Principal Investigators

Pablo Morales, MD, U.S. FDA

Robert Thatcher, 4C Medical Technologies

Jack Cronenwett, MD, Society for Vascular Surgery (SVS), Vascular Quality Initiative (VQI)

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Goals & Aims

• Implement the RAPID core data set (clinical and GUDID data elements) in a variety of healthcare information systems to advance the collection and exchange of interoperable electronic health data;

• Represent the RAPID core data elements (CDEs) in interoperable, standards-based models (LOINC, SNOMED, HL7);

• Describe a minimal set of common domain variables (general patient identifiers & common clinical data elements) needed to aggregate data sets from multiple sources;

• Develop a core set of unique device attributes (AUDI) to complement the RAPID core data set and common domain variables to support PAD studies;

• Assess & evaluate quality of data in the AccessGUDID database for devices used to treat peripheral vascular disease;

• Develop projects to demonstrate extraction & use of patient-level data for the RAPID core data elements to support regulatory applications;

• Assess and evaluate data governance, sharing, access and publication guidelines of RAPID data partners

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Working Groups

• Informatics and GUDID

• Governance, Access and Data Sharing

• Protocol Development & Registry-based Trial Framework

• Educational Outreach

• Additional Members/Organizations

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Phase II Work Products

• SPEED OPG Manuscript

• GUDID Final Report