Issues is used as a collaboration tool within Data Central (including RBQM and eIQ Review) and Analytics for users to communicate and resolve issues for data available in these modules, including non-eCRF data, as well as issues related to subjects or EDC queries.

Issues are created and tracked within elluminate and are not pushed to any external systems except for optionally sending an email notification to the user the issue has been assigned to.

Licensed elluminate users can create, assign, and take actions on issues, regardless of their reviewer role in Data Central. Unlicensed users only have access to their assigned issues, to which they can review and respond.

Issues created in Data Central (including RBQM and eIQ Review) and Analytics are included in the Issues panel within Data Central, as well as the global Issues module. 

Note: For details on how to create and manage RBQM related issues refer to the RBQM section.

Create Issues

Issues can be created from most records and listings within Data Central, including graphical patient profiles.

Tip: Easily create an issue and apply it to multiple records when creating an issue from a Domain or Exception Listing. An example of this would be if you had a question about how several records were coded, and rather than entering the same issue text for each record, you enter the issue once and apply it to multiple records. This saves time when dealing with common issues.

1. Identify where you are creating the issue from (click the drop-down arrow to expand a section):
   • The Subjects Listing
     1. Highlight a record.
     2. Click on the Create Issue icon in the panel toolbar, or right-click on a record and select Create Issue.
        
        
   • A Domain or Exception Listing:
     

     Create A Single Issue
     

     1. Highlight a Record.
     2. Click on the Create icon (the plus sign) in the panel toolbar, or right-click on a record and select Create.
     3. Select Create Domain Issue or Create Record Issue.
        

     Create a Single Issue on a Field

     1. Right-click on a cell.
     2. Select Create Field Issue.

     Apply Issue to Multiple Records

     1. Click the checkbox(es) on the left of each record where you will add the issue.
     2. Click on the Create icon (the plus sign) in the panel toolbar, or right-click on a record and select Create.
     3. Select Create Domain Issue or Create Record Issue.
        
        

        Note: If the user selects multiple records in an Exception Listing, and each has a different QueryText value, the Issue Text field will be disabled, and there will be a message saying that there are multiple values in the issue text. When the issues are created, each issue will have its text populated based on the selected record.

   • The Graphic Patient Profile

     Issue related to the Whole Profile

     1. Click the Create Issue icon in the panel toolbar.

     Issue related to a Specific Section of the Profile

     1. Click on the Create Issue icon located to the right of that section.
     
   • The Details View
     1. Click the Create icon (the plus sign) in the panel toolbar.
     2. In the drop-down, select either Create Issue or Create Domain Issue.
        
2. The Create Issue window opens.
   
   

   Tip: This window can be moved by dragging it elsewhere on the screen in order to view the window behind it.

   Issue details are provided in the top section of the window. Depending on where the issue was created, details may include Type, Subject, Data Store, Site, Domain, Field, and Value.
3. Click the Priority drop-down arrow and select Priority.
4. Click User, Role, or User Group in Assign To.
   

   Note: Assignment can be to a specific user, role, or user group. 

5. Click the User / Role / User Group drop-down arrow and select the appropriate user, role, or user group.
   

   Note: Names that display in the Assign To User drop-down include licensed users with access to the record where the issue is being created and unlicensed users.

6. By default, the Due By date displayed is based on the configured default priority. Optionally, update the date by entering over the date displayed, or using the calendar icon.
7. The Visit ID field may already be populated based on Data Central configuration, or it can be manually added or edited. 
8. Enter the Issue Text.
9. Click in the Send Notification to the User/Role/User Group checkbox if appropriate. If the issue is assigned to an unlicensed elluminate user, be sure to check the box.
   1. Select either Send immediately or Send in batch. If Send in batch is selected, be sure a task is scheduled to send Issue Notifications.
10. Click in the Receive notifications for these changes checkbox if you (as creator of the issue) would like to receive notification when there are changes to priority, assignment, and status. By default, all three boxes are checked. Uncheck any boxes if you do not want to receive notification.
11. Click Save. The new issue is added to the Issues listing.

Note: The email sent for a single issue includes additional source details based on the record where the issue was created.

Note: For A Domain or Exception Listing, when multiple issues are created at the same time, a single email goes to each appropriate user. The email will have a list of issues with a link to the user's open issues. The email will not list the details of the issue (subject, etc.) as there could be more than one subject in the batch. 

Note: Issues related to a study will have the the study name(s) in the subject line of the issue notification email.

Access the Issues Panel

The Issues panel is accessed from the left navigation. The panel can be docked to the sheet, allowing the user to see issues along with other panels docked to the sheet. To work with Issues in full screen, maximize the panel.

Tip: To view issues for records on domains marked are critical, scroll to the right of the window and check the Criticality column.

Filter Issues Panel Results

Filters are available for columns in the Issues panel. Columns that are filtered have a filter icon next to the column header. 

Filter and sort Issues by the assigned user, role, or group within the Assigned To column.

Tip: Find any issues assigned to you that require your action by filtering on columns Status=Open and Assigned To=your user id.

