Clinical test research type medical record quality control system

Abstract

The invention provides a clinical trial research type medical record quality control system, and relates to the technical field of drug clinical trials. Comprising a data collection and input end, a data verification and verification end, a data integration and standardization end, a data quality control end, a data query and report end, a data access and authority control end, a data auditing and tracking end and a data quality monitoring and feedback end. The data collection and input end, the data verification and verification end, the data integration and standardization end, the data quality control end, the data query and report end, the data access and authority control end, the data auditing and tracking end and the data quality monitoring and feedback end are in data communication through a private network and a private line network. Through the clinical test research type medical record quality control system, researchers and clinical workers can manage clinical test medical record data more conveniently and reliably, the accuracy and consistency of the data are ensured, and the quality and credibility of clinical tests are improved.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical clinical trials, and particularly to a quality control system for clinical trial research medical records. Background Art

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

[0003] In clinical trials, the meaning of medical record management has broad and narrow senses. Narrow medical record management refers to the management of the physical properties of medical records, that is, the work procedures such as the recovery, sorting, binding, numbering, providing and storage of medical record materials. Broad medical record management not only mechanically manages the physical properties of medical records, but also conducts health information management on medical records, that is, deeply processes the content of medical record records, extracts valuable information from medical record materials, and conducts scientific management, such as establishing a relatively complete indexing system, classifying and processing relevant materials in medical records, analyzing and statistics, monitoring the quality of collected materials, and providing high-quality health information services to medical staff, hospital administrators and other information users.

[0004] In traditional clinical trials, there are some defects in the quality control of research medical records, which may affect the accuracy, integrity and reliability of trial data. The following are some common defects:

[0005] Manual data entry: In the traditional way, researchers may need to manually enter trial data, which is easy to introduce data entry errors and affect the accuracy of data.

[0006] Omissions and errors: Due to manual operations, data omissions and errors are likely to occur, thus affecting the integrity and accuracy of trial data.

[0007] Difficult to trace: In the traditional way, it is difficult to accurately trace the modification, deletion and change history of data, which may affect the credibility and transparency of data.

[0008] Lack of real-time monitoring: It is difficult to monitor data quality problems in real time in the traditional way, and bad data may not be detected and processed in time.

[0009] Difficult data integration: Trial data is usually scattered in multiple sources and formats, and it is difficult and error-prone to manually integrate data.

[0010] Difficult to ensure data security: In the traditional way, it may be necessary to rely on paper documents, which poses risks to data security and confidentiality.

[0011] Lack of real-time reporting: In the traditional method, the lack of real-time reporting and feedback mechanisms results in problems not being discovered and resolved in a timely manner.

[0012] Generally speaking, there are multiple problems in the quality control of research medical records in traditional clinical trials, which may lead to inaccuracy, incompleteness, and reliability issues of trial data. Therefore, there is room for improvement. The present invention provides a quality control system for research medical records in clinical trials. Summary of the Invention

[0013] Aiming at the deficiencies of the existing technology, the object of the present invention is to propose a quality control system for research medical records in clinical trials, and the specific solution is as follows:

[0014] A quality control system for research medical records in clinical trials includes a data collection and input end, a data verification and validation end, a data integration and standardization end, a data quality control end, a data query and reporting end, a data access and permission control end, a data audit and tracking end, and a data quality monitoring and feedback end;

[0015] Data communication between the data collection and input end, the data verification and validation end, the data integration and standardization end, the data quality control end, the data query and reporting end, the data access and permission control end, the data audit and tracking end, and the data quality monitoring and feedback end is carried out through a private network dedicated line.

[0016] Further, the data collection and input end includes a data collection form design module, a data input interface module, a data verification and validation module, a data import and export module, a data verification rule and business logic module, and a data review and validation module;

[0017] The data collection form design module is used to provide interfaces and tools for designing data collection forms. The data input interface module is used to provide a data input interface for researchers to input clinical trial data. The data verification and validation module is used to perform data verification and validation to ensure the accuracy and integrity of the input data. The data import and export module is used to support the batch import and export functions of data, so as to import data and export the data into common data formats. The data verification rule and business logic module is used to define data verification rules and business logics to ensure that the input data meets the requirements and standards of clinical trials. The data review and validation module is used to provide the functions of data review and validation to ensure the accuracy of the input data.

