Manage Domains and Variables in Specifications

You can add domains 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 on the row or checkbox at the left of the specification, and click Domains in the toolbar.
Right-click on the row and select Domains.

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

Access Details View

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

Use Breadcrumbs

The hyperlinked breadcrumbs display the specification name and version, the status of the version; and the domain associated to the variable list.

Import Domains From a Standard

Import Domains When a Standard Was Selected in the Specification

If you selected a standard when you created the new specification, then the standard browser will be filtered for just that standard. If the specification requires multiple standards, then a standard should not be selected when creating the new specification.

Click the Import Domains icon and select Import From Standard.

The Import Domains from Standard browser opens and the standard version selected in the specification is already highlighted. If no standard was selected then the tree displays a list of possible standards.
Click in the checkboxes next to the domains you wish to import. Use the scrollbar on the right to see more. The checkbox at the top of the list is a select all.
Click Import. The Domains listing displays with the imported domains. Note: columns that display in the Domain listing vary depending if the specification type is a mapping or exception listing.
To add additional domains, import from another specification or use the Add icon (the plus sign) in the toolbar.

Add Domains if a Standard Was Not Selected in the Specification

If a standard was not selected when creating the specification, then you may use the standard browser 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.

Click the arrows to expand the listed standards.
Select the standard and version. After making your selection the domains populate in the window on the right.
Select the domains by clicking in the checkbox(es).
Click Import.
Continue selecting domains from multiple standard versions.
Click Import. The Domain listing displays with the imported domain(s).

Import Domains From Another Specification

You can also import 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 on your specification) then thy system will display 'No Data'.

Click the Import Domains icon and select Import From Specification.
The Import Domain from Specification window opens.
Click the drop-down next to the study to display the specification available to import from.
The available domains populate at the right.
Select the domains you wish to import by clicking in the checkboxes at the left, or select the checkbox in the header to select all.
Click Import. The Domain listing displays with the imported domain(s).

Add a New Custom Domain

Users also have the ability to add custom domains and enter the details.

Click the Add icon (the plus sign) in the toolbar. The Create Domain window opens.
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. These symbols are not supported, and text entered within them will not display in the Details panel.
Click Save.

Edit a Domain

From the Domains window Edit, Deactivate and Delete domains. The icons become active once you select a domain.

You first select a domain by clicking in the row, or in the checkbox at the left of a domain and then clicking on the icon in the toolbar, or right-clicking on a row and selecting the action from the drop-down.

You may also open the Details window and use the Edit icon at the top right to open the Edit Domain window.

From the Edit Domain window (fields are populated with current values for the selected domain):
Enter changes to the attributes. Name and Description are required.

Note: Do not use the symbols '< >' when entering into any of the fields. These symbols are not supported, and text entered within them will not display in the Details panel.
Click Save to save the changes and close the window, or click cancel to close the window without saving changes.

Activate / Deactivate a Domain

The Active column indicates if a domain is active or not. Users can activate a deactivated domain, or deactivate an active domain.

Select the domains you wish to activate or deactivate by clicking in the checkbox(es) at the left.
Click the Activate / Deactivate icon in the toolbar or right-click and select Activate / Deactivate from the drop-down menu.

Delete a Domain

Select the domains you wish to delete by clicking in the checkbox(es) at the left.
Click the Delete icon (the trashcan) in the toolbar or right-click and select Delete from the drop-down menu.
A warning window displays, giving the option to Delete, Cancel the action, or Deactivate the domain.

View Domain Variables and Codelists

To view the list of variables and codelists for a domain, you may use the Variables or Codelists buttons at the top of the window, right-click on a record and select Variables or Codelists from the drop-down menu, or from the Details view you may use the Go to Variables or Go to Codelists buttons at the bottom right.

Another way to see the list of variables for a domain is to select the Domain Name hyperlink within the row.

The list of variables is different from the specification and domain lists as it is an editable grid.

Use the breadcrumbs at the top to return to previous screens.

Update Domain Approval Workflow

If a specification has the “Requires Domain Approval” flag checked, then the status of each individual domain is updated as it gets reviewed and approved. The specification can only be approved once all domains are approved. If the Requires Domain Approval flag is not checked the status of the domains automatically reflects the status of the specification.

A domain is defaulted to the status of 'In Development'. Use the Change Status icon to update the status as you work through review cycles and approval. To be edited, the domain must be in the 'In Development' status.

Click the (active) record or click the checkbox at the left of the domain.
Click the Change Status icon in the toolbar, or you may also right-click the record and select Change Status.
Select the status from the drop-down.

Manage Variables

The Variables list is an Excel-like grid that allows editing of values of the variables for a domain used in mapping. It autosaves data entry, allows copy and paste, select and drag to copy, as well as undo and redo. It provides data validation. Errors must be fixed before the data is saved.

Updates can only be made if the domain has the status of 'In Development'.

