Create unscheduled Expedited Reports or batch print reports

You can use the Batch Reports function to schedule and generate reports for multiple cases. Before using this function, verify that no cases or reports are open.
  1. Select Reports, then select Compliance, and select Expedited.
  2. Click Batch Print or Create Report and search for the case for which the expedited report has to be scheduled.

    Table 6-1 Expedited Reports - Fields and Fields Description

    Field Description

    Suspect Product

    Displays the Trade Name for which the report has been scheduled. A (+) displayed at the end of the Product Name denotes that more than one Suspect Company Product exists.

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

    F / LT

    Denotes Fatal / Life Threatening

    If the case is both F and LT, only F is displayed.

    If the case is neither F nor LT, 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.

  3. When the system displays the search results, select the locked cases for which the expedited report is to be scheduled.
  4. Click Batch.
  5. When the system opens the Batch Print or Create Reports dialog box, enter the appropriate information and click OK.

The system generates the unscheduled expedited report. The Expedited Batch Printing dialog box supports printing Batch CIOMS, Medwatch, and VAERS on Oracle Argus Safety Web locally.

Note:

The Batch print or create Reports for E2B reports is supported for locked cases only. These reports are generated as only final report with Run at option enabled, and Save with case, mark as submitted checkbox as checked and disabled (default) for E2B reports.

Table 6-2 Batch Print or Create Reports dialog box—Fields and Field Description

Field Description

Format

Enables you to print reports As Draft or As Final.

  • The Print As Final option is available only if all the selected cases are locked.
  • If Print As Final is selected, then the option Save with case, mark as submitted is also available as a checkbox option.
  • Click the options Print As Final and Save with case, mark as submitted to generate final Regulatory Reports and create a submission record with each case identical to the current functionality.
  • Click the options combination of Print As Final only (and not Save with case, mark as submitted) to generate final Regulatory Reports without creating a submission record with each case.
  • If the report is associated with a blinded study, select the Blind study product checkbox.

Destination

Check the Printer checkbox to print the report

Protect Confidentiality of Reporter and Patient

Check this checkbox to hide the Reporter and Patient information on the expedited reports.

Scheduling

  • If Run Now is selected, all the selected reports run against all selected cases and a PDF is generated.

    The Run Now option is visible only when a MedWatch, MedWatch Drug, CIOMS, or VAERS form is selected on the Batch Expedited Report screen.

    If you select an unlocked case, the report gets printed in draft form only and is not saved.

  • Select Run at and enter the appropriate date and time when the generation of reports should occur.