Clinical test ward system and data management method

Abstract

The invention discloses a clinical test ward system and a data management method, and relates to the technical field of medical information systems.According to the clinical test ward system, through an elaborately-designed modular architecture, the intuition of a user interface and the simplicity and convenience of operation are optimized, the use efficiency of real-time data is greatly improved, and the use efficiency of the real-time data is improved. According to the system, the data processing timeliness and accuracy are ensured, the data analysis process is simplified through the cross-module synergistic effect, the clinical decision process is accelerated, meanwhile, the transparency and compliance of research are ensured, and a new standard is established for data management in the clinical research field. The innovative scheme not only improves the efficiency and quality of clinical tests, but also opens up a broader road for the development of future medical research.

Description

Technical Field

[0001] The present invention relates to the technical field of medical information systems, and in particular to a clinical trial ward system and a data management method. Background Art

[0002] Clinical trials, especially ward studies, are a key step in the development of new drugs, used to evaluate the safety of drugs, determine the maximum tolerated dose and pharmacokinetic characteristics. With the deepening of medical research and the surge in data volume, traditional clinical trial ward systems and data management methods have gradually exposed their limitations and shortcomings. These challenges have become an important driving force for technological innovation.

[0003] In the prior art, clinical trial ward systems are usually composed of multiple independent subsystems, including project management, subject recruitment and monitoring, data collection, safety event reporting, statistical analysis and document management. These systems operate independently and are interconnected through manual interfaces or limited automated processes. For example, project management relies on spreadsheets and customized databases to track research progress, while subject health monitoring may involve a variety of physiological monitoring devices, and the data generated needs to be manually entered into a central database; In terms of data management, traditional methods often use paper CRFs or early electronic data collection systems. Researchers need to fill out CRFs manually and then transcribe and clean the data. This process is not only time-consuming, but also prone to errors. The management of adverse events (AEs) usually relies on manual reporting and classification by the clinical team, which may lead to reporting delays and inconsistencies.

[0004] Although these systems meet the needs of clinical research to a certain extent, they have obvious defects in the real-time, accuracy and efficiency of data use: 1. Data real-time and accuracy issues: Due to data entry delays and manual operation errors, data in clinical trials often cannot reflect the actual situation in a timely manner, affecting the efficiency and safety of the research. In addition, the consistency and integrity of the data are difficult to ensure, which may affect the reliability of the research results; 2. Operational complexity and non-intuitive user interface: The user interface of existing systems is often not user-friendly, and the operation process is complicated, requiring users to receive special training to be proficient in use, which increases the learning cost and reduces the practicality of the system; 3. Complicated data analysis process: Traditional data analysis process usually requires exporting data to statistical software for processing, which is time-consuming and prone to data loss or errors, delaying the research process; 4. Challenges of research transparency and compliance: The lack of an effective electronic document management system has called into question the transparency and compliance of research. Manual document management and AE reporting processes may result in missing or irregular documents, affecting regulatory review. 5. Security and privacy protection: As the amount of data increases, how to ensure data security and the privacy of subjects has become an increasingly serious problem. Existing data encryption and access control measures may not be sufficient to cope with increasingly complex network security threats; Therefore, the prior art urgently needs a technical solution for a clinical trial ward system and data management method. Summary of the invention

[0005] In order to solve the above technical problems, the present invention provides a clinical trial ward system, which includes: a project management module, a subject management module, an AE management module, a CRF configuration module, a file management module, a physiological monitoring equipment integration module, a data encryption and access control module, and a statistical software integration module; The project management module is used to create clinical trial projects; The subject management module is connected to the project management module and is used to input subject information according to the clinical trial project and track and record the trial progress; The AE management module is connected with the project management module and the subject management module, and is used to record, classify, track and report adverse events of the subjects according to the progress of the trial; The CRF configuration module is connected with the project management module and the AE management module, and is used to design and manage the electronic case report form according to the report results; The document management module is connected with the project management module, the AE management module, and the CRF configuration module to provide an electronic repository for the clinical trial project for storing, retrieving, and sharing all project-related documents, including electronic case report forms; The physiological monitoring device integration module is connected to the subject management module and the file management module, and is used to collect and record the subject's physiological data according to the electronic case report form; The data encryption and access control module is connected to the file management module and the physiological monitoring device integration module, and is used to encrypt the collected and recorded physiological data and set access rights; The statistical software integration module is connected with the project management module, the subject management module, the AE management module, the CRF configuration module, the file management module, and the data encryption and access control module, and is used to analyze the data and generate a statistical report based on the analysis results. The data includes clinical trial projects, subject information, adverse events reported by subjects, electronic case report forms, and physiological data.

[0006] Further, the project management module includes: a project planning unit, a task tracking unit, a goal setting unit, a resource allocation unit, and a timeline monitoring unit; The project planning unit is used to create a project and enter project information, the task tracking unit is used to monitor project progress, the goal setting unit is used to set project nodes, the resource allocation unit is used to arrange project resources, and the timeline monitoring unit is used to formulate a project schedule.

[0007] Furthermore, the subject management module includes: a subject information registration unit, a trial progress tracking unit, a resource management unit, and a budget management unit; The subject information registration unit is used to input subject information, the trial progress tracking unit is used to monitor the status of the subject in the trial, the resource management unit is used to allocate trial resources, and the budget management unit is used to manage the trial budget.

[0008] Further, the AE management module includes: an AE reporting unit, an AE classification unit, an AE tracking unit, and an AE reporting unit; The AE reporting unit is used to record adverse events, the AE classification unit is used to classify adverse events, the AE tracking unit is used to monitor the progress of adverse events, and the AE reporting unit is used to generate adverse event reports for subjects.

[0009] Further, the CRF configuration module includes: a CRF design unit, a CRF verification unit, a CRF association unit, and a CRF access control unit; The CRF design unit is used to create and modify the electronic case report form template; The CRF verification unit is used to verify the electronic case report form data in real time through a built-in first formula group, wherein the function of the first formula group returns a Boolean value to indicate whether the data meets a preset verification rule and is valid; The first formula group expression is: ; Among them, V represents the verification function, data represents the input data, and rules represents the preset verification rules. Indicates that the data meets the preset validation rules and is valid. The data does not meet the preset validation rules and is invalid; The CRF association unit is used to bind the electronic case report form to specific subjects and visit cycles; The CRF access control unit is used to set access and editing permissions for the electronic case report form based on user roles and permissions.

