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RAPID Working Group Meeting

April 13, 2016 @ 08:00 - 17:00

Meeting Recordings

 

Meeting Objectives

  • Share RAPID overview with new stakeholders
  • Finalize RAPID Phase I
    • Face-to-face meetings of clinical, informatics and GUDID work groups to finalize Phase I work of prior conference calls
    • Work group reports and group discussion of any lingering issues
    • Identify strategy for reporting deliverables and finishing Phase I
  • Develop pathway to execute RAPID Phase II
    • Learning from others
    • Potential benefit for payers
    • Workable deadline and milestones
  • Discuss potential mechanisms and/or clinical studies where RAPID Phase III may be implemented
    • Manufacturers interests
    • International collaborations
    • US regulations and potential execution

 

Agenda

07:30-8:00 AM           Registration and Refreshments

08:00-8:50 AM           Welcome

RAPID:  Within the context of a National Medical Device Surveillance System

Mitch Krucoff, Duke University

RAPID: Current state, and Plan for the day

Pablo Morales, FDA

Jack Cronenwett, Dartmouth-Hitchcock

Robert Thatcher, Cardiovascular Systems

09:00 -11:00 AM        Working Group break-outs: Finalize RAPID Phase I deliverables

 Clinical Work Group                                                                                                                      

Schuyler Jones, Duke University

  • Review work group, timeline, work performed, and key contributions
  • Finalize Phase I list of 100 data elements
    • Complete remaining data element and permissible value definitions
    • Complete remaining mapping of RAPID data elements to registries/trials’ CRFs
  • Plan & establish timeline for reporting deliverables
  • Summarize lessons learned and key points for report out to large group
  • Roadmap / assignments of work required to reach goals of Phase II and III

Informatics Work Group

James Tcheng, Duke University

  • Review working group goals, timeline, and key contributions
  • Finalize the minimum meta-data for the RAPID common clinical terminology set
  • High level review the work product of the clinical WG (informatics conformance perspective)
  • Plan the formulation / composition of the work product that will be most useful to (non-informatics) stakeholders
  • Plan the work (including resourcing) to accomplish an informatics instantiation of the RAPID common clinical term set
  • Discuss the “supplemental” UDI content gap from a principles / framework perspective (with the GUDID WG)
  • Plan & establish timeline for reporting deliverables

GUDID Work Group

Terrie Reed, FDA

  • Review working group goals, timeline, and key contributions
  • Review GUDID Summary and work on generalizing learnings from peripheral vascular registry experience to other device registries
  • Plan & establish timeline for reporting deliverables
  • Roadmap / assignments of work required to reach goals of Phase II and III

11:00 -11:15 AM        Break & Box lunch set-up

 

11:15-12:45 PM          Integration of Work Groups

Moderator: Jack Cronenwett, Dartmouth-Hitchcock

Working lunch, reports from each work group & discussion of topics that need joint review as we move into Phase II planning

Break-out Session Reports

  • Clinical WG             Schuyler Jones, Duke University
  • Informatics WG     James Tcheng, Duke University
  • GUDID Work Group            Terrie Reed, FDA

Commentators:

Barry Daniels,GMDN – Use of GMDN or other device categories

Julia Skapik, ONC – Integration with national data standards

12:45-1:00 PM            Break

 

1:00-2:30PM               RAPID Phase II, Core Data Set Extraction
Moderator:
Pablo Morales, FDA

Operationalizing data extraction from multiple sources using the core PVI dataset

Joe Drozda, Mercy Health System

  • Partnering with payers for data extraction /BMC2 experience

Hitinder Gurm, University of Michigan

Sophia Autrey, Center for Medicare and Medicaid Services

Bret Shillingstad, Epic

  • Open discussion

2:30 – 2:45 PM           Break

2:45-3:45 PM              RAPID Phase III

Moderators: Robert Thatcher, Cardiovascular Systems, Jack Cronenwett, Dartmouth-Hitchcock

Utilizing the RAPID core data set for research, quality improvement and safety surveillance

Perspectives from the medical device industry

Perspectives from international partners

Sara Takahashi, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

3:45-4:00 PM              MDEpiNet Perspective, Next Steps

Danica Marinac-Dabic, FDA

Pablo Morales, FDA

Jack Cronenwett, Dartmouth-Hitchcock

Robert Thatcher, Cardiovascular Systems

Details

Date:
April 13, 2016
Time:
08:00 - 17:00
Event Category:
Event Tags:

Venue

Sheraton Silver Spring
8777 Georgia Ave.
Silver Spring, 20910 United States
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