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 (PDF) (MS Word)
- ICH ICSR Version 2.1 SGML DTD
- Sample data set
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.
- Download 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
- ICH 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.
- ICH ICSR Acknowledgment Message, DTD Version 1.1
- Version 1.1 Sample data set
The MD5 digest for the ich-icsrack-v1.1.dtd is: dbea047e4e47d42000951b2188ac8120
- ICH 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:
- ich-icsr-latin1.dcl supports the ISO 8859-1 (Latin 1) character set. This character set supports English, and most Western European languages.
- ich-icsr-latin7.dcl supports the ISO 8859-7 (Latin 7) character set. This character set supports Greek.
- ich-icsr-sjis.dcl Corrected (October 1999) file that supports the Shift JIS character set for encoding Japanese.
- ich-icsr-utf8.dcl supports the ISO 10646 (UNICODE) UTF-8 character set. This character set supports almost all of the worlds currently written languages.
- ich-icsr-mult.dcl 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.