CDISC Technology
HITSP, 15th October 2008
Dave Iberson-Hurst
CDISC VP Technical Strategy
1
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
2
Overview
3
CDISC
The 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.
4
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
5
Standard
Description
Implementation
Version Release
Date
SDTM, SEND
Ready for regulatory submission of CRT
Over 12,000 downloads as of Apr 08
2004*
ODM
CDISC Transport Standard for acquisition, 2001*
exchange, submission (define.xml) archive
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 machinereadable 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
6
* Specification referenced via FDA Final Guidance
The Foundation Stone
7
Design
Execute
Protocol
CDASH
LAB
Analyse & Submit
SDTM
(SEND)
ADaM
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
8
Key Principles
9
Aligned With and By BRIDG
Biomedical Research Integrated Domain Model
(BRIDG)
Protocol
10
CDASH
LAB
SDTM
(SEND)
ADaM
Same Concept, Same Meaning
Biomedical Research Integrated Domain Model
(BRIDG)
Protocol
11
CDASH
LAB
SDTM
(SEND)
ADaM
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.
12
The Revised, 2-layered (2-views)
BRIDG Model
Understandable to Domain
Experts
Consistent levels of abstraction and explicitness in
multiple sub-domain ‘Requirements Models’
Sub-Domain 1
Unambiguously mappable to HL7
Reference Implementation Model
13
Sub-Domain 2
Sub-Domain 3
Sub-Domain 4
Sub-Domain 5
Consistent levels of standards-compliance
and explicitness in a single ‘Analysis
Model’
Slide courtesy of Charlie Mead & John Speakman, NCI
Use of BRIDG
Application
Development
14
Message
Development
Data Exchange
Standards
Alignment
Application
Development
15
Message
Development
Data Exchange
Standards
Quarter 2, 2009
Biomedical Research Integrated Domain Model
(BRIDG)
Protocol
16
CDASH
LAB
SDTM
(SEND)
By The End of 2009
Biomedical Research Integrated Domain Model
(BRIDG)
Protocol
17
CDASH
LAB
SDTM
(SEND)
ADaM
Separation of Content and Transport
Protocol
CDASH
LAB
SDTM
(SEND)
Transport
• Key Items
– BRIDG (broader audience via ISO)
– Terminology
– Consistently applied across all standards
18
ADaM
Transport
BRIDG
Protocol
CDASH
LAB
ODM & Extensions
19
SDTM
SEND)
ADaM
Define.xml
SAS XPT
Transport
BRIDG
Protocol
CDASH
LAB
ODM & Extensions
20
SDTM
(SEND)
ADaM
HL7 V3
Use of XML
• CDISC
– Operational Data Model
– Laboratory Model
• HL7
– HL7 Messages (FDA regulatory submission)
– CDA being investigated
21
Integrated with healthcare
Medical Research
Protocol
CDASH
LAB
SDTM
(SEND)
ADaM
Healthcare
22
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
23
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
24
FDA PDUFA IV IT
Plan
25
Target Clinical Data Flow
Site
Sponsor
CDISC Content and Interchange
CDASH
CDASH
ODM
Interchange:
HL7 output file
CDISC Content
Trial Design
FDA Reviewers
Sponsor
Data
Warehouse
(ODM)
Site Data
Archive
(ODM)
26
MedWatch AE
Reports (ICSR)
Data Checker
and Loader
Janus
FDA/NCI
Analytical Data
Warehouse
Review
Tools
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
27
Summary
28
Summary
•
•
•
•
•
Complete the “Foundation Stone” of content
Consistency across the CDISC standards
Stability of the CDISC standards
Evolution of the CDISC standards
Supported by CDISC XML and HL7 XML
transport mechanisms
• Linked to RIM
29