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TIG metadata and domain specifications refer to controlled terminology and formats defined both within and external to this guide. Controlled terminology is required to be used as specified in this guide.

CDISC controlled terminology may be referenced here:

• https://www.cdisc.org/standards/terminology/controlled-terminology

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1. To collect data using controlled terms (e.g., Mild, Moderate, Severe)
   1. When appropriate a subset of a terms may be used rather than all available terms.
2. To ask a specific question on the CRF (e.g., Temperature)
3. To create a variable name in the database (e.g., TEMP for the collection of vital sign data when a unique variable name must be created for each vital sign result)

In tabulation datasets,

Controlled terminology is specified in domain tables and is expected to be used. The following is appliable when implementing controlled terminology in tabulation datasets.

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