Building an active medical product safety surveillance system in Taiwan: Adaptation of the U.S. Sentinel System common data model structure to the National Health Insurance Research Database in Taiwan

Huang K.FANG-JU LINOu H.-T.Hsu C.-N.Huang L.-Y.CHI-CHUAN WANGToh S.2020-12-172020-12-17202110538569https://scholars.lib.ntu.edu.tw/handle/123456789/527103Purpose: Using real-world data to support regulatory decision has become a global movement. However, a robust platform for active surveillance of medical product safety has not been established in Taiwan. Methods: Following the common data model structure[SDGs]SDG3Article; cause of death; cohort analysis; data base; data quality; data quality assessment; electronic health record; Food and Drug Administration; human; longitudinal study; major clinical study; national health insurance; postmarketing surveillance; priBuilding an active medical product safety surveillance system in Taiwan: Adaptation of the U.S. Sentinel System common data model structure to the National Health Insurance Research Database in Taiwanjournal article10.1002/pds.5168331469082-s2.0-85096710072