[0010] Furthermore, the document management module includes: a document storage unit, a document retrieval unit, a document sharing unit, and a document annotation unit; The document storage unit is used to store project documents, the document retrieval unit is used to search for documents, the document sharing unit is used to share documents, and the document remark unit is used to record document information.

[0011] Furthermore, the physiological monitoring device integrated module includes: a data acquisition unit, a data processing unit, an abnormality detection unit, and a real-time alarm unit; The data acquisition unit is used to acquire physiological data from the physiological monitoring device, the data processing unit is used to process the acquired physiological data, the abnormality detection unit is used to detect abnormalities in the physiological data, and the real-time alarm unit is used to immediately alarm when an abnormality is detected.

[0012] Further, the data encryption and access control module includes: a data encryption unit, an access permission setting unit, and an audit log unit; The data encryption unit uses the second formula group to encrypt and decrypt physiological data, the access permission setting unit is used to set the physiological data access permission, and the audit log unit is used to record the physiological data access history; The second formula group expression is: c, D(k, c) ; Among them, E represents the encryption function, D represents the decryption function, k represents the encryption key, m represents the plaintext data, and c represents the ciphertext data.

[0013] Furthermore, the statistical software integration module includes: a data analysis unit, a model building unit, a report generation unit, a chart display unit, and a data export unit; The data analysis unit is used to receive data from each module, the data including clinical trial projects, subject information, adverse events reported by subjects, electronic case report forms, physiological data, and perform preprocessing; the model construction unit is used to construct a statistical model according to the objectives and research hypotheses of the clinical trial, and analyze the relationship between the preprocessed data through the statistical model; the report generation unit is used to generate a statistical report based on the analysis results, and the statistical report contains statistical indicators, result summaries, hypothesis test results and conclusions; the chart display unit is used to provide graphical tools, including histograms, scatter plots, box plots, survival curves, and generate charts based on statistical reports; the data export unit is used to export the preprocessed data, statistical reports and charts into multiple formats, including CSV format, PDF format, and Excel format.

[0014] Furthermore, the present invention provides a clinical trial ward data management method, comprising the following steps: Step S1, using the project management module to create a clinical trial project; Step S2: Enter the subject information through the subject management module according to the clinical trial project, and track and record the trial progress; Step S3, using the AE management module to record, classify, track and report adverse events of the subjects according to the trial progress; Step S4, designing and managing the electronic case report form according to the report results through the CRF configuration module; Step S5: Use the data encryption and access control module to provide an electronic repository for the clinical trial project, for storing, retrieving and sharing all project-related documents, including electronic case report forms; Step S6, collecting and recording the subject's physiological data according to the electronic case report form through the file management module; Step S7: Encrypt the collected and recorded physiological data through the data encryption and access control module, and set access rights; Step S8: Analyze the data through the statistical software integration module and generate a statistical report based on the analysis results. The data includes clinical trial projects, subject information, adverse events reported by the subjects, electronic case report forms, and physiological data.

[0015] The embodiments of the present invention have the following technical effects: The clinical trial ward system of the present invention provides a clear project overview through the dynamic update function and visual charts in the project management module, allowing users to understand the real-time status of the project at a glance, including task progress, milestone achievement and resource allocation. This intuitive display method greatly reduces the user's learning curve, and the overall situation of the project can be grasped without complicated operations. The batch import function of the subject management module is combined with the manual addition option to ensure the rapid entry of subject information. At the same time, it supports barcode printing, simplifies the management of visit plans, and further improves the convenience of operation; The close cooperation between the physiological monitoring equipment integration module and the data encryption and access control module realizes the automatic collection and encrypted storage of the subject's physiological data. The data acquisition unit is responsible for extracting data from various physiological monitoring devices, the data processing unit performs analysis, and the anomaly detection unit can promptly identify any indicators that deviate from the normal range and trigger the alarm mechanism of the real-time alarm unit. This series of automated processes ensures the real-time availability of data, enables researchers to respond immediately to any emergencies, and improves the timeliness and accuracy of data processing; The introduction of the statistical software integration module provides strong support for the analysis of clinical trial data. It is closely connected with the CRF configuration module, AE management module, etc., automatically processes data from different modules, reduces manual operations, and avoids potential human errors. The instant statistical results and chart functions of the statistical software integration module allow researchers to obtain preliminary analysis results while collecting data, significantly shortening the time cycle from data collection to decision-making, and accelerating the progress of clinical trials; The AE reporting unit, AE classification unit, AE tracking unit and AE reporting unit of the AE management module ensure the timely recording, classification, tracking and reporting of adverse events. The efficient operation of this module, together with the secure electronic repository of the document management module, provides a solid foundation for the transparency and compliance of the research. All relevant documents, including protocols, ethical approvals, investigator manuals and regulatory documents, are properly stored and managed, ensuring the traceability of all activities throughout the clinical trial process and meeting the requirements of regulatory agencies; In summary, the clinical trial ward system of the present invention not only optimizes the intuitiveness of the user interface and the ease of operation through a carefully designed modular architecture, but also greatly improves the efficiency of real-time data use, ensures the timeliness and accuracy of data processing, and simplifies the data analysis process through cross-module synergy, accelerates the process of clinical decision-making, and ensures the transparency and compliance of the research, setting a new standard for data management in the field of clinical research. This innovative solution not only improves the efficiency and quality of clinical trials, but also opens up a broader path for the development of future medical research. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0017] Figure 1 is a framework diagram of a clinical trial ward system provided by an embodiment of the present invention; Figure 2 is a flow chart of a clinical trial ward data management method provided by an embodiment of the present invention; Figure 3 is a structural diagram of a project management module provided by an embodiment of the present invention; Figure 4 is a structural diagram of a subject management module provided in an embodiment of the present invention; Figure 5 is a structural diagram of an AE management module provided in an embodiment of the present invention; Figure 6 is a structural diagram of a CRF configuration module provided in an embodiment of the present invention; Figure 7 is a structural diagram of a file management module provided by an embodiment of the present invention; Figure 8 is a structural diagram of an integrated module of a physiological monitoring device provided by an embodiment of the present invention; Fig. 9 is a structural diagram of a data encryption and access control module provided by an embodiment of the present invention; Fig.10 It is a structural diagram of the statistical software integration module provided by an embodiment of the present invention. DETAILED DESCRIPTION

[0018] In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work belong to the scope of protection of the present invention.

