What happens when a trial participant reports a severe symptom in Healthnotes?

The site sees it as urgent, and a clinician decides what it means. If a participant's check-in answers trip a red-flag question the protocol defines, such as a fever above a set temperature, the submission is marked urgent in the Symptom Management queue on app.burna.ai straight away. The participant's answers are their own report, not a grade. When the encounter is graded, the engine proposes CTCAE grades from those reports with their source, and a proposed grade of 3 or higher also marks the submission urgent. A clinician reviews the proposal, edits it if needed and signs under 21 CFR Part 11 before it becomes part of the record. Severity and seriousness are separate questions: a grade 3 event is not automatically a serious adverse event, and whether an event meets the serious criteria is the investigator's determination.