March 27, 2026



CDISC protocol terminology was retired with the March 27, 2026 CDISC publication; files will continue to be made available in the Archive folder of the NCI Ftp. The CDISC Protocol terminology has been superseded by the ICH M11 Protocol terminology. Refer to the CDISC website for more information and access to the ICH terminologies: https://www.cdisc.org/standards/terminology/cdisc-ich





Contents:



Archive                       		(directory for earlier file versions)

ReadMe.txt                    		(this file)

Protocol CDISC ReadMe.doc         	Copy of Excel ReadMe tab in Word format

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

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

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

                                	(same as "Changes" tab in Excel file)

Protocol Terminology.OWL.zip		terms by codelist, OWL/RDF format

Protocol Terminology.html		terms by codelist, HTML format

Protocol Terminology.odm.xml		terms by codelist, ODM XML format

Protocol Terminology.pdf		terms by codelist, PDF format

Protocol Terminology.txt          	terms by codelist, text format

Protocol Terminology.xls          	terms by codelist, Excel format





Background:



CDISC is an international standards development organization for non-clinical and clinical research data, 

and is approved by the U.S. FDA, Japanese PMDA, and Danish DKMA as a standard electronic submission

format. CDISC and NCI work together to develop and maintain CDISC controlled terminologies, which are also integrated and distributed as part of NCI Thesaurus (NCIt).



Further information is available at:

     http://www.cancer.gov/cancertopics/terminologyresources/CDISC