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Cardiology Special Interest Group Presentation to Technical Steering Committee

A presentation on the feasibility of integrating and expanding clinical research networks in cardiology. Emphasis on developing therapeutic area standards in a public forum with broad stakeholder participation. Focus on raw data as a single source for various uses across patient care, research, and quality improvement. Involvement with industry organizations and ongoing support from key stakeholders. Planned pilot study on cross-therapeutic area dataset using standardized data elements.

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Cardiology Special Interest Group Presentation to Technical Steering Committee

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  1. CardiologySpecial Interest GroupPresentation to Technical Steering Committee September 12, 2005

  2. NIH Roadmap contract: BAA-RM-04-23 Re-engineering the Clinical Research Enterprise: Feasibility of Integrating and Expanding Clinical Research Networks Recognition that therapeutic area standards development needs to be done in a public forum, formalized development process and broad participation from experts and stakeholders representing a variety of domains Focus on contributing to the public domain, not an specific implementation effort. Background

  3. Define the raw data and let it be the single source for all possible uses Source Data Systems Analyses & Reporting Patient care Research QI Payment Patient safety Decision Support EMR Administration Clinical Documents Public Health Reporting And more…

  4. Mission

  5. Charter

  6. Operational Design HL7 Standards Development Infrastructure Proposed Cardiology SIG Stakeholder Working Groups Industry American College of Cardiology CDC NIH (NHLBI / NIAID) Working Groups Society of Thoracic Surgeons European Society of Cardiology American Heart Association FDA CMS

  7. American College of Cardiology Meeting, March 2005, with AHA/ACC/STS/VA/NIH Ongoing engagement and support received Discussion started on role of ACC/AHA Task Force on Data Standards Stakeholder Kickoff Meeting, May 2005 34 Attendees representing 29 organizations Participation in NIH Roadmap ‘Interoperability Working Group’ HL7 Efforts Experience from ECG Waveform standard development WGM Jan 2005 – RCRIM Discussion WGM May 2005 – Participation and ad hoc discussions WGM Sept 2005 – SIG Application Review Supported by Patient Care Technical Committee Approved by the HL7 Architectural Review Board RCRIM Follow-up discussion Groundwork and Formal Support

  8. Stakeholder Follow-up Meeting, September 23, 2005 ‘Call for data elements’ American Heart Association meeting, November 2005, with AHA/ACC/STS/VA/NIH Upcoming

  9. Activity diagram Draft in clinical review Master set of data elements, including clinical definitions Attribute sets reviewed (ISO 11179, caDSR, RIM, CDISC SDTM) DCRI cardiology trial set and CDISC SDTM used to pilot attributes & format Data element relationship to terminology sets explored Further discussion with ACC/AHA Task Force on Data Standards on clinical definitions and stewardship role Mapping data elements to Activity Diagram Pilot study Cardiology and Psychology cross-therapeutic area dataset Single source to supply patient care, administrative reporting, research and QI purposes CTN Best Practices clinical sites and/or others to participate. Storyboards supporting pilot study to be pursued first Standards needed for pilot study implementation to be pursued first Ongoing Rendering of data elements in content & structure formats Planned Activities

  10. draft ActivityDiagram

  11. Thank you for your consideration.

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