Methods Used to Assess Risk in Clinical Trials

Abstract

The present invention discloses a method for assessing the risk of clinical trials, which divides the collected data into two categories, that is, the key data associated with the safety of subjects and the data quality data are two dimensions for clinical trial participating hospitals. risk assessment. According to the method of this application, various clinical trial data can be combined to carry out risk quantification to obtain clinical trial safety risk sub-indicator data, data quality risk sub-indicator data, and risk index data of participating hospitals in clinical trials. Risk level allocation and monitoring human resources are accurately entered into clinical trial participating hospitals. Based on the specific safety risk sub-indicator data and data quality risk sub-indicator data, the risk degree of each component data index is monitored, and the corresponding monitoring work is carried out to achieve the purpose of real-time management and control of clinical trials, and to maintain Improve the quality of clinical trials.

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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