What's included

What goes into the metadata build

• Dataset- and variable-level metadata captured as each SDTM and ADaM domain is programmed, not backfilled later
• Codelists and controlled terminology kept aligned with the mapping and ADaM specifications
• Origin, derivation, and comment fields documented so reviewers can trace every variable to its source
• Value-level metadata built for variables that require it, matching CDISC Define-XML standard structure
• Draft define file checked against the growing dataset set as programming progresses through start-up and conduct
• Structure prepared for the final validation pass performed at close out