What's included

What goes into DSUR preparation

• Development Safety Update Reports (DSURs) compiled on schedule and reconciled against ICSR processing records
• PSURs and sponsor-specific periodic summaries prepared from the same case data, with no separate reconciliation step
• Signal-informed summaries that reflect findings from ongoing signal review, not compiled independently of it
• Reports drafted against a documented, agreed format so health authority submission is never a last-minute assembly job
• A defensible narrative sponsors can stand behind under agency review