[0018] Further, the data verification and validation end includes a format verification module, a range verification module, a logical relationship verification module, a mandatory field verification module, a data consistency verification module, and a logical rule verification module;

[0019] The format verification module is used to check whether the format of the data conforms to the specified format requirements. The range verification module is used to verify whether the data is within the specified range. The logical relationship verification module is used to check whether the logical relationship between the data is reasonable. The required field verification module is used to check whether there are required fields not filled. The data consistency verification module is used to check the consistency between the data. The logical rule verification module is used to define and apply custom logical rules to verify the legality and consistency of the data.

[0020] Further, the data integration and standardization end includes a data integration module, a data cleaning and transformation module, a data standardization module, a terminology mapping module, and a data quality assessment module;

[0021] The data integration module is used to obtain clinical record data from different data sources and integrate it into a centralized database. The data cleaning and transformation module is used to clean and transform the collected clinical record data. The data standardization module is used to convert the clinical record data into a unified standard format and coding. The terminology mapping module is used to perform terminology mapping for the system, mapping the terms and coding in different data sources to a unified standard terminology system. The data quality assessment module is used to perform quality assessment on the integrated and standardized data, checking the integrity, consistency, and accuracy of the data.

[0022] Further, the data quality control end includes a data verification and validation module, a data consistency check module, a missing data handling module, a data normalization module, and a data quality reporting module;

[0023] The data verification and validation module is used to verify and validate the collected clinical record data. The data consistency check module is used to check the consistency of the clinical record data in different data sources. The missing data handling module is used to detect and handle the missing values in the clinical record data. The data normalization module is used to perform normalization processing on the clinical record data, unifying the format and unit of the data. The data quality reporting module is used to generate a data quality report, summarizing and presenting the quality indicators and statistical information of the data.

[0024] Further, the data quality control end further includes a data review and audit module, and the data review and audit module is used to provide data review and audit functions, tracking the modification and change records of the data.

[0025] Further, the data query and reporting end includes a data query module, a custom report module, a data export module, a data visualization module, and a data statistics and summary module;

[0026] The data query module is used to provide a flexible data query function, allowing users to retrieve data according to various conditions and parameters. The custom report module is used to allow users to create custom reports according to their needs. The data export module is used to allow the query results or report data to be exported into common data formats. The data visualization module is used to provide a data visualization function, displaying clinical record data in the form of charts, graphs, etc. The data statistics and summary module is used to be able to perform statistics and summaries on clinical record data, generating various statistical indicators and summary information.

[0027] Further, the data access and permission control end includes a user authentication module, a role and permission management module, a data access control module, a data encryption and secure transmission module, and an audit log module;

[0028] The user authentication module is used to require users to authenticate their identities. The role and permission management module is used to manage data access permissions by defining different user roles and permission levels. The data access control module is used to restrict users' access permissions to specific data. The data encryption and secure transmission module is used to adopt data encryption technology to ensure that data will be encrypted during the data transmission process. The audit log module is used to record users' operations and data access records in the system and generate audit logs.

[0029] Further, the data audit and trace end includes an audit log recording module, an audit data trace module, an anomaly detection and alert module, and a data traceability module;

[0030] The audit log recording module is used to automatically record users' operations and data access records and record them in the audit log. The audit data trace module is used to be able to trace and record the change history of data. The anomaly detection and alert module is used to detect abnormal data access and operation behaviors and generate corresponding alerts. The data traceability module is used to trace the source and change history of data.

[0031] Further, the data quality monitoring and feedback end includes a data quality indicator monitoring module, a data quality anomaly detection module, a data quality feedback and correction module, and a data quality report and visualization module;

[0032] The data quality indicator monitoring module is used to define and monitor various data quality indicators. The data quality anomaly detection module is used to be able to automatically detect abnormal data quality situations. The data quality feedback and correction module is used to provide data quality feedback to users and guide users to take appropriate correction measures. The data quality report and visualization module is used to be able to generate data quality reports and visualization charts.

