Enhancement: Require a Tool to Enter Local Specific Information in E2B (R3) (Doc ID 2644059.1)

Last updated on MAY 09, 2024

Applies to:

Goal

Enhancement: Tool to enter local specific information in E2B(R3)

This is an enhancement request to better support the process for the generation of local language case narratives in E2B(R3) files.


i.e

To generate a report in Argus Safety, the user has to lock the case.

To add a local language narrative to a report in a locked case, the local PV function has to:

• Unlock the case
• Enter the local narrative
• Lock the case
• Re-generate the reports

This can cause human errors and potential subsequent compliance issues:

• The user may not lock the case correctly
• The user may involuntarily disturb the Japanese workflow

If the Health Authority (HA) has a gateway the E2bR3 files have to contain the local specific fields before uploading.
 
This is an increasingly relevant problem because more and more health authorities ask for case narratives in local language and local specific fields e.g. Korean product code.

The game changer was the new field for the local language narrative in the E2B(R3) format.

Among the countries where the authorities are now asking for local language narratives are China, Japan, Korea, Mexico, Russia, Spain and Switzerland. Potentially this list of countries requesting local language narratives will grow.

Solution

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