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

Controlled Terminology

CDISC controlled terminology may be referenced here:

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

Some codelists, such as Laboratory Test Codes (LBTESTCD), are extensible. This 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, such as AE Action Taken with Study Treatment, 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).

Controlled Terminology for Data Collection

Using controlled terminology during data collection builds in traceability and transparency and supports mapping of data to tabulation datasets. Controlled terminology can be used in the following ways during data collection:

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