Case report form generation method and device, computer equipment and storage medium

A case report form and computer program technology, applied in the field of clinical trials, can solve the huge labor cost and time cost of CRF, and achieve the effect of improving the design efficiency, reducing the involved cost, and solving the labor cost and time cost.

Pending Publication Date: 2022-02-01
浙江太美医疗科技股份有限公司
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Problems solved by technology

[0005] In view of this, the implementation mode of this description is dedicated to providing a method, device, computer equipment, storage medium and computer program product for generating a case report form, so as to solve the huge labor cost and time spent in the traditional technology of using CRF design tools to generate CRF cost problem

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  • Case report form generation method and device, computer equipment and storage medium
  • Case report form generation method and device, computer equipment and storage medium
  • Case report form generation method and device, computer equipment and storage medium

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[0027] The technical solutions in some implementations of this specification will be clearly and completely described below in conjunction with the drawings in some implementations of this specification. Obviously, the described implementations are only part of the implementations of this specification, not all of them. Based on the implementations in this specification, all other implementations obtained by those of ordinary skill in the art without making creative efforts fall within the scope of this specification.

[0028] Drug clinical trials refer to the systematic research of drugs in humans to determine the efficacy and safety of drugs. Drug clinical trials are divided into phase I, phase II, phase III clinical trials, and phase IV clinical trials. Phase I mainly involves preliminary clinical pharmacology and human safety evaluation tests. Phase II can be understood as the initial evaluation stage of therapeutic effect, which mainly involves the preliminary evaluation...

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Abstract

The invention provides a case report form generation method and device, computer equipment, a storage medium and a computer program product. The method comprises the following steps: acquiring a visit matrix of a clinical test item; matching in a form template library by using the form name in the visit matrix to obtain a target form template corresponding to the form name; and finally, sorting the target form templates based on the sequence of the visit in the visit matrix, and generating the case report form. The case report form is automatically generated based on the obtained visit matrix, the design efficiency of the case report form is improved, the related cost of the case report form is reduced, and the problem that in the prior art, a CRF design tool is used for generating CRF, and huge labor cost and time cost are consumed is solved.

Description

technical field [0001] This description relates to the technical field of clinical trials, in particular to a method, device, computer equipment, storage medium and computer program product for generating a case report form. Background technique [0002] Electronic data capture (Electronic Data Capture, EDC) is a computer network-based technology for clinical trial data collection, through the organic combination of software, hardware, SOP (Standard Operating Procedure, standard operating procedure) Collect and transmit clinical data directly in an optimized form. The EDC system uses an electronic case report form (Electronic Case Report Form) instead of a paper case report form to collect and manage clinical trial data. And the CRF (Case Report Form, case report form) of the clinical trial is a file used in the clinical trial to record the symptoms, signs or laboratory examination data of each subject during the trial. [0003] For clinical trials, the importance of the c...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G16H15/00G06F40/18G06F40/186
CPCG16H15/00G06F40/18G06F40/186
Inventor 袁首王团团李东煊
Owner 浙江太美医疗科技股份有限公司
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