Creating ICH E2B R3 Profile for Submitting Serious, Unexpected ADRs of Clinical Trial Origin to CFDA (Chinese Health Authority)
(Doc ID 2393471.1)
Last updated on MAY 13, 2021
Applies to:Oracle Argus Interchange - Version 8.1 and later
Oracle Argus Safety - Version 8.1 and later
Information in this document applies to any platform.
On 25th January 2018, CFDA posted the following announcement on their website:
On 27th April 2018, CFDA published final guidance confirming that:
The following steps provide guidance on how to customize ICH based R3 profile in Argus Safety version AS 8.1+ for CFDA submissions.
The scope of this document includes:
- Creating a R3 Profile using the OOTB ICH E2B R3 profile in Argus version AS 8.1+
- Setting up reporting Destination
- Capturing Chinese Narrative
- Transmission of Chinese Narrative in R3 file
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In this Document
|2.1. Creating a R3 Profile using the OOTB ICH E2B R3 profile|
|2.2 Setting up Reporting Destination|
|2.3. Capturing Chinese Narrative|
|2.4. Transmission of Chinese Narrative in R3 file|
|2.5 Update on Final E2B R3 IG By NMPA|