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Using controlled terminology and formatting from data collection through tabulation and analysis builds in traceability and transparency across study data. Controlled terminology and formats are required to be used as specified in this guide. General guidance for use of controlled terminology and formats is provided in this section with detailed instructions provided as part of sections specific to collection, tabulation, and analysis standards. TIG metadata and specifications refer to controlled terminology and formats defined both within and external to this guide. 

Controlled TerminologyControlled

To support implementation of standards, controlled terminology is used in the following ways to support implementation of standards.to:

Metadataspec
Standards for CollectionStandards for TabulationStandards for Analysis 
  • To collect data values using terminology Ask specific questions on the CRF (e.g., Mild, Moderate, Severe)To ask a specific question on the CRF Temperature)
  • Collect data values using terminology (e.g., TemperatureY or N)
  • To create a variable name Name variables in the operational database (e.g., TEMP for the collection of vital sign data when a unique variable name must be created for each vital sign result).
  • To consistently represent applicable variable values. Name domain datasets and variables in datasets when applicable.
  • Coding...
  • Standardizing to a unit...

Using Submission values?

  • To consistently represent applicable variable values. 
  • Add here

CDISC Controlled Terminology and supporting documentation 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. Controlled terminology is available via the CDISC website, https://www.cdisc.org/standards/terminology/controlled-terminology.

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