2. CDISC Initiative: Healthcare Link
Patient Care Clinical Research
World World
CDISC Initiative:
Healthcare Link
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.
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
Slide courtesy of Landen Bain, CDISC
DIA CDM Meeting, Florida, March 2007. 2
3. HIMSS 07 - New Orleans
DIA CDM Meeting, Florida, March 2007. 3
4. Clinic Back Office
6
1
5
2
3
4
Picture courtesy of Charles Jaffe, MD, PhD
DIA CDM Meeting, Florida, March 2007. 4
5. Before RFD
Trial Registry Clinical Trials
Biosurviellance Safety
Clinicians need to re-
enter data several
times to serve many
EHR needs. No re-use of
data
DIA CDM Meeting, Florida, March 2007. 5
6. A Framework for Interoperability
• 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
Slide courtesy of Landen Bain, CDISC
DIA CDM Meeting, Florida, March 2007. 6
7. RFD Profile
• A standard way Retrieve Form external data
RFD = of displaying for Data-Capture
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 = Retrieve Form
for Data Capture
Slide courtesy of Landen Bain, CDISC
DIA CDM Meeting, Florida, March 2007. 7
8. Before RFD
Trial Registry Clinical Trials
Biosurviellance Safety
Clinicians need to re-
enter data several
times to serve many
EHR needs. No re-use of
data
DIA CDM Meeting, Florida, March 2007. 8
9. After RFD
Trial Registry Clinical Trials
Biosurviellance Safety
RFD provides for
EHR easy re-use of the
data already in the
EHR and for a better
process to capture
new data.
DIA CDM Meeting, Florida, March 2007. 9
10. RFD Profile
ArchiveF
A
orm
D
Form Filler
Form Archiver
Retrieve Submit
Form Form
B C
Form Manager Form Receiver
DIA CDM Meeting, Florida, March 2007. 10
11. Overview
Pfizer Lilly Novartis Genzyme SAIC
Form Filler
Allscripts
Cerner Siemens Allscripts Allscripts
Accenture
Form Manager
Sentrx
IBM Novartis DIFZ IBM
Relsys
Form Receiver
Sentrx Phase
Novartis SAS IBM
Relsys Forward
Form Archiver
SAS IBM SAS Assero SAS
DIA CDM Meeting, Florida, March 2007. 11
12. RFD Sceanrios
• Pharmaco-vigilance
Five Life Science Use Cases
• Investigational New Drug Trials
• Bio-surveillance
• Labs and Images
• Disease registry
DIA CDM Meeting, Florida, March 2007. 12
13. 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.
DIA CDM Meeting, Florida, March 2007. 13
14. Investigational New Drug Trials
• Team: Lilly, Cerner, Phase Forward, IBM
Investigational New Drug Trials
• 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
DIA CDM Meeting, Florida, March 2007. 14
15. 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.
DIA CDM Meeting, Florida, March 2007. 15
16. 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.
DIA CDM Meeting, Florida, March 2007. 16
17. Disease registry
• Team: Genzyme, DIFZ, SAS, Outcome,
Allscripts, Assero
• Standard: XForm, ODM
• Scenario: EHR user completes a guest form
for disease registry.
DIA CDM Meeting, Florida, March 2007. 17
18. 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
DIA CDM Meeting, Florida, March 2007. 18
19. 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
DIA CDM Meeting, Florida, March 2007. 19
20. User Requirements
1. An instrument used to capture source data 6. Source data shall only be modified with the
shall ensure that the data is captured as knowledge or approval of the investigator.
specified within the protocol.
2. Source data shall be Accurate, Legible, 7. Source documents and data shall be
Contemporaneous, Original, Attributable, protected from destruction.
Complete and Consistent.
3. An audit trail shall be maintained as part of 8. The source document shall allow for
the source documents for the original accurate copies to be made.
creation and subsequent modification of all
source data.
4. The storage of source documents shall 9. Source documents shall be protected
provide for their ready retrieval. against unauthorized access.
5. The investigator shall maintain the original 11. The location of source documents and
source document or a certified copy. the associated source data shall be clearly
identified at all points within the capture
process.
10. The sponsor shall not have exclusive 12. When source data are copied, the process
control of a source document. used shall ensure that the copy is an exact
copy preserving all of the data and metadata
of the original.
DIA CDM Meeting, Florida, March 2007. 20
21. eSDI Scenarios 4 & 5
Scenario 5
Sponsor
Scenario 4
Paper Source electronic Source
DIA CDM Meeting, Florida, March 2007. 21
22. RFD and eSource
ArchiveF
A
orm
D
Form Filler
Form Archiver
Retrieve Submit
Form Form
B C
Form Manager Form Receiver
DIA CDM Meeting, Florida, March 2007. 22
23. RFD and eSource
Investigator sphere
of control
EHR
FA
DIA CDM Meeting, Florida, March 2007. 23
24. RFD Flow
1. Request Form
2. Form
ODM &
XForms
ODM
3. Insert
Initial Offline: Use
Data ODM metadata
to create form
XML
Sponsor
Site ODM
4. Submit Data
DIA CDM Meeting, Florida, March 2007. Form Archiver 24
25. User Requirements
1. An instrument used to capture source data 6. Source data shall only be modified with the
shall ensure that the data is captured as knowledge or approval of the investigator.
FA
specified within the protocol.
2. Source data shall be Accurate, Legible, 7. Source documents and data shall be
Contemporaneous, Original, Attributable, protected from destruction. FA
Complete and Consistent.
3. An audit trail shall be maintained as part of 8. The source document shall allow for
the source documents for the original FA accurate copies to be made. FA
creation and subsequent modification of all
source data.
4. The storage of source documents shall
FA 9. Source documents shall be protected FA
provide for their ready retrieval. against unauthorized access.
5. The investigator shall maintain the original 11. The location of source documents and
source document or a certified copy. the associated source data shall be clearly
FA identified at all points within the capture FA
process.
10. The sponsor shall not have exclusive 12. When source data are copied, the process
control of a source document. used shall ensure that the copy is an exact
FA copy preserving all of the data and metadata
FA
of the original.
DIA CDM Meeting, Florida, March 2007. 25
26. … and reality, the IHE Connectathon
DIA CDM Meeting, Florida, March 2007. 26
27. Summary
• Practical Demonstration
• Based on Standards
– ODM
– SDTM
– E2B
– DICOM
• Architecture allows for eSource and ability to
meet the regulatory need.
DIA CDM Meeting, Florida, March 2007. 27
