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CDISC and related initativies

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.

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CDISC and related initativies

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  1. 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

  2. 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

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

  4. All terms and conceptsare incorporated from NCI Thesaurus thorugh NCI EVS During 2006-2007 SDTM variables specifiedas Common DataElements & ControlledTerminologies In OWL format NCI Thesaurus CDISCClinical Data Interchange Standards Consortium UMLS RCRIM Regulated Clinical Research and Information Management,technical committee Relationship HL7/CDISC BRIDGBiomedical Research Integrated Domain Group Model HL7 “Health Level Seven”

  5. "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, FDA27 January 2006 Ongoing work at FDA Announcement of CDISC/SDTMas a standard format CDISCClinical Data Interchange Standards Consortium RCRIM Regulated Clinical Research and Information Management,technical committee Relationship HL7/CDISC Janus Model and Data Warehouse HL7 “Health Level Seven” “… populate a cross-study database and do more comprehensive analyses for the benefit of patients.”

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