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| Variable | Described Value Domain | Value Domain in ODM Data Type(s) | Constrains | Rules |
|---|
| 1 | --DTC | ISO 8601 datetime | datetime, date, time, partialDate, partialTime, partialDatetime, incompleteDatetime, intervalDatetime |
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| 2 | --DTC | ISO 8601 duration | durationDatetime |
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| 3 | --SEQ | Num | float |
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| 4 | TDSTOFF | Num | integer | 0 or any positive integer |
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| 5 | RPRFDY | Num | integer | 0; 1 |
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| 6 | ECDOSE | Num | float | Any positive number | With a rule that a value can't be 0 |
Deduction
| # | CDISC Use Case | Is Represented in the MDR as |
|---|
| 1 | External dictionary's component | Described value domain |
| 2 | External dictionary NOS | Described value domain |
| 3 | TESTCD & TEST pairing |
EVD with VM | | Enumerated value domain with value meaning |
| 4 |
2 | CDASH CT as subset of SDTM CT |
3 | - Enumerated value domain
- Relationship
- Relationship propety of "how"
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| 5 | Term mappings (e.g., RACEC to RACE) | - Enumerated value domain
- Relationship (source EVD & target EVD)
- Relationship
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, with a documented property 4| 6 | PK unit codelist vs. normalized unit codelists | - Enumerated value domain
- Relationship (source EVD & target EVD)
- Relationship propety of "how"
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| 7 | Quantitative numerical results, ADaM's AVAL, SDTM's --STRESN | |
a documented property of "how"- 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
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| 8 |
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| 9 | QRS 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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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.
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- Does ADaM's parameter VLM have any relevance here?
- 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.
- 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?
