Method for assessing risk of clinical test

Abstract

The invention discloses a method for evaluating the risk of a clinical test, and the method comprises the steps: dividing collected data into two types, i.e., key data related to the safety of a subject and data quality data, and carrying out the risk evaluation of a hospital where the clinical test participates. According to the method of the invention, various clinical test data can be combinedand then subjected to risk quantification to obtain clinical test safety risk sub-item index data, data quality risk sub-item index data and risk index data of clinical test participation hospitals, and human resources are allocated and monitored according to clinical test risk levels to accurately enter the clinical test participation hospitals. And on the basis of the specific safety risk sub-item index data and the data quality risk sub-item index data, the risk degree of each formed data index is monitored, corresponding monitoring work is executed to achieve the purpose of controlling theclinical test in real time, the rights and interests of the testee are maintained, and the clinical test quality is improved.

Description

technical field [0001] The invention relates to the technical field of clinical trials, in particular to an algorithm for evaluating key data and data quality data associated with the safety of subjects in clinical trial data, and obtaining risk data and risk data of participating hospitals in clinical trials according to the evaluation results. According to the level of risk, the monitoring human resources are accurately deployed to better protect the rights and interests of the subjects and improve the quality and efficiency of the test. 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 implement...

AI Technical Summary

Problems solved by technology

The unresolved issues are: 1. The risk assessment model has not been clearly disclosed

In other words, it is impossible to monitor the risk changes of the implementation facilities in real time

2. Risk assessment parameters are not clearly disclosed

However, the problem with this invention patent application is that the method is to mark the original parameter position mark corresponding to the structured test parameter on the original file through the artificial intelligence automatic learning algorithm (see paragraph 0174 of the description)

However, there is no specific calculation method in the patent for this invention, but it is only an idea, which cannot meet the actual needs of use.

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