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REGULATORY REPORTING

Does Burna AI code adverse events to MedDRA?

Yes. Every adverse event Burna AI grades carries a MedDRA Lowest Level Term (LLT) code, produced in the same pass over the note as the CTCAE grade, with the source sentence attached. The code comes from the MedDRA release the grading CTCAE version is built on: each of CTCAE v6.0's 850 terms is a MedDRA v28.0 LLT, and CTCAE v5.0 was built on MedDRA 20.1. From the LLT the code walks up the MedDRA hierarchy to the Preferred Term, High Level Term, High Level Group Term and System Organ Class, so the term the safety team codes is the term the clinician graded and nobody retypes the verbatim. MedDRA itself is maintained by the MSSO for ICH and publishes new releases twice a year; meddra.org lists the current one. More on coding inside grading: burna.ai/meddra-coding.

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