Manage Domains and Variables in Specifications

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Domains can be added by importing from a standard, importing from another specification, or creating a custom domain manually.

Access Domains

There are a variety of ways to access Domains:

  • Click the hyperlinked Name of the specification.
  • Select the specification by clicking the row or the checkbox to the left of the specification, then click Domains on the toolbar.
  • Right-click the row and select Domains from the menu.
    Specification Domains

Important: If no domains have been added to the specification, the screen displays No Data. 

Access the Details View

  1. Select the specification by clicking the row or the checkbox to the left of the specification.
  2. Click the Details icon in the toolbar, and the Details window opens on the right side of the screen.
  3. Click the arrow to the left of Domains to expand domain details within the Details view.
  4. Click the Go to Domains button to open the Domains window.

Specification Domains

Use Breadcrumbs

Specification Breadcrumbs

The hyperlinked breadcrumbs display the specification name and version, the version's status, and the domain associated with the variable list.

Import Domains From a Standard

Import Domains When a Standard Was Selected in the Specification

If a standard was selected during creation of the specification, the standard browser will be filtered to display only that standard. If the specification requires multiple standards, a standard should not be selected when creating the new specification. 

  1. Click the Import Domains icon and select Import From Standard.
    Import Domains
    The Import Domains from Standard browser window opens, and the standard version selected in the specification is already highlighted. If no standard was selected, the tree displays a list of possible standards.
    Import Domains
  2. Select the checkboxes next to the domains to import, use the scrollbar on the right to view additional domains, or select the checkbox at the top of the list to select all.

  3. Click Import. The Domains listing displays the imported domains.

    Note: Columns displayed in the Domain listing vary depending on whether the specification type is a mapping or exception listing.

  4. To add additional domains, import from another specification or use the Add (plus sign) icon in the toolbar.

Add Domains if a Standard Was Not Selected in the Specification

If a standard was not selected when creating the specification, the standard browser can be used to select domains from multiple standards.  Click the Import Domains icon and select Import From Standard to display the standards browser. The browser displays a tree of available standards.

  1. Click the arrows to expand the listed standards. 
    Import From Standard
  2. Select the standard and version. After the selection is made, the domains populate in the window on the right. Import Domains
  3. Select the domains by clicking the checkbox(es).
  4. Click Import.
  5. Continue selecting domains from multiple standard versions.
  6. Click Import. The Domain listing displays the imported domains.

Import Domains From Another Specification

Domains can also be imported from another specification.  

Note: If the selected specification does not contain any data to import (i.e., no domains or codelists that are not already included in the current specification), the system displays No Data.

  1. Click the Import Domains icon and select Import From Specification. 
    Import From Specification
  2. The Import Domains from Specification window opens.
    Import Domains From Specification
  3. Click the drop-down next to the study to display the specifications available to import from.
  4. The available domains populate to the right.
  5. Select the domains to be imported by clicking the checkboxes to the left, or select the checkbox in the header to select all. 
  6. Click Import. The Domain listing displays the imported domains.

Add a New Custom Domain

Users can also add custom domains and enter the corresponding details.

  1. Click the Add (plus sign) icon in the toolbar. The Create Domain window opens.
    Create Domain

  2. Enter appropriate details in each field. Name and Description are required fields that can be edited at a later date.

    Note: Do not use the symbols '< >' when entering into any of the fields (except for the Source Table and Source Logic fields). These symbols are not supported, and text entered within them will not display in the Details panel.

    Note: The Source Table and Source Logic fields allow up to 1000 characters. These fields accept all characters, including numbers, letters, and special characters.

  3. Click Save.

Edit a Domain

From the Domains window, domains can be edited, deactivated, or deleted. The corresponding icons become active once a domain is selected.

