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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 below with more specific expectations in collection, tabulation, and analysis guidance. TIG metadata and domain specifications refer to controlled terminology and formats defined both within and external to this guide. 

• Names of controlled terminology codelists with allowable terms to populate the variable. Codelist names are specified in paratheses. Multiple codelist names indicate the variable is subject to one or more of the codelists.

Controlled Terminology

CDISC controlled terminology may be referenced here:

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