[0019] Embodiment 1: Figure 1 As shown, the present invention provides a clinical trial ward system, which includes: a project management module, a subject management module, an AE management module, a CRF configuration module, a file management module, a physiological monitoring equipment integration module, a data encryption and access control module, and a statistical software integration module.

[0020] The project management module is used to manage, create, plan, execute and monitor clinical trial projects, track tasks, milestones, resource allocation and timelines, and ensure that the project proceeds as planned. The project management module traverses the business process nodes through the project ID, dynamically updates the visual charts of project tasks, milestones and resource allocation, and realizes comprehensive management of project information; Furthermore, the project management module is the central hub of the system, which manages the overall process of clinical trials, including project planning, task allocation, milestone setting and resource scheduling. It has data exchange requirements with the subject management module, AE management module, CRF configuration module, file management module and statistical software integration module. Among them, AE (Adverse Event) stands for adverse events. Among them, the data exchange requirements with the subject management module include: 1. Subject information synchronization: The project management module needs to obtain the latest subject list, basic information and status updates from the subject management module to ensure the correct allocation of tasks and resources; 2. Resource allocation feedback: The project management module will send resource allocation instructions to the subject management module based on the progress of the trial and resource availability, including subject recruitment, grouping, visit plan adjustment, etc.; 3. Budget and expense tracking: The project management module shares budget information and expense records with the subject management module to monitor the project's financial status; The data exchange requirements with the AE management module include: 1. AE event notification: After recording an adverse event, the AE management module needs to immediately notify the project management module to adjust the project plan or resource allocation, and initiate emergency procedures when necessary; 2. AE impact assessment: The project management module needs to obtain detailed information of AE events from the AE management module and assess their impact on project milestones and timelines; The data exchange requirements with the CRF configuration module include: 1. CRF requirements and changes: The project management module proposes the creation or modification requirements of CRF templates to the CRF configuration module according to the changes in the experimental design; 2. Data quality control: The project management module requires the CRF configuration module to provide data validation rules and logic check results to ensure the integrity and accuracy of the data; The data exchange requirements with the file management module include: 1. Document version control: The project management module needs to obtain the latest version information of research plans, ethical approval documents and other important documents to ensure that all participants follow the latest guidance; 2. Compliance check: The project management module conducts compliance checks based on the documents provided by the document management module to ensure that the trial complies with regulations and ethical standards; The data exchange requirements with the statistical software integration module include: 1. Data analysis requirements: The project management module submits data analysis requests to the statistical software integration module, including statistical analysis or report generation of specific data sets; 2. Result feedback: The statistical software integration module will feed back the analysis results and reports to the project management module for project decision-making and reporting.

[0021] The subject management module is connected to the project management module, and is used to enter subject information according to the clinical trial project, and track and record the trial progress, resource allocation and budget management, support batch import or manual addition of subjects, manage AE reporting, visit plans and barcode printing, and ensure the accuracy of subject information and the smooth progress of the trial; Furthermore, the subject management module is used for inputting, managing, tracking and reporting subject information, interacting with the project management module to ensure that subject information is accurately associated with a specific project, receiving real-time physiological data from the physiological monitoring device integration module to monitor the health status of the subject, and providing subject information to the AE management module so as to quickly locate and take action when an adverse event occurs; Among them, the core role of the subject management module in the clinical trial ward system is to ensure the accuracy of subject information and the smooth progress of the trial. It is closely connected with the project management module, working together to achieve effective control of all aspects of the clinical trial; Information about tracked subjects includes: 1. Basic identity information: including the subject’s name, age, gender, contact information, medical history, family medical history and other personal information to ensure that the research team understands the subject’s background; 2. Health status: record the changes in the health status of the subjects before and after the trial, including laboratory test results, vital signs such as blood pressure, heart rate, medication use, etc.; 3. Trial status: Track the subject’s participation status in the clinical trial, such as whether all visits have been completed, whether adverse events have occurred, whether the subject has withdrawn from the study, etc.; 4. Randomization information: record which group the subject was assigned to, such as the control group or the experimental group, and the specific treatment regimen received; 5. Visit schedule: Manage the subject's visit plan, including appointment time, visit type (such as baseline visit, follow-up visit) and visit location; Tracking the progress of the trial includes: 1. Milestones: monitor the achievement of key time points, such as the first enrollment, the last subject completing the trial, data lock date, etc. 2. Task execution: Track the progress of various tasks related to the subjects, such as blood sample collection, questionnaire filling, imaging examination, etc.; 3. Data integrity: Ensure that all subject data are correctly collected, entered and verified to prevent data loss or errors; Regarding resource allocation and budget management, including: 1. Resource scheduling: Rationally arrange the physical space, equipment, personnel and materials required for the experiment to ensure sufficient resource support at each stage; 2. Cost accounting: Calculate the cost of each activity, including labor, materials, and outsourced service costs, based on the experimental design and execution; 3. Budget monitoring: Continuously monitor the difference between actual expenditure and budget, identify overspending risks and take measures to adjust; 4. Financial forecast: Based on the current progress and expected resource consumption, forecast future funding needs to help with financial planning and decision-making; 5. Audit and Reporting: Generate financial reports regularly for review by internal audit and external regulators to ensure financial transparency and compliance; In specific operations: 1. Batch import and manual addition: Subject information can be imported in batches through electronic spreadsheets, or manually entered one by one in the system to meet the needs of clinical trials of different scales; 2. Automated workflow: The system can automatically trigger task assignment, reminders, and report generation, reducing manual intervention and improving efficiency; 3. Integrated barcode technology: Use barcode printing and scanning functions to improve data entry speed and accuracy and avoid human errors; 4. Security and privacy protection: Ensure the secure storage and transmission of subject information in compliance with HIPAA and other data protection regulations.

