An electronic data acquisition system which is freely configurable in terms of functionality

CN122889207APending Publication Date: 2026-10-09黄智华
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Patent Information

Application Number
CN202410407911.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-04-07
Publication Date
2026-10-09

AI Technical Summary

Technical Problem

[0004]上述现有技术中设计的插件均是在出厂时就已经固定插入,在后续使用过程中很难实现新插件的插入,而目前现有EDC系统的功能模块并不全面,这就导致了EDC系统难以实现用户端功能配置,并且后续数据字段定位以及数据收集、数据统计分析及数据导出也很难实现,进而导致某些关键数据无法进行数据收集和分析

Benefits of technology

[0021]本申请设计的一种可自由进行功能配置的电子数据采集系统,包括文档编辑模块、功能配置模块以及功能锁定模块;所述文档编辑模块用于建立文档编辑界面,并生成CRF文档;所述功能配置模块和文档编辑模块通信连接,用于在CRF文档中嵌入功能插件,还用于为CRF文档配置电子数据采集功能;所述功能锁定模块和文档编辑模块通信连接,用于锁定CRF文档,还用于对CRF文档进行数据采集;其中,所述功能插件包括日期插件、下拉菜单插件、公式计算插件、编号插件、导出设置组件、执行测试组件以及角色设置组件。通过上述设计,在操作上用户能够实现日期插件、下拉菜单插件、公式计算插件、编号插件、导出设置组件、执行测试组件以及角色设置组件的自由配置,无需程序员再在后台进行修改,减少项目配置的时间和成本。

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Abstract

The application designs an electronic data acquisition system which can freely configure functions, comprising a document editing module, a function configuration module and a function locking module; the document editing module is used for establishing a document editing interface and generating a CRF document; the function configuration module and the document editing module are in communication connection, used for embedding a function plug-in in the CRF document and obtaining the CRF document; the function locking module and the document editing module are in communication connection, used for exporting data collected by the CRF document; wherein the function plug-in comprises a date plug-in, a drop-down menu plug-in, a formula calculation plug-in, a numbering plug-in, an export setting component, an execution test component and a role setting component. Through the above design, the user can realize the free configuration of the date plug-in, the drop-down menu plug-in, the formula calculation plug-in, the numbering plug-in, the export setting component, the execution test component and the role setting component in operation, without the need for programmers to modify in the background, reducing the time and cost of project configuration.
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Description

Technical Field

[0001] This invention belongs to the field of electronic data acquisition systems, and specifically relates to an electronic data acquisition system with freely configurable functions. Background Technology

[0002] An EDC (Electronic Data Capture System) is a platform software specifically designed for the collection and transmission of clinical trial data. With technological advancements, more and more data management functions are being incorporated into EDC systems. Mainstream EDC systems not only offer various data collection methods but also robust data verification capabilities. Furthermore, they include excellent user communication solutions, enabling effective communication among users within the same project regarding the data collected. Due to its significant advantages, the EDC system has replaced traditional paper-based case report forms for collecting clinical trial data.

[0003] Existing technologies, such as the Chinese Patent Publication No. 202110869043.3, disclose a data entry method and EDC system based on electronic logs in an EDC system, including the following steps: S1. Upon receiving an electronic log request from the subject's end, query whether the electronic log function is enabled for the corresponding subject's project. If so, proceed to step S2; S2. Query the folder / check item with the log function enabled in the corresponding project, and return the corresponding data entry page to the subject's end based on the query results; S3. Associate the data entered by the subject with the corresponding data point in the experimental database to complete the entry of the corresponding data point. Subjects can register by scanning a QR code associated with their subject ID, which allows them to associate their subject's end with their subject ID at the same time as registration. When entering data, they directly target their own database, which has advantages such as high efficiency and convenience. At the same time, it only accepts registrations from subject users, which can reduce system pressure and prevent unauthorized registrations. However, in the process of using the existing technology, the inventors found that the existing technology has at least the following problems:

[0004] The plugins designed in the aforementioned existing technologies are all pre-installed at the factory, making it difficult to insert new plugins during subsequent use. Furthermore, the existing EDC system does not have a complete set of functional modules, which makes it difficult for the EDC system to configure user-end functions. It is also difficult to locate data fields, collect data, perform statistical analysis, and export data, which in turn makes it impossible to collect and analyze certain key data. Summary of the Invention

[0005] To address the aforementioned issues, this application presents an electronic data acquisition system with freely configurable functions. This system moves the configuration of functional plugins to the front end, rather than placing them as underlying logic in the software backend, thereby enabling users to freely configure functional plugins.

