1. Healthcare Link Web and
Flow
CDISC Interchange
November 4, 2010
Landen Bain

2. Healthcare Link + eSDI
November 2005, Libertyville, Illinois

3. © 2010
Agenda
1. The focus: data capture, not data mining
2. Finding healthcare partners: IHE
3. The approach: web services and workflow
automation – Web and Flow
4. The specifications: RFD, CRD, eSDI,
Redaction, RPE
3

4. 4Photos courtesy of Women’s Clinic of Lincoln, NE
Start with the nitty-gritty world of the study
coordinator, not the rarefied world of data

5. © 2010 5
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.

6. © 2010
The approach: Web and Flow
• Web 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

7. 7
I’ve got Mrs. Jones here for
her research visit and I need
to retrieve her form so that I
can do the data capture.
And here’s some data on her
to start off.
Sure, here’s the form we
need for Mrs Jones. I’ve
inserted the data you sent
me, and you do the rest.
Electronic Health Record
Research System

8. 8
OK, here’s the completed
form. Thanks for inserting
the data I sent you. I’ve
completed the rest and
filed a copy.
OK, got it.
Electronic Health Record
Research System

9. 9
Case Report Form
EHR
Clinical Research
QualityPublic Health
Quality Measure
Outbreak Report
IHE-CDISC Retrieve Form
for Data Capture (RFD) =
key common workflow
integration profile
(easy for EHRs to implement)
RFD
RFD RFD
Safety
Integrating Workflow: EHRs and Clinical Research

10. © 2010
Specifications
1. ‘make the connection’ - Retrieve Form for Data-
capture (RFD)
2. ‘pre-populate the data’ - Clinical Research Data
(CRD)
3. ‘comply with source documentation requirements’
- eSource
4. ‘tailor the pre-population’ - Redaction Services
5. ‘broaden the scope’ - Retrieve Process for
Execution (RPE)
10

11. 11
RFD Profile
Retrieve
Form
Submit
Form
Archive
Form
Form Manager
B
Form Receiver
C
Form Filler
A
Form Archiver
D

12. 14

13. 15
Pre-population Problem
Post-approval Study
EMR
Legacy
Disease Registry
AE Report
To Regulatory AgencyICHICSR
CDASH

14. 16
• EMRs speak a standard language (HL7 CCD)
• Form Managers translate from this common language
Pre-population Solution
Post-approval Study
EMR
CCD
Disease Registry
AE Report
To Regulatory Agency

15. 17
• 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.
Transformations
17

16. 18
• RFD 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)
18
Retrieve Form
Transaction
Form Manager
B
Form Filler
A
Prepopulation
Data (CRD)
Form

17. 19
RFD and eSource
19
EHR
Investigator sphere
of control
FA

18. 20
eSource Data Interchange (eSDI) Initiative
• Goals
– to 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 safety
• Product (2 year development process)
– Version 1.0 document posted at
http://www.cdisc.org/eSDI/eSDI.pdf
20

19. 21
HITSP Clinical Research IS
21

20. 22
Identified Gap
• The 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 form
• Resolution:
– A new IHE profile called Redaction Services has been accepted
for inclusion in the Quality, Research, and Public Health (QRPH)
domain for development in 2010

21. 23
Redaction Services - 2010
1. Export
Document (CRD)
2. Retrieve
Extraction
Specification
4. Send
Redacted
Document
Redactor
B
Extraction Def. Mgr.
C
Document Source
A
Document Receiver
D
3. Return
Redacted
Document
Healthcare Research

22. 25
RPE 2.0 Transactions
ProcessDefinitionManager
ProcessActivityExecutor
ProcessStateManager
InitiateActivity
ReceiveProcessStateAlert
RetrieveProcessDefinitions
Subscribe
ReceiveProcessDefinitions
ReceiveProcessDefinitions
DeployProcessDefinition
RetrieveProcessDefinitions
Subscribe
InitiateProcess
RetrieveActivities
UpdateActivity
ReceiveProcessStateAlert
• Transactions broadly concerned with:
– Access to process definitions
– Runtime management of process state and activities

23. 2626
SHARP Service Bus
Orchestration Engine
(RPE)
Step-based Knowledge Acquisition
Graphical User
Interface
Demographics Labs
Text
(UIMA)
Coded
Diagnoses

24. © 2010 27
Strength through collaboration.