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Inspection task assignment method based on clinical test index data analysis result

A technology of clinical trials and index data, applied in the field of clinical trial monitoring tasks, can solve problems such as untimely monitoring, waste of resources, operating costs, and neglect of risk conditions

Active Publication Date: 2021-09-28
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

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.

Method used

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  • Inspection task assignment method based on clinical test index data analysis result
  • Inspection task assignment method based on clinical test index data analysis result
  • Inspection task assignment method based on clinical test index data analysis result

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Embodiment Construction

[0084] The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the drawings in the embodiments of the present invention.

[0085] This embodiment provides a monitoring task assignment method based on the analysis results of clinical trial index data, and its logic flow chart is as follows figure 1 shown. Specifically:

[0086] Import the clinical trial data collected by EDC and other systems into the clinical trial data acquisition and conversion module to convert the data format, and convert it into a standard clinical trial data format such as SDTM format data. In this application, it is achieved in the following ways:

[0087] S1: Establish a standardized SDTM database step, and establish a standardized SDTM database in the clinical trial system according to the SDTM standard;

[0088] The steps of establishing a standardized SDTM database include setting project environment, project informa...

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Abstract

The invention provides an inspection task assignment method based on a clinical test index data analysis result, and the method comprises the steps: firstly, a comprehensive risk assessment method based on historical and dynamic clinical test index data is provided; and a risk threshold value of each clinical test risk index data of a system consisting of a plurality of clinical test participation hospitals under a clinical test item is dynamically adjusted, the clinical test index data is compared with the risk threshold value of the clinical test risk index data to obtain a specific index risk level of the clinical test participation hospitals. Secondly, the risk threshold value of each clinical trial risk index determined by a system composed of a plurality of clinical trial participation hospitals and quantified based on the comprehensive risk level of the clinical trial indexes is also dynamic rather than a fixed value. According to the invention, through the above effects, the purposes of improving the accuracy of risk assessment and the matching efficiency of dispatching inspection tasks, reducing the cost and improving the inspection quality of clinical tests are finally achieved.

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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G06Q10/06G06Q10/04
CPCG06Q10/06311G06Q10/06315G06Q10/06316G06Q10/0635G06Q10/04
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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