Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

  1. A VD may have these properties
    1. An Administrative record
    2. A definition
    3. A data type
    4. A relationship to another VD
    5. A unit of measure, especially quantitative results
    6. A Format template e.g., CDASH's dates, ADaM's SAS format, etc.
    7. A length descriptor, for character data type
  2. A VD may be either enumerated, described, or continuous
    1. Enumerated VD contains discrete values, e.g., {MILD, MODERATE, SEVERE}
    2. Described VD contains a description of what data values are permissible, e.g., LLT from MedDRA by MSSO
    3. Continuous VD contains awhose PV may be free text, with or without any nomenclature.
  3. A PV may belong to 1..n VD
    1. A Permissible Value may have a Value Meaning
      1. Representation of its value meaning is independent of, and shall not be constrained by, the representation of its corresponding value
    2. A Value Meaning may have 1:n representations, hence taking a unique form of PV
    3. For a Permissible Value to become a member of VD, use a start date
    4. To retire a Permissible Value from a VD, use an end date

...