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

Last updated on JULY 13, 2023

Applies to:

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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