SDTMIG v4.0


In Development

High-level Scope & Major Changes in SDTMIG v4.0

  • SUPP to NSV
  • Metadata restructuring
  • Biospecimens domains
  • Multiple subject instances (MSI)
  • QX (QRS Instrument Reference) Domain
  • Deprecate --BLFL
  • Protocol Deviations
  • Event Adjudication (EA) Domain