Page History
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- CDISC Controlled Terminology
- Conditional codelist
- PK unit codelist vs. normalized unit codelists
- External dictionaries, e.g., MedDRA, WHODrug Global, LOINC, DUNS, etc.
- Dataset and variable identifiers for data referential purpose, e.g., IDVAR, IDVARVAL, RDOMAIN
- Partially controlled:
- "UNPLAN" for SE.ETCD, otherwise not controlled
- "Screen Failure" for DM.ACTARM, otherwise subject to study design
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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 | ||
| 2 | --DTC | ISO 8601 duration | durationDatetime | ||
| 3 | --SEQ | Num | float | ||
| 4 | TDSTOFF | Num | integer | 0 or any positive integer | |
| 5 | RPRFDY | Num | integer | 0; 1 | |
| 6 | ECDOSE | Num | float | Any positive number | With a rule that a value can't be 0 |
Deduction
| # | CDISC Use Case | Is Represented as |
|---|---|---|
| 1 | TESTCD & TEST pairing | EVD with VM |
| 2 | CDASH CT as subset of SDTM CT | |
| 3 | Term mappings (e.g., RACEC to RACE) | Relationship, with a documented property of "how" |
| 4 | PK unit codelist vs. normalized unit codelists | Relationship, with a documented property of "how" |
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 the BC can reference a codelist, which includes only the Height BC units. This subset will have an identifier such as a concept code.
Overview
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