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Reporting Category Existence Needs To Be Condition For Report Scheduling (Doc ID 2460255.1)

Last updated on JULY 12, 2020

Applies to:

Oracle Argus Safety Japan - Version 8.1.2 and later
Information in this document applies to any platform.


PMDA Report is auto scheduled for an unexpected license if the case product has multiple Japanese licenses.

The actual behavior is that PMDA Report is always auto scheduled for the smallest LICENSE_ID license of case product unexpectedly.

When a console product is having multiple Japanese licenses, say license-A to license-C, and the product is used for case product, and user wish to have PMDA report schedule for license-C (the largest license_id value), clicking [Auto Schedule] button or "Report Scheduling" AG-service process automatically schedules PMDA report for license-A (the smallest license_id).

1) Prepare on Argus Console:
    --Reporting Destination for PMDA ICSR R3
    --Expedited Report Rule for scheduling PMDA ICSR report for Japanese MKT Drug
2) Create product and licenses on Argus Console:
    ...|--License-A --MKT Drug --Authorization Country = Japan
    ...|--License-B --MKT Drug --Authorization Country = Japan
    ...|--License-C --MKT Drug --Authorization Country = Japan
3) Note each license's LICENSE_ID.
    License_id of License-A is the smallest among these licenses.
    License_id of License-C is the biggest among these licenses.
4) Create a new spontaneous domestic case with License-C of Product-A.
5) On Case Form >> Analysis >> PMDA Info >> General, enter License Category and Reporting Category for License-C.
    *This means that user expect to schedule the report for this license.
    Leave blank for the other licenses.
6) Enter the rest data for ICSR R3 for PMDA for the case.
7) On Case Form >> Regulatory Reports, click [Auto Schedule].  --->PMDA ICSR R3 for License-A is scheduled.
8) Delete the PMDA ICSR R3 for License-A schedule.
9) Manually schedule PMDA ICSR R3 for License-C by clicking [Schedule New Report].  PMDA ICSR R3 for License-C is scheduled.
10) Lock the case.  "Auto Schedule Later" check-box is checked. -- If not, check it.
11) Close Case Form and wait for a while.
12) Open Case Form for the case and go to Case Form >> Regulatory Reports.  --->PMDA ICSR R3 for License-A is scheduled additionally.






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