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Specifies the SDTM class for the domain. 

Specifies the 2-letter domain code.

Implementation Options 

Provides the variable names. 

Provides suggested text for a collection question. Values in this column are complete sentences:

• Without text in brackets or parentheses.
• With text in brackets which should be replaced with protocol-specified verbiage.
• With text in parentheses indicating the text is optional.
• With text separated with a forward slash to indicate optional wording.

Prompt 

Provides suggested text for the specific domain. Implementers should refer to the CDASH Model to create alternative prompt text that may be used that meets CDASH conformance rules. Prompt is a short version of the question. Some text is presented inside brackets [ ] or parentheses (). Text inside brackets should be replaced with protocol-specified verbiage. [NULL] in this column indicates that populating a prompt is not required on a CRF screen/page if not needed.

Specifies the data type of the variable. Values for in this column are:

• Num for numeric data
• Char for character or alphanumeric data
• Date
• Time

CDASHIG Core 

This column contains the CDASHIG core designations for basic data collection fields (i.e., Highly Recommended (HR), Recommended/Conditional (R/C), Optional (O)). See Section 3.2, Core Designations for Basic Data Collection Fields.

Specifies expectations for inclusion of the variable in the resulting dataset. Values in this column are:

• Req for variables which are Required and must be included in the resulting dataset and cannot be null for any record. Such variables are basic to the identification of a data record or are necessary to make the record meaningful. 
• Exp for variables which are Expected to be included in the resulting dataset, even if all values are null. Such variables are considered necessary to make the data record useful in the context of the domain.
• Perm for variables for which it is Permissible to include or exclude the variable from the resulting dataset. Permissible variables must be included in the resulting dataset when data appropriate for the variable have been collected or derived, even if all values are null.

This column provides the suggested mapping to the SDTMIG tabulation dataset variable name. It may help facilitate the creation of the SDTMIG variables needed for submission. When . Values in this column are:

• N/A for when no direct mapping to

• a tabulation dataset variable is available

• .
• SUPP–.QNAM for when a value represented in the

• field

• will be mapped to

• as a Supplemental Qualifier.

This column contains Provides information on the suggested mapping of the CDASHIG collection variable to the SDTMIG tabulation variable. Mapping instructions in the CDASHIG metadata tables provide more complete guidance than that in the CDASH Model. When domain-level metadata are not available, consult the CDASH Model for SDTM mapping instructions.

This column contains the 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 ISO CT, but rather are converted to the ISO format when the SDTM-based submission datasets are created.      

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.