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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 Terminology

To support implementation of standards, controlled terminology will be used to:

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  • 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 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 to dataset variable values. 

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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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External sources for controlled terminology are referenced in this guide will be used as indicated in alignment with regulatory requirements.

To support implementation of standards, controlled terminology will be used to:

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 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 to dataset variable values. 


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Formats

Standards for tabulation and analysis require representation of dates and/or times, intervals of time, and durations of time in ISO 8601 format as defined by the International Organization for Standardization (ISO) (http://www.iso.org). The appropriate date and/or time ISO format must be used when specified. Additional ISO formats are referenced in this guide will be used as indicated in alignment with regulatory requirements.

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