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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 detailed expectations provided as part of guidance for collection, tabulation, and analysis guidance. TIG metadata and specifications refer to controlled terminology and formats defined both within and external to this guide. 

CDISC Controlled Terminology

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

Controlled terminology codelists are either extensible or non-extensible. For extensible codelists, terms not already in the list as either a CDISC Submission Value, a CDISC Synonym(s), or an NCI 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 addedused. 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.Controlled Terminology. Changes to existing terms and requests for new codelists can also be submitted to NCI-EVS for consideration. Submission of terminology requests to NCI-EVS is highly encouraged to ensure the consistency and transparency of data for all users of the TIG. 

Controlled terminology requests can be submitted to NCI-EVS 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 at http://ncitermform.nci.nih.gov/ncitermform/?version=cdisc).

without adding any terms to the list. The extenisbility 

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Controlled Terminology

Controlled Terminology for Data Collection

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