Research type medical record system for clinical test

Abstract

The invention discloses a research type medical record system for clinical tests. The research type medical record system comprises a medical record data collection end, a data management and storage end, a data verification and quality control end, a data query and retrieval end, a data analysis and statistics end, a safety and privacy protection end and a cooperation and coordination end. The medical record data collection end, the data management and storage end, the data verification and quality control end, the data query and retrieval end, the data analysis and statistics end, the security and privacy protection end and the cooperation and coordination end are in data communication through a private network and a private line network; the medical record data collection end comprises an electronic form entry module, an electronic questionnaire module, a paper medical record scanning module, a data import module, a data collection tool integration module, a data verification and normalization check module and a data quality control module. According to the invention, the efficiency and accuracy of the test can be improved, and the credibility and repeatability of the test result can be improved.

Description

Technical Field

[0001] This invention relates to the field of database security, specifically to a research-based medical record system for clinical trials. Background Technology

[0002] A clinical trial investigational medical record system is a system used to manage and record patient-related data during clinical trials. It aims to provide a centralized platform for managing and tracking trial data to support the design, execution, and analysis of trials.

[0003] Research-based medical record systems are used in clinical trials to analyze and process medical record data, providing data processing support for clinical trial research.

[0004] Existing research medical record systems have a single data processing mode, which affects the efficiency and accuracy of trials and has a certain impact on the use of research medical record systems. Therefore, a research medical record system for clinical trials is proposed. Summary of the Invention

[0005] The technical problem to be solved by this invention is: how to solve the problem that the existing research medical record system has a single data processing mode, which affects the efficiency and accuracy of the experiment and has a certain impact on the use of the research medical record system. The invention provides a research medical record system for clinical trials.

[0006] The present invention solves the above-mentioned technical problems through the following technical solutions: the present invention includes a medical record data collection terminal, a data management and storage terminal, a data verification and quality control terminal, a data query and retrieval terminal, a data analysis and statistics terminal, a security and privacy protection terminal, and a collaboration and coordination terminal;

[0007] The medical record data collection end, data management and storage end, data verification and quality control end, data query and retrieval end, data analysis and statistics end, security and privacy protection end, and collaboration and coordination end communicate with each other via a dedicated network.

[0008] The medical record data collection terminal includes an electronic form entry module, an electronic questionnaire module, a paper medical record scanning module, a data import module, a data collection tool integration module, a data verification and standardization check module, and a data quality control module.

[0009] The data management and storage terminal includes a data storage module, a data classification and archiving module, a data access permission control module, a data backup and recovery module, a data version control module, a data sharing and collaboration module, and a data encryption and security module;

[0010] The data verification and quality control module includes a data verification rule module, a missing data detection module, a logical consistency check module, a data cleaning module, a data review and approval module, a data quality indicator monitoring module, and a data audit and tracking module.

[0011] The data query and retrieval terminal includes a flexible query condition module, an advanced query and filtering module, a custom query template module, a fast search module, a data sorting and arrangement module, a data export and reporting module, and a query history storage module;

[0012] The data analysis and statistics module includes a data visualization module, a descriptive statistical analysis module, a statistical inference analysis module, a data mining and machine learning module, a survival analysis module, an advanced data analysis module, and a report and results export module. The security and privacy protection module includes a data encryption module, an access control module, a data auditing and logging module, an anonymization and de-identification module, a data backup and recovery module, a compliance and regulatory compliance module, and a training and awareness enhancement module.

[0013] The security and privacy protection module includes a data encryption module, an access control module, a data auditing and logging module, an anonymization and de-identification module, a data backup and recovery module, a compliance and regulatory compliance module, and a training and awareness enhancement module.

[0014] The collaboration and coordination module includes a user permission and role management module, a data sharing and collaboration space module, a task assignment and tracking module, a data coordination and consistency check module, a discussion and message function module, a file sharing and version control module, and a meeting and scheduling module.

[0015] Furthermore, the electronic form module is used by the system to provide electronic forms and record the medical record data of the research subjects. The electronic form module includes an electronic form unit and an electronic form database unit for storing electronic form data information.

[0016] The electronic questionnaire module is used to support the creation and distribution of electronic questionnaires and to collect medical record data of research subjects. The electronic questionnaire module includes an electronic questionnaire unit and an electronic questionnaire database unit for storing electronic questionnaire information.

[0017] The paper medical record scanning module is used by the system to provide paper medical record scanning function, allowing researchers to convert paper medical records into electronic form. The paper medical record scanning module includes a paper medical record scanning unit and a paper medical record database unit for storing the scanned paper medical record information.

[0018] The data import module is used by the system to support the import of medical record data from other data sources. The data import module includes a data import unit and a data import database unit for storing data import information.

[0019] The data acquisition tool integration module includes a data acquisition tool integration unit for integrating the system with other data acquisition tools, such as electronic health record systems or laboratory information management systems. This allows researchers to directly extract medical record data from these systems, reducing data entry workload and error rates. The data acquisition tool integration database unit stores data acquisition tool integration information.

[0020] The data verification and standardization check module is used by the system to provide data verification and standardization check functions to ensure the accuracy and consistency of medical record data. The data verification and standardization check database unit is used to store data verification and standardization check information.

[0021] The data quality control module is used to support data quality control measures in the system, such as data cleaning and outlier detection. The data quality control module includes a data quality control unit and a data quality control database unit for storing data quality control information.

[0022] Furthermore, the data storage module is used to provide secure data storage functionality for the system, and the data storage module includes a data storage unit and a data storage database unit for storing data storage information.

[0023] The data classification and archiving module is used by the system to classify and archive medical record data for easy management and retrieval. The data classification and archiving module includes a data classification and archiving unit and a data classification and archiving database unit for storing data classification and archiving information.

[0024] The data access permission control module includes a data access permission control unit, which provides access permission control functions to protect the security and privacy of medical record data. Researchers can set data access permissions according to user roles and permission levels to ensure that only authorized personnel can access and modify medical record data; and a data access permission control database unit, which stores data access permission control information.

