My Oracle Support Banner

C.1.6.1 Is Set 'False' For Added Attachment Classification on PMDA ICSR (Doc ID 2367703.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 8.1.1 to 8.1.1 [Release 8.1]
Information in this document applies to any platform.


C.1.6.1 in E2B R3 for PMDA is set 'False' when attached a file to a case with
specifying attachment classification which was added to Attachment
Classification Code List.


1) Add a new value to Attachment Classification Code List. (e.g. Other)
2) Set attachment classification value in PMDA reporting destination
...(e.g. Source Document - Other is selected as attachment classification)
3) Create a new case.
4) Attach a PDF file at Case Form >> Additional Information >> Notes and
...Set value as follows.
...Classification = <attachment classification> added at step-1). (e.g. Other)
...Description = <proper text>
5) Enter the rest necessary data for E2B to the case.
...Schedule E2B R3 report for PMDA agency on Case Form >> Regulatory Reports.
6) Click Draft link of E2B R3 report. ICSR Viewer opens.
--->C.1.6.1 is set 'False', which is not transmitted in E2B R3.



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.