The sponsor is required to ensure that each year a Development Safety Update Report (DSUR) on the medicinal product is submitted to the reviewing committee (MREC or CCMO) and the competent authority (CCMO or Ministry of Health, Welfare and Sport).
The DSUR contains at least:
- a list of all suspected (expected and unexpected) serious adverse reactions, along with an aggregate summary table of all reported serious adverse reactions, arranged by organ system, per study;
- a report concerning the safety of the subjects, consisting of a complete safety analysis and an evaluation of the balance between the efficacy and the harmfulness of the medicine under investigation.
Details on the safety report are available in the ICH Guideline E2F – Development Safety Update Report (DSUR). A DSUR may be combined with the progress report. In that case the (international) fixed date for the DSUR may be leading.
Safety reports must be submitted from the date of submission of the research file until the study has ended in the Netherlands. The end of the study is generally the last visit of the last patient, unless otherwise defined in the research protocol.