1. Dave Iberson-Hurst CDISC VP Technical Strategy
CDISC Technology
HITSP, 15th October 2008
Dave Iberson-Hurst CDISC VP Technical Strategy

2. 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

3. Overview

4. 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.

5. Technical Vision Documented in Technical Road Map
Next version released Q4 2008/Q1 2009
Will encompass
more integrated approach
improved process

6. Standard Description 2004* 2001* 2005* 2002 2004 2008 (BRIDG) 2006
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, 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 Guidance

7. The Foundation Stone Design Execute Analyse & Submit Protocol CDASH
LAB
SDTM (SEND)
ADaM

8. The Foundation Stone Integrated standards Protocol to Submission
Then …
We can grow standards into other areas
The basis for the evolution of the CDISC products

9. Key Principles

10. Aligned With and By BRIDG
Biomedical Research Integrated Domain Model (BRIDG)
Protocol
CDASH
LAB
SDTM
(SEND)
ADaM

11. Same Concept, Same Meaning
Biomedical Research Integrated Domain Model (BRIDG)
Protocol
CDASH
LAB
SDTM (SEND)
ADaM

12. 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.

13. The Revised, 2-layered (2-views) BRIDG Model
Consistent levels of abstraction and explicitness in multiple sub-domain ‘Requirements Models’
Understandable to Domain Experts
Sub-Domain 1
Sub-Domain 2
Sub-Domain 3
Sub-Domain 4
Sub-Domain 5
Unambiguously mappable to HL7 Reference Implementation Model
Consistent levels of standards-compliance and explicitness in a single ‘Analysis Model’
Slide courtesy of Charlie Mead & John Speakman, NCI

14. Application Development Data Exchange Standards
Use of BRIDG
Application Development
Message Development
Data Exchange Standards

15. Application Development Data Exchange Standards
Alignment
Application Development
Message Development
Data Exchange Standards

16. Biomedical Research Integrated Domain Model (BRIDG)
Quarter 2, 2009
Biomedical Research Integrated Domain Model (BRIDG)
Protocol
CDASH
LAB
SDTM
(SEND)

17. Biomedical Research Integrated Domain Model (BRIDG)
By The End of 2009
Biomedical Research Integrated Domain Model (BRIDG)
Protocol
CDASH
LAB
SDTM
(SEND)
ADaM

18. 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

19. Transport Define.xml ODM & Extensions SAS XPT BRIDG Protocol CDASH LAB
SDTM SEND)
ADaM
ODM & Extensions
Define.xml
SAS XPT

20. Transport ODM & Extensions HL7 V3 BRIDG Protocol CDASH LAB SDTM (SEND)
ADaM
ODM & Extensions
HL7 V3

21. Use of XML CDISC HL7 Operational Data Model Laboratory Model
HL7 Messages (FDA regulatory submission)
CDA being investigated

22. Integrated with healthcare
Medical Research
Protocol
CDASH
LAB
SDTM
(SEND)
ADaM
Healthcare

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. 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
STOP PRESS!
RFD Goes Live. First two subjects enrolled in a live study 15th December 2008

25. FDA PDUFA IV IT Plan

26. Target Clinical Data Flow
Site
Sponsor
CDISC Content and Interchange
Interchange:
HL7 output file
CDISC Content
CDASH
CDASH
ODM
Trial Design
Sponsor
Data
Warehouse
(ODM)
Data Checker
and Loader
FDA Reviewers
Janus
FDA/NCI
Analytical Data
Warehouse
Review
Tools
Site Data
Archive
(ODM)
MedWatch AE Reports (ICSR)

27. PDUFA IV IT Plan Lists key CDISC projects Links SDTM CDISC HL7 BRIDG
SEND
CDASH
ADaM
Links

28. Summary

29. 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
2009