My Oracle Support Banner

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

Last updated on MARCH 05, 2019

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 fails 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.




To view full details, sign in with your My Oracle Support account.

Don't have a My Oracle Support account? Click to get started!

In this Document

My Oracle Support provides customers with access to over a million knowledge articles and a vibrant support community of peers and Oracle experts.