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Healthcare Link Web and FlowCDISC InterchangeNovember 4, 2010Landen BainHealthcare Link + eSDINovember 2005, Libertyville, Illinois

2AgendaThe focus: data capture, not data miningFinding healthcare partners: IHEThe approach: web services and workflow automation Web and FlowThe specifications: RFD, CRD, eSDI, Redaction, RPE 3 20104Photos courtesy of Womens Clinic of Lincoln, NEStart with the nitty-gritty world of the study coordinator, not the rarefied world of data

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Integrating the Healthcare Enterprise (IHE) is an initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE promotes the coordinated use of established standards such as DICOM and HL7 to address specific clinical need in support of optimal patient care. Systems developed in accordance with IHE communicate with one another better, are easier to implement, and enable care providers to use information more effectively. 2010The approach: Web and FlowWeb Services: Set up a direct conversation between the healthcare system (EMR) and the research system (EDC).Collaborative Workflow Automation: Enable the two systems to initiate actions and exchange information.6 20107

Ive got Mrs. Jones here for her research visit and I need to retrieve her form so that I can do the data capture. And heres some data on her to start off.Sure, heres the form we need for Mrs Jones. Ive inserted the data you sent me, and you do the rest.Electronic Health RecordResearch System8

OK, heres the completed form. Thanks for inserting the data I sent you. Ive completed the rest and filed a copy.OK, got it.Electronic Health RecordResearch System9Case Report FormEHRSecondary UsesPrimary Use

Clinical ResearchQuality Public Health Quality MeasureOutbreak Report

IHE-CDISC Retrieve Form for Data Capture (RFD) = key common workflow integration profile (easy for EHRs to implement)RFDRFDRFD Safety Integrating Workflow: EHRs and Clinical Research

Specificationsmake the connection - Retrieve Form for Data-capture (RFD)pre-populate the data - Clinical Research Data (CRD) comply with source documentation requirements - eSourcetailor the pre-population - Redaction Servicesbroaden the scope - Retrieve Process for Execution (RPE)

10 201011RFD ProfileRetrieve FormSubmit FormArchiveForm

Form ManagerB

Form ReceiverC

Form FillerAForm Archiver

D12RFD Flow12

CRD

XML

ODM

XML

SiteSponsor1. Request Form2. Submit form3. Archive FormOffline: Use ODM metadata to create form

Form Archiver

ODM +CCD pre-pop

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RFD Flow

CRD

XML

ODM

XML

SiteSponsor2. Submit form3. Archive FormOffline: Use ODM metadata to create form

Form Archiver

ODM +CCD pre-pop

1. Request Form 201013

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14Bringing two worlds within one pixel of each other, visually. But behind the presentation lie technical filaments that preserve the separation of the two worlds.When Inform displays within a physical pc at a site on a standard browser, that does not require 21 CFR 11 compliance on that pc. Thin client yes; pc no. RFD provides a thin tunnel, also exempt.15

Pre-population Problem

Post-approval StudyEMR

Legacy

Disease Registry

AE ReportTo Regulatory Agency

ICHICSR

CDASH

16EMRs speak a standard language (HL7 CCD) Form Managers translate from this common language

Pre-population Solution

Post-approval StudyEMR

CCD

Disease Registry

AE ReportTo Regulatory Agency17

If all EMRs agree to send CCD, then each Form Manager only has to support one data format.A transformation is still necessary to bridge from CCD to the world of research.

Transformations1718RFD Integration Profile: specifies actors and transactions (Retrieve, Submit, Archive)CRD Content Profile: further defines the Retrieve transaction, specifying exactly what the Form Filler can send to the Form Manager

Clinical Research Data Capture (CRD) 18Retrieve Form Transaction

Form ManagerB

Form FillerAPrepopulation Data (CRD)

Form

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RFD and eSource19

EHRInvestigator sphere of controlFA20eSource Data Interchange (eSDI) InitiativeGoalsto make it easier for physicians to conduct clinical research, collecting data only once in an industry standard format for multiple downstream uses, and thereby to improve data quality and patient safetyProduct (2 year development process) Version 1.0 document posted at http://www.cdisc.org/eSDI/eSDI.pdf

20 21HITSP Clinical Research IS21

22Identified GapThe data sent from the EHR to the EDC must conform to the protocol. Currently there is a gap in the ability to redact the CCD to conform to the protocol-required data as specified in the case report formResolution:A new IHE profile called Redaction Services has been accepted for inclusion in the Quality, Research, and Public Health (QRPH) domain for development in 201023Redaction Services - 20101. Export Document (CRD)2. Retrieve Extraction Specification4. Send Redacted Document

RedactorB

Extraction Def. Mgr.C

Document SourceADocument ReceiverD3. Return RedactedDocument

HealthcareResearch24RPE 1.0 Actors & Transactions

EHRResearch Sponsor/RegistryResearch Sponsor25RPE 2.0 TransactionsProcessDefinitionManagerProcessActivityExecutorProcessStateManagerInitiateActivityReceiveProcessStateAlertRetrieveProcessDefinitionsSubscribeReceiveProcessDefinitionsReceiveProcessDefinitionsDeployProcessDefinitionRetrieveProcessDefinitionsSubscribeInitiateProcessRetrieveActivitiesUpdateActivityReceiveProcessStateAlert

Transactions broadly concerned with:Access to process definitionsRuntime management of process state and activities2626SHARP Service BusOrchestration Engine(RPE)Step-based Knowledge AcquisitionGraphical User InterfaceDemographicsLabsText (UIMA)Coded Diagnoses27

Strength through collaboration.

201027ProtocolDefManager

ProtocolExecutor

ProtocolStateManager

RetrieveProtocolDef [1]

EnterPatientRequest [2]PatientScreeningVisitsScheduled [3]RecordPatientScreeningVisit [4]EnrollPatientRequest [5]PatientStudyVisitsScheduled [6]RecordPatientStudyVisit [7]

AmendProtocolDef [8]

AlertProtocolState [9]