Total Number of Rows Section

The system displays the search results in the Total Number of Rows section.

It is worth noting that only those reports that are assigned to any LAM groups are listed in Affiliate > Bulk Reporting.

Reports that are unassigned or assigned to Central user group are not listed in Affiliate > Bulk Reporting.

Total Number of Rows section

The following table lists and describes the fields and columns in this section.

Field Description

Selected

Allows the user to select the report.

Lock State

Displays the Case status of the case to depict if the case is locked or un-locked.

Status

Displays the Report Status e.g. Scheduled or Generated etc.

Click the status to view the report details.

Case Number

Displays the Case number.

Click the Case Number link to open the case.

Country of Incidence

Displays the view Country of Incidence.

Report Type

Displays the Case Report Type

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 associated with the selected case.

F or LT

Fatal / Life Threatening

If any of the events in the case are Fatal or Life Threatening F or 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

Displays 7 if the report is due within 7 days

Displays 15 if the report is due in more than 7 days

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.

Initial / Follow-up (#)

Initial or Follow-up

If Follow-up, the follow-up number is printed

Due Date

Displays the due date.

Days Past Due

Displays the number of days the report is past due date.

Downgrade

Allows the user to view if the report is downgrade.

Displays Yes if the report is a downgrade report else.

Tip:

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