[0033] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0034] (1) The clinical trial research medical record quality control system is a system used to manage and control the quality of clinical trial medical records, ensuring the accuracy, integrity, and consistency of research medical records, as well as standardizing and optimizing the processes of medical record collection, recording, and management. Through the clinical trial research medical record quality control system, researchers and clinical workers can more conveniently and reliably manage clinical trial medical record data, ensure the accuracy and consistency of the data, and improve the quality and credibility of clinical trials.

[0035] (2) The problem of manual data entry can be improved through the data collection and entry terminal, the problems of omission and error can be improved through the data verification and validation terminal and the data quality control terminal, the problem of difficult data integration can be improved through the data integration and standardization terminal, the problem of difficult data security guarantee can be improved through the data access and permission control terminal, the problem of difficult traceability can be improved by the data audit and tracking terminal, and the problem of lack of real-time reporting can be improved through the data query and report terminal and the data quality monitoring and feedback terminal.

[0036] (3) The system of the present invention can improve the quality, compliance, and management efficiency of test data. These terminals can provide functions such as real-time data access, standardized data management, and data quality control, making clinical trial management more intelligent, standardized, and efficient. At the same time, these terminals can also help researchers promptly discover and solve potential problems, ensuring the accuracy and credibility of test data. Description of the Drawings

[0037] Figure 1 It is the architecture diagram of the data collection and entry terminal of the present invention;

[0038] Figure 2 It is the architecture diagram of the data verification and validation terminal of the present invention;

[0039] Figure 3 It is the architecture diagram of the data integration and standardization terminal of the present invention;

[0040] Figure 4 It is the architecture diagram of the data quality control terminal of the present invention;

[0041] Figure 5 It is the architecture diagram of the data query and report terminal of the present invention;

[0042] Figure 6 It is the architecture diagram of the data access and permission control terminal of the present invention

[0043] Figure 7 It is the architecture diagram of the data audit and tracking terminal of the present invention;

[0044] Figure 8 It is the architecture diagram of the data quality monitoring and feedback terminal of the present invention.