[0022] The AE management module is connected with the project management module and the subject management module to automatically record, classify, track and report adverse events of the subjects according to the progress of the trial; Furthermore, the AE management module is responsible for recording, classifying, tracking and reporting adverse events, and needs to be synchronized with the subject management module and the project management module to ensure that the events are associated with the correct subjects and projects, and needs to access the documents in the file management module to comply with the reporting procedures; Regarding automated recording of adverse events: 1. Event capture: The system is integrated into the daily activities of clinical trials to automatically capture any data that may indicate adverse events, such as abnormal vital signs, laboratory test results outside the normal range, and changes in symptoms reported by subjects; 2. Intelligent prompts: When the system detects a potential adverse event, it will alert researchers through in-system notifications, requiring further evaluation and confirmation; 3. Standardized entry: Once an adverse event is confirmed, the system provides a structured form to record the details of the event, including event description, severity, assessment of the relationship with the trial drug, event start and end dates, etc.; Regarding classification of adverse events: 1. Predefined categories: The system usually contains a predefined adverse event classification system, such as MedDRA, which helps standardize event description and coding; 2. Intelligent classification: Using natural language processing and machine learning technology, the system can automatically analyze event descriptions and classify them into the correct MedDRA terms, simplifying the classification process; Regarding tracking adverse events: 1. Dynamic update: The system allows researchers to update the status of adverse events at any time, including the development of the event, treatment measures, recovery status, etc., to maintain the real-time and accuracy of event records; 2. Event Progress Report: The system automatically generates a timeline view of adverse events, showing the entire process from the occurrence to the resolution of the event, which is convenient for review and analysis; Regarding reporting adverse events: 1. Automated report generation: The system can automatically create adverse event reports, including event summaries, impact analysis, follow-up action recommendations, etc., simplifying the report writing process; 2. Regulatory reporting: Ensure that all adverse events that need to be reported to regulatory agencies are submitted in a timely and accurate manner and comply with clinical trial regulatory requirements; 3. Internal communication: The system also facilitates the sharing of adverse event information within the research team, ensuring that all relevant personnel are kept up to date with the latest developments; Regarding the specific scope of adverse events: Adverse events in the context of clinical trials are any unexpected medical problems, whether or not related to the trial intervention, including but not limited to: Side effects: any adverse reactions caused by the test drug, such as nausea, dizziness, rash, etc.; Disease exacerbation: aggravation of the subject's original disease; Newly developed disease: any disease that occurs in a subject during the trial; Injury or accident: any physical harm associated with the test process; Death: The death of a subject occurring during or shortly after the trial.

[0023] The CRF configuration module is connected with the project management module and the AE management module, and is used to customize the design and management of the electronic case report form according to the report results, including dynamic generation of the electronic case report form, data verification, logic rule setting, and safe and controllable data management; Further, the CRF configuration module provides the functionality to configure the case report form, ensuring that all necessary data fields and logic checks are correctly set, works closely with the project management module to ensure that the design of the CRF meets the project requirements, and has data flow with the statistical software integration module to support data structuring before data analysis; Regarding the customized design of electronic case report form: 1. Template design: Use the design tools in the CRF configuration module to create CRF templates based on the research plan and objectives. These templates can include various field types, such as text boxes, drop-down menus, check boxes, etc., to accommodate different types of data entry requirements; 2. Layout Adjustment: Through the drag-and-drop function, users can easily adjust the position of fields, ensuring that the layout of the CRF is intuitive and logical, making it easy for data entry personnel to use; 3. Multi-version support: The CRF configuration module supports the creation of multiple versions of CRF to reflect changes in the protocol or data collection requirements that may occur during the research process; About dynamically generating electronic case report forms: 1. Conditional branching logic: Based on pre-set logic rules, the system can dynamically display or hide certain fields or entire sections, presenting only the CRF section related to the subject's specific condition, reducing unnecessary data entry.

[0024] 2. Automated filling: For repetitive or predictable information, the system can automatically fill in known data, such as basic information of the subject or previous laboratory results, to improve efficiency and reduce errors.

[0025] About data validation and logic rule setting: 1. Built-in validation rules: During the data entry stage, the CRF configuration module can set data validation rules, such as value range check, required field check, etc., to provide immediate feedback on errors and ensure data quality; 2. Logical consistency check: The system can perform logical consistency checks across fields or CRFs, such as checking whether the relationship between two related variables is reasonable, helping to identify potential data inconsistencies or errors; About secure and controllable data management: 1. Permission control: The CRF configuration module supports user-level permission management. Only authorized users can access, modify or approve specific CRFs to protect data security. 2. Audit trail: All changes to the CRF will be recorded, including who, when and what changes were made, to ensure data integrity and traceability and meet regulatory requirements; 3. Backup and recovery: Regularly back up CRF data and configurations so that they can be quickly restored in the event of data loss or system failure to ensure research continuity; 4. Compliance monitoring: The system can continuously monitor the use of CRF to ensure that it complies with the norms and standards of clinical research, such as the International Conference on Harmonization-Good Clinical Practice Guidelines.

