December 19, 2025



This directory contains data files and documentation for controlled terminology used by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to support the ICH M11 Protocol template and Technical Specification. It represents all ICH M11 controlled terminology developed and in production to date. Additional terminology will be developed on an ongoing basis to support ICH guidelines. Future additions and/or changes to the terminology set will be handled via the terminology change request and maintenance process. Changes to the terminology can be communicated to ICH via the CDISC change request webform: https://evsexplore.semantics.cancer.gov/evsexplore/termform?formId=cdisc-form





Contents:



Archive                       		(directory for earlier file versions)

ReadMe.txt				(this file)

ICH M11 ReadMe.doc	      		ReadMe tab in ICH M11 terminology file, doc format

ICH M11 Publication Date Stamp.txt	information regarding current version date of ICH M11 terminology

ICH M11 Terminology Changes.txt		detailed description of term changes (text)

ICH M11 Terminology Changes.xls		detailed description of term changes (Excel)

ICH M11 Terminology.OWL.zip		terms by codelist, OWL/RDF format

ICH M11 Terminology.html		terms by codelist, HTML format

ICH M11 Terminology.odm.xml		terms by codelist, ODM XML format

ICH M11 Terminology.pdf			terms by codelist, PDF format

ICH M11 Terminology.txt         	terms by codelist, text format

ICH M11 Terminology.xls	     		terms by codelist, Excel format





Background:



ICH is a global organization that brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical development with a goal of developing international guidelines and technical specifications. ICH, CDISC, and NCI work together to develop and maintain ICH M11 controlled terminology, which is also integrated and distributed as part of NCI Thesaurus (NCIt).



Further information is available at: 

https://www.ich.org

https://www.cdisc.org/standards/terminology/cdisc-ich