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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 specifications refer to controlled terminology and formats defined both within and external to this guide. 

Controlled Terminology

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.

CDISC Controlled Terminology codelists are either extensible or nonextensible. For extensible codelists, new terms (those not already listed as either a CDISC Submission Value, a CDISC Synonym TOBA-359 - Getting issue details... STATUS , or an NCI Preferred Term) may be 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. TOBA-655 - Getting issue details... STATUS 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.

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 implementation of standards.

Standards for CollectionStandards for TabulationStandards for Analysis 
  • Ask specific questions on the CRF (e.g., Temperature)
  • Collect data values using terminology (e.g., Y or N)
  • 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)
  • 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 trial
  • 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 used when specified. Additional ISO formats are referenced in this guide and will be used as indicated in alignment with regulatory requirements.

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