What's included

What gets coded, and to what standard

  • Adverse events and medical history coded to the current MedDRA version specified in the coding conventions
  • Concomitant medications and non-drug treatments coded to the current WHO Drug Dictionary
  • Coding decisions applied against a study-specific coding convention document, so term selection stays consistent across coders and sites
  • Uncoded and auto-coding-failed terms queried back to source rather than force-matched
  • Coded terms cross-checked against safety data during SAE reconciliation before lock

Consistent terms, every time

The same coding conventions apply across every subject and site, avoiding inconsistent term selection that complicates downstream analysis.

Reconciled before lock

Coded terms are checked against safety data during SAE reconciliation before the database locks.