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

Controlled Terminology

CDISC controlled terminology Controlled Terminology can be referenced here: https://www.cdisc.org/standards/terminology/controlled-terminology. 

Some controlled Controlled terminology codelists are extensible. This means that values that are not already represented in that list (either as either extensible or non-extensible. For extensible codelists, terms not already in the list as either a CDISC Submission Value, a synonymCDISC Synonym(s), 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 Preferred Term may be defined and used with standards in the TIG. For non-extensible codelists, terms in the codelist must be used as-is and new terms cannot be added. New terms defined for extensible codelists should be submitted to the National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS) for review and possible inclusion in CDISC controlled terminology.

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).

without adding any terms to the list. The extenisbility 

• 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.

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