CDISC and related initativies

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
During 2006-2007
All terms and conceptsare incorporated from NCI
Thesaurus thorugh NCI EVS
SDTM variables specifiedas Common DataElements
ControlledTerminologies
NCI Thesaurus
In OWL format
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
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.