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.
More on regulatory reporting.
- Does Burna AI generate regulatory reports such as FDA MedWatch, IRB and SAE reports?
- What is a SUSAR in clinical trials, and when must it be reported?
- What is an ICSR (individual case safety report) in pharmacovigilance?
- What is E2B(R3), and does Burna AI support E2B(R3) submissions?
- Which safety reports does pharmacovigilance require, from ICSRs to DSURs and PBRERs?
- How does Burna AI handle 21 CFR Part 11 electronic records and signatures?