CDISC and related initativies

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Presentation transcript:

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

July 2004 Announcement of CDISC/SDTM as a standard format CDISC Clinical Data Interchange Standards Consortium RCRIM Regulated Clinical Research and Information Management, technical committee Relationship HL7/CDISC HL7 “Health Level Seven”

During 2006-2007 Relationship HL7/CDISC All terms and concepts are incorporated from NCI Thesaurus thorugh NCI EVS During 2006-2007 SDTM variables specified as Common Data Elements & Controlled Terminologies In OWL format NCI Thesaurus CDISC Clinical Data Interchange Standards Consortium UMLS RCRIM Regulated Clinical Research and Information Management, technical committee Relationship HL7/CDISC BRIDG Biomedical Research Integrated Domain Group Model HL7 “Health Level Seven”

Ongoing work at FDA Announcement of CDISC/SDTM as a standard format CDISC Clinical Data Interchange Standards Consortium RCRIM Regulated Clinical Research and Information Management, technical committee Relationship HL7/CDISC "The FDA has the largest pool of randomized clinical trial data in the world, but it cannot be analyzed now because it is inaccessible" Dr. Janet Woodcock, Deputy Commissioner for Operations and Chief Operating Officer, FDA 27 January 2006 Janus Model and Data Warehouse HL7 “Health Level Seven” “… populate a cross-study database and do more comprehensive analyses for the benefit of patients.”