[0025] The data backup and recovery module is used to ensure that the system has a data backup and recovery mechanism to prevent data loss or damage. The data backup and recovery module includes a data backup and recovery database unit, which is used to store data backup and recovery information.

[0026] The data version control module is used by the system to provide data version control functions, track and manage different versions of medical record data, and the data version control module includes a data version control unit and a data version control database unit for storing data version control information.

[0027] The data sharing and collaboration module is used by the system to support data sharing and collaboration functions, so that researchers can share and access medical record data. The data sharing and collaboration module includes a data sharing and collaboration unit and a data sharing and collaboration database unit for storing data sharing and collaboration information.

[0028] The data encryption and security module is used to ensure that the system has data encryption and security measures to protect the confidentiality and security of medical record data. The data encryption and security module includes a data encryption and security unit and a data encryption and security database unit for storing data encryption and security information.

[0029] Furthermore, the data verification rule module is used to configure data verification rules for the system to check the legality and consistency of medical record data. The data verification rule module includes a data verification rule unit and a data verification rule database unit for storing data verification rule information.

[0030] The missing data detection module is used to detect and identify missing values ​​in medical record data. The missing data detection module includes a missing data detection unit and a missing data detection database unit for storing missing data detection information.

[0031] The logical consistency check module is used by the system to perform logical consistency checks to verify whether the logical relationship between medical record data meets preset conditions. The logical consistency check module includes a logical consistency check unit and a logical consistency check database unit for storing logical consistency check information.

[0032] The data cleaning module provides data cleaning functionality to process outliers, duplicate data, and inconsistent data in medical record data. The data cleaning module includes a data cleaning unit and a data cleaning database unit for storing data cleaning information.

[0033] The data review and approval module is used by the system to support the data review and approval process, ensuring the accuracy and compliance of medical record data. The data review and approval module includes a data review and approval unit and a data review and approval database unit for storing data review and approval information.

[0034] The data quality indicator monitoring module is used by the system to provide data quality indicator monitoring functions, and to monitor and measure the quality of medical record data in real time. The data quality indicator monitoring module includes a data quality indicator monitoring unit and a data quality indicator monitoring database unit for storing data quality indicator monitoring information.

[0035] The data review and tracking module is used to record the review history and tracking records of data in the system, including operations such as data modification, deletion and approval. The data review and tracking module includes a data review and tracking unit and a data review and tracking database unit for storing data review and tracking information.

[0036] Furthermore, the flexible query condition module is used by the system to provide flexible query condition settings, allowing researchers to set query conditions according to different needs. The flexible query condition module includes a flexible query condition unit and a flexible query condition database unit for storing flexible query condition information.

[0037] The advanced query and filtering module is used by the system to provide advanced query and filtering functions so as to more accurately filter and retrieve medical record data. The advanced query and filtering module includes an advanced query and filtering unit and an advanced query and filtering database unit for storing advanced query and filtering information.

[0038] The custom query template module is used to support the function of custom query templates in the system, allowing researchers to save commonly used query condition combinations as templates; the custom query template module includes a custom query template unit and a custom query template database unit for storing custom query template information;

[0039] The fast search module is used by the system to provide a fast search function, allowing researchers to search for medical record data by keywords or phrases. The fast search module includes a fast search unit and a fast search database unit for storing fast search unit information.

[0040] The data sorting and arrangement module is used by the system to support data sorting and arrangement functions, so that researchers can sort and arrange medical record data according to specific fields or conditions. The data sorting and arrangement module includes a data sorting and arrangement unit and a data sorting and arrangement database unit for storing data sorting and arrangement information.

[0041] The data export and reporting module is used by the system to support exporting query results into files of a preset format. The data export and reporting module includes a data export and reporting unit and a data export and reporting database unit for storing data export and reporting information.

[0042] The query history storage module is used to store historical query records in the system. The query history storage module includes a query history storage unit and a query history storage database unit for storing query history information.

[0043] Furthermore, the data visualization module is used by the system to provide various data visualization functions, and the data visualization module includes a data visualization unit and a data visualization database unit for storing data visualization information;

[0044] The descriptive statistics analysis module is used to support commonly used descriptive statistics analysis methods in the system. The descriptive statistics analysis module includes a descriptive statistics analysis unit and a descriptive statistics analysis database unit for storing descriptive statistics analysis information.

[0045] The statistical inference analysis module is used by the system to provide statistical inference analysis functions, including hypothesis testing, confidence intervals, and analysis of variance. It includes a statistical inference analysis module, a statistical inference analysis unit, and a statistical inference analysis database unit for storing statistical inference analysis information.

[0046] The data mining and machine learning module is used to integrate data mining and machine learning algorithms into the system. The data mining and machine learning module includes a data mining and machine learning database unit, which is used to store data mining and machine learning information.

[0047] The survival analysis module is used for clinical trials or observational studies. The system may support survival analysis functions, including survival curve plotting, hazard ratio calculation, and survival prediction. The survival analysis module includes a survival analysis unit and a survival analysis database unit for storing survival analysis information.

[0048] The advanced data analysis module is used to provide advanced data analysis functions for the system. The advanced data analysis module includes an advanced data analysis unit and an advanced data analysis database unit for storing advanced data analysis information.

[0049] The Export Report and Results module is used by the system to support the export of analysis results into reports or other visualization formats for researchers to present and share. The Export Report and Results module includes an Export Report and Results unit and an Export Report and Results database unit for storing exported report and results information.

[0050] Furthermore, the data encryption module is used by the system to encrypt medical record data using data encryption technology to ensure security during data transmission and storage. The data encryption module includes a data encryption database unit, which is used to store encrypted data information.

[0051] The access control module is used to implement a strict access control mechanism in the system, allowing only authorized personnel to access and process medical record data. The access control module includes an access control unit and an access control database unit for storing access control information.

