Your note becomes a signed, cited, attributed grade in seven steps.
Below, one toxicity makes the whole trip. It’s the same walkthrough your monitor gets at a monitor visit, and the same one your IT reviewer can take apart.
- 01the note
Day 8 of cycle 3. Loose stools, more than yesterday.
- 02extraction
Loose stools, more than yesterday
- 03the criterion
CTCAE v6.0
GI-DIAR-3 - 04the grade
G3
- 05attribution
pembrolizumab
probable - 06signature
signed by your
investigator - 07the reports
IRB
sponsor
FDA
Figure 1. One toxicity, seven steps, from the note as written to the reports that leave your site.
The note
The note as written. Voice, text, or EHR.
ENC-2026-0412 · Amara Osei · Cycle 3 Day 1
S: Pt reports loose stools since cycle 2 day 3, now about 6 stools/day over baseline. Endorses dizziness on standing, resolving after a few seconds. Denies fever or blood in stool. Oral intake fair, pushing fluids.
O: BP 104/68 sitting, 92/60 standing. HR 88. Afebrile. Abdomen soft, non-tender. Skin turgor slightly reduced.
A/P: Likely treatment-related diarrhea on FOLFOX. Loperamide per protocol, oral hydration. Recheck labs today.
Extraction
Negations and clinician-stated grades are kept whole.
ENC-2026-0412 · Amara Osei · Cycle 3 Day 1
S: Pt reports loose stools since cycle 2 day 3, now about 6 stools/day over baseline. Endorses dizziness on standing, resolving after a few seconds. Denies fever or blood in stool. Oral intake fair, pushing fluids.
EXTRACTED TERMS
Diarrhea
Dizziness
Criteria
For each term, Burna retrieves the governing criterion from CTCAE v5.0 or v6.0, matched to the study's version. 850 terms, both versions, one engine.
Diarrhea
CTCAE v6.0Gastrointestinal disorders
Grade + citation
Where the evidence runs thin, Burna returns a 'cannot grade' state and names the gap.
G3
Grade 3 · Diarrhea
Increase of 7 or more stools per day over baseline; hospitalization indicated; limiting self-care ADL.
CTCAE v6.0 · GI-DIAR-3
cannot grade · returned when evidence is insufficient, with the gap named
Attribution
Comorbidities, concomitant medications and regimen composition are carried into the scoring, because an event that is true may still have another cause. The investigator sees the reasoning, and decides.
ATTRIBUTION · WHO-UMC + KRAMER
42 regimen profiles · 26 organ system classes
Review + signature
The clinician accepts, edits, or rejects. The signature is 21 CFR Part 11 aligned. The audit trail records what the AI suggested and what the human decided.
Signed: Dr. N. Adeyemi · 21 CFR Part 11
AI suggested G3 · clinician accepted
The reports come out of the signed record.
From the signed record, Burna generates the IRB report, the sponsor report and the FDA submission. The narrative arrives already written, and the packet arrives assembled.
IRB report
Site-facing safety report, built from the signed grade, its criterion and its attribution.
Sponsor report
Cross-site graded events with the evidence span and the scoring behind each attribution.
FDA submission
MedWatch-ready narrative that arrives already written.
Real time is structural.
Adding real time to a batch system is a rebuild. Burna was built on real-time infrastructure, so a grade 3 event at one site reaches the programme in seconds.
Figure 2. Propagation.
We chose this scope, and we hold to it.
The engine grades adverse events and scores attribution. Dose decisions remain with the treating clinician; response assessment remains with RECIST readers. That focus is what keeps every citation exact and every output inspectable.