[0026] The document management module is connected with the project management module, the AE management module, and the CRF configuration module to provide a secure electronic repository for clinical trial projects, for storing, retrieving, and sharing all project-related documents, including electronic case report forms, protocols, ethics approvals, investigator manuals, case report forms, and regulatory documents, which are linked to subjects and visit cycles to ensure orderly management and compliance of documents; Furthermore, the document management module stores all research-related documents, including ethics committee approval, research protocols, investigator manuals, etc., and has direct data communication with the project management module, AE management module, and statistical software integration module to ensure document accessibility and compliance; The physiological monitoring device integration module is connected to the subject management module and the file management module, and is used to automatically collect and record the subject's physiological data according to the electronic case report form, ensuring real-time monitoring of the subject's vital signs and timely discovery of abnormal conditions; Furthermore, the physiological monitoring device integration module integrates a variety of physiological monitoring devices, automatically collects and uploads data to the system, works closely with the data encryption and access control module to ensure the security of data transmission, and directly provides data to the subject management module for monitoring the health status of the subject; Regarding automatic collection and recording of subject physiological data: 1. Equipment integration: Hardware connection: The physiological monitoring equipment integration module needs to be physically or wirelessly connected with various sensors and monitoring equipment, such as heart rate monitors, blood pressure monitors, blood glucose meters, blood oxygen saturation meters, etc., to ensure the stability and real-time nature of data transmission; Software interface: Through API or dedicated communication protocols, a data exchange channel is established between the module and the device, so that the device can automatically upload data to the central database; 2. Data collection: Continuous monitoring: The device continuously collects the subject's vital signs data, such as heart rate, blood pressure, respiratory rate, body temperature, etc.; Event-triggered collection: For certain specific events, such as after exercise and after taking medicine, the system can set event-triggered collection mode to capture physiological changes under specific conditions; 3. Data recording: Real-time storage: All collected data are recorded in the database in real time to form a continuous time series data set; Data structuring: Data is organized and classified according to a predefined format to facilitate subsequent analysis and retrieval.

[0027] The data encryption and access control module is connected to the file management module and the physiological monitoring device integration module, and is used to encrypt the collected and recorded physiological data and set access rights to ensure data security and subject privacy, and prevent unauthorized access and data tampering; Furthermore, the data encryption and access control module is responsible for the security of all data, including data encryption and access permission management, and is closely related to the physiological monitoring equipment integration module, the file management module and other modules involving data transmission and storage; About data encryption: 1. End-to-end encryption: When data is sent from the physiological monitoring device to the server, end-to-end encryption technology is used to ensure that even if the data is intercepted during transmission, it cannot be decrypted and read; 2. Static data encryption: Data stored in the server or database is encrypted using a formula group, and the original data can only be accessed through the corresponding decryption key; 3. Key management: Keys should be stored securely and replaced regularly to reduce the risk of key leakage. Key management and updates should follow strict security policies; About access control: 1. User rights management: Each user account has different access levels and permissions. For example, researchers may only be able to view aggregated data without accessing personally identifiable information; medical staff may need access to complete patient records; 2. Role-based access control: Determine the type and scope of data that a user can access based on their role. This reduces the risk of data leakage caused by excessive authorization; 3. Two-factor authentication: requires users to provide two or more forms of identity verification information, such as a password plus a fingerprint, a one-time verification code, etc., to enhance account security; 4. Activity audit log: Records every data access and modification operation, including access time, user ID and operation performed. This helps track any suspicious activities and conduct investigations when necessary; About preventing data tampering: 1. Data integrity check: Use hash functions to verify data to ensure that the data has not been tampered with during transmission and storage. Any data changes will cause the hash value to change, thereby revealing potential tampering; 2. Version control and backup: Maintain multiple versions of data to ensure that even if data is damaged or deleted, it can be restored from the backup. At the same time, back up data regularly to prevent data loss; 3. Change log: records detailed information of each data change, including data values ​​before and after the change, change time, operator ID, etc., for tracking and auditing; Regarding regulatory compliance and ethical review: 1. Comply with HIPAA, GDPR and other regulations: Ensure that the data processing process complies with international and regional laws and regulations such as the Health Insurance Portability and Accountability Act (HIPAA) and the General Data Protection Regulation (GDPR) to protect the privacy of subjects; 2. Ethics Committee Approval: All data collection and use plans must be approved by the Ethics Committee to ensure that research activities respect the rights and interests of subjects and comply with ethical standards.

[0028] The statistical software integration module is connected with the project management module, the subject management module, the AE management module, the CRF configuration module, the file management module, and the data encryption and access control module, and is used to analyze the data and generate a statistical report based on the analysis results. The data includes clinical trial projects, subject information, adverse events reported by the subjects, electronic case report forms, and physiological data, which simplifies the data analysis process, provides instant statistical results and charts, and realizes efficient analysis and reporting of data; Further, the statistical software integration module integrates external statistical analysis software for data analysis and reporting, obtains data structure from the CRF configuration module, obtains data from the subject management module and the AE management module, and needs to interact with the document management module to obtain necessary study documents and guidelines; On simplifying the data analysis process: 1. Data integration: The statistical software integration module automatically collects data from various modules, including subject information, adverse event records, physiological monitoring data, project progress and resource allocation, etc., to ensure the comprehensiveness and real-time nature of the data; the data is uniformly formatted and standardized to eliminate data silos and facilitate comprehensive analysis; 2. Automated data preprocessing: Built-in data cleaning and preprocessing functions automatically identify and process missing values, outliers, and redundant data to improve data quality; provide data conversion and standardization options to ensure that the data is suitable for subsequent analysis; 3. Analysis templates and workflows: Preset a variety of statistical analysis templates, such as descriptive statistics, hypothesis testing, regression analysis, etc., to simplify the analysis steps and reduce the time of manually setting parameters; support custom workflows, users can create and save their own analysis processes for repeated use; About real-time statistical results and charts: 1. Real-time analysis: The system can process data in real time and provide immediate statistical results without waiting for a long data processing cycle; the results can be viewed immediately to support quick decision-making; 2. Interactive charts and visualization: Automatically generate various charts, such as line charts, bar charts, pie charts, scatter charts, etc., to intuitively display data distribution and trends; charts support interactive operations, users can zoom in, zoom out, filter data, and explore specific data points in depth; 3. Customized report generation: According to user needs, the system automatically generates reports containing statistical results and charts, and supports exporting to multiple formats such as PDF and Excel; report templates can be customized, and users can add titles, notes, references, etc. to create professional-level analysis reports; Efficient analysis and reporting of data: 1. Advanced analysis function: It integrates advanced statistical analysis tools, such as survival analysis, multivariate statistics, time series analysis, etc., which are suitable for complex data sets; 2. Compliance and Audit: All analysis results and reports generated by the system comply with clinical research regulations and are easy for regulatory agencies to review; the operation log of each analysis is recorded to ensure the traceability and transparency of data processing; 3. Security and privacy protection: Work together with the data encryption and access control modules to ensure the security of data and the protection of subject privacy during the analysis process.

