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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 09, 2018

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.

Purpose

On 25th January 2018, CFDA posted the following announcement on their website:

“As of May 1, 2018, serious and unexpected adverse drug reactions reported during the clinical study of the drug apply to "E2A: Management of Clinical Safety Data: Definitions and Criteria for Fast Reporting" "M1: MedDRA )"And" E2B (R3): Management of Clinical Safety Data: Data Elements for Individual Safety Report Transmission “.

On 27th April 2018, CFDA published final guidance confirming that:

serious unexpected adverse drug reactions originating from clinical trials commenced on or after 1 May 2018 should be submitted to CFDA in accordance with ICH E2B R3 implementation guide and relevant standards of CDE.

The following steps provide guidance on how to customize ICH based R3 profile in Argus Safety version AS 8.1+ for CFDA submissions.

Scope

 The scope of this document includes:

  1. Creating a R3 Profile using the OOTB ICH E2B R3 profile in Argus version AS 8.1+
  2. Setting up reporting Destination
  3. Capturing Chinese Narrative
  4. Transmission of Chinese Narrative in R3 file

Details

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In this Document
Purpose
Scope
Details
 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

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