[0006] An electronic data acquisition system with freely configurable functions includes a document editing module, a function configuration module, and a function locking module. The document editing module is used to establish a document editing interface and generate a CRF document. The function configuration module is communicatively connected to the document editing module and is used to embed function plugins into the CRF document and to configure electronic data acquisition functions for the CRF document. The function locking module is communicatively connected to the document editing module and is used to lock the CRF document and to perform data acquisition on the CRF document.

[0007] Preferably, the functional plugins include a date plugin, a drop-down menu plugin, and a formula calculation plugin;

[0008] The date plugin includes a clock selection component and a calendar selection component; the clock selection component and the calendar selection component are respectively communicatively connected to the document editing module; the clock selection component is used to insert clock data into the CRF document, and the calendar selection component is used to insert calendar data into the CRF document; through the above design, this application can insert clocks and calendars into CRF documents, and the selected clocks and calendars will directly appear in the final generated CRF document data, making it convenient for doctors or patients to promptly confirm the generation time of the CRF document;

[0009] The drop-down menu plugin includes a checkbox component, which is communicatively connected to the document editing module and is used to insert checkboxes into the CRF document. This allows doctors or patients to directly check one of multiple options in the CRF document, making it clearer and easier for users to read the data.

[0010] The formula calculation plugin includes a formula input component, which is communicatively connected to the document editing module. It is used to insert formulas into CRF documents, facilitating the integration and processing of some data and speeding up the internal processing of CRF documents.

[0011] Preferably, the functional plugin further includes a numbering plugin, which includes a numbering format setting component, a numbering rule setting component, and a numbering reference component;

[0012] The number format setting component, number rule setting component, and number reference component are interconnected and communicate with each other.

[0013] The numbering rule setting component and the numbering format setting component are communicatively connected and used to set numbering rules; the numbering format setting component sets the numbering format according to the numbering rules and generates numbering data.

[0014] The numbering reference component and the document editing module are connected in communication and are used to embed numbering data within the CRF document.

[0015] Preferably, the functional plugin further includes an export settings component, which is used to export data from the CRF document in order to obtain CRF data.

[0016] Preferably, the functional plug-in further includes an execution test component, which is used to perform operational tests on the electronic data acquisition system.

[0017] Preferably, the functional plugin further includes a role setting component, which is communicatively connected to the document editing module and is used to set the ownership attribute of the CRF document.

[0018] Preferably, the function locking module includes a data acquisition component, which is used to locate and lock the CRF document and export the CRF data.

[0019] Preferably, the function locking module further includes a role setting confirmation component, which is communicatively connected to the role setting component and is used to confirm role information.

[0020] The beneficial effects of this invention are:

[0021] This application designs an electronic data acquisition system with freely configurable functions, including a document editing module, a function configuration module, and a function locking module. The document editing module is used to establish a document editing interface and generate a CRF document. The function configuration module is communicatively connected to the document editing module and is used to embed function plugins into the CRF document and configure electronic data acquisition functions for the CRF document. The function locking module is communicatively connected to the document editing module and is used to lock the CRF document and to perform data acquisition from the CRF document. The function plugins include a date plugin, a drop-down menu plugin, a formula calculation plugin, a numbering plugin, an export settings component, an execution test component, and a role settings component. Through this design, users can freely configure the date plugin, drop-down menu plugin, formula calculation plugin, numbering plugin, export settings component, execution test component, and role settings component without requiring programmers to modify them in the background, reducing project configuration time and costs. Attached Figure Description

[0022] Figure 1A structural block diagram of an electronic data acquisition system with freely configurable functions designed for this application; Detailed Implementation

[0023] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0024] Example 1

[0025] This embodiment mainly introduces an electronic data acquisition system with freely configurable functions, including a document editing module, a function configuration module, and a function locking module. The document editing module is used to establish a document editing interface and generate a CRF document. The function configuration module and the document editing module are communicatively connected and are used to embed function plug-ins in the CRF document and to configure electronic data acquisition functions for the CRF document. The function locking module and the document editing module are communicatively connected and are used to lock and execute CRF document data acquisition.

[0026] Furthermore, the functional plugins include a date plugin, a drop-down menu plugin, and a formula calculation plugin;

[0027] The date plugin includes a clock selection component and a calendar selection component; the clock selection component and the calendar selection component are respectively communicatively connected to the document editing module; the clock selection component is used to insert clock data into the CRF document, and the calendar selection component is used to insert calendar data into the CRF document; through the above design, this application can insert clocks and calendars into CRF documents, and the selected clocks and calendars will directly appear in the final generated CRF document data, making it convenient for doctors or patients to promptly confirm the generation time of the CRF document;

[0028] The drop-down menu plugin includes a checkbox component, which is communicatively connected to the document editing module and is used to insert checkboxes into the CRF document. This allows doctors or patients to directly check one of multiple options in the CRF document, making it clearer and easier for users to read the data.

