View bulk report filter results

The filter search results appears in the Total Number of Rows section.

Field Description

Suspect Product

Displays the Trade Name for which the report has been scheduled. If more than one Suspect Company Product exists for the case, an (+) is placed at the end of the product name.

For Reports which were scheduled for the Device, the Device name is displayed.

Diagnosis

Displays the Primary Event Diagnoses PT.

(Event Verbatim)

Displays the (Verbatim as reported) of the Primary Event.

S/U/R

  • Displays the Case Level Assessments:
    • Serious (Y/N)
    • Unlisted (Y/N)
    • Causality (Y/N)
  • Unknown is treated as a "?"
  • The SUR link displays the Case Summary for the selected case.

F or LT

Fatal / Life Threatening

  • If any of the events in the case are Fatal (F) or Life Threatening (LT) is displayed.
  • If the case is both F and LT, only F is displayed.
  • If the case is neither F nor LT, only No is displayed.

7/15

Number of days for which the report is due:

  • 7—if the report is within 7 days
  • 15—if the report is due for more than 7 days
Glasses icon Indicates that the labeling was not assessed for the license for which the report was scheduled. When you click the icon, the Local Labeling screen opens.
A license is considered assessed:
  • if it has been done through local labeling (marked as assessed);
  • if there is a justification associated with the listedness, i.e., the value was changed from Unknown to Listed or Labeled, or the datasheet computed value was modified by the user.

Blind Study Product

Transmits and prints study cases with blinded information.

Mark as Submitted

  1. Select this option to mark reports as Submitted when the transmission or e-mail has been sent.

    A confirmation dialog box appears if this option is not selected.

  2. Select Yes or No.

    This selection is remembered for the next time when you print a report.

Report Form

Displays the Description of the report.

Click the Report form link to view the DRAFT Report as a PDF.

Destination

Displays the report destination (agency) for which the report is scheduled.

Downgrade

Allows the user to view if the report is downgrade.

Displays Yes if the report is a downgrade report else No.

View All

Allows administrator and workflow manager to see all items in the system.

Tip:

The icon (displayed in the lock state) in the Reports > Bulk Reporting screen denotes a SUSAR (Suspected Unexpected Serious Adverse Reaction) case.