[0045] Reference Numerals: 1. Data Collection and Input End; 101. Data Collection Form Design Module; 101a. Data Collection Form Design Unit; 101b. Data Collection Form Design Database Unit; 102. Data Input Interface Module; 102a. Data Input Interface Unit; 102b. Data Input Interface Database Unit; 103. Data Verification and Validation Module; 103a. Data Verification and Validation Unit; 103b. Data Verification and Validation Database Unit; 104. Data Import and Export Module; 104a. Data Import and Export Unit; 104b. Data Import and Export Database Unit; 105. Data Verification Rule and Business Logic Module; 105a. Data Verification Rule and Business Logic Unit; 105b. Data Verification Rule and Business Logic Database Unit; 106. Data Review and Validation Module; 106a. Data Review and Validation Unit; 106b. Data Review and Validation Database Unit; 2. Data Verification and Validation End; 201. Format Verification Module; 201a. Format Verification Unit; 201b. Format Verification Database Unit; 202. Range Verification Module; 202a. Range Verification Unit; 202b. Range Verification Database Unit; 203. Logical Relationship Verification Module; 203a. Logical Relationship Verification Unit; 203b. Logical Relationship Verification Database Unit; 204. Required Field Verification Module; 204a. Required Field Verification Unit; 204b. Required Field Verification Database Unit; 205. Data Consistency Verification Module; 205a. Data Consistency Verification Unit; 205b. Data Consistency Verification Database Unit; 206. Logical Rule Verification Module; 206a. Logical Rule Verification Unit; 206b. Logical Rule Verification Database Unit; 3. Data Integration and Standardization End; 301. Data Integration Module; 301a. Data Integration Unit; 301b. Data Integration Database Unit; 302. Data Cleaning and Transformation Module; 302a. Data Cleaning and Transformation Unit; 302b. Data Cleaning and Transformation Database Unit; 303. Data Standardization Module; 303a. Data Standardization Unit; 303b. Data Standardization Database Unit; 304. Term Mapping Module; 304a. Term Mapping Unit; 304b. Term Mapping Database Unit; 305. Data Quality Assessment Module; 305a. Data Quality Assessment Unit; 305b. Data Quality Assessment Database Unit; 4. Data Quality Control End; 401. Data Verification and Validation Module; 401a. Data Verification and Validation Unit; 401b. Data Verification and Validation Database Unit; 402. Data Consistency Check Module; 402a. Data Consistency Check Unit; 402b. Data Consistency Check Database Unit; 403. Missing Data Handling Module; 403a. Missing Data Handling Unit; 403b. Missing Data Handling Database Unit; 404. Data Normalization Module; 404a. Data Normalization Unit; 404b. Data Normalization Database Unit; 405. Data Quality Report Module;405a, Data Quality Report Unit; 405b, Data Quality Report Database Unit; 406, Data Review and Audit Module; 406a, Data Review and Audit Unit; 406b, Data Review and Audit Database Unit; 5, Data Query and Report Terminal; 501, Data Query Module; 501a, Data Query Unit; 501b, Data Query Database Unit; 502, Custom Report Module; 502a, Custom Report Unit; 502b, Custom Report Database Unit; 503, Data Export Module; 503a, Data Export Unit; 503b, Data Export Database Unit; 504, Data Visualization Module; 504a, Data Visualization Unit; 504b, Data Visualization Database Unit; 505, Data Statistics and Summarization Module; 505a, Data Statistics and Summarization Unit; 505b, Data Statistics and Summarization Database Unit; 6, Data Access and Permission Control Terminal; 601, User Authentication Module; 601a, User Authentication Unit; 601b, User Authentication Database Unit; 602, Role and Permission Management Module; 602a, Role and Permission Management Unit; 602b, Role and Permission Management Database Unit; 603, Data Access Control Module; 603a, Data Access Control Unit; 603b, Data Access Control Database Unit; 604, Data Encryption and Secure Transmission Module; 604a, Data Encryption and Secure Transmission Unit; 604b, Data Encryption and Secure Transmission Database Unit; 605, Audit Log Module; 605a, Audit Log Unit; 605b, Audit Log Database Unit; 7, Data Audit and Trace Terminal; 701, Audit Log Recording Module; 701a, Audit Log Recording Unit; 701b, Audit Log Recording Database Unit; 702, Audit Data Trace Module; 702a, Audit Data Trace Unit; 702b, Audit Data Trace Database Unit; 703, Anomaly Detection and Alert Module; 703a, Anomaly Detection and Alert Unit; 703b, Anomaly Detection and Alert Database Unit; 704, Data Traceability Module; 704a, Data Traceability Unit; 704b, Data Traceability Database Unit; 8, Data Quality Monitoring and Feedback Terminal; 801, Data Quality Indicator Monitoring Module; 801a, Data Quality Indicator Monitoring Unit; 801b, Data Quality Indicator Monitoring Database Unit; 802, Data Quality Anomaly Detection Module; 802a, Data Quality Anomaly Detection Unit; 802b, Data Quality Anomaly Detection Database Unit; 803, Data Quality Feedback and Correction Module; 803a, Data Quality Feedback and Correction Unit; 803b, Data Quality Feedback and Correction Database Unit; 804, Data Quality Report and Visualization Module; 804a, Data Quality Report and Visualization Unit; 804b, Data Quality Report and Visualization Database Unit.; Detailed Implementation Manner

[0046] The present invention will be further described in detail below in conjunction with embodiments and the accompanying drawings. However, the implementation manners of the present invention are not limited thereto.

[0047] A clinical trial research medical record quality control system includes a data collection and input end 1, a data verification and validation end 2, a data integration and standardization end 3, a data quality control end 4, a data query and report end 5, a data access and permission control end 6, a data audit and tracking end 7, and a data quality monitoring and feedback end 8.

[0048] Data communication is carried out between the data collection and input end 1, the data verification and validation end 2, the data integration and standardization end 3, the data quality control end 4, the data query and report end 5, the data access and permission control end 6, the data audit and tracking end 7, and the data quality monitoring and feedback end 8 through a private network dedicated line.

[0049] Such as Figure 1 , the data collection and input end 1 can reduce errors during manual input and improve data accuracy. It can also input trial data in real time to ensure the timeliness and accuracy of data. The data collection and input end 1 includes a data collection form design module 101, a data input interface module 102, a data verification and validation module 103, a data import and export module 104, a data verification rule and business logic module 105, and a data review and validation module 106.

