ICSR Specification and Related Files
Download the ICH ICSR M2 Version 2.3 specification
document to get instructions on using the DTDs to prepare structured data sets.
The E2BM Step 4 document provides an updated description of the data elements
for the transmission of individual case safety reports and instructions on how
to use these data elements. Version 2.1 of the DTD has been developed
to correspond to the E2BM Step 4 Document version 4.4.1
MAINTENANCE OF THE ICH GUIDELINE ON CLINICAL
SAFETY DATA MANAGEMENT : DATA ELEMENTS FOR TRANSMISSION OF INDIVIDUAL CASE
SAFETY REPORTS E2B(R2), Current Step 4 version dated 5 February 2001
E2B Implementation Working Group Questions & Answers
(R5), Current version dated March 3, 2005
ICH ICSR M2 Version 2.3 Specification Document
ICSR Version 2.1 SGML DTD
Microsoft Windows users can
also obtain the files distributed from this web page, by downloading a single
self extracting file. This file includes the specification documents, DTDs,
SGML declaration (DCL) files, a sample dataset.
the Self Extracting File now
(updated 5 Feb 2001)
An MD5 message digest has been provided
to verify the integrity of the DTD after transfer. The MD5 digest for
the ich-icsr-v2.1.dtd is: 5376de70f9fd84ca0a806f16f529c22d
ICSR Version 2.1 Message Digest
Click here to get the
MD5 Setup program and to obtain instructions
to setup and use the MD5 Tool.
The ICSR Acknowledgment Message has been
developed to allow receivers of the ICSR SGML data, such as regulatory
authorities, to provide feedback about the usability of the data in
the transmission message. The ICSR Acknowledgment Message allows senders
of ICSRs, typically pharmaceutical companies, to track and correct errors,
prior to re-transmission. ICSR Acknowledgment Message DTD Version
1.1 supports ICSR Version 2.1 / E2BM Version 4.4.1.
ICSR Acknowledgment Message, DTD Version 1.1
1.1 Sample data set
The MD5 digest for the ich-icsrack-v1.1.dtd
ICSR Acknowledgment Version 1.1 Message Digest
To meet the multi-language requirements
of the three ICH regions, five different DCL files are distributed to
be used along with the ICSR DTD version 2.n and the ICSR Acknowledgment
Message Version 1.n. Depending upon the character set being used,
the appropriate DCL file must be used:
supports the ISO 8859-1 (Latin
1) character set. This character set supports English, and most Western
supports the ISO 8859-7 (Latin 7) character set. This character set
Corrected (October 1999) file
that supports the Shift JIS character set for encoding Japanese.
supports the ISO 10646 (UNICODE) UTF-8
character set. This character set supports almost all of the worlds
currently written languages.
will support all of the currently defined
ICH ICSR languages, and it doesn't require the use of UNICODE. It
is however a "hack" and the details on appropriate use are in the
technical note of the DTD.