SDTM - Special-purpose Domains

Special-purpose Domains

The CDISC V3.x Submission Data Domain Models include special-purpose domains with a specific structure and cannot be extended with any additional qualifier or timing variables other than those specified.

  • Demographics includes a set of standard variables that describe each subject in a clinical study
  • Comments describes a fixed structure for recording free-text comments on a subject, or comments related to records or groups of records in other domains.

Additional fixed structure, non-extensible special-purpose domains are discussed in the Trial Design model.

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