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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. When extending a codelist, follow the case convention of that list. 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.

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

Metadataspec
Standards for Collection

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Standards for TabulationStandards for Analysis 
  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.

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