Microsoft Windows users can also obtain the files distributed from this web page, by downloading a single self extracting file! This file includes the corrected DCL file for use in Japan.

• Download  the Self Extracting File now (updated 10/15/1999)
  

Version 2.0 of the DTD has been developed to make certain improvements to version 1.0 of the ICH ICSR DTD. Some of the main features of version 2.0 are:

• The ability to support multiple language character sets to meet the reporting requirements of all the ICH regions
• A message header section has been added to help manage, route, identify, and track ICSR messages
• A simplified message structure to allow carriage returns to be inserted after end tags, making the SGML data file more readable.

Download the ICH ICSR M2 specification document to get instructions on using the DTDs to prepare structured data sets:

• The ICH ICSR M2 Specification Version 2.24 Document  has relevant information for preparing the SGML data sets and should be used with the E2B Step 4 document. 
•  
• The ICH ICSR M2 Specification Version 2.24 Document (Text Version) (PDF Version) 
• E2B Step 4 Document
• ICH ICSR  Version 2.0 SGML DTD
• Sample data  set
  

An MD5 message digest has been provided to verify the integrity of the DTD after transfer. The MD5 digest for the ich-icsr-v2.0.dtd is: 423eb2674374e83d18f78839de56f47f.

• ICH ICSR Version 2.0  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 SGML syntax errors, prior to re-transmission.

• ICH ICSR  Acknowledgment Message, Version 1.0
• Sample data  set
  

The MD5 digest for the ich-icsrack-v1.0.dtd is: 98b5cdc179d2d96b69c6a6e08ba1cc8b.

• ICH ICSR Acknowledgment  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 version 2.0 and the ICSR Acknowledgment Message. Depending upon the charachter set being used, the apropriate 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 ICHICSR 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 DTDs.
  



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Page Updated: April 18, 2002