Safety Information and Adverse Event Reporting Program of the U.S. Food and Drug Administration