Should annual reports on the safety of the research subjects be submitted?
Once a year, the sponsor must provide Fimea with a list of all suspected serious adverse reactions which have occurred during the period in question. The list should be accompanied by a short statement on the safety of the research subjects (section 10g of the Medical Research Act, as amended in Act 295/2004).
The DSUR Executive Summary or section 3.18 will not replace the brief report of the safety of the persons participating in the clinical trial because the focus of the sections. The brief report should be about the safety of the trial patients from the view of the clinical trial, taking into consideration all aspects of the clinical trial, not only the safety of the IMP. There are no detailed guidance of the format or the author of the report, but the author can be a person with medical education, for example the person in charge of the trial in Finland, the primary investigator or the medical adviser of the sponsor.
During the CTR (Clinical Trials Regulation (EU) 536/2014) transitional period of 31 January 2022 to 31 January 2025, please see further instructions from our website.