Clinical test item visit process automatic generation system

Abstract

A clinical test item visit process automatic generation system relates to the technical field of clinical test visit and comprises a data input end, a visit plan generation end, a visit process automation end, a visit task and reminding end, a visit process updating end and a visit document generation end. The data input end, the visit plan generation end, the visit process automation end, the visit task and reminding end, the visit process updating end and the visit document generation end are in data communication through a private network and a private line network. The system can improve the efficiency and accuracy of clinical tests, and simplify the planning and management work of the visit process.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of clinical trial visit, and particularly relates to a clinical trial project visit process automatic generation system. BACKGROUND

[0002] Clinical trials are an important part of medical research, aiming to evaluate the safety and effectiveness of new drugs, treatments or medical devices. Such trials usually involve complex design, data collection, data analysis and reporting processes, and need to follow strict regulations and ethical requirements.

[0003] In clinical trials, there are some defects in the traditional clinical trial project visit process, which may affect the efficiency, data quality and subject experience of the trial. The following are some common defects:

[0004] Manual planning and management: In the traditional way, the visit process usually needs to be planned and managed manually. Researchers need to rely on paper or electronic forms to record visit arrangements, tasks and time points, which is prone to omissions and errors.

[0005] Time and resource consumption: Manual planning and management of visit processes require a lot of time and human resources. Researchers need to constantly adjust visit plans, track the progress of subjects and arrange visits.

[0006] Lack of real-time monitoring: In the traditional way, researchers have difficulty monitoring the progress of the visit process in real time. This may lead to problems and delays.

[0007] Difficult to respond to changes: During the trial, there may be changes in the visit process, such as adjustment of visit time or addition of new visit types. In the traditional way, adjusting the visit process may require manual modification of multiple records, which is prone to errors.

[0008] Lack of reminders and warnings: The traditional way is difficult to provide timely reminders and warnings, which may cause researchers to miss visit time points or tasks.

[0009] Therefore, the present application provides a clinical trial project visit process automatic generation system. SUMMARY

[0010] In view of the deficiencies of the prior art, the present application aims to provide a clinical trial project visit process automatic generation system, and the specific scheme is as follows:

[0011] A clinical trial project visit process automatic generation system, comprising a data input end, a visit plan generation end, a visit process automation end, a visit task and reminder end, a visit process update end, and a visit document generation end;

[0012] The data input terminal, visit plan generation terminal, visit process automation terminal, visit task and reminder terminal, visit process update terminal, and visit document generation terminal communicate with each other via a dedicated network.

[0013] Furthermore, the data input terminal includes a research agreement information module, a visit requirement module, a data collection key points module, a standard and process requirement module, and a participant information module;

[0014] The research protocol information module allows users to input basic information about the research protocol; the visit requirements module allows users to input specific requirements and activities for each visit; the data collection points module allows users to input the data items to be collected and the format of the data tables; the specifications and process requirements module allows users to input any specifications and requirements related to the trial visit process; and the participant information module allows users to input basic information about the participants.

[0015] Furthermore, the visit plan generation module includes a visit sequence and scheduling module, a visit content and requirements module, a data collection form and tool module, a visit document and guide module, and an individualized visit plan module;

[0016] The visit sequence and scheduling module is used to automatically determine the sequence and planned date of each visit according to the visit requirements and time intervals defined in the research agreement. The visit content and requirements module is used to automatically list the content required for each visit according to the visit requirements specified in the research agreement and specifications. The data collection form and tool module is used to automatically generate corresponding data collection forms or tools according to the data collection requirements defined in the research agreement. The visit document and guide module is used to generate documents and guides related to each visit. The individualized visit plan module is used to generate individualized visit plans based on the specific information of the participants.

[0017] Furthermore, the automated visit process includes a process triggering and automated startup module, a visit process guidance and instruction module, an automated data collection module, an automated testing and measurement module, and an automated reminder and notification module;

[0018] The process triggering and automated startup module is used to automatically start the corresponding visit process according to the set triggering conditions. The visit process guidance and instruction module is used to provide guidance for the visit process and guide researchers to complete each visit activity. The automated data collection module is used to integrate with data collection tools to automatically collect and record data generated during the visit. The automated testing and measurement module is used to integrate with measurement equipment or instruments to automatically perform tests and measurements related to the visit. The automated reminder and notification module is used to send automatic reminders and notifications to researchers and participants.

