Clinical Trials virtual tour HL7-IHE Demonstration HIMSS 2004.

Clinical Trialsvirtual tour

HL7-IHE DemonstrationHIMSS 2004

Presented by

• Meredith Nahm– Director of Clinical Data Integration– Duke Clinical Research Institute

• Durham, North Carolina

Virtual Tour

• High-level animated walkthrough

• Detailed view– Application tools– Standards and Profiles

Clinical Trial

• Community Acquired Pneumonia Clinical Trial

• 250 Patients and 12 sites

• QT prolongation is a potential adverse event in the class of drugs under study

• Trial uses a Core Lab for Central reading of ECG’s

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Clinical Trials: Integrating with patient care

aECG ArdenCCOW

CDA CT

EUALDMODM

PIXPSARIDRIM

SDMSPL

SWFV2V3

Patients seen at PCP, hospitalsECGs sent to Core Lab; annotated on site or at Core Lab

Hospital

Hospital

Core Lab

Sponsor

FDA

PCP

Imaging

Central Lab

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Imaging aECG ArdenCCOW

CDA CT

EUAODM

PIXPSARIDRIM

SDMSPL

SWFV2V3

Sponsor identifies QT prolongationRequests additional documentation

Hospital

Hospital

Core Lab

Sponsor

FDA

Registry

PCP

Central Lab

Dictation Repository

Query broker, trusted 3rd party



aECG ArdenCCOW

CDA CT

EUAODM

PIXPSARIDRIM

SDMSPL

SWFV2V3




aECG ArdenCCOW

CDA CT

EUAODM

PIXPSARIDRIM

SDMSPL

SWFV2V3




aECG ArdenCCOW

CDA CT

EUAODM

PIXPSARIDRIM

SDMSPL

SWFV2V3

Intervals for Analysis imported into Clinical Data Management System at Core Lab



aECG ArdenCCOW

CDA CT

EUAODM

PIXPSARIDRIM

SDMSPL

SWFV2V3

Analysis data in ODM/SDM delivered to SponsorSponsor uses FDA Viewer to view waveforms



aECG ArdenCCOW

CDA CT

EUAODM

PIXPSARIDRIM

SDMSPL

SWFV2V3

Sponsor identifies QT prolongationPolls registry through a Third Party Broker



aECG ArdenCCOW

CDA CT

EUAODM

PIXPSARIDRIM

SDMSPL

SWFV2V3

Sponsor requests additional informationQueries NIST registry, and obtains documents through a Third Party broker



Sponsor submits SDM data to the FDAUsing HL7 v3 message and CDISC/HL7 standards

aECG ArdenCCOW

CDA CT

EUAODM

PIXPSARIDRIM

SDMSPL

SWFV2V3



FDA uses Patient Profile Viewer and ECG ViewerTo view SDM and waveform data

aECG ArdenCCOW

CDA CT

EUAODM

PIXPSARIDRIM

SDMSPL

SWFV2V3



Imaging aECG ArdenCCOW

CDA CT

EUAODM

PIXPSARIDRIM

SDMSPL

SWFV2V3

Patients seen at PCP, hospitalsECGs sent to Core Lab, Sponsor and FDA

Hospital

Hospital

Core Lab

Sponsor

FDA

Registry

Query broker, trusted 3rd party

Repository

PCP

Central Lab

Dictation Repository

AdobeBerdyCarefxCommerceNetDCRIDictaphoneDigital InfuzionEclipsysEpicGE HeartlabIBMINFINITTKodakKryptiqMicrosoftMisysMortaraNISTPhilipsRaining DataSentillionSiemensSNOMEDXIMIS

HL7 aECG ArdenCCOW

CDA ODMLDMRIM

SDMSPLV2V3

IHECT

EUAPIX

PSARID

SWF

Special thanks to• Mallinckrodt Institute of Radiology

– Patient Identifier Cross Referencing (PIX) server• Fred Behlen, Laitek Technologies

