Domains can be added by importing from a standard, importing from another specification, or creating a custom domain manually. When Mapping Automation is enabled for an SDTM specification, domains and variables can also be generated automatically based on the selected standard and available study data.

Access Domains

Several options are available to access domains:

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

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

Access Domain Details View

1. Select a domain by selecting the row or the checkbox next to the domain.
2. Click the Details icon in the toolbar. The Details view opens on the right.

Use Breadcrumbs

The hyperlinked breadcrumbs display the specification name and version, the version 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 is 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.
   
   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.
   
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 list displays the imported domains.

   Note: Columns displayed in the Domains list vary based on the specification type, such as Mapping or Exception Listing.

4. To add additional domains, import from another specification or use the Add 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. 
   
2. Select the standard and version. After the selection is made, the domains populate in the window on the right.
3. Select the domains by selecting the checkbox(es) on the left.
4. Click Import.
5. Continue selecting domains from multiple standard versions.
6. Click Import. The Domains list 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. 
   
2. The Import Domains from Specification window opens.
   
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 Domains list displays the imported domains.

Add a New Custom Domain

Custom domains can also be added.

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

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 does 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 when a domain is selected.

1. Select a domain by selecting the row or the checkbox next to the domain name.
2. Click the Edit icon in the toolbar, or right-click the row and select Edit from the menu.

The Edit Domain window opens and displays the current values for the selected domain.

 

3. 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 does not display in the Details panel.

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

4. Click Save to save the changes and close the window, or click Cancel to close 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 by selecting the checkboxes next to the domain names.
2. Click the Activate / Deactivate icon in the toolbar, or right-click the selection and select Activate / Deactivate from the menu.
   

Delete a Domain

1. Select the domains by selecting the checkboxes next to the domain names.
2. Click the Delete icon in the toolbar, or right-click the selection and select Delete from the menu.
3. In the warning window, select Delete, Deactivate, or Cancel.

View Domain Variables and Codelists

Several options are available to view the list of variables and codelists for a domain:

• Click the Variables or Codelists buttons in the master header.
• Right-click a record and select Variables or Codelists from the menu.
• In the Details view, click the Go to Variables or Go to Codelists buttons at the bottom right.
• Click the Domain Name hyperlink in the row to open the Variable List for that domain.

The Variable List displays as an editable grid, unlike the specification and domains lists.

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

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 are 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. The domain must remain in this status to allow edits. Use the Change Status icon to update the status as the domain progresses through review and approval cycles. 

1. Select the domain by selecting the row or the checkbox next to 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 menu.
   

Manage Variables

Important: If Mapping Automation is enabled, an SDTM specification can automatically generate domains and the Variable List when applicable study data are available. For details on creating a specification with AI, see the article, Create and Manage Specifications.

The Variable List is an editable grid used to manage variable values for a domain used in mapping. The grid supports autosave, copy and paste, drag-and-drop, and undo and redo.

Note: If Mapping Automation is enabled for the specification, see the Use Mapping Automation Recommendations section for details on recommendations, visual indicators, manual reruns, and comparison options in the Variable List.

Edit a Value

1. Double-click a cell to enable in-line editing. 
2. Enter a value. 

Data validation applies automatically. Resolve all validation errors before saving. 

OR

1. Right-click a cell in the Source Field, Method Name, Mapping Arguments, or Mapping Notes column.
2. Select Edit. The Edit window opens. 
   
3. Make updates as needed.
4. Click Save.

Other right-click options may include: Delete Row, Value-level Metadata, or options specific to the selected column, such as Codelist Name or Method Name.

Updates can be made only when the domain status is In Development.

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

Access Variable Details View

1. Click any cell in a row to select it.
2. Click the Details icon in the toolbar. The Details view opens on the right.

Variable List Columns

The columns in the Variable List vary based on the specification type, such as Mapping or Exception Listing.  Columns can include:

Use Mapping Automation Recommendations

When Mapping Automation is enabled through URL and Study Settings, and applicable data stores are selected, elluminate runs an AI model after data are imported. When a new SDTM specification is created, Mapping Automation can generate domains and variables and provide recommendations for Source Field, Method Name, and Mapping Arguments when applicable. 

AI-generated recommendations are highlighted in the Variable List. Review, accept, reject, or update recommendations directly in the grid. Accepted or updated values remove recommendation highlighting. Rejected recommendations revert to prior values when available.

Run Mapping Automation manually from the Variable List for selected variables to generate updated recommendations after changes are made. If Mapping Automation detects differences between existing values and AI-recommended values, a comparison view displays the existing and recommended Source Field, Method Name, and Mapping Arguments values side by side. Apply recommended updates or retain existing values.