[0019] Furthermore, the visit task and reminder terminal includes a visit task management module, a visit task allocation module, a visit reminder and notification module, and a reminder settings and personalization module;

[0020] The visit task management module provides a centralized interface for managing visit tasks, allowing researchers to view and track all visit tasks. The visit task assignment module allows researchers to assign visit tasks to specific researchers or team members. The visit reminder and notification module automatically sends reminders and notifications to the corresponding researchers based on the planned date of the visit task and the set reminder settings. The reminder settings and personalization module allows researchers to set the time and frequency of reminders.

[0021] Furthermore, the visit task and reminder terminal also includes a visit task status tracking module, which is used to provide visit task status tracking function.

[0022] Furthermore, the visit process update terminal includes a visit process editing module, a visit process version control module, a visit process comparison and difference analysis module, and an update notification and communication module;

[0023] The visit process editing module provides an editing interface to allow researchers to modify the visit process. The visit process version control module supports version control of the visit process so that researchers can track the evolution and history of the visit process. The visit process comparison and difference analysis module allows researchers to compare different versions of the visit process. The update notification and communication module automatically sends notifications to relevant researchers to remind them of updates and modifications to the visit process.

[0024] Furthermore, the visit process update terminal also includes a visit process approval and authorization module, which is used to support the approval and authorization process of the visit process.

[0025] Furthermore, the visit document generation terminal includes a document template library module, an automatic document generation module, a data integration and import module, a custom document generation module, and a document version control module;

[0026] The document template library module provides a document template library; the automatic document generation module automatically generates corresponding visit documents and forms based on the definition and regulations of the visit process; the data integration and import module integrates with other clinical trial data management systems or electronic health record systems to obtain necessary data and automatically populate the corresponding visit documents; the custom document generation module allows researchers to customize specific visit documents as needed; and the document version control module performs version control on the generated visit documents to track and manage document evolution and historical records.

[0027] Furthermore, the visit document generation terminal also includes an export and sharing function module, which is used to export the generated visit document into common document formats.

[0028] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0029] (1) The Clinical Trial Project Visit Process Automated Generation System is a system that automates the generation of clinical trial visit processes. It can improve the efficiency and accuracy of clinical trials and simplify the planning and management of visit processes. Through this system, researchers and clinical trial teams can plan and manage visit processes more efficiently, reducing human error and delays, and improving the quality and efficiency of the trial. It can also provide better organization and coordination for clinical trials, facilitating their smooth progress.

[0030] (2) The information involved in the visit is completed through the data input terminal. Then, the problems of manual visit planning and management are solved through the visit plan generation terminal and the visit process automation terminal. The problems of lack of real-time monitoring and difficulty in responding to changes are solved through the visit process automation terminal and the visit process update terminal. The problems of lack of reminders and early warnings are solved through the visit task and reminder terminal. Through the cooperation of each terminal, the problems of time and resource consumption are solved. Attached Figure Description

[0031] Figure 1 This is an architecture diagram of the data input terminal in this invention;

[0032] Figure 2 This is an architecture diagram of the visit plan generation terminal in this invention;

[0033] Figure 3 This is an architecture diagram of the automated visit process terminal in this invention;

[0034] Figure 4 This is an architecture diagram of the visit task and the reminder terminal in this invention;

[0035] Figure 5 This is an architecture diagram of the visit process update terminal in this invention;

[0036] Figure 6 This is an architecture diagram of the document generation end in this invention.

