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Clinical trial assistance system, clinical trial assistance program, and clinical trial assistance method

A clinical trial, support system technology, applied in electronic clinical trials, healthcare resources or facilities, instruments, etc.

Pending Publication Date: 2020-05-01
HITACHI LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] When the CRA visits the implementation facility and discovers an incident, there will be a processing cost corresponding to the incident

Method used

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  • Clinical trial assistance system, clinical trial assistance program, and clinical trial assistance method
  • Clinical trial assistance system, clinical trial assistance program, and clinical trial assistance method
  • Clinical trial assistance system, clinical trial assistance program, and clinical trial assistance method

Examples

Experimental program
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Embodiment Construction

[0028] Hereinafter, an example in which the clinical trial support system 1 according to the embodiment of the present invention supports drug clinical trials of new drugs will be described, but the clinical trial support system 1 of this embodiment is not limited to drug clinical trials and can be widely applied to general clinical trials. In addition, in this Example, although the cost was demonstrated as an example of an evaluation index, as mentioned later, various evaluation indexes can be used.

[0029] figure 1 It is a figure which shows the structure of the clinical trial support system 1 which concerns on the Example of this invention.

[0030] First, the outline of the functions of the clinical trial support system 1 according to the embodiment of the present invention will be described. In the clinical trial support system 1 of the present embodiment, a risk evaluation model 22 for estimating the frequency of accident occurrence in each implementation facility is c...

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PUM

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Abstract

The clinical trial assistance system is provided with: a calculation device that performs a prescribed process; and a storage device that is connected to the calculation device, wherein the calculation device has a visit plan creation unit that creates a visit plan of a clinical development monitor to an implementation facility, and a prediction unit that calculates an assessment index of the visit plan, the storage device stores assessment index information in which information for assessing the visit plan is recorded, and a risk assessment model recording a risk assessment result for each implementation facility, and the prediction unit that, by referring to the assessment index information and the risk assessment model, calculates the assessment index used when implementing the visit plan created by the visit plan creation unit, and outputs the visit plan selected on the basis of the assessment index.

Description

[0001] reference-based import [0002] This application claims priority based on Japanese Patent Application No. 2018-102103 filed on May 29, 2018 (2018), the content of which is incorporated herein by reference. technical field [0003] The present invention relates to a clinical trial support system. Background technique [0004] During clinical trials and drug clinical trials of new drugs (hereinafter, collectively referred to as drug clinical trials), the client (pharmaceutical company, CRO: Contract Research Organization) of the drug clinical trial commissioner (pharmaceutical company, CRO: Contract Research Organization) examines the medical Occurrence of harmful events in an organization (hereinafter referred to as implementation facility), loss of values ​​to be inspected, etc. (hereinafter referred to as incidents), shall be conducted by a clinical development supervisor (CRA: Clinical Research Associate) Visit implementation facilities and conduct on-site monitori...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G16H10/20G16H40/20
CPCG06Q10/06G16H40/20G16H10/20G06Q10/063118G06Q10/10G06Q10/06395G06Q10/0635G06Q10/06375G06F7/57
Inventor 西山晴彦木户邦彦久光彻
Owner HITACHI LTD
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