[0052] The data auditing and logging module is used to record all accesses and operations on medical record data, including viewing, modifying, and deleting, for data auditing and tracking. The data auditing and logging module includes a data auditing and logging unit and a data auditing and logging database unit for storing data auditing and logging information.

[0053] The anonymization and de-identification module is used by the system to provide anonymization and de-identification functions, replacing sensitive data such as patient identity information with anonymous or random codes to protect patient privacy. The anonymization and de-identification module includes an anonymization and de-identification unit and an anonymization and de-identification database unit for storing anonymized and de-identified information.

[0054] The data backup and recovery module is used for the system to perform data backups periodically and ensure the secure storage of backup data. The data backup and recovery module includes a data backup and recovery unit and a data backup and recovery database unit for storing data backup and recovery information.

[0055] The compliance and regulatory compliance module is used to understand whether the system complies with relevant privacy protection regulations and compliance requirements. The compliance and regulatory compliance module includes a compliance and regulatory compliance unit and a compliance and regulatory compliance database unit for storing compliance and regulatory compliance information.

[0056] The training and awareness enhancement module is used to provide training and education resources for the system. The training and awareness enhancement module includes a training and awareness enhancement unit and a training and awareness enhancement database unit for storing training and awareness enhancement information.

[0057] Furthermore, the user permission and role management module is used for the system to support the management of different user roles and permissions. The user permission and role management module includes a user permission and role management unit and a user permission and role management database unit for storing user permission and role management information.

[0058] The data sharing and collaboration space module provides a data sharing and collaboration space for the system. The data sharing and collaboration space module includes data sharing and collaboration space units and a data sharing and collaboration space database unit for storing data sharing and collaboration space information.

[0059] The task allocation and tracking module supports task allocation and tracking functions, and tracks task completion status. The module includes a task allocation and tracking unit and a task allocation and tracking database unit for storing task allocation and tracking information.

[0060] The data coordination and consistency check module provides the system with data coordination and consistency checks to ensure the accuracy and consistency of research-based medical record data. This includes checking for missing, abnormal, and inconsistent data, and providing corresponding data cleaning and correction tools. The data coordination and consistency check module includes a data coordination and consistency check unit and a data coordination and consistency check database unit for storing data coordination and consistency check information.

[0061] The discussion and message function module includes a discussion and message function unit for providing internal discussion and message functions; the discussion and message function module includes a discussion and message function unit and a discussion and message function database unit for storing discussion and message function information;

[0062] The file sharing and version control module is used to support file sharing and version control functions. The file sharing and version control module includes a file sharing and version control unit and a file sharing and version control database unit for storing file sharing and version control information.

[0063] The meeting and scheduling module includes a meeting and scheduling unit for integrating meeting and scheduling functions. The meeting and scheduling module includes a meeting and scheduling unit and a meeting and scheduling database unit for storing meeting and scheduling unit information.

[0064] Compared with the prior art, the present invention has the following advantages: the research medical record system of this clinical trial, through the set medical record data collection terminal, can better collect and organize medical record data, so as to carry out subsequent data management and analysis, reduce the workload and error rate of data entry, and automatically verify and check the data according to the pre-set rules and standards, helping researchers to find potential errors or omissions.

[0065] By setting up data management and storage terminals, data storage should have high reliability and scalability to meet the storage needs of large amounts of medical record data, facilitate management and retrieval, and protect the security and privacy of medical record data, prevent data loss or damage, and protect the confidentiality and security of medical record data.

[0066] By setting up data verification and quality control terminals, data verification is carried out to reduce errors and inconsistencies, ensure data integrity and availability, verify logical relationships, ensure data credibility, and ensure data traceability and transparency.

[0067] The data query and retrieval terminals set up can meet researchers' more refined data needs, and facilitate data traceability and reuse of query conditions, thereby improving the efficiency and accuracy of queries.

[0068] The data analysis and statistical terminals set up help researchers better understand and analyze data, discover potential correlations and patterns, and help researchers understand the distribution and basic statistical characteristics of data and assess the impact of specific treatments or interventions on survival outcomes.

[0069] By setting up security and privacy protection terminals, the security and confidentiality of medical record data can be ensured, potential security risks and data misuse can be detected and prevented, the risk of patient identity exposure can be reduced, and the availability of research data can be protected.

[0070] By setting up collaboration and coordination interfaces, it is possible to ensure that each user accesses and processes relevant medical record data according to their responsibilities and permissions, which helps to improve the quality and efficiency of research and ensures that team members always use the latest version of data files, making the system more worthy of widespread adoption. Attached Figure Description

[0071] Figure 1 This is an overall structural block diagram of the present invention;

[0072] Figure 2 This is a structural block diagram of the medical record data collection terminal of the present invention;

[0073] Figure 3 This is a block diagram of the data management and storage terminal of the present invention;

[0074] Figure 4 This is a block diagram of the data verification and quality control terminal structure of the present invention;

[0075] Figure 5 This is a block diagram of the data query and retrieval terminal structure of the present invention;

[0076] Figure 6 This is a block diagram of the data analysis and statistics terminal structure of the present invention;

[0077] Figure 7 This is a block diagram of the security and privacy protection terminal structure of the present invention;

[0078] Figure 8 This is a block diagram of the collaborative and coordinating end structure of the present invention. Detailed Implementation

[0079] The embodiments of the present invention are described in detail below. These embodiments are implemented based on the technical solution of the present invention, and provide detailed implementation methods and specific operation processes. However, the scope of protection of the present invention is not limited to the following embodiments.

[0080] like Figure 1 As shown, this embodiment provides a technical solution: a research-based medical record system for clinical trials, including a medical record data collection terminal, a data management and storage terminal, a data verification and quality control terminal, a data query and retrieval terminal, a data analysis and statistics terminal, a security and privacy protection terminal, and a collaboration and coordination terminal;

[0081] The medical record data collection end, data management and storage end, data verification and quality control end, data query and retrieval end, data analysis and statistics end, security and privacy protection end, and collaboration and coordination end communicate with each other via a dedicated network.

