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/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”

4. During 2006-2007 Relationship HL7/CDISC
All terms and concepts are incorporated from NCI Thesaurus thorugh NCI EVS
During
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”

5. 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.”