Method for assessing risk of clinical test

A clinical trial and risk technology, applied in the field of clinical trial risk assessment, can solve problems such as failure to meet the needs of use, risk assessment models not being clearly disclosed, risk assessment parameters not being clearly disclosed, etc.

Active Publication Date: 2020-09-22
上海用正医药科技有限公司
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  • Abstract
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  • Claims
  • Application Information

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 origin

Method used

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  • Method for assessing risk of clinical test
  • Method for assessing risk of clinical test
  • Method for assessing risk of clinical test

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Embodiment Construction

[0098] The present invention will be described in detail below in conjunction with specific embodiments shown in the accompanying drawings. However, these embodiments do not limit the present invention, and any structural, method, or functional changes made by those skilled in the art according to these embodiments are included in the protection scope of the present invention.

[0099] Please refer to the figure, a risk assessment method for clinical trials, the flow chart of the steps is as follows figure 1As mentioned above, it is applied to the system of clinical risk assessment, and the system is composed of figure 2 shown.

[0100] Specifically,

[0101] Multi-source test data collection step 1, multi-source test data collection step 1 is in figure 2 It is completed in the clinical test collection module 101, which is input through the data input device 105 or directly imported into the clinical test collection module 102 from various test systems through various dat...

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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...

Claims

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Application Information

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IPC IPC(8): G06Q10/06G16H10/20
CPCG06Q10/0635G06Q10/06395G16H10/20
Inventor 袁钧王柏松奚文贾申科
Owner 上海用正医药科技有限公司
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