Same safetyreportid has been assigned to the different PMDA E2B by AG service (Doc ID 2127816.1)

Last updated on JULY 13, 2023

Applies to:

Symptoms

There are multiple (initial) PMDA E2B reports in the case that are waiting for the generation.

After generating these reports by AG service (Batch report generation / Batch report generation worker), the same safetyreportid has been assigned to the different E2B.

 
Due to this, if you transmit all reports which have same safetyreportid, one of the reports will have the error in EDI In column.
Because the other report which has the same safetyreportid has already been generated and stored in the outgoing folder.
(Error) Error while saving file in outbound folders - The file 'xxxx.zip' already exists.

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STEPS
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AG Service: BRG and BRGW are ON

1. Go to case action > new
2. Enter the mandatory value
3. book-in

4. Open the case
5. Enter the mandatory information for PMDA E2B
6. Schedule initial PMDA E2B for Japan Marketed license
7. Schedule initial PMDA E2B for Japan investigational license(A)
8. Schedule initial PMDA E2B for Japan investigational license(B)
9. Save the case
10. Lock the case
11. Close the case

12. Monitor the BATCH_GENERATION_QUEUE table
All three records were inserted into this table

13. Keep monitoring the BATCH_GENERATION_QUEUE table
All three records were processed and removed from this table

14. Check the data after no record exists in BATCH_GENERATION_QUEUE table

SQL> select * from cmn_reg_reports
The generated date for all the reports have been set and status is set as "Generated".

SQL> select * FROM PMDA_CASE_E2B_WW_NUMBER

The two of three reports have the same safetyreportid in the E2B_WW_NUMBER column and these are generated at the same date/time(in the DATE_ GENERATED column).

Changes

Cause

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