[0037] Figure reference numerals: 1. Data input terminal; 101. Research agreement information module; 101a. Research agreement information unit; 101b. Research agreement information database unit; 102. Visit requirements module; 102a. Visit requirements unit; 102b. Visit requirements database unit; 103. Data collection key points module; 103a. Data collection key points unit; 103b. Data collection key points database unit; 104. Standards and process requirements module; 104a. Standards and process requirements unit; 104b. Standards and process requirements database unit; 105. Participant information module; 105a. Participant information unit; 105b. Participant information database unit; 2. Visit plan generation terminal; 201. Visit sequence and time arrangement The system is divided into three modules: 201a, Visit Order and Scheduling Unit; 201b, Visit Order and Scheduling Database Unit; 202, Visit Content and Requirements Module; 202a, Visit Content and Requirements Unit; 202b, Visit Content and Requirements Database Unit; 203, Data Collection Forms and Tools Module; 203a, Data Collection Forms and Tools Unit; 203b, Data Collection Forms and Tools Database Unit; 204, Visit Documents and Guidelines Module; 204a, Visit Documents and Guidelines Unit; 204b, Visit Documents and Guidelines Database Unit; 205, Individualized Visit Planning Module; 205a, Individualized Visit Planning Unit; 205b, Individualized Visit Planning Database Unit; 3, Automated Visit Process Terminal; 301, Process Triggering and Automated Startup Module; 301a, Process Triggering and Automated Startup Unit; 301b, Process Triggering and Automated Startup Database Unit; 302, Visit Process Guidance and Guidance Module; 302a, Visit Process Guidance and Guidance Unit; 302b, Visit Process Guidance and Guidance Database Unit; 303, Automated Data Collection Module; 303a, Automated Data Collection Unit; 303b, Automated Data Collection Database Unit; 304, Automated Testing and Measurement Module; 304a, Automated Testing and Measurement Unit; 304b, Automated Testing and Measurement Database Unit; 305, Automated Reminder and Notification Module; 305a, Automated Reminder and Notification Unit; 305b, Automated Reminder and Notification Database Unit 4. Visit Task and Reminder Terminal; 401. Visit Task Management Module; 401a. Visit Task Management Unit; 401b. Visit Task Management Database Unit; 402. Visit Task Allocation Module; 402a. Visit Task Allocation Unit; 402b. Visit Task Allocation Database Unit; 403. Visit Reminder and Notification Module; 403a. Visit Reminder and Notification Unit; 403b. Visit Reminder and Notification Database Unit; 404. Reminder Settings and Personalization Module; 404a. Reminder Settings and Personalization Unit; 404b. Reminder Settings and Personalization Module Database Unit; 405. Visit Task Status Tracking Module; 405a. Visit Task Status Tracking Unit; 405b. Visit Task Status Tracking Database Unit;5. Visit Process Update Terminal; 501. Visit Process Editing Module; 501a. Visit Process Editing Unit; 501b. Visit Process Editing Database Unit; 502. Visit Process Version Control Module; 502a. Visit Process Version Control Unit; 502b. Visit Process Version Control Database Unit; 503. Visit Process Comparison and Difference Analysis Module; 503a. Visit Process Comparison and Difference Analysis Unit; 503b. Visit Process Comparison and Difference Analysis Database Unit; 504. Update Notification and Communication Module; 504a. Update Notification and Communication Unit; 504b. Update Notification and Communication Database Unit; 505. Visit Process Approval and Authorization Module; 505a. Visit Process Approval and Authorization Unit; 505b. Visit Process Approval and Authorization Database Unit; 6. Visit Document Generation The module includes: 601. Document Template Library Module; 601a. ​​Document Template Library Unit; 601b. Document Template Library Database Unit; 602. Automatic Document Generation Module; 602a. Automatic Document Generation Unit; 602b. Automatic Document Generation Database Unit; 603. Data Integration and Import Module; 603a. Data Integration and Import Unit; 603b. Data Integration and Import Database Unit; 604. Custom Document Generation Module; 604a. Custom Document Generation Unit; 604b. Custom Document Generation Database Unit; 605. Document Version Control Module; 605a. Document Version Control Unit; 605b. Document Version Control Database Unit; 606. Export and Sharing Function Module; 606a. Export and Sharing Function Unit; 606b. Export and Sharing Function Database Unit. Detailed Implementation

[0038] The present invention will be further described in detail below with reference to the embodiments and accompanying drawings, but the embodiments of the present invention are not limited thereto.

[0039] An automated system for generating clinical trial visit procedures includes a data input terminal 1, a visit plan generation terminal 2, a visit procedure automation terminal 3, a visit task and reminder terminal 4, a visit procedure update terminal 5, and a visit document generation terminal 6.

[0040] Data communication between the data input terminal 1, the visit plan generation terminal 2, the visit process automation terminal 3, the visit task and reminder terminal 4, the visit process update terminal 5, and the visit document generation terminal 6 is conducted via a dedicated network.

