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

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

Overview

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.

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

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

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

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

Key Principles

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

Same Concept, Same Meaning Biomedical Research Integrated Domain Model (BRIDG) Protocol 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.

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

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

Application Development Data Exchange Standards Alignment Application Development Message Development Data Exchange Standards

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

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

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

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

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

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

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

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

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

FDA PDUFA IV IT Plan

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)

PDUFA IV IT Plan Lists key CDISC projects Links 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

Summary

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