Retrieve Form for Data-capture - World Wide Web Consortium · Retrieve Form for Data-capture: An...
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Retrieve Form for Data-capture:
An Integration Profile to Enable Electronic Health Record (EHR) Capture of Clinical Trial Data.
Landen BainCDISC Liaison to Healthcare
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Point of Departure
“Data are not just waiting to be gathered, collected or recorded. Data are created.”
• Paul Taylor, From Patient Data to Medical Knowledge, Blackwell Publishing 2006, p. 12.
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Retrieve Form for Data-capture
• Retrieve Form for Data-Capture, is an integration profile jointly developed by CDISC and IHE, which enables data capture for clinical research, drug safety, and other purposes within an EHR session.
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CDISC & IHEIHE --• a collaborative response to healthcare
information technology market requirements for system integration.– Develop standards-based implementation
specifications called profiles.• Useful subsets of one or more
standards• Tested at Connectathons• Demonstrated at HIMSS, RSNA, and
ACC shows
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Plight of the Site
EHREHR
Disease RegistryClinical Trial
Sponsor
Safety Org.
Public Health Org.
Adverse EventData
Case Report FormEntry Form
Outbreak Report
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Retrieve Form Architecture
Retrieve Forms [ITI-a] ↓ ↓ Submit Form [ITI-c]
Form Filler
Form Manager
Query Form Manager [ITI-b] ↓
Ex: Document
Vault
↓ Archive Form [ITI-d]
Form Receiver
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Problem Focus
• Retrieve form is problem focused:– Address the multiple data entry systems at
sites.• Retrieve form is experimental :
– Introduce the technique into a site and observe what happens.
• Retrieve form is developmental:– Start simple and iterate improvements.
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The Problem is Obvious
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17% of Sites have 5 or more data capture systems
32%
20%
24%
7%
17%
0%
10%
20%
30%
40%
50%
eCRF
1 2 3 4 5
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Root Cause
• EDC was introduced to the sites without adequate regard for the existing Information eco-system.
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Clinical Trial: Visit WorkflowSponsored by
Clinical Trial: Lab & Image DataSponsored by
Disease Registry
Sponsored by
Drug Safety
Sponsored by
Bio-Surveillance
Sponsored by
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Profile Expansion• Goals: auto-population of form, data clarification.• Infrastructure work (IHE - ITI)
• Add data clarification transaction• Beef up security• Formally test @ Connectathon
• Content work (IHE - PCC)• PV: ICSR, BAER• CDASH will define data elements for electronic case report
forms.• CDISC’s Terminology project will define code lists for
standard data elements.• Query for Existing Data will enable data extraction without a
form.
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Real World Pilots
Pharmaceuticalsbring funds, trials, partners
EHR Vendorsbring product and effort
CDISC create environment
Patient Care Sitesprovide access
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Pfizer Pilot
Form ArchiverForm ReceiverForm Manager
→ Archive Form (ITI-d)
↓ Retrieve Form (ITI-a) ↓ Submit Form (ITI-c)
ClinicalRepository
↓ Invoke Form Filler ↓ Prepopulate Form
EHR ApplicationExtendedUI
GETFORM
RFD Form Filler
FDA FDA / Company /Public-Private Org.
Health System / Physician PortalRFD Extension EHR Application
FDA / Company /Public-Private Org.