Built from live case narratives
Interim reports draw directly on safety narrative writing, so cases already documented during conduct don't get rewritten for each report.
What's included
What goes into interim reporting support
- Interim CSR sections drafted against the current data cut, following ICH E3 structure so nothing needs restructuring at final writing
- DSUR sections drafted on the annual reporting cycle, incorporating cumulative safety data across the reporting period
- Case narratives reused directly from ongoing safety narrative writing rather than redrafted for the report
- Data consistency checked against the current tables and listings before each interim submission
- Document structured to carry forward into the final CSR shell, so interim work isn't discarded at database lock
A running start on the final CSR
Interim reporting work carries forward into the CSR shell and eventual CSR full writing, instead of starting over at database lock.