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Inventory
CDASH
All CDASH CT codelists are a subset of an SDTM CT codelist. CDASHIG v2.1 metadata table contain these relevant columns & their description:
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- --PTCD and AEPTCD for "MedDRA code for the Preferred Term"
- --LOINC for "LOINC Code"
- --ATC1 and CMATC1 for WHODrug's "ATC Level 1 Description"
SDTM
In general, SDTM variable's controlled terms can be categorized into these categories:
- CDISC Controlled Terminology
- 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
ADaM
Value List
Aside from the use of CDISC CT and external dictionaries, some ADaM variables have a value list. Here is a representative list:
| Variable | Value List | Remarks | |
|---|---|---|---|
| 1 | SMQzzSC | BROAD, NARROW | |
| 2 | SMQzzSCN | 1, 2 | This is a numerical representation of BROAD and NARROW in SMQzzSC. One can deduce the value meaning by pairing these two representations. However, to a machine, it will need a method to store the definition. |
| 3 | CRITyFL | Y or Y, N | Need clarification about this "or" notation |
| 4 | CRITyFN | 1 or 1, 0 | Same as SMQzzSCN, CRITyFN is the numerical representation of CRITyFL |
Codetables
This is Codetables have sometimes referred to response codelist in casual conversations, although the their utilization goes beyond just test & responses. Use cases are:
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response. The following sections describe some of the representative use cases.
QRS Supplement to SDTMIG
These supplement publications illustrate detailed relationship among --CAT, --TEST, --ORRES,
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--STRSC, --STRESN for QRS using SDTM CT; and, the alignment to the SDTMIG QS, FT, and RS domains. Additional properties in other SDTMIG variables may occasionally be at play, e.g., --EVLINT.
Response codelist is also applicable. Coded ordinals are a good example, where responses may have a numerical value (code) & a label (decode).
Term Mappings
Two prime examples published onto the CDISC webiste are collapsing 1) RACEC (90+ terms) to RACE (7 terms), and 2) ETHNICC (70+ terms) to ETHNIC (4 terms).
TESTCD & TEST Pairing
Whether it is pairing TESTCD with TEST or PARMCD with PARM CT codelists, the idea is relating coded terms to their corresponding decode where they share the same concept. In other words, they have the same meaning with different textual representation.
Value Domains Driven by Data Types
Certain CDISC variables have prescribed value domains that hinges on data types or sub-types. Here is a list of representative sample:
| Variable | Described Value Domain | Value Domain in ODM Data Type(s) | Sub-TypeConstrains | RemarksRules | |
|---|---|---|---|---|---|
| 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 |
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.
Let Representation of Dates & Times be a CD. ISO 8601 Datetime and ISO 8601 Duration are the associated DVDs. Another class of VD is Described Value Domain (DVD). DVDs do not have enumerated members. Instead, the PV is through descriptions (VM), as suggested in the name.
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Questions
- Does ADaM's parameter VLM have any relevance here?
Overview
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