[0029] The formula calculation plugin includes a formula input component, which is communicatively connected to the document editing module. It is used to insert formulas into CRF documents, facilitating the integration and processing of some data and speeding up the internal processing of CRF documents.

[0030] Furthermore, the functional plugin also includes a numbering plugin, which includes a numbering format setting component, a numbering rule setting component, and a numbering reference component;

[0031] The number format setting component, number rule setting component, and number reference component are interconnected and communicate with each other.

[0032] The numbering rule setting component and the numbering format setting component are connected in communication and are used to set numbering rules;

[0033] The number format setting component is used to set the number format and generate number data;

[0034] The numbering reference component and the document editing module are communicatively connected and used to embed numbering data within the CRF document. Through the above design, this application can achieve data numbering within the CRF document.

[0035] Furthermore, the functional plugin also includes an export settings component, which is used to export data from the CRF document and obtain the CRF document.

[0036] Furthermore, the functional plug-in also includes an execution test component, which is used to test the operational capability of the electronic data acquisition system.

[0037] Furthermore, the function locking module includes a data acquisition component, which is used to locate and lock the CRF document, and export the data acquired from the CRF document.

[0038] This application presents a freely configurable electronic data acquisition system, comprising a document editing module, a function configuration module, and a function locking module. The document editing module establishes a document editing interface and generates a CRF document. The function configuration module is communicatively connected to the document editing module and is used to embed function plugins into the CRF document and configure electronic data acquisition functions for the CRF document. The function locking module is also communicatively connected to the document editing module, used to lock the CRF document and to perform data acquisition from the CRF document. Through this design, users can freely configure date plugins, drop-down menu plugins, formula calculation plugins, numbering plugins, export settings components, and execution test components without requiring programmers to modify them in the background, thus reducing project configuration time and costs.

[0039] Example 2

[0040] This embodiment mainly introduces an optimized design of an electronic data acquisition system with freely configurable functions, which includes a document editing module, a function configuration module, and a function locking module. The document editing module is used to establish a document editing interface and generate a CRF document. The function configuration module is communicatively connected to the document editing module and is used to embed function plug-ins in the CRF document and to configure electronic data acquisition functions for the CRF document. The function locking module is communicatively connected to the document editing module and is used to lock the CRF document and to perform data acquisition on the CRF document.

[0041] It includes a document editing module, a function configuration module, and a function locking module; the document editing module is used to establish a document editing interface and generate a CRF document; the function configuration module is communicatively connected to the document editing module and is used to embed function plugins in the CRF document and to configure electronic data acquisition functions for the CRF document; the function locking module is communicatively connected to the document editing module and is used to lock and execute CRF document data acquisition.

[0042] Furthermore, the functional plugins include a date plugin, a drop-down menu plugin, and a formula calculation plugin;

[0043] The date plugin includes a clock selection component and a calendar selection component; the clock selection component and the calendar selection component are respectively communicatively connected to the document editing module; the clock selection component is used to insert clock data into the CRF document, and the calendar selection component is used to insert calendar data into the CRF document; through the above design, this application can insert clocks and calendars into CRF documents, and the selected clocks and calendars will directly appear in the final generated CRF document data, making it convenient for doctors or patients to promptly confirm the generation time of the CRF document;

[0044] The drop-down menu plugin includes a checkbox component, which is communicatively connected to the document editing module and is used to insert checkboxes into the CRF document. This allows doctors or patients to directly check one of multiple options in the CRF document, making it clearer and easier for users to read the data.

[0045] The formula calculation plugin includes a formula input component, which is communicatively connected to the document editing module. It is used to insert formulas into CRF documents, facilitating the integration and processing of some data and speeding up the internal processing of CRF documents.

[0046] Furthermore, the functional plugin also includes a numbering plugin, which includes a numbering format setting component, a numbering rule setting component, and a numbering reference component;

[0047] The number format setting component, number rule setting component, and number reference component are interconnected and communicate with each other.

[0048] The numbering rule setting component and the numbering format setting component are connected in communication and are used to set numbering rules;

[0049] The number format setting component is used to set the number format and generate number data;

[0050] The numbering reference component and the document editing module are communicatively connected and used to embed numbering data within the CRF document. Through the above design, this application can achieve data numbering within the CRF document.

