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  1. To collect data using controlled terms (e.g., Mild, Moderate, Severe)
    1. When 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)

Text in brackets must be completed 

  1. In Findings domains, values from the relevant CDISC CT lists must also be used to create appropriate Question Text, Prompts, and/or variable names. For example, if the question is about the subject's height, incorporate the value of "Height" from the VSTEST codelist as the prompt on the CRF, and incorporate "HEIGHT" from VSTESTCD in the variable name.


In tabulation datasets,

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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Storing topic variables for general domain models

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Standards for tabulation 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).  Included in specifications...

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