What's included

What goes into the ADaM spec

  • Derivation logic for every analysis variable, written back to the specific SAP section that requires it
  • Population and subgroup flags defined consistently across ADSL and the dataset-specific ADaMs
  • Dataset structure (subject-level, BDS, or otherwise) chosen to match the analyses it feeds
  • Traceability variables retained so every derived value can be traced back to its SDTM source
  • Cross-checks against the mock TLF shells to confirm the spec supports every planned output
  • Version control and amendment history when the SAP or protocol changes after lock

Built to support the analysis, not just the data

Every derivation traces back to a specific SAP requirement, so ADaM Dataset Programming never has to guess intent.

One consistent chain from mapping to metadata

The spec builds on the SDTM mapping spec and feeds directly into the analysis datasets and their Define.xml documentation.