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Clinical trial monitoring effectiveness: Remote risk-based monitoring versus on-site monitoring with 100% source data verification.

Osamu YamadaShih-Wei ChiuMunenori TakataMichiaki AbeMutsumi ShojiEri KyotaniChiyo EndoMinami ShimadaYuko TamuraTakuhiro Yamaguchi
Published in: Clinical trials (London, England) (2020)
Remote risk-based monitoring was able to detect critical data and process errors as well as on-site monitoring with 100% source data verification, saving travel time and monitoring costs. Remote risk-based monitoring offers an effective alternative to traditional on-site monitoring of clinical trials.
Keyphrases
  • clinical trial
  • randomized controlled trial
  • electronic health record
  • systematic review
  • artificial intelligence
  • quality improvement
  • double blind