Arif M Rana, Harold Wiggin, Hilda DeGaetano, Jill Wallace-Ross, Robin J Jacobs
Formative Evaluation of Using Action Learning in a Master of Medical Education Assessment and Measurement Course
Cureus
objective describe us food drug administration fdas sentinel system implements best practices ensure trust drug safety studies using realworld data disparate sources present stepwise schematic sentinels data harmonization data quality check query design implementation reporting practices describe approaches enhancing transparency reproducibility replicability studies step sentinel data partner converts source data sentinel common data model transformed data undergoes rigorous quality checks used sentinel queries sentinel common data model framework data transformation codes several data sources data quality assurance packages publicly available designed run sentinel common data model sentinels querying system comprises suite pretested parametrizable computer programs allow users perform sophisticated descriptive inferential analysis without exchange individuallevel data across sites detailed documentation capabilities programs well codes information required execute publicly available sentinel website sentinel also provides public trainings online resources facilitate use data model querying system study specifications conform established reporting frameworks aimed facilitating reproducibility replicability realworld data studies reports sentinel queries associated design analytic specifications available download sentinel website sentinel example realworld data used generate regulatorygrade evidence scale using transparent reproducible replicable process