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  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 a
  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

Gliffy Diagram
bordertrue
displayNamecd-vd-pv-semantic
namecd-vd-pv-semantic
pagePin13

Deduction

#CDISC Use CaseIs Represented in the MDR as
1External dictionary's componentDescribed Value Domain
2External dictionary NOS, e.g., SNOMED-CTDescribed Value Domain
3Variables using CDISC CT
  • Codelist: Value Domain
  • CDISC Submission Value: Enumerated value domain
  • CDISC Definition: Value Meaning
4TESTCD & TEST pairing
  • A Conceptual Domain with two sets of VD, where each PV is bound by having the same VM
5PARMCD * PARM pairing
  • A Conceptual Domain with two sets of VD, where each PV is bound by having the same VM
6CDASH CT as subset of SDTM CT
  1. Value domain
    1. Is an Enumerated Value Domain
    2. Has a VD-to-VD relationship
      1. Relationship has property of "how", i.e., "A subset of"
7Term mappings (e.g., RACEC to RACE)
  1. Value Domain
    1. Is an Enumerated Value Domain
    2. Has a VD-to-VD relationship, i.e., source EVD & target EVD)
      1. Relationship has property of "how", i.e., "Is a value mapping to"
8

PK unit codelist vs. normalized unit codelists

  1. Value Domain
    1. Is an Enumerated Value Domain
    2. Has a VD-to-VD relationship, i.e., source EVD & target EVD)
      1. Relationship has property of "how", i.e., "Is a normalization of unit of measurement to"
9Quantitative numerical results, ADaM's AVAL, SDTM's --STRESN
  • Value Domain
    • Is a Continuous Domain, i.e., value domain whose PV are not a discrete list
  • Ideally, for a record in an SDT\M Findings dataset record, especailly pre-coordinated tests
    • {--TEST, --ORRES, --ORRESU} is a DE
    • {--TEST, --STRESC, --STRESU} is another DE
    • These 2 DEs share the same Data Element Concept (DEC), i.e., the --TEST
10Value list in ADaMIG
  • Value Domain
    • Is an Enumerated Value Domain
    • May not have Value Meaning, e.g., Y
11QRS Supplements to SDTMIG mappings
  • Each questionnaire item is a DEC
    • Its response is a VD
      • A VD may be an Enumerated value domain (e.g., coded ordinals, dichotomy), or a continuous domain (e.g., sliding scale)
      • Free text response is also a kind of continuous domain
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