[0029] Furthermore, if Figure 3 As shown, the project management module includes: a project planning unit, a task tracking unit, a goal setting unit, a resource allocation unit, and a timeline monitoring unit; The project planning unit is used to create a project and enter project information, the task tracking unit is used to monitor the project progress in real time, the goal setting unit is used to set key project nodes, the resource allocation unit is used to reasonably arrange project resources, and the timeline monitoring unit is used to formulate a project schedule to ensure that the project is executed according to the predetermined timeline.

[0030] Furthermore, if Figure 4 As shown, the subject management module includes: a subject information registration unit, a trial progress tracking unit, a resource management unit, and a budget management unit; The subject information registration unit is used to input the basic information of the subject, the trial progress tracking unit is used to monitor the status of the subject in the trial, the resource management unit is used to allocate trial resources, and the budget management unit is used to manage the trial budget.

[0031] Furthermore, if Figure 5 As shown, the AE management module includes: an AE reporting unit, an AE classification unit, an AE tracking unit, and an AE reporting unit; The AE reporting unit is used to record adverse events, the AE classification unit is used to classify adverse events, the AE tracking unit is used to continuously monitor the progress of adverse events, and the AE reporting unit is used to generate adverse event reports for subjects.

[0032] Furthermore, if Figure 6 As shown, the CRF configuration module includes: a CRF design unit, a CRF verification unit, a CRF association unit, and a CRF access control unit; The CRF design unit is used to create and modify electronic case report form templates, supporting custom question types and content, including but not limited to single choice, multiple choice, numerical input, and date selection; The CRF verification unit is used to verify the electronic case report form data in real time through a built-in first formula group, wherein the function of the first formula group returns a Boolean value to indicate whether the data meets a preset verification rule and is valid; The first formula group expression is: ; Among them, V represents the verification function, data represents the input data, and rules represents the preset verification rules. Indicates that the data meets the preset validation rules and is valid. The data does not meet the preset validation rules and is invalid; The CRF association unit is used to bind the electronic case report form to specific subjects and visit cycles; The CRF access control unit is used to set access and editing permissions for the electronic case report form based on user roles and permissions.

[0033] Furthermore, if Figure 7 As shown, the file management module includes: a document storage unit, a document retrieval unit, a document sharing unit, and a document annotation unit; The document storage unit is used to store project documents, the document retrieval unit is used to search for documents, the document sharing unit is used to share documents, and the document remark unit is used to record document-related information.

[0034] Furthermore, if Figure 8 As shown, the physiological monitoring device integrated module includes: a data acquisition unit, a data processing unit, an abnormality detection unit, and a real-time alarm unit; The data acquisition unit is used to acquire physiological data from the physiological monitoring device, the data processing unit is used to process the acquired physiological data, the abnormality detection unit is used to detect abnormalities in the physiological data, and the real-time alarm unit is used to immediately alarm when an abnormality is detected.

[0035] Furthermore, if Fig. 9 As shown, the data encryption and access control module includes: a data encryption unit, an access permission setting unit, and an audit log unit; The data encryption unit uses the second formula group to encrypt and decrypt physiological data, the access permission setting unit is used to set the physiological data access permission, and the audit log unit is used to record the physiological data access history; The second formula group expression is: c, D(k, c) ; Among them, E represents the encryption function, D represents the decryption function, k represents the encryption key, m represents the plaintext data, and c represents the ciphertext data.

[0036] Furthermore, if Fig.10 As shown, the statistical software integration module includes: a data analysis unit, a model building unit, a report generation unit, a chart display unit, and a data export unit; The data analysis unit is used to receive data from each module and pre-process the received data, such as data cleaning, standardization and conversion, to prepare for subsequent statistical analysis; wherein the data includes clinical trial projects, subject information, adverse events reported by subjects, electronic case report forms, and physiological data; the model construction unit is used to construct appropriate statistical models according to the objectives and research hypotheses of the clinical trial, including descriptive statistics, hypothesis testing, regression analysis, and survival analysis, to explore the relationships and patterns between data; the report generation unit is used to automatically generate detailed statistical reports based on the analysis results, and the statistical reports contain key statistical indicators, result summaries, hypothesis test results and conclusions; the chart display unit is used to provide a series of graphical tools, including histograms, scatter plots, box plots, and survival curves, and generate charts based on statistical reports to help intuitively present data distribution, correlations and trends, so as to facilitate scientific researchers to understand and interpret data; the data export unit is used to export pre-processed data, statistical reports and charts into multiple formats, including CSV format, PDF format, and Excel format, to facilitate further analysis or citation in academic papers.

[0037] Embodiment 2: Figure 2 As shown, the present invention also proposes a clinical trial ward data management method, which implements the clinical trial ward system as described above, including the following steps: Step S1, using the project management module to create a clinical trial project; Step S2: Enter the subject information through the subject management module according to the clinical trial project, and track and record the trial progress; Step S3, using the AE management module to record, classify, track and report adverse events of the subjects according to the trial progress; Step S4, designing and managing the electronic case report form according to the report results through the CRF configuration module, including data verification of the electronic case report form; Step S5: Use the data encryption and access control module to provide an electronic repository for the clinical trial project, for storing, retrieving and sharing all project-related documents, including electronic case report forms; Step S6, collecting and recording the subject's physiological data according to the electronic case report form through the file management module; Step S7: Encrypt the collected and recorded physiological data through the data encryption and access control module, and set access rights; Step S8: Analyze the data through the statistical software integration module and generate a statistical report based on the analysis results. The data includes clinical trial projects, subject information, adverse events reported by the subjects, electronic case report forms, and physiological data.

