The reference every SDTM program is built against
Once locked, the spec feeds directly into SDTM Dataset Programming, so there's no gap between what's specified and what's built.
What's included
What goes into the mapping spec
- Source-to-target mapping for every raw variable, domain by domain, against the current SDTM Implementation Guide version
- Controlled terminology and codelist assignments applied consistently across domains
- Derivation logic documented for computed and supplemental qualifier variables
- Annotated CRF cross-references so mapping decisions trace back to the source collection field
- Review cycles with biostatistics and data management before the spec is locked for programming
- Version-controlled updates when protocol or CRF amendments require a re-map
Traceable from raw data to submission
The same mapping decisions carry through to ADaM specifications and, ultimately, the Define.xml metadata reviewers rely on.