The Mini-Sentinel Data Quality and Characterization Procedures and Findings Report describes the Mini-Sentinel Distributed Database (MSDD) data characterization and quality checking approach implemented by the Mini-Sentinel Operations Center (MSOC). To create the MSDD, each Data Partner transformed their local source data into the Mini-Sentinel Common Data Model (MSCDM) format. This report describes the data characterization and checking process and the information used to ensure that the transformations were consistent with the MSCDM.
Jeffrey S. Brown PhD and Nicolas U. Beaulieu MA; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Lesley H. Curtis PhD; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC
Mark G. Weiner MD; Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA
Representatives of FDA and all Mini-Sentinel Data Partners
Tiffany S. Woodworth MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Robert Rosofsky; Health Information Systems Consulting LLC, Boston, MA