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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 provided guidance for collection, tabulation, and analysis guidance. TIG metadata and domain specifications refer to controlled terminology and formats defined both within and external to this guide. 

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Controlled Terminology

CDISC controlled terminology may can be referenced here:

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

Some controlled terminology codelists are extensible. This means that values that are not already represented in that list (either as a CDISC Submission Value, a synonym, or an NCI preferred term) may be added as needed. Other codelists, are non-extensible and must be used without adding any terms to the list. The extenisbility Where no CDISC Controlled Terminology exists, implementers should develop sponsor-defined terminology to ensure consistency and transparency. If gaps are identified, sponsors should submit requests to add values to CDISC CT by using the Term Suggestion form (available at http://ncitermform.nci.nih.gov/ncitermform/?version=cdisc).

• 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

Controlled Terminology for Data Collection

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