Page History

SDTM - The SDTM Standard Domain Models

A sponsor should only submit domain datasets that were actually collected (or directly derived from the collected data) for a given study. Decisions on what data to collect should be based on the scientific objectives of the study, rather than the SDTM. Note that any data collected that will be submitted in an analysis (ADaM) dataset must be traceable to a source in a tabulation (SDTM) dataset.

The collected data for a given study may use standard domains from this and other SDTM implementation guides as well as additional custom domains based on the 3 general observation classes. A list of standard domains is provided in Section 3.2.1, Dataset-level Metadata. Final domains will be published only in an SDTM implementation guide (this guide or another implementation guide, e.g., SDTMIG for Medical Devices). Therapeutic-area standards projects and other projects may develop proposals for additional domains. Draft versions of these domains may be made available in the CDISC wiki in the SDTM Draft Domains space (https://wiki.cdisc.org/display/SDD/SDTM+Draft+Domains+Home).

These general rules apply when determining which variables to include in a domain:

• The Identifier variables, STUDYID, USUBJID, DOMAIN, and --SEQ are required in all domains based on the general observation classes. Other Identifiers may be added as needed.
• Any Timing variables are permissible for use in any submission dataset based on a general observation class except where restricted by specific domain assumptions.
• Any additional Qualifier variables from the same general observation class may be added to a domain model except where restricted by specific domain assumptions.
• Sponsors may not add any variables other than those described in the preceding 3 bullets. The SDTM allows for the inclusion of a sponsor's non-SDTM variables using the Supplemental Qualifiers special-purpose dataset structure, described in Section 8.4, Relating Non-standard Variable Values to a Parent Domain. As the SDTM continues to evolve, certain additional standard variables may be added to the general observation classes. 
• Standard variables must not be renamed or modified for novel usage. Their metadata should not be changed.
• A Permissible variable should be used in an SDTM dataset wherever appropriate.  
  • If a study includes a data item that would be represented in a Permissible variable, then that variable must be included in the SDTM dataset, even if null. Refer to the Define-XML standard (available at https://www.cdisc.org/standards/data-exchange/define-xml) for additional details on how to manage no data availability.
  • If a study did not include a data item that would be represented in a Permissible variable, then that variable should not be included in the SDTM dataset and should not be declared in the Define-XML document.