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Draft PMDA Form Report created by Medical Review remains on Case Revisions - Reports (Doc ID 2317192.1)

Last updated on OCTOBER 13, 2017

Applies to:

Oracle Argus Safety Japan - Version 8.0.1 and later
Information in this document applies to any platform.


When a Draft PMDA Form report is failed to be created on Medical Review screen, that draft report remains on Case Actions >> Case Revisions >> Reports though Case Form >> Regulatory Reports tab is clear.

1) Log in to Argus Safety by J user.
2) Create a new case and enter data for E2B. Leave fields blank on Case Form >> Analysis >> PMDA Info >> Comments.
3) Open Medical Review.
4) Create Draft PMDA Form report from Medical Review.
PMDA ICSR Validation report opens.
5) Close Medical Review.
6) Go to Case Form >> Regulatory Reports. No report schedule exists.
7) Open Case Revision by Case Actions >> Case Revisions menu.
8) Collapse the Reports branch on the opened Case Revision pop-up window. The report schedule exists at Reports >> Expedited >> Pending branch.


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