This paper presents the context, sketches the methodological approach, and main aspects of the ontologising of the CDISC terminology standard in support of ontology-based annotations and metadata management of clinical trial resources (especially data and records). Such aim is a long term endeavour which involves stages of refinement and also validation. The main purpose of this paper is to put in place the methodological basis for the work of ontological engineering needed. The most challenging task is to carry out the ontologisation of terms in the CDISC terminology. The approach adopted consists in reusing, whenever possible, reference ontologies found in the biomedical domain to support the logical definitions of terminological elements.
IOS Press, Inc.
6751 Tepper Drive
Clifton, VA 20124
Tel.: +1 703 830 6300
Fax: +1 703 830 2300 firstname.lastname@example.org
(Corporate matters and books only) IOS Press c/o Accucoms US, Inc.
For North America Sales and Customer Service
West Point Commons
Lansdale PA 19446
Tel.: +1 866 855 8967
Fax: +1 215 660 5042 email@example.com