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Electronic Source Data: A Case Study DIA CDM Meeting, Florida 20th March 2007 Dave Iberson-Hurst, Assero © CDISC & Assero Ltd, 2007
DIA CDM Meeting, Florida, March 2007. 2
Patient Care World
Clinical Research World
Next Step: Development and Demonstration of
an Integration Profile (through IHE),
called Retrieve Form for Data Capture (RFD),
to be demonstrated in five use cases at HIMSS 07
An industry initiative that has successfully demonstrated
clinical information interoperability between physician
clinical systems (EHR) and pharmaceutical clinical trials
systems based on open standards.
- Duke Clinical Research Institute, CDISC, Novartis, Merck, J&J, Microsoft.
CDISC Initiative:
Healthcare Link
CDISC Initiative: Healthcare Link
Slide courtesy of Landen Bain, CDISC
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HIMSS 07 - New Orleans
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1
2
3
4
5
6
Picture courtesy of Charles Jaffe, MD, PhD
Clinic Back Office
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Before RFD
Biosurviellance Safety
Trial Registry Clinical Trials
Clinicians need to re-
enter data several
times to serve many
needs. No re-use of
data
EHR
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• Integrating the Healthcare Enterprise:
– An initiative that improves patient care by
harmonizing healthcare information exchange
– Provides a common standards-based framework
for seamlessly passing health information among
care providers, enabling local, regional and
national health information networks
– Promotes the coordinated use of established
standards–Health Level 7, ASTM, DICOM,
CDISC, W3C, IEEE, etc.—to address specific
clinical needs
A Framework for Interoperability
Slide courtesy of Landen Bain, CDISC
DIA CDM Meeting, Florida, March 2007. 7
RFD = Retrieve Form for Data-Capture • A standard way of displaying external data
capture forms inside an EHR.
• Many-to-many integration – any EHR can
retrieve forms from many external systems.
• Applications to clinical trials, registries, bio-
surveillance, and pharmacovigilance.
RFD Profile
Slide courtesy of Landen Bain, CDISC
RFD = Retrieve Form for Data Capture
DIA CDM Meeting, Florida, March 2007. 8
Before RFD
Biosurviellance Safety
Trial Registry Clinical Trials
Clinicians need to re-
enter data several
times to serve many
needs. No re-use of
data
EHR
DIA CDM Meeting, Florida, March 2007. 9
After RFD
Trial Registry Clinical Trials
EHR
RFD provides for
easy re-use of the
data already in the
EHR and for a better
process to capture
new data.
Biosurviellance Safety
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RFD Profile
Retrieve Form
Submit Form
ArchiveForm
Form Manager
B
Form Receiver
C
Form Filler
A
Form Archiver
D
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Overview
Siemens Allscripts
Accenture Cerner Allscripts Allscripts
Novartis Sentrx
Relsys IBM DIFZ IBM
Novartis Sentrx
Relsys
Phase
Forward SAS IBM
SAS SAS IBM Assero SAS
Pfizer Lilly Novartis Genzyme SAIC
Form Filler
Form Manager
Form Receiver
Form Archiver
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Five Life Science Use Cases • Pharmaco-vigilance
• Investigational New Drug Trials
• Bio-surveillance
• Labs and Images
• Disease registry
RFD Sceanrios
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Pharmaco-vigilance
• Team: Pfizer, Sentrx, Allscripts, Accenture
• Standard: XForm, ODM, ICH E2B
• Scenario: Physician investigator, using an
EHR, discovers a suspected adverse drug
event and summons a data-capture form
from the drug manufacturer to provide
information on the event.
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Investigational New Drug Trials • Team: Lilly, Cerner, Phase Forward, IBM
• Standard: XForm, ODM
• Scenario: A physician investigator utilizes an
EHR and collects Clinical Research (CR)
related data and then request a CR form to
finish collecting sponsor data.
