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PMDA E2B follow-up report was scheduled as an initial report (Doc ID 2587653.1)

Last updated on SEPTEMBER 19, 2019

Applies to:

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

Symptoms

The reporting category was changed after scheduling the initial report.
After that, initial report was generated with the updated reporting category and submitted to the destination.

Now when scheduling the follow-up report, the report was scheduled as initial report. In the CMN_REG_REPORTS.FOLLOWUP_NUM, the value (0) which means "initial" has been set to this scheduled follow-up report.


 

Steps:

1. Create a new case (e.g., Spontaneous domestic(Japan) case)
2. (for example) Go to the event tab and check on the "infection" flag
3. Go to the analysis > PMDA info tab. select reporting category (A) which is RPT_CATEGORY_ID (1)
4. Enter the all the mandatory information
5. Save the case
6. Schedule the initial PMDA E2B
7. Review CMN_REG_REPORTS.RPT_CATEGORY_ID. Confirm that RPT_CATEGORY_ID (1) has been stored.
8. Click the draft link
9. Confirm that reporting category (AA) displays in J2.1a

10. (for example) Go to the event tab and uncheck the "infection" flag
11. Go to the analysis > PMDA info tab. select reporting category (B) which is RPT_CATEGORY_ID (2)
12. Save the case

13. Go to the regulatory report tab and click the draft link
14. Confirm that reporting category (AB) displays in J2.1a
15. Lock the case
16. Generate the final report
17. Review CMN_REG_REPORTS.RPT_CATEGORY_ID.Confirm that the previous RPT_CATEGORY_ID (1) still has been stored instead of RPT_CATEGORY_ID (2)

18. Submit the initial report
19.  Confirm that status of the initial report shows "Submitted"

20. In the regulatory report tab, schedule the follow-up report (select same license/ destination / report form as initial)

- In the regulatory report tab, this follow-up report shows as "initial" instead of "F/U #1".
- In the CMN_REG_REPORTS.FOLLOWUP_NUM, the value (0) which means "initial" has been set to the follow-up report.

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References

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