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eSource, DIA CDM, Florida, March 2007
 

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    eSource, DIA CDM, Florida, March 2007 eSource, DIA CDM, Florida, March 2007 Presentation Transcript

    • Electronic Source Data: ACase StudyDIA CDM Meeting, Florida20th March 2007Dave Iberson-Hurst, Assero© CDISC & Assero Ltd, 2007
    • 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, CDISCDIA CDM Meeting, Florida, March 2007. 2
    • HIMSS 07 - New OrleansDIA CDM Meeting, Florida, March 2007. 3
    • Clinic Back Office 6 1 5 2 3 4Picture courtesy of Charles Jaffe, MD, PhD DIA CDM Meeting, Florida, March 2007. 4
    • Before RFD Trial Registry Clinical TrialsBiosurviellance Safety Clinicians need to re- enter data several times to serve many EHR needs. No re-use of dataDIA CDM Meeting, Florida, March 2007. 5
    • 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 needsSlide courtesy of Landen Bain, CDISC DIA CDM Meeting, Florida, March 2007. 6
    • 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 CaptureSlide courtesy of Landen Bain, CDISC DIA CDM Meeting, Florida, March 2007. 7
    • Before RFD Trial Registry Clinical TrialsBiosurviellance Safety Clinicians need to re- enter data several times to serve many EHR needs. No re-use of dataDIA CDM Meeting, Florida, March 2007. 8
    • After RFD Trial Registry Clinical TrialsBiosurviellance 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
    • RFD Profile ArchiveF A orm D Form Filler Form Archiver Retrieve Submit Form Form B C Form Manager Form ReceiverDIA CDM Meeting, Florida, March 2007. 10
    • 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 SASDIA CDM Meeting, Florida, March 2007. 11
    • RFD Sceanrios• Pharmaco-vigilanceFive Life Science Use Cases• Investigational New Drug Trials• Bio-surveillance• Labs and Images• Disease registryDIA CDM Meeting, Florida, March 2007. 12
    • 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
    • Investigational New Drug Trials• Team: Lilly, Cerner, Phase Forward, IBMInvestigational 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 sponsorDIA CDM Meeting, Florida, March 2007. 14
    • 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
    • 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
    • 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
    • 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 Investigatorshttp://www.cdisc.org/eSDI/eSDI.pdfDIA CDM Meeting, Florida, March 2007. 18
    • 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 2006DIA CDM Meeting, Florida, March 2007. 19
    • User Requirements1. An instrument used to capture source data 6. Source data shall only be modified with theshall 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 beContemporaneous, Original, Attributable, protected from destruction.Complete and Consistent.3. An audit trail shall be maintained as part of 8. The source document shall allow forthe source documents for the original accurate copies to be made.creation and subsequent modification of allsource data.4. The storage of source documents shall 9. Source documents shall be protectedprovide for their ready retrieval. against unauthorized access.5. The investigator shall maintain the original 11. The location of source documents andsource 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 processcontrol 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
    • eSDI Scenarios 4 & 5 Scenario 5 Sponsor Scenario 4 Paper Source electronic SourceDIA CDM Meeting, Florida, March 2007. 21
    • RFD and eSource ArchiveF A orm D Form Filler Form Archiver Retrieve Submit Form Form B C Form Manager Form ReceiverDIA CDM Meeting, Florida, March 2007. 22
    • RFD and eSource Investigator sphere of control EHR FADIA CDM Meeting, Florida, March 2007. 23
    • RFD Flow 1. Request Form 2. Form ODM & XForms ODM 3. Insert Initial Offline: Use Data ODM metadata to create form XML SponsorSite ODM 4. Submit DataDIA CDM Meeting, Florida, March 2007. Form Archiver 24
    • User Requirements1. An instrument used to capture source data 6. Source data shall only be modified with theshall ensure that the data is captured as knowledge or approval of the investigator. FAspecified within the protocol.2. Source data shall be Accurate, Legible, 7. Source documents and data shall beContemporaneous, Original, Attributable, protected from destruction. FAComplete and Consistent.3. An audit trail shall be maintained as part of 8. The source document shall allow forthe source documents for the original FA accurate copies to be made. FAcreation and subsequent modification of allsource data.4. The storage of source documents shall FA 9. Source documents shall be protected FAprovide for their ready retrieval. against unauthorized access.5. The investigator shall maintain the original 11. The location of source documents andsource 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 processcontrol 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
    • … and reality, the IHE ConnectathonDIA CDM Meeting, Florida, March 2007. 26
    • 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