cdisc technology hitsp, 15 th october 2008 dave iberson-hurst cdisc vp technical strategy 1
TRANSCRIPT
The Request• Current interchange formats (strengths and
weaknesses) – Consider all healthcare information interchange
architectures such as messaging, structured documents, health records and service oriented architectures
– Consider transport and security • Relationship among your interchange formats, if
multiple • XML now or in future plans • “Style Guide” of how information transformed into
interchange format • Available tools, e.g., mappings or transforms • Supported architectures
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CDISCThe mission of CDISC is to develop and support global, platform-independent data standards
that enable information system interoperability to improve medical research and related areas
of healthcare.
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Technical Vision• Documented in Technical Road Map
– http://www.cdisc.org/about/downloads/CDISC_Road_Map_Spring2008.pdf
• Next version released Q4 2008/Q1 2009• Will encompass
– more integrated approach– improved process
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Standard Description Implementation Version Release Date
SDTM, SEND Ready for regulatory submission of CRT
Over 12,000 downloads as of Apr 082004*
ODM CDISC Transport Standard for acquisition, exchange, submission (define.xml) archive
2001*
Define.xml Case Report Tabulation Data Definition Specification
2005*
LAB Content standard – available for transfer of clinical lab data to sponsors
2002
ADaM General Considerations document and examples of datasets for submission
2004
Protocol
Representation
Collaborative effort to develop machine-readable standard protocol with data layer
2008 (BRIDG)
Terminology
Codelists
Developing standard terminology to support all CDISC standards
2006
CDASH Data acquisition (CRF) standards 2008
Glossary Definitions of terms for clinical research 2001
* Specification referenced via FDA Final Guidance6
The Foundation Stone• Integrated standards• Protocol to Submission• The foundation stone• Then …
– We can grow standards into other areas– The basis for the evolution of the CDISC products
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Biomedical Research Integrated Domain Model (BRIDG)
Aligned With and By BRIDG
Protocol CDASHLAB
SDTM(SEND) ADaM
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Biomedical Research Integrated Domain Model (BRIDG)
Same Concept, Same Meaning
Protocol CDASHLAB
SDTM(SEND) ADaM
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BRIDG - What is it?The BRIDG model is an instance of a Domain Analysis Model (DAM). As such, it depicts a
shared representation of the dynamic and static semantics of a particular domain-of-interest.
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The Revised, 2-layered (2-views) BRIDG Model
Consistent levels of abstraction and explicitness in multiple sub-domain ‘Requirements Models’
Consistent levels of standards-compliance and explicitness in a single ‘Analysis Model’
Sub-Domain 1 Sub-Domain 2 Sub-Domain 3 Sub-Domain 4 Sub-Domain 5
Understandable to Domain Experts
Unambiguously mappable to HL7 Reference Implementation Model
Slide courtesy of Charlie Mead & John Speakman, NCI13
Biomedical Research Integrated Domain Model (BRIDG)
By The End of 2009
Protocol CDASHLAB
SDTM(SEND) ADaM
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Separation of Content and Transport
Protocol CDASH LAB
SDTM (SEND) ADaM
Transport
• Key Items– BRIDG (broader audience via ISO)– Terminology– Consistently applied across all standards
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Use of XML• CDISC
– Operational Data Model– Laboratory Model
• HL7– HL7 Messages (FDA regulatory submission)– CDA being investigated
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Integrated with Healthcare• Working with Integrating the Healthcare
Enterprise (IHE)– HIMMS 2007, 2008 and 2009– Retrieve Form for Data Capture (RFD)– Further (content) profiles being developed
• CDASH• Protocol
• RFD reached level of maturity• Ready for the next leap
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Integrated with Healthcare• Working with Integrating the Healthcare
Enterprise (IHE)– HIMMS 2007, 2008 and 2009– Retrieve Form for Data Capture (RFD)– Further (content) profiles being developed
• CDASH• Protocol
• RFD reached level of maturity• Ready for the next leap
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STOP PRESS!RFD Goes Live. First two
subjects enrolled in a
live study 15 th December 2008
Target Clinical Data Flow
MedWatch AE Reports (ICSR)
JanusFDA/NCI
Analytical DataWarehouse
FDA Reviewers
Trial Design
Sponsor Data
Warehouse(ODM)
Data Checker and Loader
Review Tools
CDASH
Sponsor
Site DataArchive(ODM)
ODM
Site
Interchange:HL7 output fileCDISC Content and Interchange CDISC Content
CDASH
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PDUFA IV IT Plan• Lists key CDISC projects
– SDTM– CDISC HL7– BRIDG– SEND– CDASH– ADaM
• Links– http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-N-0352-bkg.pdf– http://www.accessdata.fda.gov/scripts/oc/ohrms/dailylist.cfm?yr=2008&mn=6&dy=30
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