9
ICH ICSR Implementation Guide 12 April 2013
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Document History
Date of
Finalisation
Title of Document Version Published for EWG
February
2001
Maintenance of The ICH Guideline on
Clinical Safety Data Management :Data
Elements For Transmission of Individual
Case Safety Reports E2B(M)*
*Renamed E2B(R2) in 2005
4.4.1 Step 4
document
E2B
Electronic Transmission of Individual Case
Safety Reports Message Specification
(ICH ICSR DTD v2.1)
2.3 M2
May 2005 Revision of The ICH Guideline on Clinical
Safety Data Management: Data Elements
for Transmission of
Individual Case Safety ReportsE2B(R)
2.0 First Public
Consultation
E2B
June 2009 Electronic Transmission of Individual
Case Safety Reports Message
Specification
Implementation Guide
(ICH ICSR Message Version 3.96)
1.31 First Step 2
for Testing
M2 /
E2B
April 2010 Electronic Transmission of Individual Case
Safety Reports Implementation Guide
Data Elements and Message Specification
2.47 Second Step 2
for Testing
M2 /
E2B
June 2011 Electronic Transmission of Individual Case
Safety Reports (ICSRs)
Implementation Guide
Data Elements and Message Specification
3.01 Second Public
Consultation
E2B
November
2012
Implementation Guide for Electronic
Transmission of Individual Case Safety
Reports (ICSRs)
Data Elements and Message Specification
5.0 Reached Step
4 but no
publication
E2B
April
2013
Implementation Guide for Electronic
Transmission of Individual Case Safety
Reports (ICSRs)
Data Elements and Message Specification
Editorial corrections made prior to
publication of Step 4 – the accompanying
history spreadsheet should be consulted for
details of changes
5.01 Step 4
document
E2B