[0041] The collaboration between these systems automates tedious tasks, reduces the risk of human error and delays, and improves trial efficiency and data quality. Simultaneously, these endpoints can provide real-time monitoring, early warning, and alerts, making trial management more standardized, efficient, and flexible, thus providing strong support for the successful conduct of clinical trials.

[0042] like Figure 1The data input module 1 includes a research agreement information module 101, a visit requirements module 102, a data collection key points module 103, a standard and process requirements module 104, and a participant information module 105.

[0043] The research agreement information module 101 includes a research agreement information unit 101a, which allows users to input basic information about the research agreement, such as research objectives, research design, number of participants, research center, etc.; and a research agreement information database unit 101b, which stores research agreement information.

[0044] The visit requirement module 102 includes a visit requirement unit 102a, which allows the system to prompt the user to input the specific requirements and activities needed for each visit. This may include the tests to be performed, the samples collected, the visit time interval, etc.; it also includes a visit requirement database unit 102b, which stores visit requirement information.

[0045] The data collection key points module 103 includes a data collection key points unit 103a, which allows users to input the data items to be collected and the format of the data tables. The system may require users to provide detailed information such as the name, type, and unit of the data items; it also includes a data collection key points database unit 103b, which is used to store data collection key points information.

[0046] The specification and process requirements module 104 includes a specification and process requirements unit 104a, which allows the system to meet any specifications and requirements related to the test visit process that the user inputs. This may include the visit sequence, the execution method of specific steps, necessary documents, etc.; it also includes a specification and process requirements database unit 104b, which stores specification and process requirements information.

[0047] The participant information module 105 includes a participant information unit 105a, which allows users to input basic information about participants, such as name, age, and gender. This information can be used to generate personalized visit plans. It also includes a participant information database unit 105b, which stores participant information.

[0048] like Figure 2 The visit plan generation module 2 includes a visit sequence and schedule module 201, a visit content and requirements module 202, a data collection form and tools module 203, a visit document and guide module 204, and an individualized visit plan module 205.

[0049] The visit sequence and scheduling module 201 includes a visit sequence and scheduling unit 201a, which is used by the system to automatically determine the sequence and planned date of each visit based on the visit requirements and time intervals defined in the research agreement. This includes initial visits, follow-up visits, and final visits; it also includes a visit sequence and scheduling database unit 201b, which is used to store visit sequence and scheduling information.

[0050] The visit content and requirements module 202 includes a visit content and requirements unit 202a, which is used by the system to automatically list the content required for each visit according to the visit requirements specified in the research agreement and specifications. The content includes specific activities, tests, sampling, etc. This ensures that the content and process of each visit comply with the regulations. It also includes a visit content and requirements database unit 202b, which is used to store visit content and requirements information.

[0051] The data collection forms and tools module 203 includes a data collection forms and tools unit 203a, which allows the system to automatically generate corresponding data collection forms or tools based on the data collection requirements defined in the research protocol. This includes medical record forms, questionnaires, biosample collection forms, etc.; it also includes a data collection forms and tools database unit 203b, used to store data collection forms and tools information.

[0052] The visit documentation and guidance module 204 includes a visit documentation and guidance unit 204a, which allows the system to generate documents and guidelines related to each visit to help researchers understand and perform the visit process. This may include visit guidelines, visit instructions, data recording forms, etc.; it also includes a visit documentation and guidance database unit 204b, which stores visit documentation and guidance information.

[0053] The personalized visit planning module 205 includes a personalized visit planning unit 205a, which allows the system to generate personalized visit plans based on the participant's specific information (such as age, gender, disease status, etc.). This ensures that each participant's visit plan meets their specific needs; it also includes a personalized visit planning database unit 205b, which stores personalized visit planning information.

[0054] like Figure 3 The automated visit process module 3 includes a process triggering and automated startup module 301, a visit process guidance and instruction module 302, an automated data collection module 303, an automated testing and measurement module 304, and an automated reminder and notification module 305.

[0055] The process triggering and automation startup module 301 includes a process triggering and automation startup unit 301a, which enables the system to automatically start the corresponding visit process according to the set triggering conditions (such as time, event completion, etc.). This ensures that the visit starts at the appropriate time and avoids omissions or delays; it also includes a process triggering and automation startup database unit 301b, which stores process triggering and automation startup information.

