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Future Plans For CFDA Chinese Language Reporting Via E2B R3 (Doc ID 2457599.1)

Last updated on DECEMBER 05, 2019

Applies to:

Oracle Argus Safety - Version 8.1 and later
Information in this document applies to any platform.

Goal

Knowledgebase article 2393471.1 (Creating ICH E2B R3 profile for submitting serious, unexpected ADRS of clinical trial origin to CFDA (Chinese Health Authority)) provides instruction on how to generate E2B R3 files with Chinese language narrative and event as reported data.

Our understanding is that the CFDA requires that all data is reported in Chinese, not just these two data elements - can you please provide details on Oracle's plans to provide full Chinese language support in Argus Safety. Is there a specific Argus version or release date planned?

Thank you.
 

Solution

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