The data is sent and loaded into the EDC
system for further data review and analysis
by the investigator and sponsor
Investigational New Drug Trials
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Bio-surveillance
• Team: SAIC, CDC, IBM, Allscripts
• Standard: XForm
• Scenario: A physician using an EHR
discovers a suspected outbreak of a disease.
Using RFD, the physician summons a data-
capture form from CDC, completes the form,
and returns.
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Labs and Images
• Team: Novartis, Siemens
• Standards: XForm, ODM, DICOM
• Scenario: A physician investigator completes
a clinical research form that included lab and
image data.
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Disease registry
• Team: Genzyme, DIFZ, SAS, Outcome,
Allscripts, Assero
• Standard: XForm, ODM
• Scenario: EHR user completes a guest form
for disease registry.
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eSDI Document Content
• Review and analysis of the relevant existing regulations
• Twelve User Requirements for conducting regulated clinical research using eSource data collection in the context of existing regulations
• Five potential eSDI-based scenarios, three include the use of electronic health record systems (EHR)
• Template for Evaluation of eSource data collection process per the Requirements
• Good Practices Checklist for Investigators
http://www.cdisc.org/eSDI/eSDI.pdf
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eSDI History
• Started November 2004
• February & March 2005 informal comments
• 1st Draft, 14th March 2005
• 2nd Draft, 25th May 2005
• 3rd Draft,11th August 2005
• 4th Draft, 29th August 2005
• 5th Draft, 16th September 2005
• 6th Draft, 16th August 2006
• Issue 1, 20th November 2006
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User Requirements
1. An instrument used to capture source data shall ensure that the data is captured as specified within the protocol.
6. Source data shall only be modified with the knowledge or approval of the investigator.
2. Source data shall be Accurate, Legible, Contemporaneous, Original, Attributable, Complete and Consistent.
7. Source documents and data shall be protected from destruction.
3. An audit trail shall be maintained as part of the source documents for the original creation and subsequent modification of all source data.
8. The source document shall allow for accurate copies to be made.
4. The storage of source documents shall provide for their ready retrieval.
9. Source documents shall be protected against unauthorized access.
5. The investigator shall maintain the original source document or a certified copy.
11. The location of source documents and the associated source data shall be clearly identified at all points within the capture process.
10. The sponsor shall not have exclusive control of a source document.
12. When source data are copied, the process used shall ensure that the copy is an exact copy preserving all of the data and metadata of the original.
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Sponsor
Scenario 5
Paper Source electronic Source
Scenario 4
eSDI Scenarios 4 & 5
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RFD and eSource
Retrieve Form
Submit Form
ArchiveForm
Form Manager
B
Form Receiver
C
Form Filler
A
Form Archiver
D
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RFD and eSource
EHR
Investigator sphere of control
FA
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RFD Flow
ODM &
XForms
XML
ODM
ODM Site
Sponsor
1. Request Form
2. Form
3. Insert
Initial
Data
4. Submit Data
Offline: Use
ODM metadata
to create form
Form Archiver
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User Requirements
1. An instrument used to capture source data shall ensure that the data is captured as specified within the protocol.
6. Source data shall only be modified with the knowledge or approval of the investigator.
2. Source data shall be Accurate, Legible, Contemporaneous, Original, Attributable, Complete and Consistent.
7. Source documents and data shall be protected from destruction.
3. An audit trail shall be maintained as part of the source documents for the original creation and subsequent modification of all source data.
8. The source document shall allow for accurate copies to be made.
4. The storage of source documents shall provide for their ready retrieval.
9. Source documents shall be protected against unauthorized access.
5. The investigator shall maintain the original source document or a certified copy.
11. The location of source documents and the associated source data shall be clearly identified at all points within the capture process.
10. The sponsor shall not have exclusive control of a source document.
12. When source data are copied, the process used shall ensure that the copy is an exact copy preserving all of the data and metadata of the original.
FA
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… and reality, the IHE Connectathon
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Summary
• Practical Demonstration
• Based on Standards
– ODM
– SDTM
– E2B
– DICOM
• Architecture allows for eSource and ability to
meet the regulatory need.