National RAC Update Philip Goodney, MD

Submitting Requests Begin with discussions at your Regional RAC National RAC Requests reviewed every two months Submit Requests via the VQI website at http://abstracts123.com/svs1/meetinglogin Searchable utility to review all approved RAC requests at https://www.vqi.org/data-analysis/rac-approved-project-search/

RAC Team – Thank you Research Advisory Council PSO Staff Vice Chair: Grace Wang, MD 23 member council Representation from each PSO Regional Group PSO Staff Nancy Heatley Carrie Bosela Dan Neal

RAC Policies – Device Identification Approved data sets are blinded and free from indenters No PHI No identification of physician or hospital No device identifiers Device Identification may be allowed if approved by the RAC Scientific Validity and Merit Additional Clinical Oversight Additional Statistical Oversight Communications with Manufacturer Analytical Plan Review and Comment before publication

RAC Policies – Industry Studies Govern Access to datasets related to ongoing Industry Studies Primary Objectives will be reserved for Industry Study Steering Committees Defined in Industry Study Charter Defined Goals and endpoint parameters Available on VQI website Provides access to data not part of Primary Objectives Enables access to data Might require compliance with the Device Identification policy