Mapping Automation activity is tracked in the audit log. Audit entries include automatic domain and codelist creation, accepted recommendations, rejected recommendations, modified recommendations, applied recommendations, and manually triggered Mapping Automation activity at the variable level. For manually triggered Mapping Automation, audit entries include source field lineage when available. If source details cannot be fully resolved, unavailable datastore values display as 'NA'.

Note: Mapping Automation is available for SDTM specifications when AI is enabled and Mapping Automation is configured.

Review Variable List Indicators

The Variable List uses visual indicators to identify required mapping fields, intentionally unmapped variables, and system-generated recommendations.

Required mapping fields, including Source Field, Method Name, and Mapping Arguments, are highlighted when empty. Highlighting updates as values are entered and adapts based on the selected mapping method.

Variables marked as Not Mapped are visually distinguished and do not trigger validation errors for mapping fields that are intentionally excluded.

Variables with successfully generated Mapping Automation recommendations display a Mapping Automation Completed indicator. Hover over the indicator to view the 'Completed' message.

If Mapping Automation cannot generate recommendations, an error indicator displays. Hover over the indicator or the red triangle in the associated Source Field cell to view the error message.

Click the Legend icon to view the highlighting states used in the Variable List.

Run Mapping Automation

Run Mapping Automation from the Variable List when a source field is available for a variable. The action is available from the right-click menu and the toolbar. To run Mapping Automation for multiple variables, select multiple rows, then click Run Mapping Automation.

1. Select one or more variables, or click the top-left cell to select all rows.
2. Click the Run Mapping Automation icon, or right-click and select Run Mapping Automation.
3. Review the results in the Variable List.
4. Review any error messages if recommendations cannot be generated.

Review Mapping Automation Recommendations

AI-generated recommendations are highlighted in the Variable List. Recommendations can be accepted, rejected, or updated directly in the grid.

When Mapping Automation is rerun and differences are detected, a comparison view displays existing and AI-recommended values side by side for Source Field, Method Name, and Mapping Arguments. Apply the recommended values or retain the existing values as needed.

1. Review the generated recommendations for Source Field, Method Name, and Mapping Arguments.
2. Accept, reject, or update AI-generated recommendations as needed:
   • Right-click and select Accept AI Suggestion or Reject AI Suggestion.
   • Double-click a cell to enable in-line editing.
3. If edits are made, click Save in the top-right corner (only appears if edits are made).

Accepted or updated values remove recommendation highlighting. Rejected recommendations revert to prior values when available.

View Mapping Comparison

When existing values differ from AI-recommended values, right-click the variable row and select View Mapping Comparison.

The Mapping Value Comparison window opens and displays User Values and AI Recommended Values side by side.

1. Select individual values, or click Select All User Values or Select All AI Recommended Values.
2. Click Save.

Saved selections update the corresponding values in the Variable List.

Toolbar Icons and Actions

Toolbar actions vary based on the specification status and selected record. Some icons or actions may be unavailable depending on the current status of the specification, domain, or variable. The system automatically saves changes made in the grid.

Icon	Icon Name	Description
	Run Mapping Automation	Click to run Mapping Automation for selected variables. Mapping Automation provides updated recommendations for Source Field, Method Name, and Mapping Arguments when AI is enabled and Mapping Automation is configured.
	Change Status	Click to change the status of an item.
	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.
	Edit	Click to edit the item.
	Create New Version	Click to create a new version.
	Details	Click to open the Details panel.
	Issues	Click to create or view issues.
	Export	Click to export to Excel (Pinnacle 21 Format, Separate Domain Tabs, Single Variable Tab, Define.XML, or Define2.0XSL).
	Activate / Deactivate	Click to activate or deactivate.
	Delete	Click to delete a record.
	Filters	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. Note: A grayed-out Filters icon indicates that no filters are applied.
	Help	Click to access help menu (Help Center, Community, Learning Portal, support information, privacy policy, legal notices, and the version of elluminate.
	Import Codelists	Click to import a codelist.
	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

Value-level Metadata

Value-level Metadata (VLM) can be added and managed from the Variable 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 is 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 required.  Right-click the row and select Value-level Metadata, or click the Value-level Metadata icon in the toolbar.
   
    
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.
   
    
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 requires editing.
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, select the row to edit.
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 requires deletion.
2. Click the Value-level Metadata icon. The VLM window opens, with the top section displaying Variable-level Metadata.
3. In the Value-level Metadata section, select the row to delete.
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

• 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 the 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 is 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