Value of downgrade report switch is amended in PMDA E2B (R3) C.1.11.2 nullification reason

(Doc ID 2346927.1)

Last updated on JANUARY 09, 2018

Applies to:

Oracle Argus Safety Japan - Version 8.1 and later
Information in this document applies to any platform.

Symptoms

The value of "Text to display as comment when a downgrade report is scheduled" from Argus Console > System Configuration > System Management > Reporting > Expedited is amended in PMDA E2B (R3) C.1.11.2 nullification reason <nullificationreason>.

 


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STEPS
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1. Create a blind study case
2. Enter the mandatory value for PMDA E2B (R3)
3. Auto-schedule initial PMDA E2B (R3)
4. Submit the report
5. Receive ACK

6. Unlock the case as significant info
7. Key open
8. In the product tab, select the non-company product in the "Study Drug" field
9. Enter the English/Japanese justifications for changing the study drug
10. Save the case

11. Go to regulatory report tab, press the [Auto schedule] button
12. Confirm that nullification report was auto-scheduled
13. Click the draft link

In C.1.11.2 nullification reason, not only the justification text entered when changing the product in step9 but also it shows the value from "Text to display as comment when a downgrade report is scheduled" in Argus Console > System Configuration > System Management > Reporting > Expedited.



Cause

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