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PMDA Downgrade Report was scheduled Instead Of Nullification Report On Study Replace (Doc ID 2617966.1)

Last updated on DECEMBER 24, 2019

Applies to:

Oracle Argus Safety Japan - Version 8.2.1 and later
Information in this document applies to any platform.

Symptoms

When there is already submitted PMDA E2B(R3) report for the Study product,

and if the Study is replaced upon follow-up information received such that the Study product no longer exist,

then system auto schedules downgrade report for the deleted Study product.


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STEPS
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1. Create a study case with Study(001) which has several products (say PROD-A and PROD-B. Both product has the Japan INV license)
2. Go to the product tab and set PROD-B as a study drug
3. Add a new study drug and set PROD-A as a study drug
4. Go to Analysis > PMDA info tab
5. Set the reporting category (e.g., K / DD) to both Japan INV licenses
6. Enter the mandatory information for PMDA E2B (R3)
7. Save the case

8. Go to the regulatory report tab
9. Press the [Auto Schedule] button
10. Confirm that 2 initial PMDA E2B (R3) has been auto-scheduled
11. Lock the case
12. Generate a final report (e.g., report with Japan INV license from PROD-A)
13. Submit the report

14. Unlock the case
15. Change the study from Study(001) to Study(002). Note that Study(002) has one product (say PROD-B only).
16. Go to the product and 2nd tab
17. Confirm that PROD-A is no longer study drug. It shows "not study"
18. Go to the analysis > PMDA info tab
19. Confirm that the Japan INV license from PROD-A no longer exists. Only Japan license from another product "PROD-B" exists.
20. Save the case

21. Go to the regulatory report tab
22. Press the [Auto Schedule] button

The downgrade report was scheduled instead of nullification report.

Cause

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In this Document
Symptoms
Cause
Solution
References


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