Monitoring task assignment method based on clinical trial index data analysis results

Abstract

The present invention provides a monitoring task assignment method based on the analysis results of clinical trial index data. First, it provides a comprehensive risk assessment method based on historical and dynamic clinical trial index data. Dynamically adjust the risk threshold of each clinical trial risk index data in a system composed of several clinical trial participating hospitals under a clinical trial project, and compare the clinical trial index data with the risk threshold of the clinical trial risk index data to obtain the clinical trial participation Hospital-specific indicator risk levels. Secondly, the risk threshold of each clinical trial risk indicator determined by a system composed of several clinical trial participating hospitals quantified based on the comprehensive risk level of clinical trial indicators is also dynamic rather than a fixed value. In the present invention, through the above effects, the purpose of improving the accuracy of risk assessment and the matching efficiency of dispatching monitoring tasks, reducing costs, and improving the quality of clinical trial monitoring is finally realized.

Description

technical field [0001] The present invention relates to the technical field of clinical trials, in particular to a method for assessing the risks of multiple clinical trials in hospitals participating in the trials based on the comprehensive risk level obtained by analyzing the risk index data of clinical trials, and dispatching clinical trial monitoring based on the evaluation results of clinical trial risks. method of the task. Background technique [0002] Clinical Trial refers to any systematic study of drugs in humans (patients or healthy volunteers) to confirm or reveal the effects, adverse reactions and / or absorption, distribution, metabolism and excretion of experimental drugs. It is to determine the efficacy and safety of the experimental drug. Clinical trial monitoring is the supervision of the clinical trial process in order to ensure that the implementation, recording and reporting of research and development drugs in clinical trials comply with the requirements...

AI Technical Summary

Problems solved by technology

However, in the existing technical solutions, the above factors are not considered and the risk prompt factors with the same weight are given. After many risk indicators are integrated, the more serious risk situations may be ignored, resulting in failure to monitor in time

2. The evaluation of risk level is not based on a comprehensive evaluation of a cycle

In this way, it will not lead to the fact that one inspector will be assigned to many tasks, and some inspectors will not fully match the inspection tasks, resulting in waste of resources or increased operating costs.

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