CDISC Technology

HITSP, 15th October 2008Dave Iberson-Hurst

CDISC VP Technical Strategy

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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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Overview

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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

Design Execute Analyse & Submit

Protocol CDASHLAB

SDTM(SEND) ADaM

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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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Key Principles

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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

Use of BRIDG

ApplicationDevelopment

Message Development

Data ExchangeStandards

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Alignment

ApplicationDevelopment

Message Development

Data ExchangeStandards

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Biomedical Research Integrated Domain Model (BRIDG)

Quarter 2, 2009

Protocol CDASHLAB

SDTM(SEND)

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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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BRIDG

Transport

Protocol CDASHLAB

SDTM SEND) ADaM

ODM & ExtensionsDefine.xml

SAS XPT

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BRIDG

Transport

Protocol CDASHLAB

SDTM(SEND) ADaM

ODM & Extensions HL7 V3

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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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Medical Research

Healthcare

Integrated with healthcare

Protocol CDASHLAB

SDTM(SEND) ADaM

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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

FDA PDUFA IV IT Plan

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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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Summary

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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

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2009