Narrative descriptions that tell the clinical story — Safety Reporting and Pharmacovigilance for CRCs

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Two narratives, one event

Consider two descriptions of the same adverse event -- a participant who developed gastrointestinal symptoms during a clinical trial.

The first: "Patient had stomach problems. Was treated. Got better."

The second: "A 62-year-old male with a history of gastroesophageal reflux disease (GERD) developed Grade 2 nausea and vomiting on Study Day 14, eight days after the second dose of study drug (400 mg IV). Symptoms began approximately four hours after infusion completion. Ondansetron 4 mg IV was administered, followed by oral ondansetron 8 mg twice daily for three days. Study drug was not modified. The event resolved on Study Day 17. The investigator assessed the event as possibly related to the study drug, noting the temporal association with infusion and the participant's prior GERD history as a potential confounding factor."

Both describe the same clinical event. But only one is usable. The first tells you almost nothing -- who is this patient? What stomach problems? When did they start? What treatment? What does "got better" mean clinically? The second tells a complete story in 95 words: who the participant is, what happened, when it happened relative to drug exposure, what was done about it, what the outcome was, and what the investigator concluded about causality. A safety reviewer reading the second narrative can assess the event without requesting a single clarification.

This is the difference between documentation and narrative. Documentation captures data points. Narrative imposes clinical logic on those data points, arranging them in a sequence that conveys meaning. And in safety reporting, meaning is what matters. A safety database full of data points without clinical context is a collection of facts that no one can interpret. A safety database populated by well-written narratives is a tool that protects participants.