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Landen Bain CDISC Liaison to Healthcare March 17, 2006

Retrieve Form for Data Capture (RFD) A Profile to link Electronic Health Records (EHR) to Clinical Research Electronic Data Capture (EDC) Systems. Landen Bain CDISC Liaison to Healthcare March 17, 2006. Current State Data Capture at the Sites Looks Like This.

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Landen Bain CDISC Liaison to Healthcare March 17, 2006

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  1. Retrieve Form for Data Capture (RFD) A Profile to link Electronic Health Records (EHR) to Clinical Research Electronic Data Capture (EDC) Systems Landen Bain CDISC Liaison to Healthcare March 17, 2006

  2. Current StateData Capture at the Sites Looks Like This The virtual version of this mess – multiple web apps on one workstation – is no improvement.

  3. How widespread is this problem?2/3 of sites have more than one data capture system.17% have 5 or more! Source: CDISC 2004 Research Project, Analysis Q200_1 & Q200_2

  4. Problem StatementClinical Trial Site • Setting: A site is a physician clinic with an EHR for patient care and multiple EDC systems for Clinical Research. • Site personnel must enter data into more than one application, creating unnecessary work. • There is confusion about which data capture step creates the ‘source document’.

  5. Parallel UniversesHealthcare Data and Clinical Research Data Live in Parallel Universes

  6. Can we navigate the black hole? The point of data capture – the Single Source - is the skinny neck connecting the two parallel universes in which EHR and EDC systems live.

  7. Single Source Care Giver/Investigator Separate Streams Patient Data Subject Data EMR CDMS Separate Stores Single Source: DATA FLOW

  8. Single Source Credo Data collection at the site of patient care is fundamentally one process, whether the data are for documenting care or to feed a clinical trial.

  9. Single Source Vision A single data capture mechanism at the point of care which collects patient care data and clinical research data in one facile process, while respecting the semantic and regulatory requirements of these two ‘parallel universes’.

  10. RFD Principles • Take a human-centric view • Focus on the workflow of the people who are doing real work at the sites. • Enable simultaneous data capture of patient care and clinical research data. • Use existing standards (HL7 & CDISC) and comply with existing regulations (HIPAA and 21 CFR Part 11). • Use existing applications (EHR & EDC) and respect their existing capabilities • EHR is the natural place for data capture. • The EDC system continues its current role as data manager of the clinical trial data. • The EHR hosts a guest form from the EDC and allows for data capture and transfer out. • HIMSS demo 2007 is crucial to move the market.

  11. Two Sub-Problems to Solve • Interface • EHR and EDC must be aware of each other, able to transfer data safely and securely. • Content • EHR and EDC must be able to understand and use the data once transferred.

  12. Two separate IHE profiles are required to solve these two problems. • Retrieve Form for Data-capture (RFD) addresses the interface problem. • Establishes the transport layer. • Under IHE’s IT Integration (ITI) committee • Form definition profile solves the content issue. • Under IHE’s Patient Care Coordination (PCC) Committee

  13. RFD Profile Requirements • Two systems, one which creates a form, the other which retrieves and displays the form for data capture. • EDC creates the form, and receives the completed form. • EHR retrieves and displays the form, and enables the form completion.

  14. Integration Profile Development Aims • A standard way of displaying clinical research data capture forms inside an EHR. • Many-to-many integration – any EHR can talk to any EDC. • Low barrier of entry for EHR and EDC vendors. • Flexible profile to accommodate both low-tech and sophisticated implementations

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