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A.2.3.1 studyname is not getting populated in PMDA E2B when the study description is set (Doc ID 1915744.1)

Last updated on FEBRUARY 18, 2019

Applies to:

Oracle Argus Safety Japan - Version 7.0.3 and later
Information in this document applies to any platform.


If study Description (J) field under case form > general tab > Study Information is blank,
then the value in the study description in the english view supposed to display in A.2.3.1 <studyname> element.
However A.2.3.1 <studyname> element is not getting populated in PMDA E2B report.

1. Create a new clinical case and select the configured study name
2. Open the case in Japanese view mode
3. In the general tab, confirm that study description(J) is a blank
4. Change the case view mode to English
5. Confirm that the value is populated in the "Study description" field

6. Change back the case view mode to Japanese
7. Enter the mandatory value for generating PMDA E2B
8. On the regulatory report tab, schedule PMDA E2B report
9. Click the draft link

A.2.3.1 <Studyname> is not getting populated.


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