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#CDISC Use CaseIs Represented in the MDR as
1External dictionary's componentDescribed Value Domain
2External dictionary NOS, e.g., SNOMED-CTDescribed 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
  • Codelist: Value Domain
  • CDISC Submission Value: Enumerated value domain
  • CDISC Definition: Value Meaning
45TESTCD & TEST pairing
  • A Conceptual Domain with two sets of VD, where each PV is bound by having the same VM
56PARMCD * PARM pairing
  • A Conceptual Domain with two sets of VD, where each PV is bound by having the same VM
67CDASH 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"
78Term 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"
89

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"
910Quantitative 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
1011Value list in ADaMIG
  • Value Domain
    • Is an Enumerated Value Domain
    • May not have Value Meaning, e.g., Y
1112QRS 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
1213

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?