Annual report and list of suspected serious adverse reactions
Once a year throughout the duration of the clinical trial period, the sponsor must provide a list of all suspected serious adverse reactions that occurred during the trial period and a report on the trial subjects' safety. The list and the report must be submitted to the competent authorities in the member states on whose territory the trial is conducted.
In case of non-marketed medicines, the annual report and the list of suspected serious adverse reactions can be replaced by a Development Safety Update Report (DSUR, ICH E2F). Read more about DSUR.
If marketed medicines are used in the clinical trial, the template on the website of the Danish GCP unit can be used for the annual safety report.
For further information, please see section 12.4 of the Guideline for applications for authorisation of clinical trials of medicinal products in humans.