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Metadataspec
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 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.
  • Coding...
  • Standardizing to a unit...

Using Submission values?

  • To consistently represent applicable Represent to dataset variable values. 


  • Add hereTo be added

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 the 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, 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.

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