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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 the TIG 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, the case-sensitivity convention of the codelist will be followed. 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..

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

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. Additional ISO formats are referenced in this guide will be used as indicated in alignment with regulatory requirements.