[0082] Research-based medical record systems allow researchers to manage and analyze trial data more easily, improving the efficiency and accuracy of trials. Simultaneously, the system helps ensure data integrity and consistency, enhancing the reliability and reproducibility of trial results. This is crucial for evaluating the efficacy and safety of new treatments and contributes to further clinical decision-making and treatment guidance.

[0083] like Figure 2 As shown, the medical record data collection terminal includes an electronic entry form module, an electronic questionnaire module, a paper medical record scanning module, a data import module, a data collection tool integration module, a data verification and standardization check module, and a data quality control module.

[0084] The electronic data entry module includes an electronic data entry form unit, which provides electronic forms for recording the medical records of research subjects. Researchers can use the forms to enter data, filling in various fields and options, including personal information, symptom descriptions, medical history, etc.; and an electronic data entry form database unit, which stores the electronic data entry form information.

[0085] The electronic questionnaire module includes an electronic questionnaire unit for supporting the creation and distribution of electronic questionnaires to collect medical record data from research subjects. Researchers can design questionnaires and send them to research subjects for completion. The questionnaire may include multiple questions and options covering various aspects of medical record information; and an electronic questionnaire database unit for storing the electronic questionnaire information.

[0086] The paper medical record scanning module includes a paper medical record scanning unit, which provides the system with paper medical record scanning functionality, allowing researchers to convert paper medical records into electronic form. Researchers can scan paper medical record documents and upload them to the system for subsequent data management and analysis; and a paper medical record database unit, which stores the scanned paper medical record information.

[0087] The data import module includes a data import unit for supporting the import of medical record data from other data sources. Researchers can import existing medical record data into the system in an appropriate format for integration and analysis with other data within the system; and a data import database unit for storing data import information.

[0088] The data acquisition tool integration module includes a data acquisition tool integration unit for integrating the system with other data acquisition tools, such as electronic health record systems or laboratory information management systems. This allows researchers to directly extract medical record data from these systems, reducing data entry workload and error rates. The data acquisition tool integration database unit stores data acquisition tool integration information.

[0089] The data verification and standardization check module includes a data verification and standardization check unit, which provides data verification and standardization check functions to ensure the accuracy and consistency of medical record data. The system may automatically verify and check the data according to pre-set rules and standards to help researchers discover potential errors or omissions; and a data verification and standardization check database unit, which stores data verification and standardization check information.

[0090] The data quality control module includes a data quality control unit, which supports data quality control measures such as data cleaning and outlier detection. Researchers can perform quality control steps on the collected medical record data to ensure the accuracy and integrity of the data; and a data quality control database unit, which stores data quality control information.

[0091] like Figure 3 As shown, the data management and storage terminal includes a data storage module, a data classification and archiving module, a data access permission control module, a data backup and recovery module, a data version control module, a data sharing and collaboration module, and a data encryption and security module.

[0092] The data storage module includes a data storage unit for providing secure data storage functionality to preserve the medical records of research subjects. This can include databases or cloud storage. The data storage should possess high reliability and scalability to meet the storage needs of large amounts of medical record data; and a data storage database unit for storing data storage information.

[0093] The data classification and archiving module includes a data classification and archiving unit, which allows the system to classify and archive medical record data for easier management and retrieval. Researchers can classify data according to research projects, research stages, disease types, etc., and set corresponding archiving strategies to ensure orderly storage and management of data; the data classification and archiving database unit is used to store data classification and archiving information.

[0094] The data access permission control module includes a data access permission control unit, which provides access permission control functions to protect the security and privacy of medical record data. Researchers can set data access permissions according to user roles and permission levels to ensure that only authorized personnel can access and modify medical record data; and a data access permission control database unit, which stores data access permission control information.

[0095] The data backup and recovery module includes a data backup and recovery unit, which ensures the system has a data backup and recovery mechanism to prevent data loss or damage. Regular data backups ensure the security of medical record data and allow for data recovery when needed, guaranteeing data integrity and availability; the data backup and recovery database unit stores data backup and recovery information.

[0096] The data version control module includes a data version control unit, which provides data version control functionality to track and manage different versions of medical record data. This is crucial for long-term research and data change tracking. Researchers can view and compare different versions of data and perform necessary reviews and audits; the data version control database unit stores data version control information.

[0097] The data sharing and collaboration module includes a data sharing and collaboration unit for supporting data sharing and collaboration functions, enabling researchers to share and access medical record data. This helps promote cooperation and information exchange among research teams and improve research efficiency; and a data sharing and collaboration database unit for storing data sharing and collaboration information.

[0098] The data encryption and security module includes a data encryption and security unit, which ensures the system has data encryption and security measures to protect the confidentiality and security of medical record data. This includes encrypting data transmission and storage to ensure that data is not accessed or tampered with by unauthorized personnel during transmission and storage; and a data encryption and security database unit for storing data encryption and security information.

[0099] like Figure 4 As shown, the data verification and quality control terminal includes a data verification rule module, a missing data detection module, a logical consistency check module, a data cleaning module, a data review and approval module, a data quality indicator monitoring module, and a data audit and tracking module.

[0100] The data validation rule module includes a data validation rule unit, used by the system to configure data validation rules to check the legality and consistency of medical record data. These rules can include validation rules for field types, value ranges, logical relationships, etc. When medical record data is entered or imported, the system automatically applies these rules to perform data validation to reduce errors and inconsistencies; the data validation rule database unit is used to store data validation rule information.

[0101] The missing data detection module includes a missing data detection unit for detecting and identifying missing values ​​in medical record data. Missing data detection helps identify integrity issues in medical record data and prompts researchers to supplement missing data to ensure data integrity and usability; and a missing data detection database unit for storing missing data detection information.

