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#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 pairingEnumerated value domain with value meaningpairing
  • 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
64CDASH CT as subset of SDTM CT
  1. Enumerated value domain
  2. Relationship
  3. Relationship propety of "how"
57Term mappings (e.g., RACEC to RACE)
  1. Enumerated value domain
  2. Relationship (source EVD & target EVD)
  3. Relationship propety of "how"
68

PK unit codelist vs. normalized unit codelists

  1. Enumerated value domain
  2. Relationship (source EVD & target EVD)
  3. Relationship propety of "how"
79Quantitative 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
810

911QRS 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

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