[0050] The data collection form design module 101 includes a data collection form design unit 101a, which is used for the system to provide flexible interfaces and tools to design data collection forms. Researchers can create and customize data collection forms according to specific clinical trial requirements, including medical record information, vital signs, laboratory results, etc.; it also includes a data collection form design database unit 101b, which is used to store data collection form design information.

[0051] The data input interface module 102 includes a data input interface unit 102a, which is used for the system to provide an intuitive and easy-to-use data input interface for researchers to input clinical trial data. The interface usually adopts the form of tables, forms or interface elements to facilitate users to input data quickly and conveniently; it also includes a data input interface database unit 102b, which is used to store data input interface information.

[0052] The data verification and validation module 103 includes a data verification and validation unit 103a, which is used for the system to perform data verification and validation to ensure the accuracy and integrity of the input data. It can check the format, range, logical relationship, etc. of the data and provide warnings or correction suggestions for errors or inconsistencies; it also includes a data verification and validation database unit 103b, which is used to store data verification and validation information.

[0053] The data import and export module 104 includes a data import and export unit 104a, which is used for the system to generally support the batch import and export functions of data, so as to import data from other systems or data sources and export the data into common data formats (such as CSV, Excel, etc.) for backup or further analysis. It also includes a data import and export database unit 104b, which is used to store data import and export information.

[0054] The data verification rules and business logic module 105 includes a data verification rules and business logic unit 105a, which is used for the system to allow researchers to define data verification rules and business logic to ensure that the entered data meets the requirements and standards of clinical trials. These rules can include required fields, data range limits, logical relationships, etc., to help reduce input errors and data inconsistencies. It also includes a data verification rules and business logic database unit 105b, which is used to store data verification rules and business logic information.

[0055] The data review and verification module 106 includes a data review and verification unit 106a, which is used for the system to provide the functions of data review and verification to ensure the accuracy of the entered data. This can include the review and verification of the entered data by data reviewers and the confirmation of the data after passing the review. It also includes a data review and verification database unit 106b, which is used to store data review and verification information.

[0056] Such as Figure 2 , the data verification and validation terminal 2 can verify the data to ensure data consistency and accuracy. It can also prevent and correct data entry errors and improve data quality. The data verification and validation terminal 2 includes a format verification module 201, a range verification module 202, a logical relationship verification module 203, a required field verification module 204, a data consistency verification module 205, and a logical rule verification module 206.

[0057] The format verification module 201 includes a format verification unit 201a, which is used for the system to check whether the format of the data meets the specified format requirements. For example, whether the date field is entered in the specified date format, whether the numeric field is in a legal numeric format, etc. It also includes a format verification database unit 201b, which is used to store format verification information.

[0058] The range verification module 202 includes a range verification unit 202a, which is used for the system to verify whether the data is within the specified range. For example, whether the value of a certain field is within the preset range, such as age, weight, etc. It also includes a range verification database unit 202b, which is used to store range verification information.

[0059] The logical relationship verification module 203 includes a logical relationship verification unit 203a, which is used to systematically check whether the logical relationship between data is reasonable. For example, whether the value of a certain field is consistent with the values of other fields or conforms to the logical relationship; it also includes a logical relationship verification database unit 203b, which is used to store logical relationship verification information.

[0060] The mandatory field verification module 204 includes a mandatory field verification unit 204a, which is used to systematically check whether there are any mandatory fields not filled in. These fields are usually key data items and must be filled in to continue with subsequent data entry and analysis; it also includes a mandatory field verification database unit 204b, which is used to store mandatory field verification information.

[0061] The data consistency verification module 205 includes a data consistency verification unit 205a, which is used to systematically check the consistency between data. For example, whether the value of a certain field is consistent with the values of other related fields and whether there are any logical conflicts or inconsistencies; it also includes a data consistency verification database unit 205b, which is used to store data consistency verification information.

[0062] The logical rule verification module 206 includes a logical rule verification unit 206a, which is used to allow the system to define and apply custom logical rules to verify the legality and consistency of data. These rules can be based on the specific requirements and standards of clinical trials to ensure that the data conforms to the expected rules and conditions; it also includes a logical rule verification database unit 206b, which is used to store logical rule verification information.

