Missing study information in PMDA paper report form-2
(Doc ID 2008331.1)
Last updated on FEBRUARY 18, 2019
Applies to:Oracle Argus Safety Japan - Version 7.0.2 to 8.1 [Release 7.0.0 to 8.1]
Information in this document applies to any platform.
If there are more than one reporters in the case, the study information (A.2.3.x) does not populate in the PMDA Paper report form-2(Page2).
1. Create a case with report type:Post Marketing Surv.
2. In the general tab, set more than one reporters
3. Save the case
4. Schedule PMDA E2B
5. Click draft link
The study information is populated properly in PMDA E2B (A.2.3.x).
6. Change the view format to PMDA Paper report
7. Check the form-2(Page2)
The "Clinical study name, etc" field in the "Reference cited" section is a blank.
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