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pro-ctcae-patient-reporting
How does Burna AI handle a Grade 3 or higher patient-reported event?
When a patient self-reports a Grade 3 or higher adverse event via PRO-CTCAE, the assigned provider receives an automatic notification with a time-based action deadline. The case lands in the Symptom Management queue in the provider app with the full grade proposal, source citation, and rationale. The clinician reviews, edits if needed, signs with 21 CFR Part 11 e-signature, and the event flows into the encounter record with full audit trail.