Draft Report button updates (Enhancement 26335541)

Draft report generation on click of the Draft Report button from the toolbar has been enhanced to allow you to select destination and product along with the Report Form.

When you click the Draft Report button, the View Draft screen is displayed with blank selection in the drop-downs for Report Form, Destination and Product.

  • Report Form drop-down: You can select any report, as all the expedited reports are listed.
  • Destination drop-down: Displays the list of Reporting Destination configured in Argus Console similar to the list of destination displayed from Case Form > Regulatory Reports > Schedule New Report window > Destination.
  • Product drop-down: When Report Form and Destination are selected, the Product drop-down automatically displays the matching product name based on the Report Form and Destination as per the below logic:
    • For the Drug Report Forms, the left most Suspect product having Drug license that matches the agency country is auto selected.
    • For the Device Report Forms, the left most Suspect product having Device license that matches the agency country is auto selected.
    • For the Vaccine Report Forms, then left most Suspect product having Vaccine license that matches the agency country is auto selected.
    • When there is no Product with license that matches the License type and agency country found in the case, then left most suspect product is auto selected.

License with the earliest award date of the selected product that matches the agency country is used for report generation. For PMDA E2B/Paper reports, the first available license of the selected product from PMDA tab > License record where Reporting Category is used for report generation.

The following common profile switches are removed from Argus Console as the draft report generation has the flexibility to specify agency:
  • Reporting > eMDR > Default Reporting Destination for draft eMDR generation
  • Reporting > eVAERS > Default Reporting Destination for draft eVAERS generation
  • Argus J > Default name of Regulatory Agency for Draft Expedited PMDA Reports
The following screens are enhanced with the feature to view draft report that allows selection of report form, destination, and product:
  • Medical Review
  • Coding Review
  • Worklist > Local Labeling > View Default Report
  • Local Affiliate > Local Labeling > View Default Report
  • Local Affiliate > Local Labeling > Medical Review > View Draft