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CDISC Controlled Terminology

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and supporting documentation (available at https://www.cdisc.org/standards/terminology/) are managed as publications separate from this guide. Users of the TIG are encouraged to reference CDISC Controlled Terminology regularly to access controlled terms and for additional information.

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Metadataspec
Standards for CollectionStandards for TabulationStandards for Analysis 
  • Ask specific questions on the CRF (e.g., Temperature)
  • Collect data values using terminology (e.g., Y or N)
  • Name variables in the operational database (e.g., TEMP_VSORRES for the collection of vital sign data when a unique variable name must be created for each vital sign result)
  • Name domain datasets and variables in datasets when applicable
  • Represent collected, assigned, and derived values in datasets


  • Represent the level of imputation for numeric date/time variables
  • Represent the subject status at different phases of the trialstudy
  • Represent the derivation method for cases of data imputation
  • Represent values for analysis concepts as applicable

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