PMDA Downgrade/nullification Report Scenario when All Events are Non-Reportable

When reportable event is deleted from a Case Form by significant follow-up change, downgrade report against E2B to PMDA cannot be sent. Also, user is not able to send the nullification report when all the reportable events are deleted.

As per MHLW notification for investigational drugs, if reportable events disappears (becomes invalid events) by follow-up information and if there are no "reportable event" as result, it is necessary to report as nullification report. If reportable event(s) become non-reportable by follow-up information then a downgrade report is sent.

For Marketed drugs, when events in the case are updated in such a manner that none of the events in the case is valid then only nullification report is sent. If the reportable event becomes non-reportable by the follow-up information then a downgrade report shall be sent.

• Definition of "Non-Reportable" and "Invalid" events:
  • Non-Reportable events - same as it exists today.
  • Invalid events are:
    • Deleted events and
    • Those events for which the "Not include for the report in Japan" (available in the Case Form | Japan Event tab) checkbox is checked
• The PMDA E2B follow-up Downgrade report is generated when all the valid events in the case became "non-reportable". A downgrade report shall:
  • Include all the latest valid events that exist in the case.
  • Ignore non-coded events as it has already been implemented in the current functionality.
  • Not reference previously submitted report's data.
• For Marketed reports (reporting categories (1, 2, 3 and 4), In a scenario when events in the case are updated in such a manner that none of the events in the case remains valid (as described in the point # 1b above) then the PMDA E2B Nullification report is generated.
• For investigational reports (reporting categories (8, 9, 10, and 11), if all the reportable events w.r.t. previously submitted report becomes invalid (as described in the point # 1b above) by the follow-up information then the PMDA E2B Nullification report is generated.
• As per the existing implementation, the nullification E2B report will get its data (including the REACTION section) from the previous submitted E2B XML.
• When the nullification E2b reports is auto-scheduled for the above mentioned scenarios:
  • A new common profile switch "PMDA E2B Nullification Reason Text for No Valid Event Scenario" is created in console under Argus J > Reporting with default value in Japanese - (There is no valid event available in the case). The profile switch is a text box having a maxlength of 200 characters. It support English as well as Japanese data entry.
  • The value specified in the common profile switch "PMDA E2B Nullification Reason Text for No Valid Event Scenario" is used for the value of E2B element A.1.13.1 NULLIFICATIONREASON in PMDA E2B.

This enhancement is applicable for PMDA E2B Downgrade/nullification reports.