Investigation of the Factors Affecting Risk-Based Quality Management of Investigator-Initiated Investigational New-Drug Trials for Unapproved Anticancer Drugs in Japan.

Published in: Therapeutic innovation & regulatory science (2017)

The results of this research suggest that the feasibility of risk-based monitoring and sampling source data verification was indicated for noncritical data and patients after the third case.

Keyphrases

deep learning
machine learning
end stage renal disease
electronic health record
ejection fraction
big data
newly diagnosed
chronic kidney disease
prognostic factors
peritoneal dialysis
clinical trial
quality improvement
patient reported outcomes
drug induced
phase ii