Manage Codelists and Values in Specifications

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Codelists are terminology sets associated to 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 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.

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

Codelists.png

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, 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 Actions Overview

From the listing, toolbar icons and buttons become active after selecting records by clicking in the checkbox(es) at the left, or you may also right-click on a record and select an action. 

Clicking on the Details icon opens the Details view.  At the top right corner are the Edit and Close icons, and at the bottom are options to expand and see the Codelist Values, go to the Values list, or expand and see the associated variables. 

CodelistsDV.png

Actions include:

  • Values button: Click to go to the Values page.
  • Domains button: Click to go to Domains page.
  • Methods button: Click to go to the Methods page.
  • Import Codelists icon: Import From Standard, or Import From Specification.
  • Attachments icon: Upload Annotated CRF, Upload Supporting Doc, or Manage Documents.
  • Add icon: Click to create a Codelist.
  • Edit icon: Click to edit the selected Codelist.
  • Details icon: Click to open / close the Details view.
  • Issues icon: Click to create or view issues.
  • Delete icon: Click to delete the selected Codelist.
  • Previous/Next Page icon: Click to see more rows, if applicable. Default page size is 25 rows.
  • Filters icon: Identifies if filters are applied to the columns.

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 on the desired  standard and controlled terminology version number on the left.  The codelist details of the selected version opens at the right of the window.  

  1. Click the Import Codelists icon and select Import From Standard.
    ImportCodelists.png
    The Import Codelists from Standard browser opens and the controlled terminology version selected in the specification is already highlighted. If no controlled terminology was selected then the tree displays a list of possible standards and their associated controlled terminology versions.
    ImportFromStd.png
  2. Click in the checkboxes next to the Codelist Name 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.
  3. Click Import. The Codelist listing displays with the imported codelist.
  4. To add additional codelists, import from another specification or use the Add icon (the plus sign) 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 on your specification) then thy system will display 'No Data'.

  1. Click the Import Codelists icon and select Import From Specification
    ImportCodelists.png
  2. The Import Codelists from Specification window opens.
    ImportCodelistSpec.png
    Click the drop-down next to the study to display the specification available to import from.
  3. The available codelist(s) populates at the right.
  4. Select the codelists you wish to import by clicking in the checkboxes at the left, or select the checkbox in the header to select all. 
  5. Click Import. The Codelist listing displays with the imported codelist.

Add a New Custom Codelist

  1. Click the Add icon (the plus sign) in the toolbar. The Create CodeList window opens.
    CreateCodeList.png
  2. Enter appropriate details in each field. Name and Type are required fields.

    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.


    1. Name: Must be unique.
    2. Display Name: Short descriptive name.
    3. Description: Description of the codelist.
    4. Extensible: Checkbox indicating values can be added to the codelist.
    5. 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).
  3. Click Save.

Edit Codelist Attributes

  1. Select the codelist you wish to edit by clicking the records, or clicking in the checkbox at the left of a codelist, or right-clicking on a row.
  2. From the listing, click the Edit icon in the toolbar or right-click and select Edit from the drop-down menu. Or from the Details view, click the Edit icon.
  3. The Edit CodeList window opens and is populated with current values for the selected codelist.
    EditCodeList.png
  4. Enter changes to the attributes. Name and Type 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.

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

Delete Codelists

  1. Select the codelists by clicking in the checkbox(es) at the left of the codelists you wish to delete.
  2. Click the Delete icon in the toolbar or right-click and select Delete from the drop-down menu.
  3. 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. 

Codelists_2.png

Manage Codelist Values

The Codelist Values list is an Excel-like grid that allows 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 '< >' when entering into any of the fields. These symbols are not supported, and text entered within them will not display.  

Columns in the 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

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.

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.

CodeListValues.png

Use Toolbar Actions

  • Click the Domains button to access the Domains in the specification.
  • Click the Methods button to access the Methods in the specification.
  • Click the Attachments icon for options to Upload Annotated CRF, Upload Supporting Doc, or Manage Documents.
  • Click the Add icon (the plus sign) to add a value.  These are values added to custom created codelists or to extensible standard codelists. The row adds to the bottom of the list. 
  • Click the Delete icon (the trashcan) to delete the selected value. When you click the trashcan icon to delete a value a confirmation window displays giving the opportunity to cancel your action. To delete multiple rows, select those rows and click the delete icon.
  • Click the Issues icon to create or view issues.
  • In the screenshot above the Filters icon is grayed out, indicating there are no column filters applied to the list.  
    • If the icon is highlighted, it indicates at least one column has a filter applied.  Click the highlighted Filters icon and select Clear Filters, to clear all filters; or you can clear individual filters by clicking on the red circle.

Use Breadcrumbs

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

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

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