This project will create a publicly-available common protocol for Data Quality Metrics for electronic health record (EHR) data. The project will define 30-40 Data Quality Metrics across both inpatient and ambulatory care settings and will assess these metrics in an aggregated EHR dataset. Since use of EHR data in Sentinel needs to meet FDA data quality standards, creation of a common protocol to assess data quality of new EHR-based data sources supports the FDA priority for creation of a Real-World Evidence (RWE) Data Enterprise.
Judith Maro, PhD, MS; Jeffrey Brown, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Christine Halbig, MPH; Alicia Muzzi, MPH; Suzanne Carter, PhD, MBA; Daniel Kiernan; Lauren Zichitella, MS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Joshua Lin, MD, MPH, SCD; Massachusetts General Hospital, Boston, MA
Keith Marsolo, PhD; Duke Department of Population Health Sciences
Michael Sullivan; Jennifer Stacey; Jim Phillips; Brecht Claerhout, MSc; Steven Kindrot, MBA; Matvey Palchuck, MD, MS; Maggie Berryman; TriNetX, Cambridge, MA
Sarah Dutcher, PhD; Food and Drug Administration, Silver Spring, MD