My Oracle Support Banner

PMDA E2B A.1.0.1 <safetyreportid> issue for the next safety report id prefix (Doc ID 2099470.1)

Last updated on FEBRUARY 01, 2021

Applies to:

Oracle Argus Safety Japan - Version 7.0.5 to 8.1 [Release 7.0.0 to 8.1]
Information in this document applies to any platform.

Symptoms

The case with PMDA E2B is migrated from the legacy system.

If migrated safety report number (A.1.0.1) ends with "9" or "_Z", 

Argus will create a new PMDA E2B by adding ':' at the end in A.1.0.1 or PMDA ICSR validation error appears for A.1.0.1.

 

 

Steps:
------------------------------------------------------
Scenario#1: migrated safety report number (A.1.0.1) ends with "9"
------------------------------------------------------
1. Check the pmda_case_e2b_ww_number.E2B_WW_NUMBER

There is the migrated record for the submitted report from legacy system.
The value in E2B_WW_NUMBER ends with "9". (eg., JP-ORACLE-2016M1000007A9)

2. Schedule the PMDA E2B for the different Japan license to generate the next safetyreportid prefix.

3. Click the draft link

<safetyreportid>JP-ORACLE-2016M1000007A:</safetyreportid>

The inappropriate value ":" is appended to the end of safetyreportid.

 

------------------------------------------------------
Scenario#2: migrated safety report number (A.1.0.1) ends with "_Z"
------------------------------------------------------
1. Check the pmda_case_e2b_ww_number.E2B_WW_NUMBER

There is the migrated record for the submitted report from legacy system.
The value in E2B_WW_NUMBER ends with "_Z". (eg., JP-ORACLE-2016M1000007A_Z)

2. Schedule the PMDA E2B for the different Japan license to generate the next safetyreportid prefix.

3. Click the draft link

PMDA I.C.S.R.Validation error occurs
Elements having Invalid Characters
A.1.0.1 SAFETYREPORTID

Changes

 

Cause

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
Symptoms
Changes
Cause
Solution
References


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