Every grade arrives with the criterion that produced it.
Capture by voice, note, or EHR sync. Grade against CTCAE v5 and v6 with the evidence span attached. Review, sign, and export with a complete audit trail.
CTCAE-v5.0-GI-0023
Nausea, Grade 2 criterion
Nausea
Grade 2 · ModerateCTCAE v5.0 · MedDRA 10028813 · Gastrointestinal disorders
Grade 2: Oral intake decreased without significant weight loss, dehydration, or malnutrition.
Evidence span: "only managed about half of most meals this week"
CTCAE-v5.0-GI-0023G2
Grade 2 · Moderate
number and word, color blind safe
Eight hundred and fifty terms, and the one your patient has.
Burna holds the whole CTCAE, both versions. When your note describes a toxicity, the engine retrieves the one criterion that governs it and binds the grade to that. The v6 revision carried 837 changes, and the engine runs both versions at once.
CTCAE v6.0 · GI-DIAR-3
Diarrhoea, Grade 3
Increase of ≥7 stools per day over baseline; hospitalization indicated.
Each mark is one CTCAE term. Burna retrieves the one that governs the event in front of you, and binds the grade to it.
Capture the encounter however your site already works.
Voice-first, ambient, or SMART on FHIR.
structured rows
ENC-2026-0142 · Amara Osei · Cycle 2, Day 3
“I have felt sick to my stomach since the third day after the infusion. I am keeping fluids down, but I have only managed about half of most meals this week.”
Transcribed live · voice note 00:42
Burna grades against the version your protocol names.
Dual-version v5/v6, evidence spans, and a named gap where the criteria run thin.
Nausea
Grade 2 · ModerateCTCAE v5.0 · MedDRA 10028813 · Gastrointestinal disorders
Grade 2: Oral intake decreased without significant weight loss, dehydration, or malnutrition.
Evidence span: "only managed about half of most meals this week"
CTCAE-v5.0-GI-0023Your clinician reviews every draft before it counts.
Edit in place. Dismissed events collapse and stay on the record.
ENC-2026-0142 · Amara Osei · 3 adverse events
The signature is what turns a draft into a record.
Your investigator signs with a statement of meaning under 21 CFR Part 11. The signature, the meaning and the moment are recorded together, so the record answers an auditor’s first questions without anyone opening a second system.
It leaves in the format your EDC expects.
The signed record leaves in the structure your EDC expects, carrying the criterion, the evidence span and the attribution with it. A monitor opening it six weeks later finds the answer already attached.
Both versions run at once. CTCAE v6.0 is live while ongoing trials still run v5.0, and each study is graded against the version its protocol names. 850 terms, 837 changes between the two versions, one engine.
The full CTCAE reference is searchable inside the product, both versions, no login required for browsing.