  1. Select a domain by clicking the row or checking the box to the left of the domain name.
  2. Click the Edit icon in the toolbar, or right-click the row and select the desired action from the drop-down list.
  3. The Edit Domain window opens, displaying the current values for the selected domain.
    Edit Domain
     

  4. Enter updates to the attributes. Name and Description fields  are required.

    Note: Do not use the symbols '< >' in any fields (except Source Table and Source Logic). These symbols are not supported, and text entered within them will not display in the Details panel.

    Note: The Source Table and Source Logic fields allow up to 1000 characters. These fields accept all characters, including numbers, letters, and special characters.

  5. Click Save to save the changes and close the window, or click Cancel to close the window without saving.

Activate / Deactivate a Domain

The Active column indicates whether a domain is active or inactive. Domains can be activated or deactivated as needed.

  1. Select the domains to activate or deactivate by clicking the checkboxes to the left of the domain names.
  2. Click the Activate / Deactivate icon in the toolbar, or right-click the selection and select Activate / Deactivate from the drop-down menu.
    Activate / Deactivate

Delete a Domain

  1. Select the domains to delete by clicking the checkboxes to the left of the domain names.
  2. Click the Delete icon in the toolbar, or right-click the selection and select Delete from the drop-down menu.
  3. A warning window displays, providing options to Delete, Cancel, or Deactivate the domain.

View Domain Variables and Codelists

To view the list of variables and codelists for a domain, several options are available:

  • Click the Variables or Codelists buttons at the top of the window.
  • Right-click a record and select Variables or Codelists from the drop-down menu
  • From the Details view; click Go to Variables or Go to Codelists buttons at the bottom right. 

Another option is to click the Domain Name hyperlink within the row to open the list of variables for that domain.

The variables list differs from the specification and domain lists because it is presented as an editable grid.

Use the breadcrumbs at the top of the window to navigate back to previous screens. 

Variable List

Update Domain Approval Workflow

If a specification has the Requires Domain Approval flag selected, the status of each individual domain is updated as it is reviewed and approved. The specification can be approved only after all domains have been approved. If the Requires Domain Approval flag is not selected, the domain status automatically reflects the specification status.

A domain defaults to the status of In Development. Use the Change Status icon to update the status as the domain progresses through the review and approval cycles. To be edited, the domain must remain in the In Development status.

  1. Click the active record or select the checkbox to the left of the domain. 
  2. Click the Change Status icon in the toolbar, or right-click the record and select Change Status.
  3. Select the desired status from the drop-down list.
    Change Status

Manage Variables

The Variables list is an Excel-like grid that allows editing of variable values for a domain used in mapping. It supports autosave, copy and paste, select and drag to copy, as well as undo and redo actions. Data validation is applied automatically, and any errors must be corrected before data is saved. 

Updates can be made only when the domain has a status of In Development. 

Note: Do not use the symbols '< >' in any fields. These symbols are not supported, and text entered within them will not display.

The columns in the Variables list vary depending on whether the specification type is a Mapping or Exception Listing.  Columns in the list can include:

COLUMN DESCRIPTION
Sequence A number indicating the variables' order as they should appear in mapped datasets.
Target Variable Name Variable name. Required and must be unique within the domain.
Variable Label Short description of the variable. Required.
Origin

Source of values for the target variable per the Define-XML Completion Guidelines. Double-click in the cell to make a selection. 

Options include: Assigned, Collected, CRF, eDT, Derived, Not Available, Predecessor, Protocol
Supporting Document

Double-click in the cell to make a selection.

Options in the drop-down will include all attachments added to the Specification.
Origin Metadata Additional information about the Origin. For example, for CRF Origin, use the reference type or page references; for Predecessor Origin, use the description.
Key Sequence Numeric sort order that provides a key to identify rows uniquely. Variables that are part of the unique sort order will have values. Other variables will have this field blank.
Role

Indicator of how the variable is used within the dataset, per CDISC SDTM and SEND implementation guides.

Double-click in the cell to make a selection.

