eSource, DIA CDM, Florida, March 2007

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


HIMSS 07 - New Orleans


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2

3

4

5

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Picture courtesy of Charles Jaffe, MD, PhD

Clinic Back Office


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


• 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



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


RFD = Retrieve Form for Data Capture


Before RFD



Clinicians need to re-

enter data several

times to serve many

needs. No re-use of

data

EHR


After RFD


EHR

RFD provides for

easy re-use of the

data already in the

EHR and for a better

process to capture

new data.



RFD Profile

Retrieve Form

Submit Form

ArchiveForm

Form Manager

B

Form Receiver

C

Form Filler

A

Form Archiver

D


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


Five Life Science Use Cases • Pharmaco-vigilance

• Investigational New Drug Trials

• Bio-surveillance

• Labs and Images

• Disease registry

RFD Sceanrios


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.


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


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.


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.


Disease registry

• Team: Genzyme, DIFZ, SAS, Outcome,

Allscripts, Assero

• Standard: XForm, ODM

• Scenario: EHR user completes a guest form

for disease registry.


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


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


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.


Sponsor

Scenario 5

Paper Source electronic Source

Scenario 4

eSDI Scenarios 4 & 5

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http://images.google.co.uk/imgres?imgurl=http://www.idealliance.org/proceedings/xml04/papers/150/IRS-TransmissionFileStruct.png&imgrefurl=http://www.idealliance.org/proceedings/xml04/papers/150/How-US-Govt-Using-XML-1YL.html&h=619&w=597&sz=123&hl=en&start=62&tbnid=EuRqpfT-V5_YIM:&tbnh=136&tbnw=131&prev=/images%3Fq%3Dpaper%2Bsource%26start%3D42%26ndsp%3D21%26svnum%3D10%26hl%3Den%26lr%3D%26rls%3DGGLJ,GGLJ:2006-36,GGLJ:en%26sa%3DN


RFD and eSource

Retrieve Form

Submit Form

ArchiveForm

Form Manager

B

Form Receiver

C

Form Filler

A

Form Archiver

D


RFD and eSource

EHR

Investigator sphere of control

FA


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


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

FA

FA

FA

FA

FA

FA

FA

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FA


… and reality, the IHE Connectathon


Summary

• Practical Demonstration

• Based on Standards

– ODM

– SDTM

– E2B

– DICOM

• Architecture allows for eSource and ability to

meet the regulatory need.

eSource, DIA CDM, Florida, March 2007

Business

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