Retrieve Form for Data-capture:

An Integration Profile to Enable Electronic Health Record (EHR) Capture of Clinical Trial Data.

Landen BainCDISC Liaison to Healthcare

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.

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.

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

Plight of the Site

EHREHR

Disease RegistryClinical Trial

Sponsor

Safety Org.

Public Health Org.

Adverse EventData

Case Report FormEntry Form

Outbreak Report

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

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.

The Problem is Obvious

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

Root Cause

• EDC was introduced to the sites without adequate regard for the existing Information eco-system.

Clinical Trial: Visit WorkflowSponsored by

Clinical Trial: Lab & Image DataSponsored by

Disease Registry

Sponsored by

Drug Safety

Sponsored by

Bio-Surveillance

Sponsored by

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.

Real World Pilots

Pharmaceuticalsbring funds, trials, partners

EHR Vendorsbring product and effort

CDISC create environment

Patient Care Sitesprovide access

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.

lbain@cdisc.org

IHE CDISC

ONLY CONNECT