Registry Assessment of Peripheral Interventional Devices (RAPID) Roadmap Working Group

 

AGENDA AND LINKS TO SLIDES

07:15-07:45: Registration & Refreshments

07:45-08:00: Welcome & MDEpiNet Perspective 

Danica Marinac-Dabic, Mitch Krucoff

08:00-09:20 Rationale and Intended Uses for RAPID

Moderators: Mitch Krucoff, Danica Marinac-Dabic

Project Overview – Jack Cronenwett

National Registry Perspective – Kathleen Hewitt

Industry Perspective – Robert Thatcher

FDA Perspective – Pablo Morales

ONC Perspective – Kevin Larsen

EHR Vendor Perspective –Bret Shillingstad

Discussion (30 min)

9:20-9:40 Break

9:40-10:40 Developing the Pathway to RAPID

Moderators: Pablo Morales, Jack Cronenwett

Logistics: Key Steps to Operationalizing the Roadmap – Rebecca Wilgus

Charge for the Clinical Committee – Schuyler Jones

Charge for the Informatics Committee –James Tcheng

Charge for the Access GUDID Committee – Terrie Reed

Discussion (30 min)

10:40-13:10 Committee Breakout Working Sessions, with lunch

Clinical Committee (Room 110-114) – Chair: Schuyler Jones

Informatics Committee (Main Meeting Room) – Chair: James Tcheng

Access GUDID Committee (Room 116-118) – Chair: Terrie Reed

13:10-14:40: Planning the Future: Phases II and III

Moderators: Donna Buckley and Daniel Canos

Phase II: Integrating Structured Data Sets and Supporting Data Extraction Interoperability:

Potential to incorporate Veteran’s Administration data – Ehrin Armstrong

Potential for EHR data abstraction – Clifford Cavanaugh

Potential for Medicare claims data abstraction – Rosemarie Hakim

Industry experience with data extraction – Ted Heise

Phase III: CRN-based Clinical Trial Options:

An academic perspective – Ralph Brindis

An industry perspective – Jeannette Bankes

An FDA perspective – Ken Cavanaugh

Discussion (30 min)

14:40-14:50 Break

14:50-15:50 Committee Reports, Next Steps

Moderators: Bram Zuckerman, Robert Thatcher

Clinical Committee Update – Schuyler Jones

Informatics Committee Update – James Tcheng

GUDID Committee Update – Terrie Reed

Discussion (30 min)

15:50-16:00 Wrap Up & Adjournment

Mitch Krucoff, Danica Marinac-Dabic, Jack Cronenwett, Pablo Morales, Robert Thatcher