Written against the case, not around it
Narratives are drafted from the same case record pharmacovigilance maintains, so the clinical description and the safety database agree from the first draft.
What's included
What goes into a safety narrative
- Narrative drafted from the case source data as soon as an event meets the reporting threshold, not batched for later
- Clinical course, relevant medical history, and outcome described in the structure health authorities expect for expedited and periodic reports
- Case facts checked directly against the pharmacovigilance case record before the narrative is finalized
- Causality assessment and investigator comments incorporated as they're received from site
- Narrative held current for reuse in interim reports, DSURs, and the eventual CSR patient narratives
Reused, not rewritten
Narratives drafted during conduct feed directly into interim CSR/DSUR support, so the same case isn't written from scratch twice.
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