Download HCLSIG$$Drug_Safety_and_Efficacy

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