[0063] Such as Figure 3 , the data integration and standardization end 3 can integrate data from different sources to form a complete trial data set, which is convenient for management and analysis. Data standardization makes different data formats consistent, reducing confusion and errors. The data integration and standardization end 3 includes a data integration module 301, a data cleaning and transformation module 302, a data standardization module 303, a terminology mapping module 304, and a data quality assessment module 305.

[0064] The data integration module 301 includes a data integration unit 301a, which is used to systematically obtain clinical medical record data from different data sources (such as electronic medical record systems, laboratory information systems, etc.) and integrate it into a centralized database. This can avoid the scattered storage and management of data and facilitate the unified processing and analysis of data; it also includes a data integration database unit 301b, which is used to store data integration information.

[0065] The data cleaning and transformation module 302 includes a data cleaning and transformation unit 302a, which is used for the system to clean and transform the collected clinical record data to ensure the accuracy and consistency of the data. This may involve processing steps such as correcting errors in the data, filling in missing values, and unifying the formats and units of the data; it also includes a data cleaning and transformation database unit 302b, which is used to store data cleaning and transformation information.

[0066] The data standardization module 303 includes a data standardization unit 303a, which is used for the system to convert clinical record data into a unified standard format and coding to ensure the comparability and consistency of data in different studies. Common standards include SNOMED CT, LOINC, ICD, etc., and the medical record data can be coded and classified according to these standards; it also includes a data standardization database unit 303b, which is used to store data standardization information.

[0067] The terminology mapping module 304 includes a terminology mapping unit 304a, which is used for the system to perform terminology mapping, mapping the terms and codes in different data sources to a unified standard terminology system. This can eliminate the differences in terms in different data sources, making it more convenient to compare and analyze the data; it also includes a terminology mapping database unit 304b, which is used to store terminology mapping information.

[0068] The data quality assessment module 305 includes a data quality assessment unit 305a, which is used for the system to assess the quality of the integrated and standardized data, checking the integrity, consistency, and accuracy of the data. This helps to discover and correct problems in the data and improve the credibility and reliability of the data; it also includes a data quality assessment database unit 305b, which is used to store data quality assessment information.

[0069] Such as Figure 4 , the data quality control terminal 4 can automatically detect data quality problems, such as missing values, outliers, etc., to ensure the credibility of the data. It can help improve the accuracy and integrity of the data and reduce the impact of invalid data. The data quality control terminal 4 includes a data verification and validation module 401, a data consistency check module 402, a missing data processing module 403, a data normalization module 404, a data audit and review module 406, and a data quality report module 405.

[0070] The data verification and validation module 401 includes a data verification and validation unit 401a, which is used for the system to verify and validate the collected clinical record data to ensure the accuracy of the data. This includes checking aspects such as the format, range, and logical relationships of the data, and discovering and correcting errors and outliers in the data; it also includes a data verification and validation database unit 401b, which is used to store data verification and validation information.

[0071] The data consistency check module 402 includes a data consistency check unit 402a, which is used to check the consistency of clinical record data in different data sources by the system to ensure the consistency of data between different data sources. This may involve checking the consistency of data such as basic information, diagnosis, treatment plans, etc. in different data sources; it also includes a data consistency check database unit 402b, which is used to store data consistency check information.

[0072] The missing data processing module 403 includes a missing data processing unit 403a, which is used to detect and process missing values in clinical record data by the system to ensure the integrity of the data. This may include methods such as filling in missing values and interpolation estimation to ensure that each variable in the dataset has available data; it also includes a missing data processing database unit 403b, which is used to store missing data processing information.

[0073] The data normalization module 404 includes a data normalization unit 404a, which is used to normalize clinical record data by the system to unify the data format and units. This helps to eliminate format differences in the data and improve the data comparison and analysis capabilities; it also includes a data normalization database unit 404b, which is used to store data normalization information.

[0074] The data review and audit module 406 includes a data review and audit unit 406a, which is used to provide data review and audit functions by the system, track the modification and change records of the data to ensure the traceability and credibility of the data; it also includes a data review and audit database unit 406b, which is used to store data review and audit information.