[0102] The logical consistency check module includes a logical consistency check unit, used by the system to perform logical consistency checks to verify whether the logical relationships between medical record data meet preset conditions. For example, the system can check the date order and consistency of calculated fields in the medical record data to ensure that the logical relationships of the data are correct; and a logical consistency check database unit, used to store logical consistency check information.

[0103] The data cleaning module includes a data cleaning unit, which provides data cleaning functions to handle outliers, duplicates, and inconsistencies in medical record data. The data cleaning process can be performed through automated algorithms or manual review to ensure data quality and accuracy; and a data cleaning database unit, which stores data cleaning information.

[0104] The data review and approval module includes a data review and approval unit, which supports the data review and approval process to ensure the accuracy and compliance of medical record data. Researchers can review medical record data, verify its correctness, and perform necessary approvals to ensure its credibility and usability; the data review and approval database unit stores data review and approval information.

[0105] The data quality indicator monitoring module includes a data quality indicator monitoring unit, which provides the system with data quality indicator monitoring functions to monitor and measure the quality of medical record data in real time. This can include monitoring indicators such as data integrity rate, data error rate, and data consistency, helping researchers to promptly identify and resolve data quality issues; and a data quality indicator monitoring database unit, which stores data quality indicator monitoring information.

[0106] The data auditing and tracking module includes a data auditing and tracking unit, used to record the auditing history and tracking records of data, including operations such as data modification, deletion, and approval. This helps to trace the history of data changes and ensures data traceability and transparency; and a data auditing and tracking database unit, used to store data auditing and tracking information.

[0107] like Figure 5 As shown, the data query and retrieval terminal includes a flexible query condition module, an advanced query and filtering module, a custom query template module, a fast search module, a data sorting and arrangement module, a data export and reporting module, and a query history storage module.

[0108] The flexible query criteria module includes a flexible query criteria unit, which allows the system to provide flexible query criteria settings, enabling researchers to set query criteria according to different needs. This can include basic patient information (such as name, age, gender), disease diagnosis information, treatment history, etc. Researchers can set query criteria according to specific research objectives to obtain medical record data that meets the requirements; and a flexible query criteria database unit, which is used to store flexible query criteria information.

[0109] The advanced query and filtering module includes an advanced query and filtering unit, which provides advanced query and filtering functions for more precise screening and retrieval of medical record data. This can include the setting of advanced query conditions such as logical operators, date ranges, and numerical ranges to meet researchers' needs for more refined data processing; and an advanced query and filtering database unit, which stores advanced query and filtering information.

[0110] The custom query template module includes a custom query template unit, which supports the function of custom query templates in the system, allowing researchers to save commonly used query condition combinations as templates so that they can directly use the templates when making repeated queries, thereby improving the efficiency and accuracy of queries; and a custom query template database unit, which stores custom query template information.

[0111] The fast search module includes a fast search unit for providing the system with fast search functionality, allowing researchers to search medical record data by keywords or phrases. This is very useful for situations requiring rapid location of specific information, such as searching for a specific disease name or treatment plan; and a fast search database unit for storing information from the fast search unit.

[0112] The data sorting and arrangement module includes a data sorting and arrangement unit for supporting data sorting and arrangement functions, enabling researchers to sort and arrange medical record data according to specific fields or conditions. This facilitates data analysis and comparison based on research needs. A data sorting and arrangement database unit stores data sorting and arrangement information. The data export and reporting module includes a data export and reporting unit for supporting the export of query results to various file formats, such as Excel, CSV, and PDF. This allows researchers to use the query results for further data analysis, statistics, and report compilation. A data export and reporting database unit stores data export and reporting information.

[0113] The query history storage module includes a query history storage unit for storing historical query records, allowing researchers to view previous query records to trace and reuse query conditions and results; and a query history storage database unit for storing query history information.

[0114] like Figure 6 As shown, the data analysis and statistics module includes a data visualization module, a descriptive statistics analysis module, a statistical inference analysis module, a data mining and machine learning module, a survival analysis module, an advanced data analysis module, and a report and results export module.

[0115] The data visualization module includes a data visualization unit, which provides various data visualization functions, including charts, statistical graphs, trend graphs, etc., to intuitively present the characteristics and trends of medical record data. This helps researchers better understand and analyze the data, and discover potential correlations and patterns; and a data visualization database unit, which stores data visualization information.

[0116] The descriptive statistics analysis module includes a descriptive statistics analysis unit, which supports commonly used descriptive statistics analysis methods such as mean, median, standard deviation, and frequency to provide a summary description of medical record data. This helps researchers understand the distribution and basic statistical characteristics of the data. The descriptive statistics analysis database unit stores descriptive statistics analysis information.

[0117] The statistical inference analysis module includes a statistical inference analysis unit, which provides statistical inference analysis functions, including hypothesis testing, confidence intervals, and analysis of variance. This helps researchers perform statistical inference on medical record data, determine whether the observed results are statistically significant, and compare and analyze variables. The statistical inference analysis database unit stores statistical inference analysis information.

[0118] The data mining and machine learning module includes a data mining and machine learning unit for integrating data mining and machine learning algorithms to help researchers discover hidden patterns, trends, and correlations in medical record data. By applying clustering analysis, classification algorithms, and predictive models, it is possible to deeply mine information and knowledge from medical record data. The data mining and machine learning database unit is used to store data mining and machine learning information.

[0119] The survival analysis module includes a survival analysis unit, which, for clinical trials or observational studies, may support survival analysis functions such as survival curve plotting, hazard ratio calculation, and survival prediction. This helps researchers assess the impact of specific treatments or interventions on survival outcomes; and a survival analysis database unit, used to store survival analysis information.

[0120] The advanced data analysis module includes an advanced data analysis unit, which provides advanced data analysis functions such as multiple regression analysis, factor analysis, and path analysis to explore and interpret complex relationships and causal relationships in medical record data; and an advanced data analysis database unit, which stores advanced data analysis information.

