METHOD AND SYSTEM FOR EXECUTING RISK-BASED MONITORING OPERATION FOR CLINICAL TRIALS AND COMPUTER-READABLE RECORDING MEDIUM THEREOF

摘要

The present invention relates to a method for executing a risk-based monitoring operation for clinical trials, a system for the same, and a computer-readable recording medium thereof. According to an aspect of the present invention, the clinical trial management system includes a data collection unit and a risk monitoring unit. A method for executing a risk-based monitoring operation for clinical trials includes the steps of: collecting data of multiple clinical trials through a data collection unit; and determining the risk regarding specific clinical trial items of a specific site based on the data on the clinical trials collected in advance through a risk monitoring unit. The risk determining step includes a step of comparing the value of the specific clinical trial with the average or median values of the same item calculated from the data of the clinical trials collected in advance.;COPYRIGHT KIPO 2018