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CDISC and related initativies W3C HCLS Task Force on Drug Safety and Efficacy Proposed Focus Activitiy: Scenario and Task Activtity for Converting CDISC's SDTM into an RDF based model -- to be demo'ed to CDISC/RCRIM From HCLS discussion forum Chimezie Ogbuji: “[HL7] best suited as a messaging interlingua between systems than as a primary representation model.” Kerstin: We also identified inherent problems as CDISC's standards are focusing on exchange of data per clinical study, and not on making data recombinant cross clinical studies. Chimezie Ogbuji “.. what is needed is a seperate 'Reference Ontology of the Healthcare Domain' and a 'Model of Healthcare Information' “ Kerstin: Interesting initative Workshop on Clinical Trial Ontology, part of national Centre for BioMedical Ontology Relationship HL7/CDISC July 2004 CDISC Clinical Data Interchange Standards Consortium RCRIM Regulated Clinical Research and Information Management, technical committee HL7 “Health Level Seven” Announcement of CDISC/SDTM as a standard format All terms and concepts are incorporated from NCI Thesaurus thorugh NCI EVS Relationship HL7/CDISC SDTM variables specified as Common Data Elements & Controlled Terminologies During 2006-2007 In OWL format CDISC Clinical Data Interchange Standards Consortium RCRIM Regulated Clinical Research and Information Management, technical committee HL7 “Health Level Seven” NCI Thesaurus UMLS BRIDG Biomedical Research Integrated Domain Group Model Relationship HL7/CDISC Ongoing work at FDA CDISC Clinical Data Interchange Standards Consortium Announcement of CDISC/SDTM as a standard format RCRIM Regulated Clinical Research and Information Management, technical committee Janus Model and HL7 “Health Level Seven” "The FDA has the largest pool of Data Warehouse randomized clinical trial data in “… populate a cross-study the world, but it cannot be database and do more analyzed now because it is comprehensive analyses for inaccessible" the benefit of patients.” Dr. Janet Woodcock, Deputy Commissioner for Operations and Chief Operating Officer, FDA 27 January 2006