Options include: Grouping Qualifier, Identifier, Record Qualifier, Result Qualifier, Rule, Supplemental Qualifier, Synonym Qualifier, Timing, Topic, and Variable Qualifier.
Type

Variable data type.

Double-click in the cell to make a selection.

Options include: Char, text, integer, float, datetime, date, Date (dd-MON-yyyy), Num, time, Time (24 hour), partialDate, partialTime, partialDatetime, incompleteDateTime, durationDatetime.
Length Maximum expected variable length (digit). Only used when the Data Type is text, integer, or float.
Required

Double-click in the cell to make a selection.

Options for SDTM include: Required, Req, Expected, Exp, Permissible, Perm.

Options for CDASH include: Highly Recommended, HR, Recommended/Conditional, R/C, Cond, Optional, O.

Options for ADaM include: Required, Req, Conditional, Cond, Permissible, Perm.
Code List Name

A hyperlink that opens the Codelist window, which provides details of the displayed codelist and includes an Edit Codelist button at the top right.

If the column is empty, type a codelist name directly or right-click to Select Codelist from an imported codelist, or choose Delete Row. If a codelist name that has not been imported is entered, a flag appears in the field with the warning 'This Codelist is not in the imported Codelists.'

If the column is populated with a codelist, right-click to view additional options: View Codelist, Select Codelist, Remove Codelist, or Delete Row.
Source Field Defines the field name from the source Data Store that maps to the target domain and variable. When creating an SDTM Specification, if the study is configured for Specification Automation, some variables may have the Source Field column pre-populated.
Method Name

Double-click in the cell to make a selection.

Options in the drop-down list include all Methods added to the Specification.
Mapping Arguments

Enter any arguments for mapping the source variable to its target destination.

To edit Mapping Arguments:

  1. Right-click to open the context menu and select Edit. 
  2. The Edit window opens with fields for Target Variable, Source Field, Method Name, Mapping Arguments, and Mapping Notes to support accurate definition of mapping transformations. 
  3. Make updates as needed.
  4. Click Save.

Edit Mapping Arguments.png 

Edit Mapping Arguments window.png
Mapping Notes This is an open text box to enter the mapping, which describes the variable derivation.
To edit Mapping Notes to open the context menu and select Edit. Update the Mapping Notes field in the same Edit window (shown above in Mapping Arguments) and click Save.

 

Manage Variables

Using AI to Predefine Source Values for Variables

When a new SDTM Specification is created, and the Specification automation tag is enabled for the study in the Metadata, it will automatically generate Domains and Variable Lists and populate the Source Fields column for certain variables. elluminate's AI engine derives the fields for this column based on recently imported data and the study's SDTM Standard.

Note: For details on creating a Specification with AI enabled, see the Create and Manage Specifications article in the Specifications section.

Variable List - AI

Note: Users can import or create Domains and Variable Lists for their Specifications to supplement or replace the AI-generated content.

Use Toolbar Actions

Toolbar actions are active when the specification has a status of In Development.

The system automatically saves changes made in the grid.

A manual save control can also be used to save on demand. This control becomes active when unsaved, validated changes are present.

Toolbar Buttons and Icons

Toolbar Actions Icons

BUTTONS / ICONS ACTIONS
Codelists Navigate to the Codelists within the specification.
Methods Navigate to the Methods within the specification.
View Method Opens the properties window for the method associated with a variable. From this window, the Methods listing is accessible, with the method's row highlighted. If needed, actions can be performed from the toolbar.  
Attachments Click to view options: Upload Annotated CRF, Upload Supporting Doc, or Manage Documents.
Add Use to manually add a variable. When created, the new variable appears in the bottom row.
Value-level Metadata Click the icon to add or modify Value-level Metadata for a selected variable, or right-click the row and select Value-level Metadata from the menu. For more details, see Value-level Metadata
Delete Click to delete the selected variable(s). A warning dialog appears, providing an option to cancel the action.
Filters (active)


Filters (inactive)		 A solid white Filters icon indicates that filters are applied within the listing. Click the icon to clear all filters, or clear individual filters by clicking the red circle next to the filtered column name.

