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CDASH
All CDASH CT codelists are a subset of an SDTM CT codelist. CDASHIG v2.1 metadata table contain these relevant columns & their description:
- Controlled Terminology Codelist Name: This column contains the Controlled Terminology (CT) codelist name, e.g., "LOC", that is associated with the field. The SDTMIG indicates that certain variables (e.g., dates) use ISO formats as CT. However, in CDASH these variables are generally not collected using the ISO CT; these variables are converted to the ISO Format when the SDTM-based submission datasets are created.
- Subset Controlled Terminology/CDASH Codelist Name: This column contains the CDISC Controlled Terminology or CDASH Subset Codelist name that may be used for that specific variable (e.g., EXDOSFRM).
CDASH Model and CDASHIG have data collection fields that are specialized for external dictionaries. Suffice to add, there is dedicated column in the metadata table for users to easily discern this property. Examples:
- --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 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 | |
| 4 | CRITyFN | 1 or 1, 0 |
Codetables
This is sometimes referred to response codelist, although the utilization goes beyond just test & responses. Use cases are:
- QRS Supplements to SDTMIG: Illustrate detailed relationship among --CAT, --TEST, --ORRES, and -STRSC. Additional properties in other SDTMIG variables may occasionally be at play, e.g., --EVLINT
- Response codelist is applicable. Coded ordinals are a good example, where responses may have a numerical value (code) & a label (decode).
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 | ODM Data Type(s) | Sub-Type | Remarks | |
|---|---|---|---|---|---|
| 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
Questions
- Does ADaM's parameter VLM have any relevance here?
Overview
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