How to Use Controlled Terminology and Formats

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 in this section with more detailed expectations 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

Standards in this guide reference both CDISC Controlled Terminology and terminology from other external sources.

CDISC Controlled Terminology and supporting documentation 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-extensible. For extensible codelists, new terms may be defined and used with TIG standards if not already listed as either a CDISC Submission Value, a CDISC Synonym(s), or an NCI Preferred Term. Terms in non-extensible codelists must be used as-is and new terms cannot be added or used. It is highly recommended that new terms for extensible 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 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...

Controlled terminology is used in the following ways to support implementation of standards.

Controlled terminology is used in the following ways to support data collection:

1. To collect data using controlled terms (e.g., Mild, Moderate, Severe)
   1. Where appropriate a subset of a terms may be used rather than all available terms.
2. To ask a specific question on the CRF (e.g., Temperature)
3. To create a variable name in the database (e.g., TEMP for the collection of vital sign data when a unique variable name must be created for each vital sign result).

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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.

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

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 ISO format must be applied when specified.