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When will the full integration for R3 Reporting to Chinese Health Authorities be fully integrated with Argus? In Particular C.1.CN.1 E2B (R3) New Elements By Regional Requirements (Doc ID 2626351.1)

Last updated on JANUARY 13, 2020

Applies to:

Oracle Argus Interchange - Version 8.1.2 and later
Information in this document applies to any platform.

Goal

When will the full integration for R3 Reporting to Chinese Health Authorities be fully integrated with Argus?

i.e.

    CDE (Center For Drug Evaluation, NMPA) http://www.cde.org.cn/ - this is for Clinical Trial cases.
    CDR (National Center for ADR Monitoring, China /Center for Drug Re-evaluation, NMPA) http://www.cdr-adr.org.cn/- this is for Post-Marketed cases.



In particular:

Data Element / Title Element
C.1.CN.1 / Report Source

Notes
1=Regulatory authority,
2=Patient/friends
3=Medicalinstitution,
4=Business License
5=Literature (Full literature needed)
6=Study (ADR originated from authorization studies)
7=Program (ADR originated from marketing programs),
8=Others



Currently the following steps allow customers to customize ICH based R3 profile in Argus Safety version AS 8.1+ for CFDA submissions to be accepted
successfully.

Creating ICH E2B R3 profile for submitting serious, unexpected ADRS of clinical trial origin to CFDA (Chinese Health Authority). (Doc ID 2393471.1)

For future full integration we also have the below enhancements logged:


NEED ARGUS SAFETY TO SUPPORT CHINESE CHARACTERS(Bug 22472413)

Does Argus comply with Chinese PV requirements(Bug 19283335)

Oracle Consulting also have a customized Argus Chinese user interface available today on version 8.1.2+.
This is targeted for China local companies as it is truly English and Chinese and replaces Japanese.

This can be provided as part of a services engagement. (Refer Note 2457599.1)

 

 

 

Solution

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In this Document
Goal
Solution
References


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