Reporting of suspected unexpected serious adverse reactions (SUSARs) seen in clinical trials (e-form)
Reporting of suspected unexpected serious adverse reactions (SUSARs) seen in clinical trials (the form opens in a new window)
Clinical trial sponsors must report suspected unexpected serious adverse reactions (SUSARs) that arise in clinical trials. SUSARs must be reported throughout the entire trial period.
Before you submit a report, please note:
- It must be clearly stated that the investigator and/or the sponsor has assessed that the incident is associated with the investigational medicinal product and therefore is an adverse reaction
- It must appear from the report that the adverse reaction is serious
- It must appear from the report that the adverse reaction is unexpected in relation to the reference safety information
- SUSARs must be unblinded before they are submitted to the Danish Medicines Agency, and it must be clearly specified which investigational medicinal product the patient has received
Submission of follow-up information
In connection with the submission of follow-up information on a SUSAR, the new information must appear clearly from the report, and before the submission it should be considered carefully whether the new information is relevant. For example, minor changes of dates and typographical corrections are not relevant information, and laboratory results should be accompanied by a conclusion concerning the relevance to the current SUSAR.
Adverse reactions related to non-investigational medicinal products
An adverse reaction, which is exclusively suspected to be related to non-investigational medicinal products, and where there is no interaction with the investigational medicinal products, should not be reported in relation to the trial but should be reported as a spontaneous adverse reaction. Read more about the reporting of spontaneous adverse reactions on our website under Side effects from medicines.
Adverse reactions occurred in non-intervention trials
Adverse reactions arising in non-intervention trials must also be reported as spontaneous reports because these trials are not regulated by the clinical trials regulation.