Issues created throughout the elluminate platform are available in the Issues module.

Access Issues Module

1. Click the 9-dot icon to open the Platform Menu.
2. Select Issues under Data Review.

The Issues listing opens with default filters applied: Status = Open and Assigned To = the user. Therefore, only open issues assigned to the logged-in user are visible. Modify any column filters to view desired issues. To turn the default view off or on, open the Global Issues Settings window and uncheck or check the 'Use Default Filters' setting.

The Issues listing includes all issues created in Analytics, Data Central (including eIQ Review, RBQM, and Orchestrator), the Operational Data Repository, Specifications, and the SCE.

Issue Sources

The source of the issue identifies where the issue was created within Data Central, Analytics, RBQM, Operational Data Repository, Specifications, or the SCE. The source of the issue can be accessed in two places:

• from the Module column in the Issues listing
• from the Type field in Details view

An Issue can be created from a record, listing, or graphical patient profile within Data Central (including eIQ Review and Orchestrator), from a sheet within Analytics, manually created in RBQM, system-generated from RBQM based on configured actions, from a form or record within a panel grid (listing) in the Operational Data Repository, from Specifications, and from a file in the SCE. Access to records within those modules is required to open the source of the issue.

Links in the Module column include:

• Subject Details – Data Central
• Subject Listing – Data Central
• Graphical Patient Profile – Data Central
• Domain Listing – Data Central
• Listing Details – Data Central
• Query Details – Data Central
• Analytics – The sheet in Analytics
• KRI  –  Data Central RBQM (system generated based on configured actions)
• QTL  –  Data Central RBQM (system generated based on configured actions)
• RBQM  –  Manually created in RBQM
• Specifications  –  Specifications
• Operational Data Repository  –  Operational Data Repository
• eIQ Review  –  Data Central eIQ Review
• SCE  –  Statistical Computing Environment 

Access the Source from the Listing View

From the Issues listing, click a link in the Module column of a record. The record from where the issue was created opens if the necessary privileges are held.

Note: The number in the blue badge indicates the number of issues in the filtered list.

Access the Source from the Details View

The Details view of the issue opens to the right of the listing when a record is double-clicked, a record is right-clicked and Details is selected, or a record is selected and the Details icon in the toolbar is clicked.

The Type field is a hyperlink to where the issue was created.

1. Click the link in the Type field.
   
   The screenshot below shows the link to the source of the issue in the Type field. Clicking the link opens Data Central to the record where the issue was created.
   

Note: When an issue is created from Analytics based on a single study (with no selected subject), the Type displays as Subject in the Issues listing instead of Study. However, clicking the Analytics link in the Module column opens the sheet where the issue was created, with the sheet filtered for that study. 

Export Issues Listing

The Issues listing can be exported with or without comments, and with file lock. 

Selecting 'Export Issues with File Lock' provides a file that can be used to update open issues with responses and elluminate usernames. This file can then be uploaded and merged with open (including in progress) issues in elluminate. Responses are accepted for eligible issues, and the users identified are recorded as the Answered By user. Upon completion of the upload, issues with a response and user are automatically updated to Answered status. 

From the Issues window, click the Export icon and select Export Issues, Export Issues with Comments, or Export Issues with File Lock. The Excel file downloads.

Tip: Selecting Export Issues with Comments provides all entered comments in the last column. For the best view of the Comments column, highlight the column and Wrap Text.

Open an Issue from the Exported Issues Listing

1. In the exported Excel file, click Enable Editing.
2. In the Issue Id column, click the hyperlinked Issue Id number. This opens the issue within the module where it was created. Appropriate system, study, and record privileges are required to access the issue.

Answer Issues by Importing Issue Data

Use the exported issues listing with file lock to answer issues. The spreadsheet has only two columns that can be updated: Issue Response and Answered By. This process only applies to issues with an open or in progress status and updates them to answered. 

Note: Import is only available for users with the Issue Administration privilege.

1. Open the exported issues listing with file lock.
2. Click Enable Editing.
3. Add issue responses in the Issue Response field for all issues requiring a response.
4. Optionally, add a valid elluminate user to the Answered By column. If an elluminate username is not added to this column, a user selection prompt appears in the Import Issues window later in the process.
5. Save the updated file.
6. From the Issues window, click the Import Issues icon.
7. Drop or browse and select the updated file. An Import Issues window opens with the Total Issues Count and the number of Answered Issues. 
   