[0121] The Export Reports and Results module includes an Export Reports and Results unit, which allows the system to export analysis results as reports or other visualizations for researchers to present and share. Exported reports may include statistical results, charts, summaries, etc., for researchers to further report and interpret. The Export Reports and Results database unit stores the exported reports and results information.

[0122] like Figure 7 As shown, the security and privacy protection module includes a data encryption module, an access control module, a data auditing and logging module, an anonymization and de-identification module, a data backup and recovery module, a compliance and regulatory compliance module, and a training and awareness enhancement module.

[0123] The data encryption module includes a data encryption unit, used by the system to encrypt medical record data using data encryption technology, ensuring security during data transmission and storage. This prevents unauthorized access and theft of sensitive data; and a data encryption database unit, used to store encrypted data information.

[0124] The access control module includes an access control unit, which implements a strict access control mechanism to allow only authorized personnel to access and process medical record data. This can be achieved through user authentication, role-based access control, and other methods to ensure the security and confidentiality of medical record data; and an access control database unit, which stores access control information.

[0125] The data auditing and logging module includes a data auditing and logging unit, used to record all accesses and operations on medical record data, including viewing, modification, and deletion, for data auditing and tracking. This helps to identify and prevent potential security risks and data misuse; the data auditing and logging database unit is used to store data auditing and logging information.

[0126] The anonymization and de-identification module includes an anonymization and de-identification unit, which provides anonymization and de-identification functions to replace sensitive data such as patient identity information with anonymous or randomized codes to protect patient privacy. This reduces the risk of patient identity exposure while protecting the availability of research data; and an anonymization and de-identification database unit, which stores the anonymized and de-identified information.

[0127] The data backup and recovery module includes a data backup and recovery unit for periodically backing up system data and ensuring the secure storage of backup data. This prevents data loss and data corruption due to unforeseen circumstances, while enabling timely data recovery to ensure data integrity and availability; and a data backup and recovery database unit for storing data backup and recovery information.

[0128] The compliance and regulatory compliance module includes a compliance and regulatory compliance unit, which is used to ensure that the system complies with relevant privacy protection regulations and compliance requirements, such as the EU's General Data Protection Regulation (GDPR). This includes measures such as compliance review of data processing and storage processes, risk assessment, and privacy impact assessment; and a compliance and regulatory compliance database unit, which is used to store compliance and regulatory compliance information.

[0129] The training and awareness enhancement module includes a training and awareness enhancement unit for providing training and educational resources to improve users' awareness and understanding of data security and privacy protection. This helps users operate the system correctly, follow security standards, and reduce the risk of data leakage and misuse; and a training and awareness enhancement database unit for storing training and awareness enhancement information.

[0130] like Figure 8 As shown, the collaboration and coordination module includes a user permission and role management module, a data sharing and collaboration space module, a task assignment and tracking module, a data coordination and consistency check module, a discussion and message function module, a file sharing and version control module, and a meeting and scheduling module.

[0131] The user permissions and role management module includes a user permissions and role management unit, which supports the management of different user roles and permissions, such as researchers, clinicians, and data managers. This ensures that each user accesses and processes relevant medical record data according to their responsibilities and permissions; and a user permissions and role management database unit, which stores user permissions and role management information.

[0132] The data sharing and collaboration space module includes a data sharing and collaboration space unit, which provides a space for researchers and clinicians to share and discuss medical records, research results, and project progress. This helps promote teamwork and knowledge exchange, and improve research efficiency and quality. The data sharing and collaboration space database unit stores the data sharing and collaboration space information.

[0133] The task assignment and tracking module includes a task assignment and tracking unit for supporting task assignment and tracking functions, allowing researchers to assign tasks to specific members and track task completion. This helps coordinate team work, ensures each task is completed on time, and reduces communication and coordination barriers; and a task assignment and tracking database unit for storing task assignment and tracking information.

[0134] The data reconciliation and consistency check module includes a data reconciliation and consistency check unit, which provides the system with data reconciliation and consistency check functions to ensure the accuracy and consistency of research medical record data. This includes checking for missing, abnormal, and inconsistent data, and providing corresponding data cleaning and correction tools; and a data reconciliation and consistency check database unit, which stores data reconciliation and consistency check information.

[0135] The discussion and messaging module includes a discussion and messaging function unit, which provides internal discussion and messaging capabilities, allowing team members to engage in real-time discussions and exchanges on medical record data. This facilitates problem-solving, exchange of opinions, and knowledge sharing, contributing to improved research quality and efficiency; and a discussion and messaging function database unit, which stores discussion and messaging information.

[0136] The file sharing and version control module includes a file sharing and version control unit, which supports file sharing and version control functions, allowing team members to share and manage research-related files and documents, such as research plans, data dictionaries, and reports. The version control function tracks the document's modification history, ensuring team members always use the latest version. A file sharing and version control database unit stores file sharing and version control information.

[0137] The meeting and scheduling module includes a meeting and scheduling unit for integrating meeting and scheduling functions into the system, allowing team members to coordinate meeting arrangements, participate in workshops and discussions, and other activities. This helps promote real-time communication and face-to-face collaboration, improving teamwork capabilities; and a meeting and scheduling database unit for storing meeting and scheduling unit information.

[0138] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0139] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0140] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the present invention.

