E2B(R3): Revision of the E2B(R2) ICH Guideline (previously coded E2B(M)) on Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports

Regulatory Resource: E2B(R3): Revision of the E2B(R2) ICH Guideline (previously coded E2B(M)) on Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports

Description:

This guideline has now been updated based upon feedback received during Step 3 public consultation in 2005, as well as additional considerations following its submission to ISO for development as an International Standard. Key parts of this updated guideline will be incorporated into the Implementation Guide for Electronic Transmission of Individual Case Safety Reports Message Specification (see http://estri.ich.org/new-icsr/index.htm) which is currently available for public awareness.

Download Document: E2B(R3): Revision of the E2B(R2) ICH Guideline (previously coded E2B(M)) on Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports

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