This column contains the SDTM class for the domain.
Domain
Thiscolumn contains the 2-letter domain code.
Order Number
The 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 Definition
This 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 columnin the CDASH Modelcontains 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 Modelcontains 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 columncontains 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.