Claims

1. A research-based medical record system for clinical trials, characterized in that, This includes the medical record data collection end, data management and storage end, data verification and quality control end, data query and retrieval end, data analysis and statistics end, security and privacy protection end, and collaboration and coordination end; The medical record data collection end, data management and storage end, data verification and quality control end, data query and retrieval end, data analysis and statistics end, security and privacy protection end, and collaboration and coordination end communicate with each other via a dedicated network. The medical record data collection terminal includes an electronic form entry module, an electronic questionnaire module, a paper medical record scanning module, a data import module, a data collection tool integration module, a data verification and standardization check module, and a data quality control module. The data management and storage terminal includes a data storage module, a data classification and archiving module, a data access permission control module, a data backup and recovery module, a data version control module, a data sharing and collaboration module, and a data encryption and security module; The data verification and quality control module includes a data verification rule module, a missing data detection module, a logical consistency check module, a data cleaning module, a data review and approval module, a data quality indicator monitoring module, and a data audit and tracking module. The data query and retrieval terminal includes a flexible query condition module, an advanced query and filtering module, a custom query template module, a fast search module, a data sorting and arrangement module, a data export and reporting module, and a query history storage module; The data analysis and statistics module includes a data visualization module, a descriptive statistical analysis module, a statistical inference analysis module, a data mining and machine learning module, a survival analysis module, an advanced data analysis module, and a report and results export module. The security and privacy protection module includes a data encryption module, an access control module, a data auditing and logging module, an anonymization and de-identification module, a data backup and recovery module, a compliance and regulatory compliance module, and a training and awareness enhancement module. The security and privacy protection module includes a data encryption module, an access control module, a data auditing and logging module, an anonymization and de-identification module, a data backup and recovery module, a compliance and regulatory compliance module, and a training and awareness enhancement module. The collaboration and coordination module includes a user permission and role management module, a data sharing and collaboration space module, a task assignment and tracking module, a data coordination and consistency check module, a discussion and message function module, a file sharing and version control module, and a meeting and scheduling module.

2. The research-based medical record system for clinical trials according to claim 1, characterized in that: The electronic entry form module is used by the system to provide electronic forms and record medical record data of research subjects. The electronic entry form module includes an electronic entry form unit and an electronic entry form database unit for storing electronic entry form data information. The electronic questionnaire module is used to support the creation and distribution of electronic questionnaires and to collect medical record data of research subjects. The electronic questionnaire module includes an electronic questionnaire unit and an electronic questionnaire database unit for storing electronic questionnaire information. The paper medical record scanning module is used by the system to provide paper medical record scanning function, allowing researchers to convert paper medical records into electronic form. The paper medical record scanning module includes a paper medical record scanning unit and a paper medical record database unit for storing the scanned paper medical record information. The data import module is used by the system to support the import of medical record data from other data sources. The data import module includes a data import unit and a data import database unit for storing data import information. The data acquisition tool integration module includes a data acquisition tool integration unit for integrating the system with other data acquisition tools, and a data acquisition tool integration database unit for storing data acquisition tool integration information. The data verification and standardization check module is used by the system to provide data verification and standardization check functions to ensure the accuracy and consistency of medical record data. The data verification and standardization check database unit is used to store data verification and standardization check information. The data quality control module is used to support data quality control measures in the system. The data quality control module includes a data quality control unit and a data quality control database unit for storing data quality control information.

3. The research-based medical record system for clinical trials according to claim 1, characterized in that: The data storage module is used to provide secure data storage functions for the system. The data storage module includes a data storage unit and a data storage database unit for storing data storage information. The data classification and archiving module is used by the system to classify and archive medical record data for easy management and retrieval. The data classification and archiving module includes a data classification and archiving unit and a data classification and archiving database unit for storing data classification and archiving information. The data access permission control module includes a data access permission control unit for providing access permission control functions to the system. The data access permission control module includes a data access permission control unit and a data access permission control database unit for storing data access permission control information. The data backup and recovery module is used to ensure that the system has a data backup and recovery mechanism to prevent data loss or damage. The data backup and recovery module includes a data backup and recovery database unit, which is used to store data backup and recovery information. The data version control module is used by the system to provide data version control functions, track and manage different versions of medical record data, and the data version control module includes a data version control unit and a data version control database unit for storing data version control information. The data sharing and collaboration module is used by the system to support data sharing and collaboration functions, so that researchers can share and access medical record data. The data sharing and collaboration module includes a data sharing and collaboration unit and a data sharing and collaboration database unit for storing data sharing and collaboration information. The data encryption and security module is used to ensure that the system has data encryption and security measures to protect the confidentiality and security of medical record data. The data encryption and security module includes a data encryption and security unit and a data encryption and security database unit for storing data encryption and security information.

4. The research-based medical record system for clinical trials according to claim 1, characterized in that: The data verification rule module is used to configure data verification rules in the system to check the legality and consistency of medical record data. The data verification rule module includes a data verification rule unit and a data verification rule database unit for storing data verification rule information. The missing data detection module is used to detect and identify missing values ​​in medical record data. The missing data detection module includes a missing data detection unit and a missing data detection database unit for storing missing data detection information. The logical consistency check module is used by the system to perform logical consistency checks to verify whether the logical relationship between medical record data meets preset conditions. The logical consistency check module includes a logical consistency check unit and a logical consistency check database unit for storing logical consistency check information. The data cleaning module is used by the system to provide data cleaning functions, and is used to process outliers, duplicate data and inconsistent data in medical record data; the data cleaning module includes a data cleaning unit and a data cleaning database unit for storing data cleaning information. The data review and approval module is used by the system to support the data review and approval process, ensuring the accuracy and compliance of medical record data. The data review and approval module includes a data review and approval unit and a data review and approval database unit for storing data review and approval information. The data quality indicator monitoring module is used by the system to provide data quality indicator monitoring functions, and to monitor and measure the quality of medical record data in real time. The data quality indicator monitoring module includes a data quality indicator monitoring unit and a data quality indicator monitoring database unit for storing data quality indicator monitoring information. The data review and tracking module is used to record the review history and tracking records of data in the system, including operations such as data modification, deletion and approval. The data review and tracking module includes a data review and tracking unit and a data review and tracking database unit for storing data review and tracking information.

