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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 more ; detailed expectations instructions are 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

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CDISC Controlled Terminology and supporting documentation (available at https://www.cdisc.org/standards/terminology/) 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.

CDISC Controlled Terminology codelists are either extensible or non-extensiblenonextensible. For extensible codelists, new terms may be defined and used with TIG standards if (those not already listed as either a CDISC Submission Value, a CDISC Synonym(s), or an NCI Preferred Term) may be defined and used with the TIG. Terms in non-extensible nonextensible codelists must be used as-is and ; new terms cannot be added or used. When extending a codelist, follow the case-sensitivity convention of that listthe codelist will be followed. It is highly recommended that (1) new terms for CDISC Controlled Terminology extensible codelists and (2) Changes to existing terms and requests for new codelists be submitted to the National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS) for review and possible inclusion in CDISC 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 helps ensure the consistency and transparency of data for all users of the TIG. Controlled terminology requests can be submitted to NCI-EVS by using the Term Suggestion form available at http://ncitermform.nci.nih.gov/ncitermform/?version=cdisc.

Controlled terminology from external sources...

External sources for controlled terminology are referenced in this guide and will be used as indicated, in alignment with regulatory requirements.

The following table summarizes how controlled terminology supports Controlled terminology is used in the following ways to support implementation of standards.

Metadataspec

Standards for Collection Standards for Tabulation Standards for Analysis  To collect data using controlled terms Ask specific questions on the CRF (e.g., Mild, Moderate, Severe) Where appropriate a subset of a terms may be used rather than all available terms. Temperature) Collect data values using terminology To ask a specific question on the CRF (e.g., Temperature Y or N) To create a variable name Name variables in the operational database (e.g., TEMP_VSORRES for the collection of vital sign data when a unique variable name must be created for each vital sign result) .

The following is appliable when implementing controlled terminology in tabulation datasets.

• Variables with controlled terminology should match the case in the controlled terminology list When extending a controlled terminology list, follow the case convention of that list. 
• Controlled terminology should be submitted in the same text case used in the controlled terminology list. When extending a controlled terminology list, the case-sensitivity convention of that list should be followed.

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Name domain datasets and variables in datasets when applicable Represent collected, assigned, and derived values in datasets Represent the level of imputation for numeric date/time variables Represent the subject status at different phases of the study Represent the derivation method for cases of data imputation Represent values for analysis concepts as applicable

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 date and/or time ISO format must be applied used when specified. Additional ISO formats are referenced in this guide and will be used as indicated in alignment with regulatory requirements.