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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 guidance for use of controlled terminology and formats are 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

Controlled terminology is used in the following ways to support implementation of standards.

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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Controlled terminology from external sources...Controlled terminology will be used in the following ways to support implementation of standards.

• To collect data using controlled terms (e.g., Mild, Moderate, Severe)
  • Where appropriate a subset of a terms may be used rather than all available terms.
• To ask a specific question on the CRF (e.g., Temperature)
• 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).

All codelists displayed in the CRF must use or directly map to the current published controlled terminology submission values, when it is available. Subsets of published CT, such as those provided in CDASH terminology, can be used.

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 ISO format must be applied when specified.

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