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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 expectations for use of controlled terminology and formats are 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

Standards in this guide reference both CDISC Controlled Terminology and terminology from other external sources.

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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