5. The research-based medical record system for clinical trials according to claim 1, characterized in that: The flexible query condition module is used to provide flexible query condition settings for the system, allowing researchers to set query conditions according to different needs. The flexible query condition module includes a flexible query condition unit and a flexible query condition database unit for storing flexible query condition information. The advanced query and filtering module is used by the system to provide advanced query and filtering functions so as to more accurately filter and retrieve medical record data. The advanced query and filtering module includes an advanced query and filtering unit and an advanced query and filtering database unit for storing advanced query and filtering information. The custom query template module is used to support the function of custom query templates in the system, allowing researchers to save commonly used query condition combinations as templates; the custom query template module includes a custom query template unit and a custom query template database unit for storing custom query template information; The fast search module is used by the system to provide a fast search function, allowing researchers to search for medical record data by keywords or phrases. The fast search module includes a fast search unit and a fast search database unit for storing fast search unit information. The data sorting and arrangement module is used by the system to support data sorting and arrangement functions, so that researchers can sort and arrange medical record data according to specific fields or conditions. The data sorting and arrangement module includes a data sorting and arrangement unit and a data sorting and arrangement database unit for storing data sorting and arrangement information. The data export and reporting module is used by the system to support exporting query results into files of a preset format. The data export and reporting module includes a data export and reporting unit and a data export and reporting database unit for storing data export and reporting information. The query history storage module is used to store historical query records in the system. The query history storage module includes a query history storage unit and a query history storage database unit for storing query history information.

6. The research-based medical record system for clinical trials according to claim 1, characterized in that: The data visualization module is used to provide various data visualization functions for the system. The data visualization module includes a data visualization unit and a data visualization database unit for storing data visualization information. The descriptive statistics analysis module is used to support commonly used descriptive statistics analysis methods in the system. The descriptive statistics analysis module includes a descriptive statistics analysis unit and a descriptive statistics analysis database unit for storing descriptive statistics analysis information. The statistical inference analysis module is used by the system to provide statistical inference analysis functions, including hypothesis testing, confidence intervals, and analysis of variance. It includes a statistical inference analysis module, a statistical inference analysis unit, and a statistical inference analysis database unit for storing statistical inference analysis information. The data mining and machine learning module is used to integrate data mining and machine learning algorithms into the system. The data mining and machine learning module includes a data mining and machine learning database unit, which is used to store data mining and machine learning information. The survival analysis module is used for clinical trials or observational studies. The system may support survival analysis functions, including survival curve plotting, hazard ratio calculation, and survival prediction. The survival analysis module includes a survival analysis unit and a survival analysis database unit for storing survival analysis information. The advanced data analysis module is used to provide advanced data analysis functions for the system. The advanced data analysis module includes an advanced data analysis unit and an advanced data analysis database unit for storing advanced data analysis information. The Export Report and Results module is used by the system to support the export of analysis results into reports or other visualization formats for researchers to present and share. The Export Report and Results module includes an Export Report and Results unit and an Export Report and Results database unit for storing exported report and results information.

7. The research-based medical record system for clinical trials according to claim 1, characterized in that: The data encryption module is used by the system to encrypt medical record data using data encryption technology to ensure security during data transmission and storage. The data encryption module includes a data encryption database unit, which is used to store encrypted data information. The access control module is used to implement a strict access control mechanism in the system, allowing only authorized personnel to access and process medical record data. The access control module includes an access control unit and an access control database unit for storing access control information. The data auditing and logging module is used to record all accesses and operations on medical record data, including viewing, modifying, and deleting, for data auditing and tracking. The data auditing and logging module includes a data auditing and logging unit and a data auditing and logging database unit for storing data auditing and logging information. The anonymization and de-identification module is used by the system to provide anonymization and de-identification functions, replacing sensitive data such as patient identity information with anonymous or random codes to protect patient privacy. The anonymization and de-identification module includes an anonymization and de-identification unit and an anonymization and de-identification database unit for storing anonymized and de-identified information. The data backup and recovery module is used for the system to perform data backups periodically and ensure the secure storage of backup data. The data backup and recovery module includes a data backup and recovery unit and a data backup and recovery database unit for storing data backup and recovery information. The compliance and regulatory compliance module is used to understand whether the system complies with relevant privacy protection regulations and compliance requirements. The compliance and regulatory compliance module includes a compliance and regulatory compliance unit and a compliance and regulatory compliance database unit for storing compliance and regulatory compliance information. The training and awareness enhancement module is used to provide training and education resources for the system. The training and awareness enhancement module includes a training and awareness enhancement unit and a training and awareness enhancement database unit for storing training and awareness enhancement information.

8. The research-based medical record system for clinical trials according to claim 1, characterized in that, The user permission and role management module is used to support the management of different user roles and permissions in the system. The user permission and role management module includes a user permission and role management unit and a user permission and role management database unit for storing user permission and role management information. The data sharing and collaboration space module is used to provide data sharing and collaboration space for the system. The data sharing and collaboration space module includes a data sharing and collaboration space unit and a data sharing and collaboration space database unit for storing data sharing and collaboration space information. The task allocation and tracking module is used to support the task allocation and tracking functions and track the completion status of tasks. The task allocation and tracking module includes a task allocation and tracking unit and a task allocation and tracking database unit for storing task allocation and tracking information. The data coordination and consistency check module is used by the system to provide data coordination and consistency check functions to ensure the accuracy and consistency of research medical record data, including checking for missing, abnormal and inconsistent data, and providing corresponding data cleaning and correction tools; the data coordination and consistency check module includes a data coordination and consistency check unit and a data coordination and consistency check database unit for storing data coordination and consistency check information; The discussion and message function module includes a discussion and message function unit for providing internal discussion and message functions; the discussion and message function module includes a discussion and message function unit and a discussion and message function database unit for storing discussion and message function information; The file sharing and version control module is used to support file sharing and version control functions. The file sharing and version control module includes a file sharing and version control unit and a file sharing and version control database unit for storing file sharing and version control information. The meeting and scheduling module includes a meeting and scheduling unit for integrating meeting and scheduling functions. The meeting and scheduling module includes a meeting and scheduling unit and a meeting and scheduling database unit for storing meeting and scheduling unit information.

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