– DICOM SR to CDA transformation• The SIMI Group

– State Department of Health application• Michael Palmer, Zurich Biotech

– SAS to ODM conversion• NorthEast Monitoring

– Corelab software integrating aECGs• CSS Informatics

– FDA Patient Profile Viewer• AMPS

– FDA aECG Viewer• Amnon Shabo, IBM Haifa

– Sample CDA Botulism Case Report• Data Conversion Labs

– Sample Structured Product Labeling transformation


HL7 aECG ArdenCCOW

CDA ODMLDMRIM

SDMSPLV2V3

IHECT

EUAPIX

PSARID

SWF

Demo Executive Committee

• HL7– Karen Van Hentenryck, HL7

Associate Director– Landen Bain, Co-chair, HL7

Marketing Committee

• IHE– Joyce Sensmeier, HIMSS– Chris Carr, RSNA


HL7 aECG ArdenCCOW

CDA ODMLDMRIM

SDMSPLV2V3

IHECT

EUAPIX

PSARID

SWF

Invitation to Tour

• Guided Tours start on the quarter hour• Self-guided Tours anytime

– Maps available at Reception

• Complete a tour, win a prize– Get each location initialled by participant– Go to reception with completed map– Enter a business card to win

• HL7 Working Group Registration (drawing 1/day)

• HIMSS 2005 Registration (drawing 1/week)

GE

RA600

Guided tours on the quarter hour; Self-guided tours any time

Take A Tour, Win A Prize!•Get a stamp at every stop on a tour•Take stamped Tour Guide to receptionist•Enter to win a Prize! -HL7 Registration or -HIMSS 2005 Registration

Continuity of Care Tour

Clinical Trials Tour

Patient Safety Tour

Public Health Tour

aECG Annotated ECG (V3) 4, 16, 19, 20,21, 27

Arden Arden Syntax Medical Logic Modules 17, 19, 26

CCOW Clinical Context Object Workgroup 1,14, 15, 17, 18, 28, 29, 30

CDA Clinical Document Architecture (RIM) 2, 6, 7, 9, 10, 11, 12, 13, 20, 22, 23, 24, 25, 26, 32

CT Integration Profile for Consistent Time 1, 2, 18, 30

EUA Enterprise User Authentication (Kerberos) 1, 2, 14, 18, 28, 30

Integration Profiles: 1, 2, 3, 6, 8, 10, 11, 14, 15, 18, 28, 29, 30, 31

LDM Lab Data Model (V3, CDISC) 20

ODM Operational Data Model (CDISC) 20, 21

PIX Patient Identifier Cross Referencing (V2) 1, 11

PSA Patient Synchronized Application (CCOW) 1, 14, 18,28, 29, 30,

RID Retrieve Information for Display 1,8, 10,11,15,18,29, 30

RIM Reference Information Model (V3) 2, 4,6, 7, 9, 10, 11, 12, 13, 16,19,20,21, 22, 23, 24, 25, 26, 27,32

SDS Submissions Data Standard (CDISC) 20, 21

SPL Structured Product Label (CDA) 19

SWF Scheduled Work Flow (V2, DICOM) 1,2,3,29,31

V2 Version 2 messaging 1,5,6, 8, 9,11,12,17,18,22,25,26,32

V3 Version 3 messaging 4,9,10,11,16,19,20,21,22,24,27,32

Start

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GE CPortal

Sentillio

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INFIN

ITTXim

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Kryptiq

CommerceNet

MS InfoPath

GE MUSE ACP/F

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NIST

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Raining Data

Dictaphone

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AIS

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Tour Guide

HL7-IHE Interoperability Demonstration

Booth 4638

Walking Tour


HL7 aECG ArdenCCOW

CDA ODMLDMRIM

SDMSPLV2V3

IHECT

EUAPIX

PSARID

SWF

Thank you

• Questions?

• Tours starting now

• This presentation will be available on www.rsna.org/IHE/hl7ihedemo

Clinical Trials virtual tour HL7-IHE Demonstration HIMSS 2004.

Documents

sitesqt prolongation

fda viewer

potential adverse event

class of drugs