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Metadataspec
Standards for CollectionStandards for TabulationStandards for Analysis 
  • To collect data using controlled terms (e.g., Mild, Moderate, Severe)
    • Where appropriate a subset of a terms may be used rather than all available terms.
  • To ask a specific question on the CRF (e.g., Temperature)
  • 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).

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.

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  • To consistently represent variable values. 
  • Coding...
  • Standardizing to a unit...
  • Add here




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.

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