[0056] The visit process guidance and instruction module 302 includes a visit process guidance and instruction unit 302a, which provides guidance for the visit process, instructing researchers to complete each visit activity according to the prescribed steps and sequence. This can reduce operational errors and omissions and ensure process consistency; it also includes a visit process guidance and instruction database unit 302b, which stores visit process guidance and instruction information.

[0057] The automated data collection module 303 includes an automated data collection unit 303a, which enables the system to integrate with data collection tools to automatically collect and record data generated during visits. This reduces errors from manual data entry and improves the accuracy and completeness of the data; it also includes an automated data collection database unit 303b for storing automated data collection information.

[0058] The automated test and measurement module 304 includes an automated test and measurement unit 304a, which allows the system to be integrated with measurement equipment or instruments to automatically perform visit-related tests and measurements. This reduces manual operation and measurement errors, and improves data consistency and reliability; it also includes an automated test and measurement database unit 304b for storing automated test and measurement information.

[0059] The automated reminder and notification module 305 includes an automated reminder and notification unit 305a, which allows the system to send automated reminders and notifications to researchers and participants to inform them of upcoming visits and related requirements. This ensures that all relevant parties are prepared at the right time and place and follow the appropriate procedures. It also includes an automated reminder and notification database unit 305b for storing automated reminder and notification information.

[0060] like Figure 4 The visit task and reminder terminal 4 includes a visit task management module 401, a visit task allocation module 402, a visit reminder and notification module 403, a reminder setting and personalization module 404, and a visit task status tracking module 405.

[0061] The visit task management module 401 includes a visit task management unit 401a, which provides a centralized interface for managing visit tasks, allowing researchers to view and track all visit tasks. Each visit task has relevant information, such as visit name, planned date, and participant information. It also includes a visit task management database unit 401b, which stores visit task management information.

[0062] The visit task assignment module 402 includes a visit task assignment unit 402a, which allows researchers to assign visit tasks to specific researchers or team members. This ensures that each visit task has a clearly defined responsible person and reduces the workload of task assignment and coordination; it also includes a visit task assignment database unit 402b, which stores visit task assignment information.

[0063] The visit reminder and notification module 403 includes a visit reminder and notification unit 403a, which allows the system to automatically send reminders and notifications to the relevant researchers based on the planned date of the visit and the set reminder settings. This can include emails, text messages, or internal system notification messages to remind them of the upcoming visit; it also includes a visit reminder and notification database unit 403b, which stores visit reminder and notification information.

[0064] The reminder settings and personalization module 404 includes a reminder settings and personalization unit 404a, which allows researchers to set the timing and frequency of reminders to suit their workflows and needs. They can choose how far in advance to send reminders and decide whether periodic recurring reminders are needed; it also includes a reminder settings and personalization database unit for storing reminder settings and personalization information.

[0065] The visit task status tracking module 405 includes a visit task status tracking unit 405a, which provides the system with visit task status tracking functionality, enabling researchers to understand the progress of each visit task. They can view completed tasks, incomplete tasks, and delayed tasks, along with the corresponding reasons and notes; it also includes a visit task status tracking database unit 405b, which stores visit task status tracking information.

[0066] like Figure 5 The visit process update module 5 includes a visit process editing module 501, a visit process version control module 502, a visit process comparison and difference analysis module 503, an update notification and communication module 504, and a visit process approval and authorization module 505.

[0067] The visit process editing module 501 includes a visit process editing unit 501a, which provides an editing interface for researchers to modify the visit process. They can add, delete, or adjust visit steps to reflect actual research needs or revised protocol requirements; it also includes a visit process editing database unit 501b, which stores visit process editing information.

[0068] The visit process version control module 502 includes a visit process version control unit 502a, which supports version control of the visit process so that researchers can track its evolution and history. Each time the visit process is modified or updated, the system creates a new version and retains the information of the previous version. It also includes a visit process version control database unit 502b, which stores visit process version control information.

[0069] The visit process comparison and difference analysis module 503 includes a visit process comparison and difference analysis unit 503a, which allows researchers to compare different versions of the visit process to understand the differences and changes between each version. This helps to evaluate the evolution and improvement of the visit process and ensures that researchers understand the visit steps of each version; it also includes a visit process comparison and difference analysis database unit 503b, which stores visit process comparison and difference analysis information.

