Codelists are terminology sets associated with a specification. Typically, codelists are imported from a standard and include multiple values.
A user can import codelists from standard controlled terminologies or from another active specification and can create custom codelists. Functionality includes adding, editing, and deleting attributes of a codelist, managing the list of values for each codelist, associating codelists with values, and creating issues.
Note: Updates can only be made if the specification has the status of 'In Development.'
A blue badge at the right of Codelists displays the number of codelists associated with the specification. Items on the page in blue text are hyperlinks; the breadcrumbs contain the name and version of the specification, and clicking the hyperlink returns to the specification. The selected Standard and Controlled Terminology are hyperlinks to the Standards module, and the columns Name and Values are hyperlinks to the Codelist Values.
The other columns include Open Issues, Display Name, Description, Type, Extensible, CDISC Code, and External Reference.
Codelists Toolbar Icons & Actions
From the listing, toolbar icons and buttons become active after selecting records by selecting the checkbox to the left of the row or by right-clicking a record and selecting an action.
Click the Details icon opens the Details view. Use the Edit and Close icons in the top right corner. At the bottom of the Details view, expand and view Codelist Values, access the Values list, or expand to view associated variables and access the Variables list.
| BUTTONS / ICONS | ACTIONS |
|---|---|
| Values | Navigate to the Values page for the Codelist. |
| Domains | Navigate to the Domains page for the Specification. |
| Methods | Navigate to the Methods page for the Specification. |
| Import Codelists | Import from a Standard or from another active Specification. |
| Attachments | Upload a supporting document or an annotated CRF or manage previously uploaded documents. |
| Add | Manually create a new Codelist. |
| Edit | Modify the selected Codelist. |
| Details | View the details and properties of the selected Codelist. |
| Issues | Create or view the Specification Codelist Issues for the selected Codelist. |
| Delete | Delete the selected Codelist |
| Previous / Next | Navigate through the pages. |
| Filters (active) Filters (inactive) | A solid white Filters icon indicates filters are applied within the listing. Click the icon to clear filters, or clear an individual filter by clicking on the red circle next to the filtered column name. A grayed-out Filters icon indicates that no filters are applied within the Codelist listing. |
Import a Codelist
Codelists can be imported from a standard or from another specification. Users also have the ability to add custom codelists and enter the details.
Import From Standard
The standard browser opens to the version of the selected controlled terminology in the specification. If no controlled terminology was assigned to the specification, click the desired standard and controlled terminology version number on the left. The codelist details of the selected version are open on the right of the window.
Click the Import Codelists icon and select Import From Standard.
The Import Codelists from Standard browser window opens, and the controlled terminology version selected in the specification is already highlighted. If no controlled terminology was selected, the tree displays a list of possible standards and their associated controlled terminology versions.- Select the checkboxes next to the Codelist Name entries to import. Use the scrollbar on the right to view additional items, or select the checkbox at the top of the list to select all.
- Click Import. The Codelist listing displays the imported codelist.
- To add additional codelists, import from another specification or use the Add (plus sign) icon in the toolbar.
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 included in the current specification), the system displays No Data.
Click the Import Codelists icon and select Import From Specification.
The Import Codelists from Specification window opens.
Click the drop-down next to the study to display the specifications available to import from.- The available codelist(s) populates on the right.
- Select the codelists to import by selecting the checkboxes to the left, or select the checkbox in the header to select all.
- Click Import. The Codelist listing displays the imported codelists.
Add a New Custom Codelist
Click the Add icon in the toolbar. The Create CodeList window opens.
Enter appropriate details in each field. Name and Type are required fields.
Note: Do not use the symbols '< >' in any fields. These symbols are not supported, and text entered within them does not display in the Details panel.
- Name: Must be unique.
- Display Name: Short descriptive name.
- Description: Description of the codelist.
- Extensible: Checkbox indicating values can be added to the codelist.
- Type: Decoded (has a decode value), Enumerated (typically used with a list of values), or External (refers to another source such as MedDRA or WHO Drug).
- Click Save.
Edit Codelist Attributes
- Select the codelist to edit by clicking the record row, selecting the checkbox to the left of the codelist, or right-clicking a record row.
- From the listing, click the Edit icon in the toolbar, right-click, and select Edit from the drop-down menu, or click the Edit icon in the Details view.
The Edit CodeList window opens, populated with the current values for the selected codelist.
Enter updates to the attributes. Name and Type are required.
Note: Do not use the symbols '< >' in any fields. These symbols are not supported, and text entered within them does 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.
Delete Codelists
- Select the codelists to delete by selecting the checkboxes to the left of the codelist names.
- Click the Delete icon in the toolbar, or right-click and select Delete from the menu.
- A Delete CodeList(s)? warning window opens. Click OK to delete the selected codelists, or select Cancel to cancel the action.
View Codelist Values
There are several ways to access and view codelist Values. Click the hyperlink in either the Name or Values column of a record or select a record and click the Values button in the toolbar. With the Details window open, click the arrow at the bottom next to Codelist Values to expand the section, or click the 'Go to Values' button. The list of values is an editable grid, similar to the variables list.
Use the breadcrumbs at the top to return to previous screens.
Manage Codelist Values
The Codelist Values list is an Excel-like grid that allows the editing of values for a codelist 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 '< >' in any fields. These symbols are not supported, and text entered within them does not display.
Columns in Codelist Values
| COLUMN | DESCRIPTION |
|---|---|
| Code | Value name. Required and must be unique within the codelist. |
| Decode | Short description of the value. This is the display value for Decoded codelists. |
| Sequence | A number indicating the order of values if each value has significance relative to others in the codelist. Equivalent to the Define XML Rank attribute. |
| CDISC Code | Unique code value for elements in CDISC controlled terminologies. Applicable only for codelists inherited from CDISC controlled terminologies. |
| Description | Optional description for the value. |
| Synonyms | Optional alternative terms for the value. Multiple synonyms can be included, separated by a comma. |
| Source Values | Users can optionally define specific values for each controlled terminology in their study. This feature allows for documenting necessary mappings that are not included in the CDISC controlled terminology standard. Note: Right-click in the column cell to open the Edit Source Values window. |
Users have a dedicated workspace that offers a larger area for editing, enabling accurate definitions of their mapping transformations.
CodeLists Toolbar Icons & Actions
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 is active when there are changes to be saved and these changes have been validated.
| BUTTONS / ICONS | ACTIONS |
|---|---|
| Domains | Access the Domains in the specification. |
| Methods | Access the Methods in the specification. |
| Attachments | Click for options to Upload Annotated CRF, Upload Supporting Doc, or Manage Documents. |
| Add | Manually create a new value. These values are added to custom-created codelists or to extensible codelists. A row is added to the bottom of the list to insert the new value. |
| Delete | Click one or more rows of values to delete. A confirmation window appears with the option to cancel the action. |
| Issues | Create or view issues. |
| Filters (active) Filters (inactive) | A solid white icon indicates filters are applied in the Codelist listings. Click the icon to clear filters and individual filters by clicking on the red circle next to the filtered column's name. A grayed-out filter icon indicates no filters are applied within the codelist's listing. |
Use Breadcrumbs
The hyperlinked breadcrumbs display the specification name and version, the status of the version, and the codelist associated with the values list.
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 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 the cell to the right (or left)
- Common windows copy/cut/paste
- Common windows undo/redo