Written from a locked record
The summary is drafted only after safety database lock, so the narrative never has to be revised for a database that's still moving.
What's included
What goes into the summary
- The full case series summarized from the locked safety database, following safety database lock
- SAE incidence, seriousness, causality, and outcome tabulated and written up in CSR-ready narrative form
- Findings cross-checked against the final DSUR and any SUSAR reports filed during the study
- Narrative language and terminology aligned to MedDRA-coded terms so the CSR and safety database read consistently
- A traceable summary handed to medical writing with every statement linked back to its source case
Handed off, not handed over
Feeds directly into medical writing for CSR assembly, with the same team that processed the cases standing behind the narrative.
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