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Describe how the actual description of content in the CDASH Model is not actually included in the CDASH Model and appendix provides this information.

This section provides an explanation of the columns used in the CDASH Model. Note: When multiple options are contained in a single cell, the options are separated by a semicolon.

"Explanation of headers in the CDASH Model and CDASH Metadata Tables" 


HeadingExplanation
Observation Class

This column contains the SDTM class for the domain.

Domain

This column contains the 2-letter domain code.

Order NumberThe values in this column are used to help sequence the variables as they appear in the metadata table. There is no implied meaning, significance, or conformance expectations. The values increase by 1 for each variable within a unique grouping of Observation Class plus domain.  
CDASHIG Variable

This column provides the CDASH root variable name (e.g., --ONGO, --DAT).

CDASHIG Variable Label 

This column contains a suggested root variable label that that may be used for the CDASHIG variable

DRAFT CDASHIG DefinitionThis column provides a draft definition of the root variable. This text may or may not mirror text in the SDTM. Currently, there is a new CDASH/SDTM team creating variable definitions. Once these definitions are finalized, the CDASH definitions will be updated to harmonize with them.
Question Text

This column in the CDASH Model contains the recommended question text for the data collection field. Question Text is a complete sentence. Some text is presented inside brackets [ ] or parentheses (). The text inside brackets should be replaced with protocol-specified verbiage; text inside parentheses is optional. Text separated with a forward slash indicates optional wording from which the sponsor may choose. 

Prompt 

This column in the CDASH Model contains the recommended prompt text for the data collection field. The Prompt is a short version of the question. Some text is presented inside brackets [ ] or parentheses (). The text inside brackets should be replaced with protocol-specific verbiage; text inside parentheses is optional. Text separated with a forward slash / indicates optional wording from which the sponsor may choose

Data Type 

This column contains the simple data type of the CDASH variable (i.e., Char, Num, Date, Time).

SDTMIG Target 

This column provides the suggested mapping to the SDTM root variable. When no direct mapping to an SDTM root variable is available, the column contains "N/A." When the column contains "SUPP--.QNAM", it means that the value represented in the CDASH variable shall be mapped to an SDTM Supplemental Qualifier.
Note: CDASH variables noted as not having a direct map to SDTM variables (i.e., NSVs) may have SDTM variable equivalents in future versions.

Mapping Instructions

This column contains information on the suggested mapping of the root variable to the SDTM variable. 

Controlled Terminology Codelist Name 

This column contains the Controlled Terminology (CT) codelist name (e.g., "LOC") that is associated with the field. Certain variables (e.g., dates) use ISO formats as CT; however, in CDASH these variables are generally not collected using ISO CT, but rather converted to the ISO format when the SDTM-based submission datasets are created. 

Whereas the SDTM Model provides the NCI C Code for each variable, the CDASH Model includes the Controlled Terminology codelist name. However, when individual codelist names are used for each domain, the CDASH model does not include any codelist name. 

For example, the CDASH model variable --TEST includes no Controlled Terminology codelist Name. However, the CDASH metadata table for each findings domain provides the  Controlled Terminology codelist name (e.g., VSTEST).

Implementation Notes 

This column contains further information, such as rationale and implementation instructions, regarding how to implement the CRF data collection fields and how to map CDASHIG variables to SDTMIG variables.

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