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Events missing in PSR/ReSD when Followup report is submitted after Downgrade report within same timeframe (Doc ID 2644477.1)

Last updated on MARCH 02, 2020

Applies to:

Oracle Argus Safety Japan - Version 8.1.3 to 8.1.3 [Release 8.1]
Information in this document applies to any platform.

Symptoms

 

An Event of regular Followup report submission after previous report was downgraded is not printed on PSR Form-3 and 4 and ReSD Form-10 and 11.

The case was having Event-1 and a report was submitted.
Then the Event-1 was changed unreportable and Downgrade report was submitted.
PSR Form-3 and 4 and ReSD Form-10 and 11 prints Event-1 of the case at this time.
Then new Event-2 was added or altered to the case and regular Follow-up report was submitted with Event-2.
PSR Form-3 and 4 and ReSD Form-10 and 11 are expected to print Event-2 of the case but do not.

 

Steps to Repeat:
-------------------
1) Create a new case and enter data for PMDA R3 ICSR. Enter Event-1 for case event.
2) Schedule Initial PMDA R3 I.C.S.R on the case.
3) Generate and transmit the PMDA R3 ICSR.
4) Import ACK and submit the Initial PMDA R3 ICSR.
5) Create a new PSR and set PSR Config for printing the above case report.
6) Print Draft the PSR.
7) After PSR is generated, open the generated PSR and check Form-3 and 4. ---> Event-1 of the case is printed at PSR Form-3 and 4.
8) Open the case and modify event Listedness to Listed for Event-1.
9) Schedule Downgrade F/U#1 PMDA R3 ICSR.
10) Generate and transmit the Downgrade F/U#1 PMDA R3 ICSR.
11) Import ACK and submit the Downgrade F/U#1 PMDA R3 ICSR.
12) Open the case and add Event-2 for case event and set Event-2 reportable (Serious, Related, Unlisted).
13) Schedule regular F/U#2 PMDA R3 ICSR.
14) Generate and transmit the regular F/U#2 PMDA R3 ICSR.
15) Import ACK and submit the regular F/U#2 PMDA R3 ICSR.
16) Print Draft the same PSR of step-5) and 6).
17) After PSR is generated, open the generated PSR and check Form-3 and 4.
---> Both Event-1 and Event-2 of the case is NOT printed at Form-3 and 4. Event-2 is expected to be printed.
18) Copy the PSR and modify the copied PSR Config to ReSD.
19) Print Draft the ReSD.
20) After ReSD is generated, open the generated ReSD and check Form-10 and 11.
---> Both Event-1 and Event-2 of the case is NOT printed at Form-10 and 11. Event-2 is expected to be printed.

 

 

 

Cause

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In this Document
Symptoms
Cause
Solution
References


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