Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

#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-CTRat 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
5TESTCD & TEST pairing
  • A Conceptual Domain with two sets of VD, where each PV is bound by having the same VM
6PARMCD * PARM pairing
  • A Conceptual Domain with two sets of VD, where each PV is bound by having the same VM
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"
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"
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"
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
11Value list in ADaMIG
  • Value Domain
    • Is an Enumerated Value Domain
    • May not have Value Meaning, e.g., Y
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
13

...