Report Handling

If an initial paper report (or a follow-up) was scheduled with Agency having the PMDA E2B (R2) profile, and now the Agency configuration is updated to E2B (R3) profile then the paper report respects the ongoing series and a new follow-up is generated in (R3) paper format.

Note that, when submitting a follow-up report for a report submitted and received as an (R2) Report, it is possible to switch to an (R3) Report. However, submitting a follow-up report for a report submitted and received as an (R3) Report, you will not be able to switch to an (R2) Report.

Figure 4-1 Sample (R3) Report

Sending a FAX report (PMDA Paper Report Form) for immediate notifications

In case of a death in a case, it is now possible to generate and send a FAX report for immediate notification to PMDA.

In the PMDA E2B profile, the Argus Safety application distinguishes the PMDA reporting destination from other partner reporting destinations configured in Argus Console, based on the Agency Type and Agency Country fields configured in the Reporting Destination code list.

The E2B or Paper Report is scheduled for PMDA only when the When Agency Type is Regulatory Authority and Country is selected as Japan.

In the event of this not being the case, the application will not transmit the J.4b value in it and will also not perform the associated validation for the J.4b value.

The E2B Viewer > PMDA Paper Report Forms view still displays the associated J.4b value for PMDA E2Bs as it is still based on an E2B report.