[0038] This embodiment aims to demonstrate the actual operation process and methods of the clinical trial ward system, as well as the synergy between modules and units, through a specific clinical trial project. The system consists of eight main modules, each of which contains several units, which together serve the efficient management, data security, compliance and data analysis of clinical trials; First, project initiation and planning; First, if Figure 3 As shown, a new clinical trial project is created through the project planning unit of the project management module, and basic information such as the trial name, objectives, estimated sample size, and principal investigator are entered. Next, the task tracking unit is used to set a task list, including subject recruitment, data collection, and adverse event monitoring, while assigning responsibilities to individuals to ensure that each task has a clear person in charge. Secondly, the goal setting unit is used to define key nodes of the project, such as the first enrollment, mid-term evaluation, and final report submission, to monitor whether the project is proceeding as planned. Then, the resource allocation unit will reasonably arrange human, material, and financial resources to ensure that the project has sufficient resource support. Finally, the timeline monitoring unit will develop a detailed project schedule, track the completion of each stage, and ensure that the project is executed according to the scheduled timeline; Secondly, subject management and information registration; Secondly, if Figure 4 As shown, the subject information registration unit in the subject management module is used to enter the basic information of the first batch of subjects participating in the trial according to the clinical trial project, including but not limited to age, gender, medical history and contact information. Next, the trial progress tracking unit begins to track the status changes of each subject in the trial, including drug reactions, adverse events and visit cycles. At the same time, the resource management unit will adjust the subject recruitment strategy and resource allocation in a timely manner according to the progress of the trial to ensure the smooth progress of the trial. Finally, the budget management unit will continue to monitor the expenses related to the subjects, such as transportation subsidies and medical examination fees, to ensure effective control of the budget; Again, adverse event management and classification; Again, if Figure 5 As shown, the AE reporting unit of the AE management module will be activated to record all adverse events reported by subjects according to the progress of the trial, followed by the AE classification unit, which will classify adverse events and determine their severity and relevance to the trial drug. After that, the AE tracking unit will continue to monitor the development of adverse events and record any treatment measures and their effects. Finally, the AE reporting unit will organize adverse event information and generate a formal adverse event report for review by the regulatory agency; Next, the electronic case report form was designed and configured; Then, if Figure 6As shown, the CRF design unit of the CRF configuration module starts working, which is used to design the electronic case report form according to the report results, and supports the customization of various question types, such as single choice, multiple choice and numerical input. Subsequently, the CRF verification unit sets the data verification rules to ensure the correctness and consistency of the input data. Then, the CRF association unit binds the electronic case report form to specific subjects and visit cycles for easy data tracking. Finally, the CRF access control unit restricts access to and editing of the electronic case report form according to the user's role and permissions to maintain data security; Then, the secure storage and management of files; Then, if Figure 7 As shown, the document storage unit of the document management module provides an electronic repository for clinical trial projects, which will store electronic case report forms, project documents such as study plans, ethics approval documents, and regulatory guidelines. The document retrieval unit provides document search functions to ensure rapid location of documents. The document sharing unit allows team members to share documents and promote information exchange. Finally, the document note unit records the modification history and version control of the document to maintain the integrity and compliance of the document; At the same time, automatic monitoring and abnormality detection of physiological data; At the same time, Figure 8 As shown, the data acquisition unit of the physiological monitoring device integrated module automatically acquires data from various physiological monitoring devices according to the electronic case report form. The data processing unit analyzes the collected data, while the anomaly detection unit detects abnormal fluctuations in the data. Once an abnormality is detected, the real-time alarm unit will immediately sound an alarm to ensure that researchers can respond quickly; Furthermore, data security encryption and access control; Furthermore, if Fig. 9 As shown, the data encryption unit of the data encryption and access control module uses an advanced encryption algorithm to encrypt sensitive physiological data to protect the security of physiological data. The access permission setting unit sets the access permission for physiological data, and the audit log unit records the access history of physiological data to ensure the transparency and traceability of the use of physiological data; Finally, data analysis and report generation; Finally, if Fig.10 As shown in the figure, the data analysis unit of the statistical software integration module receives data from various modules, including clinical trial projects, subject information, adverse events reported by subjects, electronic case report forms, and physiological data, and performs data cleaning and standardization to prepare for subsequent analysis. The model building unit builds statistical models based on the purpose of the trial and performs hypothesis testing and regression analysis. The report generation unit automatically generates statistical reports, the chart display unit provides data visualization, and the data export unit supports exporting results into multiple formats to facilitate further analysis and writing of the final report.

[0039] Through the above steps, the clinical trial ward system realizes the full process management from project planning to data analysis, ensuring the real-time, accuracy and security of the data, while improving the efficiency and quality of clinical trials.

[0040] Regarding the synergy and collaborative work between the modules mentioned above, it is worth further elaborating that the modules achieve seamless collaboration through data exchange and information sharing. For example, the project management module shares subject status and resource information with the subject management module to adjust the trial plan; the AE management module synchronizes adverse event reports with the document management module to ensure the integrity and compliance of the documents; the statistical software integration module integrates data from the CRF configuration module, AE management module, etc., conducts comprehensive analysis, and generates reports.

[0041] It should be noted that the terms used in the present invention are only for describing specific embodiments, rather than limiting the scope of the present application. As shown in the present specification, unless the context clearly indicates an exception, the words "one", "a", "a kind of" and / or "the" do not specifically refer to the singular, but may also include the plural. The terms "include", "comprise" or any other variant thereof are intended to cover non-exclusive inclusion, so that the process, method or device including a series of elements includes not only those elements, but also includes other elements not explicitly listed, or also includes elements inherent to such process, method or device. In the absence of more restrictions, the elements defined by the sentence "include one..." do not exclude the presence of other identical elements in the process, method or device including the elements.

[0042] It should also be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention. Unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", etc. should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be an indirect connection through an intermediate medium, or it can be a connection between the two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0043] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the technical solutions of the embodiments of the present invention.

