Template for annual safety report of investigator-initiated research with a medicinal product
In response to an initiative of UMC Utrecht, the CCMO has made a template available for the annual safety report for investigator-initiated research with a medicinal product.
This is caused by the fact 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.