C.1.6.1 Is Set 'False' For Added Attachment Classification on PMDA ICSR
Last updated on MARCH 03, 2018
Applies to:Oracle 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.
HOW TO REPEAT:
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.
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