Issues for Unlicensed Users

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Who are Unlicensed Users?

Unlicensed Users are typically individuals from a third party, such as a CRO or central lab, or someone who has a connection to the data but does not need full access to elluminate. Unlicensed Users have Issues assigned to them and can respond to those Issues.

How do Unlicensed Users access their Issues?

First, an elluminate administrator must create an account for the Unlicensed User. The Unlicensed User then receives an email from CDR containing the URL, a username, and a temporary password, which they must change upon their first login. If Single Sign-On is being used, the process may differ.

When an Issue is assigned, the Unlicensed User receives a notification email with a direct link to the Issue in the Global Issues module within elluminate. The creator of the Issue is automatically cc'd on these email notifications. Be sure to review the information in the email regarding the Issue. Depending on the Issue type, the details in the email may differ.
Issue Notification

Click the View Issues link in the email to open elluminate. Enter your login credentials if prompted.

By default, only Issues that have been assigned to you with a status of 'Open' display. Use the scrollbar at the bottom of the window to see all columns. 
Issues Listing for Unlicensed User

After logging into elluminate, the Unlicensed User can answer the Issue(s) and / or add comments.

Unlicensed Users cannot access the record in the module where the Issue was created or perform any other functions within elluminate.

Manage the Issues Listing

The Issues listing includes functionality to help locate relevant Issues more efficiently.

  • Sort the list by clicking on a header column and selecting Sort Ascending or Sort Descending.
  • Filter the list by clicking on a header column and selecting Filter. Enter the filter parameters and select Filter Rows (The Assigned To column cannot be filtered). Or select Clear to clear that column's filter.Sort and Filter
  • Multiple fields can be filtered in the Related Details column. Click the drop-down next to Any and enter a Value. If Any is selected, the column filters for that value in any of the fields. Or, select a field from the drop-down and enter a value. Use the plus sign to add multiple filters.
    Filter Related Details Column
  • Clear or Reset all filters by clicking the Filters icon in the top toolbar and selecting, Reset Filters, Clear Filters, or remove them individually by selecting each one that has the red circle with the minus sign. 
    Reset and Clear Filters

View Issue Details and Add Comments to an Issue

As you begin reviewing Issues, check for existing comments. If an Issue has existing comments, the number of comments is displayed in the Comments column (indicated by a bubble icon in the header). To view the comments, select a record and click the Details icon in the top toolbar. The details open on the right. To view Record Details, expand the Record Details section. 
Details View

To view or add Comments, expand the Comments section. Comments can be used to communicate with the sender of the Issue. To add a comment, simply enter the comment in the 'Your comment here' field and click Add. It is added to the comments shown below.
Comments

Answer Issues Directly in the Listing

Once ready to answer Issues, use one of the following methods:

  • Select an individual Issue and click the Answer Issue icon in the top toolbar.
  • Select multiple Issues by checking the checkbox(es) to the left of the records, then click the Answer Issue icon in the top toolbar.
  • Import responses from an Excel file. See the Answer Issues by Importing Issue Data section below for details

To answer an individual Issue or multiple Issues at one time:

  1. Select a single Issue by clicking in the row of a record, or select multiple Issues by checking the boxes in the left column of the Issues to be answered.
  2. Click the Answer Issue icon in the toolbar. 
  3. In the Issue Action window, enter the Response.
    Issue Action Window
  4. Click Yes.

Answer Issues by Importing Issue Data

Issues can also be answered by using the exported Issues listing. The spreadsheet has only two columns that can be updated: Issue Response and Answered By. This process only applies to Open or In-Progress Issues and changes the status to Answered.

To answer Issues through an exported list of Issues:

  1. Export the list of Open Issues by clicking the Export icon in the toolbar and selecting Export Issues with File Lock. The file is downloaded to your computer.
  2. Open the exported Issues listing with File Lock.
  3. Click Enable Editing.
  4. Add an issue response in the Issue Response field for all Issues requiring a response.
  5. Optionally, add a valid elluminate user to the Answered By column. If an elluminate username is not added to this column, the Unlicensed User's username is added to the Answered By column.
  6. Save the updated file.
  7. From the Issues window, click the Import Issues icon.
  8. Drop, or browse and select, the updated file. An Import Issues window opens with the Total Issues Count and the number of Answered Issues.
    Import Issues Window
  9. The Apply user to blank Answered By fields is greyed out and has the username of the Unlicensed User performing the import. This username populates the Answered By field if that field was left blank or an invalid username was added in the spreadsheet.

    Note: When uploading the file, if the system identifies a discrepancy with any of the answered Issues (such as an Issue changing from an open status to cancelled, already being answered, or an invalid user being entered or lacking access), 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.
    Import issues

  10. Click Import.

Once imported, all Issues answered by a valid elluminate user have their status updated to Answered.

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