[0070] The update notification and communication module 504 includes an update notification and communication unit 504a, which automatically sends notifications to relevant researchers when the visitation process is updated, reminding them of the updates and modifications. This ensures that every member of the team is informed of the changes in a timely manner and can make corresponding operational adjustments. It also includes an update notification and communication database unit 504b, which stores update notifications and communication information.

[0071] The visit process approval and authorization module 505 includes a visit process approval and authorization unit 505a, which enables the system to support the approval and authorization process for visit processes, ensuring that modifications and updates to the visit process are properly reviewed and approved. This helps maintain the quality and compliance of the visit process; it also includes a visit process approval and authorization database unit 505b, which stores visit process approval and authorization information.

[0072] like Figure 6 The document generation terminal 6 includes a document template library module 601, an automatic document generation module 602, a data integration and import module 603, a custom document generation module 604, a document version control module 605, and an export and sharing function module 606.

[0073] The document template library module 601 includes a document template library unit 601a, which provides the system with a document template library containing common visit documents and forms, such as visit record forms, informed consent forms, and questionnaires. These templates can be customized and configured according to research needs. It also includes a document template library database unit 601b, which stores document template library information.

[0074] The document auto-generation module 602 includes a document auto-generation unit 602a, which enables the system to automatically generate corresponding visit documents and forms based on the definition and regulations of the visit process. According to the requirements of each visit step, the system will populate relevant data fields, subject information, and researcher information; it also includes a document auto-generation database unit 602b, which stores the automatically generated document information.

[0075] The data integration and import module 603 includes a data integration and import unit 603a, which allows the system to integrate with other clinical trial data management systems or electronic health record systems to obtain necessary data and automatically populate the corresponding visit documents. This reduces the workload and error risk of manual data entry; it also includes a data integration and import database unit 603b, which stores data integration and import information.

[0076] The custom document generation module 604 includes a custom document generation unit 604a, which allows researchers to customize specific visit documents as needed. They can select document templates, add or delete fields, and adjust formatting and layout to meet research requirements and protocol requirements; it also includes a custom document generation database unit 604b for storing custom document generation information.

[0077] The document version control module 605 includes a document version control unit 605a, which supports version control of generated access documents to track and manage document evolution and history. Each time a document is generated or updated, the system creates a new version and retains previous version information. It also includes a document version control database unit 605b for storing document version control information.

[0078] The export and sharing module 606 includes an export and sharing function unit 606a, which allows generated visit documents to be exported to common document formats (such as PDF and Word) for sharing with other researchers or regulatory agencies. The system also provides secure file sharing capabilities to ensure document confidentiality and data protection; and includes an export and sharing function database unit 606b for storing export and sharing function information.

[0079] The above description is merely a preferred embodiment of the present invention. The scope of protection of the present invention is not limited to the above embodiments. All technical solutions falling within the scope of the present invention's concept are within the scope of protection of the present invention. It should be noted that for those skilled in the art, any improvements and modifications made without departing from the principles of the present invention should also be considered within the scope of protection of the present invention.

Claims

1. An automated system for generating visit procedures for clinical trial projects, characterized in that, It includes a data input terminal (1), a visit plan generation terminal (2), a visit process automation terminal (3), a visit task and reminder terminal (4), a visit process update terminal (5), and a visit document generation terminal (6); The data input terminal (1), the visit plan generation terminal (2), the visit process automation terminal (3), the visit task and reminder terminal (4), the visit process update terminal (5), and the visit document generation terminal (6) communicate with each other via a dedicated network.

2. The automatic generation system for clinical trial project visit process according to claim 1, characterized in that, The data input terminal (1) includes a research agreement information module (101), a visit requirement module (102), a data collection key points module (103), a standard and process requirement module (104), and a participant information module (105); The research protocol information module (101) is used by the user to input basic information about the research protocol. The visit requirements module (102) is used by the user to input specific requirements and activities required for each visit. The data collection key points module (103) is used by the user to input the data items to be collected and the format of the data tables. The specifications and process requirements module (104) is used by the user to input any specifications and requirements related to the trial visit process. The participant information module (105) is used by the user to input basic information about the participants.

