CCMO Template for annual safety report of investigator-initiated research with a medicinal product

The reason for this new template is that the safety reports of investigator-initiated research with a medicinal product often lack essential information for the review committees. Therefore, in the template all topics are discussed that need to be addressed in a safety report (development safety update report, DSUR).

In general, a safety report is submitted for each product, with data from multiple studies. A safety report for investigator-initiated research with a medicinal product will often be submitted for each study, unless the investigator has carried out several studies with the same medicinal product; in that case all data must be combined in the safety report.

The template is based on the ICH guideline E2F on development safety update report.

For more information, please consult the relevant news item on the CCMO website, which can be found here.