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PRO-CTCAE AND PATIENT REPORTING

How does Burna AI capture patient-reported symptoms in a clinical trial?

Through Healthnotes, the participant app a sponsor deploys through its sites. A site issues the participant a PRO token from app.burna.ai, tied to the study and the site; the participant opens it in Healthnotes, and the token is the login. At each check-in the participant answers PRO-CTCAE questions in NCI's exact wording, plus any red-flag questions the protocol defines. Those answers are stored exactly as given, as the participant's own report, and each reported symptom is recorded as evidence. Separately, when the site's encounter is graded, the engine reads those reports and proposes CTCAE grades, each with its source, for a clinician to review, edit and sign under 21 CFR Part 11. A sponsor can also compose and schedule a study's questionnaires and publish them to participants without an app release.

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