Tip: Find any issues you opened that were answered to see the response and then close the issue by filtering on columns Opened By=your user id and Status=Answered.

Note: For more details on using filters, check out the article Use Filters in Data Central in the Data Central section.

Open Record Details View

From the Issues panel or the Related Issues section of a Record Details panel, there are multiple ways to open the issue details view:

• Highlight a row and click the Details icon in the panel toolbar.
• Right-click on a row and select Details.
• Double-click on a row.

The panel toolbar displays a set of icons that allows you to navigate forward and backward through the issues listing, action issues, dock the panel, maximize / restore the panel, or close the panel. 

Use the scrollbar on the right to see more of the panel. The top portion of the panel shows the issue details, followed by Record Details (if configured), Comments, Related Queries (if available), and Related issues which can be expanded to see existing or add new.

Tip: URLs can be configured to include Record Details for Issues. Issues created for a record include an expandable Record Details section. This section is found just above the Comments section. Unlicensed users will also have this section. Click Record Details to expand and view the details.

Tip: From the Details view of an issue or query, expand the Related Issues section at the bottom of the panel to see all related issues. If an issue record has Issues associated with it, the badge identifying the number of Issues will not display until Related Issues is expanded. Issues can be actioned from the Related Issues section using the toolbar above the section.

View the Source of the Issue

There are two ways to open the record, listing, or graphical patient profile where the issue was created:

• From the Issues Listing, click on a link in the Type column for a record.
  
• From the Details View, click the link in the Type field.
  

The source opens in a new panel on the sheet which can be docked. Types include:

• Domain: Opens the domain listing, or the graphical patient profile.
• Query: Opens the query record.
• Record: Opens the record within a listing.
• Subject: Opens the subject detail record or the graphical patient profile.
• Study: Opens the RBQM dashboard where the issue was created. 
• Site: Opens the RBQM dashboard where the issue was created.
• Country: Opens the RBQM Countries dashboard where the issue was created.

Action Issues

Issues can be managed one record at a time by working in the Details view or actioned in groups from the Issues panel. Available actions depend on the Reviewer Role and the Status of the issue. Issues are open until they are answered or canceled. After an open issue is answered, the status is updated to Answered. Issues with a status of Answered can be Closed.  

Available Actions

• Previous / Next Record - Click the directional arrow to move to the previous or next record.
• Start Progress - Click to set an open issue to In Progress. (This action / status is only available when configured for the URL). 
• Move Issue to Pending - Click to move issue to pending, and enter reason. This is a sub-status of an Open issue.
• Answer Issue - Click to Answer an open or in progress issue.
• Close Issue - Click to Close an answered issue.
• Close as Irresolvable - Click to close as irresolvable, and enter reason. This is a sub status of a closed issue.
• Snooze Issue - This is only available for RBQM related Issues.
• Cancel Issue - Click to Cancel an open or closed issue.
• Reopen Issue - Click to Reopen a closed issue.
  • The Reopen Issue window opens.
  • Make updates to Priority, Assign To, User / Role, Reason For Reopening, and Send Notification Email (checkbox).
• Edit Issue - All Data Central users can click to edit the priority, assignment, user/role/user group, or email notification on open or answered issues. The creator of the issue or a user with the Issue Administration privilege can also edit the Due By date, and the Issue Text.
• Maximize / Restore - Click to view full screen / return to view in sheet.
• Record Details - (if configured for the URL) - In the Record Details section, click to expand the arrow to see domain record details. Unlicensed users will also have this section.
• View or Add Comments - In the Comments section, click the expand arrow to see existing comments and add new comments.
  

  Note: Property details of a reopened issue are added to the Comments section by the system.

Action a Single Issue

1. Open the Details View for an issue.
2. The individual issue opens in a separate panel.
3. Use the panel toolbar icons to perform the appropriate actions for that individual issue.
4. Optionally, scroll down to the Record Details section (if available) and expand to see domain record details.
5. Optionally, scroll down to the Comments section and expand to see existing or add new comments.
6. Optionally, click the Edit icon in the panel toolbar, and the Edit Issue window opens.
   Tip: This window can be moved by dragging it elsewhere on the screen, allowing dialog behind the window to be seen.
7. Make updates to Priority, Assign To, User / Role / User Group, or Send Notification Email (checkbox). The creator of the issue or a user with the Issue Administration privilege can also update the Due By date and the Issue Text.
8. Click the Save button (the Save button will highlight after an update is made).

Note: To reopen a closed issue you must perform the action in Details View.

Action Multiple Issues

1. In the Issues panel, check the boxes to the left of each record to be actioned.
2. Click the Action icon.
3. From the drop-down, select the appropriate action.
   
   

   Note: Actions that are grayed out indicate they are not available. Sometimes a field within a record must be highlighted first for an action to become active. In the screenshot, the selected issues have an open status, therefore the actions available are Start Progress, Move Issue to Pending, Answer Issue, and Cancel Issue. 

   Tip: To work through answered issues, set the filter Status=Answered.