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

Columns in the Variables list include:

COLUMN	DESCRIPTION
Sequence	Number indicating the order of variables 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 selection. Options include: Assigned, Collected, CRF, eDT, Derived, Not Available, Predecessor, Protocol
Supporting Document	Double-click in the cell to make selection. Options in the drop-down will include all attachments added to the Specification.
Origin Metadata	Additional information about the Origin. E.g., for CRF Origin the Reference Type or page references; or for Predecessor Origin, the description.
Key Sequence	Numeric sort order that provides a key to uniquely identify rows. Variables that are part of the unique sort order will have values. Other variables will have this field remain 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 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 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 Data Type is text, integer, or float.
Required	Double-click in the cell to make 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	Hyperlink to open the Codelist window that provides details of the codelist displayed, as well as an Edit Codelist button at the top right. If the column is empty, type in a codelist name directly, or right-click to Select Codelist from a codelist already imported or Delete Row. If you type in a codelist name that had not been imported, a flag will appear in the field with a warning, 'This Codelist is not in the imported Codelists'. If the column is populated with a codelist, right-click to select options: View Codelist, Select Codelist, Remove Codelist, or Delete Row.
Method Name	Double-click in the cell to make selection. Options in the drop-down will include all Methods added to the Specification.
Mapping Notes	This is an open text box used to enter the mapping, a description of the variable derivation.

Toolbar actions are active if the specification has the status of 'In Development'.

The system autosaves changes made in the grid.

The user may select a control to save changes on demand. This control will be active when there are changes to be saved and these changes have been validated.

Use Toolbar Actions

Click the Codelists button to access the Codelists in the specification.
Click the Methods button to access the Methods in the specification.
Click the View Method button to open the properties window for the method associated to a variable in the list. From this window you can go to the Methods listing, and the method row is highlighted. Perform any actions from the toolbar if needed.
Click the Attachments (the paperclip) icon to Upload Annotated CRF, Upload Supporting Doc, or Manage Documents.
Use the Add icon (the plus sign) to add a variable. The row adds to the bottom of the list when a variable is added.
Use the Value-level Metadata icon to add or modify value-level metadata to a selected Variable. You may also right-click a row and select Value-level Metadata from the menu. For details on adding and managing VLM see Value-level Metadata.
Use the trashcan icon to Delete a variable. When you click the trashcan icon to delete a variable a confirmation window displays giving the opportunity to cancel your action. To delete multiple rows select those rows and click the delete icon. You may also right-click and select Delete Row.
If the Filters icon is highlighted, it indicates that at least one column has a filter applied. If the Filters icon is grayed out, it indicates there are no column filters applied to the list.
- Filtered columns are highlighted in orange. Click the highlighted Filters icon for options to clear all filters, or clear individual filters by clicking on the red circle.

Value-level Metadata

Value-level Metadata (VLM) can be added and managed from the Variables list according to the Define.XML standard. This is a critical part of 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

From the Variable List, click in the Variable row where you wish to add VLM.
Click the Value-level Metadata icon. The VLM window opens. Notice the top portion of the window displays Variable-level Metadata.
In the Value-level Metadata section, click the Add VLM icon. An entry row is added.
Enter the Sequence.
Enter the Condition. When you hover over the field a tooltip with detailed instructions displays.
Enter the Name.
Select the Type from the drop-down.
Enter the Length.
Select the Codelist from the drop-down.
Select the Origin from the drop-down.
Enter the Origin Metadata.
Select the Attachment from the drop-down.
Select the Method from the drop-down.
Enter the Mapping Notes.
Click the Save icon. If required fields are not completed, they will outline in red.
Click the Close button.

Edit VLM

From the Variable List, click in the Variable row where you wish to edit VLM.
Click the Value-level Metadata icon. The VLM window opens. Notice the top portion of the window displays Variable-level Metadata.
In the Value-level Metadata section, highlight the row you wish to edit.
Click the Edit VLM icon.
Make changes.
Click the Save icon.
Click the Close button.

Delete VLM

From the Variable List, click in the Variable row where you wish to delete VLM.
Click the Value-level Metadata icon. The VLM window opens. Notice the top portion of the window displays Variable-level Metadata.
In the Value-level Metadata section, highlight the row you wish to delete.
Click the Delete VLM icon.
Click the Close button.

Use Column Options

Columns can be sorted and filtered when clicking the column header. To sort, click on the header and select Ascending or Descending.

To filter, click on the header, select Filter. Filter options allow you to either include or exclude selections, include the blank values if appropriate, enter text to search and Filter Rows.

Click Clear to clear filters.

Use Cell Options

Cell Selection

Click on a cell to select it
Click and drag to select multiple cells
Click on 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 cell below (or above)
Tab key (or shift-Tab) moves to cell to the right (or left)
Common windows copy/cut/paste
Common windows undo/redo