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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 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

Gliffy Diagram
bordertrue
displayNamecd-vd-pv-semantic
namecd-vd-pv-semantic
pagePin5

Gliffy Diagram
bordertrue
namevd-classes
pagePin13

Deduction

#CDISC Use CaseIs Represented in the MDR as
1External dictionary's component
  1. Value Domain
    1. Is a Described Value Domain
2External dictionary NOS, e.g.,
SNOMED-CT
Rat Genome Database
  1. Value Domain
    1. Is a Described Value Domain
3number-number in DM.AGETXT
  1. Value Domain
    1. Has a format template, e.g., {integer}-{integer}
    2. Is a Continuous Domain
4Variables using CDISC CT
  1. Codelist: Value Domain (Enumerated Value Domain)
  2. CDISC Submission Value:
Enumerated value domain
  1. PV
  2. CDISC Definition: Value Meaning
4
5TESTCD & TEST pairing
  • A Conceptual Domain with two sets of VD, where each PV is bound by having the same VM
5
6PARMCD * PARM pairing
  • A Conceptual Domain with two sets of VD, where each PV is bound by having the same VM
6
7CDASH 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"
7
8Term 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
9

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"
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10Quantitative 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
10
11Value list in ADaMIG
  • Value Domain
    • Is an Enumerated Value Domain
    • May not have Value Meaning, e.g., Y
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12QRS 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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Questions

  1. Does ADaM's parameter VLM have any relevance here?
  2. Is EVS onboard with managing subsets? In other words, must subsets need to have a unique identifier?
    However, for the BC Height the valid units of measure may only include two units, cm and in . CDISC 360 requires the instantiation of a codelist subset so that th e BC can reference a codelist , which includes only the Height BC units . This subs et will have an identifier such as a concept code.
  3. Do we treat different components of an external dictionary as separate described value domains? For example, MedDRA's LLT, HLGT, etc as separate DVD in the repository?
  4. The use case of SDTM variables having partially controlled values is weird. Any good suggestions?
  5. PV-to-PV relationship will be useful for VD with VD-to-VD relationship. Example: Mapping of RACEC to RACE, ADaM's variable pairs of numeric & text variables with values such as {0, 1} and {Y, N}. Does it make sense?