3. The automatic generation system for clinical trial project visit process according to claim 2, characterized in that, The visit plan generation module (2) includes a visit sequence and schedule module (201), a visit content and requirements module (202), a data collection form and tools module (203), a visit document and guide module (204), and an individualized visit plan module (205); The visit sequence and scheduling module (201) is used to automatically determine the sequence and planned date of each visit according to the visit requirements and time intervals defined in the research agreement. The visit content and requirements module (202) is used to automatically list the content required for each visit according to the visit requirements specified in the research agreement and specifications. The data collection form and tool module (203) is used to automatically generate corresponding data collection forms or tools according to the data collection requirements defined in the research agreement. The visit document and guide module (204) is used to generate documents and guides related to each visit. The individualized visit plan module (205) is used to generate an individualized visit plan based on the specific information of the participants.

4. The automatic generation system for clinical trial project visit process according to claim 1, characterized in that, The automated visit process terminal (3) includes a process triggering and automated start module (301), a visit process guidance and guidance module (302), an automated data collection module (303), an automated testing and measurement module (304), and an automated reminder and notification module (305). The process triggering and automation startup module (301) is used to automatically start the corresponding visit process according to the set triggering conditions. The visit process guidance and instruction module (302) is used to provide guidance for the visit process and guide researchers to complete each visit activity. The automated data collection module (303) is used to integrate with data collection tools to automatically collect and record data generated during the visit. The automated testing and measurement module (304) is used to integrate with measurement equipment or instruments to automatically perform tests and measurements related to the visit. The automated reminder and notification module (305) is used to send automatic reminders and notifications to researchers and participants.

5. The automatic generation system for clinical trial project visit process according to claim 1, characterized in that, The visit task and reminder terminal (4) includes a visit task management module (401), a visit task allocation module (402), a visit reminder and notification module (403), and a reminder setting and personalization module (404); The visit task management module (401) provides a centralized interface for managing visit tasks, enabling researchers to view and track all visit tasks. The visit task allocation module (402) allows researchers to assign visit tasks to specific researchers or team members. The visit reminder and notification module (403) automatically sends reminders and notifications to the corresponding researchers based on the planned date of the visit task and the set reminder settings. The reminder settings and personalization module (404) allows researchers to set the reminder time and frequency.

6. The automatic generation system for clinical trial visit procedures according to claim 5, characterized in that, The visit task and reminder terminal (4) also includes a visit task status tracking module (405), which is used to provide visit task status tracking function.

7. The automatic generation system for clinical trial project visit process according to claim 1, characterized in that, The visit process update terminal (5) includes a visit process editing module (501), a visit process version control module (502), a visit process comparison and difference analysis module (503), and an update notification and communication module (504). The visit process editing module (501) provides an editing interface to allow researchers to modify the visit process. The visit process version control module (502) supports version control of the visit process so that researchers can track the evolution and history of the visit process. The visit process comparison and difference analysis module (503) allows researchers to compare different versions of the visit process. The update notification and communication module (504) automatically sends notifications to relevant researchers to remind them of updates and modifications to the visit process.

8. The automatic generation system for clinical trial visit procedures according to claim 7, characterized in that, The visit process update terminal (5) also includes a visit process approval and authorization module (505), which is used to support the approval and authorization process of the visit process.

9. The automatic generation system for clinical trial project visit process according to claim 1, characterized in that, The visit document generation terminal (6) includes a document template library module (601), an automatic document generation module (602), a data integration and import module (603), a custom document generation module (604), and a document version control module (605); The document template library module (601) is used to provide a document template library. The document automatic generation module (602) is used to automatically generate corresponding visit documents and forms based on the definition and regulations of the visit process. The data integration and import module (603) is used to integrate with other clinical trial data management systems or electronic health record systems to obtain necessary data and automatically populate the corresponding visit documents. The custom document generation module (604) is used by researchers to customize specific visit documents as needed. The document version control module (605) is used to perform version control on the generated visit documents in order to track and manage the evolution and history of the documents.

10. The automatic generation system for clinical trial visit procedures according to claim 9, characterized in that, The visit document generation terminal (6) also includes an export and sharing function module (606), which is used to export the generated visit document into a common document format.

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