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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 guidance for use of controlled terminology and formats is provided in this section; detailed instructions are provided as part of sections specific to collection, tabulation, and analysis standards. TIG metadata and domain specifications refer to controlled terminology and formats defined both within and external to this guide. CDISC controlled terminology may be referenced here: 

Controlled Terminology

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

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) 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.

CDISC Controlled Terminology codelists are either extensible or nonextensible. For extensible codelists, new terms (those not already listed as either

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Some codelists, such as Laboratory Test Codes (LBTESTCD), are extensible. This means that values that are not already represented in that list (either as a CDISC Submission Value, a synonymCDISC Synonym, or an NCI preferred termPreferred 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. 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 defined and used with the TIG. Terms in nonextensible codelists must be used as-is; new terms cannot be added or used. When extending a codelist, the case-sensitivity convention of the 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 consideration. Submission of terminology requests to NCI-EVS 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).

Data Collection

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

The following table summarizes how controlled terminology supports implementation of standards.

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1. When appropriate a subset of a terms may be used rather than all available terms.

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In tabulation datasets,

Terms from controlled terminology should be in the case that appears the source codelist or code system (e.g., CDISC codelist or external code system such as MedDRA). See Section 4.2.4, Text Case in Submitted Data.

If a controlled terminology codelist exists for a variable in a SEND domain, the name of the codelist will be populated in the Controlled Terms, Codelist, or Format column of the domain model to indicate that a distinct set of controlled values exists and is expected to be used. The SEND CT indicates whether a particular codelist is extensible. The domain dataset models included in Sections 5, Models for Special-purpose Domains, and 6, Domain Models Based on the General Observation Classes, of this document provide additional information about the Controlled Terms, Codelist, or Format column; notes on proper use; and examples.

Storing topic variables for general domain models

The topic variable for the Interventions and Events general observation-class models is often stored as verbatim text. For an Events domain, the topic variable is --TERM. For an Interventions domain, the topic variable is --TRT. For a Findings domain, the topic variable --TESTCD should use controlled terminology (e.g., "SYSBP" for systolic blood pressure). If CDISC Controlled Terminology exists, it should be used; otherwise, sponsors should define their own controlled list of terms. If the verbatim topic variable in an Interventions or Event domain is modified to facilitate coding, the modified text is stored in --MODIFY. In most cases—other than Physical Examination (PE)—the dictionary-coded text is derived into --DECOD. Because the PEORRES variable is modified instead of the topic variable for PE, the dictionary-derived text would be placed in PESTRESC. The variables used in each of the defined domains are:

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Domain

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Original Verbatim

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Modified Verbatim

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Standardized Value

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Formats

Standards for tabulation and analysis

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Standards for tabulation 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).   Included in specifications...The appropriate date and/or time ISO format must be used when specified. Additional ISO formats are referenced in this guide and will be used as indicated in alignment with regulatory requirements.