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The file name of PMDA E2B still has the hyphen(-) on post 6.0.7.7 (Doc ID 2017950.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 6.0.7 to 6.0.7 [Release 6.0]
Information in this document applies to any platform.

Symptoms

Post v6.0.7.7


The case with the PMDA E2B report has been migrated from the legacy safety system.

When generated the follow-up report from Argus,

the generated file name(SGM/ZIP) may still contains the unacceptable hyphen(-) in the 4th parameter(unique no).

 

For example:

There are the migrated case (case#: ABC-12345) with following initial PMDA E2B. Note this case and reports data was migrated from other safety system.
The last 2 characters "-1" of SAFETYREPORTID contains the hyphen(-) character.


     <safetyreportversion>1</safetyreportversion>
     <safetyreportid>JP-ORACLE-ABC-12345-1</safetyreportid>



When transmitting the follow-up report (safetyreportversion=2), system will be generated the following file names which include the hyphen.

E-ORACLE-20150101-ABC12345-1002.ZIP
  l---- I-ORACLE-20150101-ABC12345-1002.SGM
  l---- J-ORACLE-20150101-ABC12345-1002.SGM

 

The 4th parameter (unique no) in the file is "ABC12345-1002" and the hyphen character still remain.
System should be simply removed if the hyphen contains.

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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