Transcript Duke Clinical Research Institute

Cardiology
Special Interest Group
Presentation to
Technical Steering Committee
September 12, 2005
Background

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.
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…
Mission
Charter
Operational Design
HL7 Standards Development
Infrastructure
Proposed Cardiology SIG
Stakeholder Working Groups
Industry
American College of Cardiology
NIH
CDC
Society of Thoracic Surgeons
(NHLBI / NIAID)
Working Groups
European Society of Cardiology
American Heart Association
CMS
FDA
Groundwork and Formal Support

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

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
Upcoming

Stakeholder Follow-up Meeting, September
23, 2005
 ‘Call for data elements’

American Heart Association meeting,
November 2005, with AHA/ACC/STS/VA/NIH
Planned Activities


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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
draft
Activity
Diagram
Thank you for your consideration.