MedDRA coding, produced by the same engine that grades CTCAE.
Coding happens inside grading, as one workflow. Every adverse event Burna grades for you carries its MedDRA v28.0 LLT code, with the source sentence attached and the CTCAE criterion alongside.
E2B(R3) · case output
Argus · Veeva · ArisGlobal
encoded record · ENC-2031
Anemia
meddra v28.0 · coded in the same pass
source sentence · attached
“Hemoglobin 7.4 g/dL on day 8; transfusion given.”
the coder no longer reads the same note twice
Coding happens inside grading, as one workflow.
The line your clinician wrote
CTCAE v6.0
MedDRA lowest level term
“8 to 9 loose stools daily”
Diarrhea · Grade 3
Diarrhoea
“ANC 800 cells/mm³”
Neutrophil count decreased · Grade 3
Neutrophil count decreased
“ALT 3.5 x upper limit of normal”
Alanine aminotransferase increased · Grade 2
Alanine aminotransferase increased
Every CTCAE term carries its MedDRA lowest level term, so the grade and the code come out of the same reading of the same sentence. They can’t disagree.
Illustrative rendering. US and international spellings both resolve to the same term, which is why the first row reads two ways.
One pass over the note produces both codes.
MedDRA is the vocabulary your regulators speak. CTCAE is the vocabulary your clinicians speak. Both must travel with every graded adverse event in clinical research.
Burna produces them together because they describe the same clinical fact. Producing them separately, by separate teams, in separate workflows, is the line item your safety budget already knows by heart.
Terms arrive MedDRA-coded, LLT to SOC, because extraction is structured from the start.
Verbatim
“8 to 9 loose stools daily since cycle 2 day 4.”
LLT
The lowest-level term the verbatim actually supports.
PT
The preferred term your tables aggregate on.
SOC
Gastrointestinal disorders, for the regulator’s view.
One clinical fact, walked up the hierarchy in a single pass. The verbatim never gets retyped, so the code cannot drift from the note.
Your signature is captured on the encoded record, with the CTCAE grade and the MedDRA LLT code together. One artifact serves both audiences.