8. Click the drop-down and select a user to be the Answered By user for issues in the spreadsheet where the Answered By field was left blank. This selected user must have access to all issues being answered from the imported file. If valid elluminate usernames were added to the Answered By column in the spreadsheet, the field is greyed out.
9. Click Import.

Once imported, all issues that were answered by a valid elluminate user are updated to Answered.

Note: When uploading the spreadsheet, if the system identifies a discrepancy with any of the answered issues, such as an issue has changed from an open status to cancelled, has already been answered, or an invalid user was entered or didn't have access to the issue, a Skip Discrepancies checkbox and a link to view the discrepancies appears in the Import Issues window. Click the link to view the discrepancies, and check the Skip Discrepancies box to proceed.
 

Update Number of Rows in the Listing

The selected Rows Per Page value remains in place when navigating away from or returning to the Issues window.

1. From the Issues window, click the Configure icon. The Global Issues Settings window opens.
2. Update the number of Rows Per Page. The default is 20 rows, options are 10, 20, 50, 100, and 500. 
3. Click Save.

Action Issues

Issues can be actioned from the listing individually, or multiple issues can be actioned at one time. Actioning multiple issues that can be answered with the same response may save time. Action icons are at the top right of the window. Actions that are grayed out indicate they are not available.

1. Select the checkbox next to each record requiring action.

2. Click the appropriate action icon in the toolbar, or right-click and select the appropriate action. The Issue Action window opens.
   In the screenshot below, the panel is filtered to Status of Open, therefore the actions available are Start Progress (if configured to have this status), Move Issue to Pending, Reassign Issue (multiple issues must be selected), and Answer Issue.

   Note: The action of 'Start Progress' (status of In Progress) may be available when configured for the URL. If 'Start Progress' is available, users can action an Open issue to In Progress, and then to Answered.

   

3. Depending on the action taken, enter a response, answer any questions, add any reasons, or enter optional Closure Text when closing an issue.
4. Click Yes or No to answer the confirmation question.

After an open issue is answered, the status is updated to Answered.

Tip: To work through answered issues, set the Status column filter to Answered and the Opened By column filter to your userid. Appropriate toolbar actions are available based on the status of the issue.

Issue Actions Table

Available actions depend on the user’s elluminate role and the issue status. Unavailable actions are grayed out and cannot be selected. Use the table below for details. 

Open Details View

It may be helpful to view the details of a record before taking action. The Details view provides specific information about the record where the issue was created.

For example, issues generated by Orchestrator display a hyperlink with the rule name that created the issue in the Opened By field. This link navigates the user to the Rule Details panel within the Orchestrator module. Additionally, the Details view includes a table with detailed references to the data that led to the issue's creation.

1. Double-click a record, right-click a record and select Details, or select a record and click the Details icon in the toolbar. The Details view opens to the right. 

   Tip: URLs can be configured to include Record Details for Issues. Issues created for a record include an expanded Record Details section. This section is found just above the Comments section. Unlicensed users also have this section. 

2. To close the Details view, click the Close Issue Detail (x) icon in the top right corner. 

Reopen a Closed Issue

Issues with a status of Closed can be reopened. 

1. Select the row of the closed issue in the listing.
2. Click the Reopen Issue icon.
3. Update all fields in the Reopen Issue window, including the Reason for Reopening.
4. Click Save.

Note: Properties (i.e., reason for reopening, reopened by, closed by, and answered by) for issues that were reopened display in the Comments section.

Update an Issue from the Details View

1. In Details view, click the Edit icon.
   
2. In the Edit Issue window, update any of the available fields as needed.
   • The creator of the issue or a user with the Issue Administration privilege can update the Due By date and the Issue Text. Other users do not see those fields.
     
3. Click Save.

Send Deferred Notifications

Issues marked with Defer Notification at the time of creation can be sent from the Issues module.

1. Click the Filters icon in the master header and select Quick Filters to display all deferred issues, or only those personally marked with Defer Notification.
2. From the filtered list, select the records by checking the checkbox next to each issue.
3. Click the Send Deferred Notifications icon. The issue notifications are sent.

View and Add Comments in Details View

Comments provide a space for ongoing dialogue about a record and can be used by all licensed and unlicensed users.

A typical use of comments is to note something about a record that is not actionable or does not have workflow attached to it. If there is a need for tracking actions related to the comment, users should create an issue instead. Existing comments can be read from the Details view.

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

Add a Comment

1. Expand the Comments section (if not already expanded).
2. Enter the Comment.
3. Click Add.