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VariableDescribed Value DomainValue Domain in ODM Data Type(s)ConstrainsRules
1--DTCISO 8601 datetimedatetime, date, time, partialDate, partialTime, partialDatetime, incompleteDatetime, intervalDatetime

2--DTCISO 8601 durationdurationDatetime

3--SEQNumfloat

4TDSTOFFNuminteger0 or any positive integer
5RPRFDYNuminteger0; 1
6ECDOSENumfloatAny positive numberWith a rule that a value can't be 0

Model

Basic Construct

Let Severity be a Conceptual Domain (CD), then the set {MILD, MODERATE, SEVERE} is a Value Domain (VD) for this CD. Similarly, {1, 2, 3} is another set of VD, in an numerical representation. These 2 VDs fall to the VD subclass called Enumerated Value Domain (EVD). To overlay semantic, each member, or Permissible Value (PV) of the VD may have a Value Meaning (VE). Therefore, when each PV from these 2 EVDs share the same VE, they are bound.

Let Representation of Dates & Times be a CD. ISO 8601 Datetime and ISO 8601 Duration are the associated DVDs. Another class of VD is Described Value Domain (DVD). DVDs do not have enumerated members. Instead, the PV is through descriptions (VM), as suggested in the name.

Gliffy Diagram
bordertrue
namecd-vd-pv-semantic
pagePin1

Deduction

#CDISC Use CaseIs Represented in the MDR as
1External dictionary's componentDescribed value domain
2External dictionary NOSDescribed value domain
3CDISC CT
  • Codelist: Value Domain
  • CDISC Submission Value: Enumerated value domain
  • CDISC Definition: Value meaning
4TESTCD & TEST pairing
  • Conceptual Domain with the same set of VD, where each PV is bound by having the same VM
5PARMCD * PARM pairing
  • Conceptual Domain with the same set of VD, where each PV is bound by having the same VM
6CDASH CT as subset of SDTM CT
  1. Enumerated value domain
  2. Relationship
  3. Relationship propety of "how"
7Term mappings (e.g., RACEC to RACE)
  1. Enumerated value domain
  2. Relationship (source EVD & target EVD)
  3. Relationship propety of "how"
8

PK unit codelist vs. normalized unit codelists

  1. Enumerated value domain
  2. Relationship (source EVD & target EVD)
  3. Relationship propety of "how"
9Quantitative numerical results, ADaM's AVAL, SDTM's --STRESN
  • Value domain with a continuous domain, i.e., value domain whose PV are not a discrete list
  • Ideally, for a record in an SDTM 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

11QRS Supplements to SDTMIG mappings
  • Each item is a DEC
    • Its response is a VD
      • A VD may be an EVD (e.g., coded ordinals, dichotomy), or a continuous domain (e.g., sliding scale)
      • Free text response is also a kind of continue domain

Model

Basic Construct

Let Severity be a Conceptual Domain (CD), then the set {MILD, MODERATE, SEVERE} is a Value Domain (VD) for this CD. Similarly, {1, 2, 3} is another set of VD, in an numerical representation. These 2 VDs fall to the VD subclass called Enumerated Value Domain (EVD). To overlay semantic, each member, or Permissible Value (PV) of the VD may have a Value Meaning (VE). Therefore, when each PV from these 2 EVDs share the same VE, they are bound.

Let Representation of Dates & Times be a CD. ISO 8601 Datetime and ISO 8601 Duration are the associated DVDs. Another class of VD is Described Value Domain (DVD). DVDs do not have enumerated members. Instead, the PV is through descriptions (VM), as suggested in the name.

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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?