A grayed-out Filters icon indicates that no filters are applied within the listing. 

Clear Filters

Value-level Metadata

Value-level Metadata (VLM) can be added and managed from the Variables list according to the Define.XML standard. This is critical for defining mapping specifications for SDTM- and ADaM-like datasets. VLM can be viewed for individual variables on the Variables page and will be included in the Define.XML export.

Add VLM to a Variable

  1. From the Variable List, right-click the Variable row where value-level metadata (VLM) is to be added. A context menu opens with the Value-level Metadata option, or click the Value-level Metadata icon in the toolbar.
    Value-level Metadata
     
  2. The VLM window opens. Notice that the top portion displays Variable-level Metadata.
  3. In the Value-level Metadata section, click the Add VLM icon. An entry row is added.
    Add VLM
     
  4. Enter the Sequence.
  5. Enter the Condition. A tooltip with detailed instructions appears hovering over the field.
  6. Enter the Name.
  7. Select the Type from the drop-down.
  8. Enter the Length.
  9. Select the Codelist from the drop-down.
  10. Select the Origin from the drop-down.
  11. Enter the Origin Metadata.
  12. Select the Attachment from the drop-down.
  13. Select the Method from the drop-down.
  14. Enter the Mapping Notes.
  15. Click the Save icon. If required fields are not completed, the fields are outlined in red. 
  16. Click the Close button.

Edit VLM

  1. From the Variable List, click the Variable row where the VLM is to be edited.
  2. Click the Value-level Metadata icon. The VLM window opens, with the top portion displaying Variable-level Metadata.
  3. In the Value-level Metadata section, highlight the row to be edited.
  4. Click the Edit VLM icon.
  5. Make changes.
  6. Click the Save icon.
  7. Click the Close button.

Delete VLM

  1. From the Variable List, click the Variable row where the VLM is to be deleted.
  2. Click the Value-level Metadata icon. The VLM window opens, with the top portion displaying Variable-level Metadata.
  3. In the Value-level Metadata section, highlight the row to be deleted.
  4. Click the Delete VLM icon.
  5. Click the Close button.

Use Column Options

Columns can be sorted and filtered by clicking the column header.

  • To sort: Click the column header and select Ascending or Descending.
  • To filter: Click the column header and select Filter. Then select the option to Include (default) or Exclude selections, select Blank Values if applicable, enter Text to search, and click Filter Rows. 
  • To clear filters: Click Clear to remove all applied filters.

Use Cell Options

Cell Selection

  • Click a cell to select it
  • Click and drag to select multiple cells
  • Click a row heading to select an entire row

Edit Cells

  • Double-click to edit any cell in the grid
  • Drag on the corner tool of a cell to drag values to adjacent cells horizontally or vertically

Undo/Redo

  • The user can undo or redo actions using keyboard shortcuts:
    • Ctrl-Z – Undo
    • Ctrl-Y – Redo

Copy/Paste Cells

  • Copy and paste values in the grid using keyboard shortcuts:
    • Ctrl-C – Copy
    • Ctrl-X – Cut
    • Ctrl-V – Paste
  • Paste values from their system clipboard into a cell
  • Paste multiple cells from Excel into the grid

Data Validation

  • When a cell loses focus, a validation check is executed
  • If validation finds an error, the cell will be styled to draw attention
  • An error message appears on hover over the cell to explain why the validation failed and how to fix it
  • The user must fix validation errors before records are saved

Keyboard Shortcuts

  • Cell navigation using arrows
  • Enter key (or Shift-Enter) moves to the cell below (or above)
  • The tab key (or Shift-Tab) moves to the cell to the right (or left)
  • Common windows copy/cut/paste
  • Common windows undo/redo

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