Claims

1. Clinical trial ward system, characterized by, The system includes: a project management module, a subject management module, an AE management module, a CRF configuration module, a file management module, a physiological monitoring equipment integration module, a data encryption and access control module, and a statistical software integration module; The project management module is used to manage clinical trial projects; The subject management module is connected to the project management module and is used to input subject information according to the clinical trial project and track and record the trial progress; The AE management module is connected with the project management module and the subject management module, and is used to record, classify, track and report adverse events of the subjects according to the progress of the trial; The CRF configuration module is connected with the project management module and the AE management module, and is used to design and manage the electronic case report form according to the report results; The document management module is connected with the project management module, the AE management module, and the CRF configuration module to provide an electronic repository for the clinical trial project for storing, retrieving, and sharing all project-related documents, including electronic case report forms; The physiological monitoring device integration module is connected to the subject management module and the file management module, and is used to collect and record the subject's physiological data according to the electronic case report form; The data encryption and access control module is connected to the file management module and the physiological monitoring device integration module, and is used to encrypt the collected and recorded physiological data and set access rights; The statistical software integration module is connected with the project management module, the subject management module, the AE management module, the CRF configuration module, the file management module, and the data encryption and access control module, and is used to analyze the data and generate a statistical report based on the analysis results. The data includes clinical trial projects, subject information, adverse events reported by subjects, electronic case report forms, and physiological data.

2. The clinical trial ward system according to claim 1, characterized in that: The project management module includes: a project planning unit, a task tracking unit, a goal setting unit, a resource allocation unit, and a timeline monitoring unit; The project planning unit is used to create a project and enter project information, the task tracking unit is used to monitor project progress, the goal setting unit is used to set project nodes, the resource allocation unit is used to arrange project resources, and the timeline monitoring unit is used to formulate a project schedule.

3. The clinical trial ward system according to claim 1, characterized in that: The subject management module includes: a subject information registration unit, a trial progress tracking unit, a resource management unit, and a budget management unit; The subject information registration unit is used to input subject information, the trial progress tracking unit is used to monitor the status of the subject in the trial, the resource management unit is used to allocate trial resources, and the budget management unit is used to manage the trial budget.

4. The clinical trial ward system according to claim 1, characterized in that: The AE management module includes: an AE reporting unit, an AE classification unit, an AE tracking unit, and an AE reporting unit; The AE reporting unit is used to record adverse events, the AE classification unit is used to classify adverse events, the AE tracking unit is used to monitor the progress of adverse events, and the AE reporting unit is used to generate adverse event reports for subjects.

5. The clinical trial ward system according to claim 1, characterized in that: The CRF configuration module includes: a CRF design unit, a CRF verification unit, a CRF association unit, and a CRF access control unit; The CRF design unit is used to create and modify the electronic case report form template; The CRF verification unit is used to verify the electronic case report form data in real time through a built-in first formula group, wherein the function of the first formula group returns a Boolean value to indicate whether the data meets a preset verification rule and is valid; The first formula group expression is: ； Among them, V represents the verification function, data represents the input data, and rules represents the preset verification rules. Indicates that the data meets the preset validation rules and is valid. The data does not meet the preset validation rules and is invalid; The CRF association unit is used to bind the electronic case report form to specific subjects and visit cycles; The CRF access control unit is used to set access and editing permissions for the electronic case report form based on user roles and permissions.

6. The clinical trial ward system according to claim 1, characterized in that: The document management module includes: a document storage unit, a document retrieval unit, a document sharing unit, and a document annotation unit; The document storage unit is used to store project documents, the document retrieval unit is used to search for documents, the document sharing unit is used to share documents, and the document remark unit is used to record document information.

7. The clinical trial ward system according to claim 1, characterized in that: The physiological monitoring equipment integrated module includes: a data acquisition unit, a data processing unit, an abnormality detection unit, and a real-time alarm unit; The data acquisition unit is used to acquire physiological data from the physiological monitoring device, the data processing unit is used to process the acquired physiological data, the abnormality detection unit is used to detect abnormalities in the physiological data, and the real-time alarm unit is used to immediately alarm when an abnormality is detected.

8. The clinical trial ward system according to claim 1, characterized in that: The data encryption and access control module includes: a data encryption unit, an access permission setting unit, and an audit log unit; The data encryption unit uses the second formula group to encrypt and decrypt physiological data, the access permission setting unit is used to set the physiological data access permission, and the audit log unit is used to record the physiological data access history; The second formula group expression is: c,D(k,c) ; Among them, E represents the encryption function, D represents the decryption function, k represents the encryption key, m represents the plaintext data, and c represents the ciphertext data.

9. The clinical trial ward system according to claim 1, characterized in that: The statistical software integration module includes: a data analysis unit, a model building unit, a report generation unit, a chart display unit, and a data export unit; The data analysis unit is used to receive data from each module and pre-process the received data; the data includes clinical trial projects, subject information, adverse events reported by subjects, electronic case report forms, and physiological data; The model building unit is used to build a statistical model according to the objectives and research hypotheses of the clinical trial, and analyze the relationship between the pre-processed data through the statistical model; The generating unit is used to generate a statistical report according to the analysis results, wherein the statistical report includes statistical indicators, result summary, hypothesis test results and conclusions; The chart display unit is used to provide graphical tools, including histograms, scatter plots, box plots, survival curves, and generate charts based on statistical reports; The data export unit is used to export pre-processed data, statistical reports and charts into multiple formats, including CSV format, PDF format and Excel format.

10. A clinical trial ward data management method, characterized in that: The following steps are involved: Step S1, using the project management module to create a clinical trial project; Step S2: Enter the subject information through the subject management module according to the clinical trial project, and track and record the trial progress; Step S3, using the AE management module to record, classify, track and report adverse events of the subjects according to the trial progress; Step S4, designing and managing the electronic case report form according to the report results through the CRF configuration module; Step S5: Use the data encryption and access control module to provide an electronic repository for the clinical trial project, for storing, retrieving and sharing all project-related documents, including electronic case report forms; Step S6, collecting and recording the subject's physiological data according to the electronic case report form through the file management module; Step S7: Encrypt the collected and recorded physiological data through the data encryption and access control module, and set access rights; Step S8: Analyze the data through the statistical software integration module and generate a statistical report based on the analysis results. The data includes clinical trial projects, subject information, adverse events reported by the subjects, electronic case report forms, and physiological data.

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