simaerep

Find Clinical Trial Sites Under-Reporting Adverse Events

CRAN Package

Monitoring of Adverse Event (AE) reporting in clinical trials is important for patient safety. Sites that are under-reporting AEs can be detected using Bootstrap-based simulations that simulate overall AE reporting. Based on the simulation an AE under-reporting probability is assigned to each site in a given trial (Koneswarakantha 2021 doi:10.1007/s40264-020-01011-5).


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  • Depends1 package
  • Imports14 packages
  • Suggests10 packages