[0051] Furthermore, the functional plugin also includes an export settings component, which is used to export data from the CRF document and obtain the CRF document.

[0052] Furthermore, the functional plug-in also includes an execution test component, which is used to test the operational capability of the electronic data acquisition system.

[0053] Furthermore, the function locking module includes a data acquisition component, which is used to locate and lock the CRF document, and export the data acquired from the CRF document.

[0054] Furthermore, the functional plugin also includes a role setting component, which is communicatively connected to the document editing module and is used to set the ownership attribute of the CRF document.

[0055] Furthermore, the function locking module also includes a role setting confirmation component, which is communicatively connected to the role setting component and is used to confirm role information.

[0056] This application also includes a role verification component to facilitate direct access to patient information. Please refer to [link / reference]. Figure 1This application discloses a freely configurable electronic data acquisition system, comprising a document editing module, a function configuration module, and a function locking module. The document editing module establishes a document editing interface and generates a CRF document. The function configuration module is communicatively connected to the document editing module and is used to embed function plugins into the CRF document and configure electronic data acquisition functions for the CRF document. The function locking module is also communicatively connected to the document editing module, used to lock the CRF document and to perform data acquisition from the CRF document. The function plugins include a date plugin, a drop-down menu plugin, a formula calculation plugin, a numbering plugin, an export settings component, and an execution test component. Through this design, users can freely configure the date plugin, drop-down menu plugin, formula calculation plugin, numbering plugin, export settings component, execution test component, and role settings component without requiring programmers to modify them in the background, reducing project configuration time and costs.

[0057] The above description is merely an example and illustration of the present invention. Those skilled in the art can make various modifications or additions to the specific embodiments described, or use similar methods to replace them, as long as they do not deviate from the invention or exceed the scope defined in the claims, all of which should fall within the protection scope of the present invention.

Claims

1. An electronic data acquisition system with freely configurable functions, characterized in that, It includes a document editing module, a function configuration module, and a function locking module; the document editing module is used to establish a document editing interface and generate a CRF document; the function configuration module is communicatively connected to the document editing module and is used to embed function plugins in the CRF document and to configure electronic data acquisition functions for the CRF document; the function locking module is communicatively connected to the document editing module and is used to lock the CRF document and to perform data acquisition on the CRF document.

2. The electronic data acquisition system with freely configurable functions according to claim 1, characterized in that, The functional plugins include a date plugin, a drop-down menu plugin, and a formula calculation plugin; The date plugin includes a clock selection component and a calendar selection component; the clock selection component and the calendar selection component are respectively connected to the document editing module; the clock selection component is used to insert clock data into the CRF document, and the calendar selection component is used to insert calendar data into the CRF document. The drop-down menu plugin includes a checkbox component, which is communicatively connected to the document editing module and is used to insert checkboxes into the CRF document. The formula calculation plugin includes a formula input component, which is communicatively connected to the document editing module and is used to insert formulas into CRF documents.

3. The electronic data acquisition system with freely configurable functions according to claim 1, characterized in that, The functional plugin also includes a numbering plugin, which includes a numbering format setting component, a numbering rule setting component, and a numbering reference component; The number format setting component, number rule setting component, and number reference component are interconnected and communicate with each other. The numbering rule setting component and the numbering format setting component are communicatively connected and used to set numbering rules; the numbering format setting component sets the numbering format according to the numbering rules and generates numbering data. The numbering reference component and the document editing module are connected in communication and are used to embed numbering data within the CRF document.

4. The electronic data acquisition system with freely configurable functions according to claim 1, characterized in that, The functional plugin also includes an export settings component, which is used to export data from the CRF document in order to obtain CRF data.

5. The electronic data acquisition system with freely configurable functions according to claim 1, characterized in that, The functional plug-in also includes an execution test component, which is used to perform operational tests on the electronic data acquisition system.

6. The electronic data acquisition system with freely configurable functions according to claim 1, characterized in that, The functional plugin also includes a role setting component, which is communicatively connected to the document editing module and is used to set the ownership attribute of CRF documents.

7. The electronic data acquisition system with freely configurable functions according to claim 1, characterized in that, The function locking module includes a data acquisition component, which is used to locate and lock the CRF document and export the CRF data.

8. The electronic data acquisition system with freely configurable functions according to claim 1, characterized in that, The function lock module also includes a role setting confirmation component, which is communicatively connected to the role setting component and is used to confirm role information.

Citation Information

Patent Citations

  • Data entry method based on electronic log in EDC system and its EDC system

    CN113593664B