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Metadata tables guide implementation of the CDISC CDASH to build datasets for representation of collected or derived data. Domain specifications for the TIG are provided in the following sections:

Metadata tables guide implementation of the CDISC CDASH Model to build datasets for representation of collected or derived data. Domain specifications for the TIG are provided in the following sections:

All domain specifications begin with the expected name and record structure for the resulting dataset. A domain specification table follows to describe the domain's variables and their attributes. Assumptions specific to the domain are also provided to further guide implementation.

Domain specification tables are structured to present one row for each variable with columns to describe expected attributes of the variable in resulting datasets. The order of variables in a domain specification table reflects the expected order of variables in the resulting dataset. The columns in a domain specification table are:

TALK ABOUT FIELDS AND VARIABLES

ColumnPurpose
Observation Class

Specifies the SDTM class for the domain. 

Domain

Specifies the 2-letter domain code.

Data Collection ScenarioIdentifies the different data collection options in CDASH for the same domain and is best used for filtering the table. The information in this column provides the context for the CDASHIG Core Designations (e.g., denoting which fields should be present on the CRF). When only 1 data collection scenario is provided for the domain, the column contains "N/A."

Implementation Options 

 When this column contains "Horizontal-Generic," a sampling of the CDASHIG metadata is provided as a template for the metadata of the CRF in a denormalized structure.
Order NumberProvides a suggested order of variables to be displayed on a CRF. 
CDASHIG Variable

Provides the variable names. 

CDASHIG Variable Label Provides the CDASHIG variable label.  
DRAFT CDASHIG DefinitionProvides a draft definition of the CDASHIG variable. 
Question Text

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.

Data Type 

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.
Case Report Form Completion InstructionsProvides recommended example instructions for the clinical site on how to enter collected information on the CRF.
Tabulation Target 

This column provides the suggested mapping to the tabulation dataset variable. 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.
Mapping Instructions

Provides information on the suggested mapping of the collection variable to the tabulation variable. 

Controlled Terminology Codelist Name 

Specifies controlled terminology applicable to the field. Values in this column are:

  • A single, required controlled term for the variable represented by the controlled term in double quotes. This value indicates the controlled term must be populated in the variable for all records in the resulting dataset.
  • Names of controlled terminology codelists with allowable terms to populate the variable. Codelist names are specified in paratheses. Multiple codelist names indicate the variable is subject to one or more of the codelists.
  • Names of formats to be applied to values in the variable.
Subset Controlled Terminology/CDASH Codelist Name:This column contains the CDISC CT or CDASH subset codelist name that may be used for that specific variable (e.g., EXDOSFRM). 

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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