[0075] The data quality report module 405 includes a data quality report unit 405a, which is used to generate a data quality report by the system, summarize and display the quality indicators and statistical information of the data. This helps researchers to understand the quality of the data and promptly discover and solve potential data quality problems; it also includes a data quality report database unit 405b, which is used to store data quality report information.

[0076] Such as Figure 5 , the data query and report terminal 5 can query the trial data at any time, accelerating the researchers' access to the required information. It can also provide real-time reports to support the rapid analysis and decision-making of the data. The data query and report terminal 5 includes a data query module 501, a custom report module 502, a data export module 503, a data visualization module 504, and a data statistics and summary module 505.

[0077] The data query module 501 includes a data query unit 501a, which provides a flexible data query function for the system, allowing users to retrieve data according to various conditions and parameters. Users can set query conditions based on patient information, diagnosis, treatment plan, time range, etc. to obtain clinical record data that meets specific requirements; it also includes a data query database unit 501b for storing data query information.

[0078] The custom report module 502 includes a custom report unit 502a, which allows the system to allow users to create custom reports according to their needs. Users can select the required data fields, data sorting methods, filtering conditions, etc., and then generate customized reports to meet specific data analysis and display requirements; it also includes a custom report database unit 502b for storing custom report information.

[0079] The data export module 503 includes a data export unit 503a, which allows the system to export query results or report data into common data formats (such as Excel, CSV, etc.) for further data processing and analysis; it also includes a data export database unit 503b for storing data export information.

[0080] The data visualization module 504 includes a data visualization unit 504a, which provides a data visualization function for the system to display clinical record data in the form of charts, graphs, etc. This helps users to more intuitively understand and analyze data, and discover potential trends, correlations, and anomalies; it also includes a data visualization database unit 504b for storing data visualization information.

[0081] The data statistics and summary module 505 includes a data statistics and summary unit 505a, which enables the system to perform statistics and summary on clinical record data and generate various statistical indicators and summary information. Users can obtain statistical results on aspects such as the number of patients, diagnosis distribution, treatment plan usage, etc.; it also includes a data statistics and summary database unit 505b for storing data statistics and summary information.

[0082] Such as Figure 6 , through permission control, the data access and permission control terminal 6 ensures that only authorized personnel can access specific data, protecting the security of the data. The data access and permission control terminal 6 includes a user authentication module 601, a role and permission management module 602, a data access control module 603, a data encryption and secure transmission module 604, and an audit log module 605.

[0083] The user authentication module 601 includes a user authentication unit 601a, which is used for the system to require users to authenticate themselves, such as the login method of username and password, to ensure that only authorized users can access the system; it also includes a user authentication database unit 601b, which is used to store user authentication information.

[0084] The role and permission management module 602 includes a role and permission management unit 602a, which is used for the system to manage data access permissions by defining different user roles and permission levels. Each user is assigned to a specific role, and each role is granted specific permissions. For example, researchers may have the permission to access and modify data, while only managers can have higher-level permissions such as user management and system configuration; it also includes a role and permission management database unit 602b, which is used to store role and permission management information.

[0085] The data access control module 603 includes a data access control unit 603a, which is used for the system to limit users' access permissions to specific data. According to the roles and permissions of users, the system can ensure that users can only access the data within their authorized scope. This can prevent unauthorized users from accessing sensitive data or the data of other users; it also includes a data access control database unit 603b, which is used to store data access control information.

[0086] The data encryption and secure transmission module 604 includes a data encryption and secure transmission unit 604a, which is used for the system to adopt data encryption technology to ensure the security during data transmission. Sensitive data will be encrypted during transmission to prevent unauthorized access and data leakage; it also includes a data encryption and secure transmission database unit 604b, which is used to store data encryption and secure transmission information.

[0087] The audit log module 605 includes an audit log unit 605a, which is used for the system to record users' operations and data access records and generate audit logs. This helps to monitor and track data access activities, identify anomalies or improper behaviors, and provide a basis for review and investigation; it also includes an audit log database unit 605b, which is used to store audit log information.

[0088] As Figure 7 , the data audit and tracking terminal 7 can track the change history of data to help track the modification and operation of data. The data audit and tracking terminal 7 includes an audit log recording module 701, an audit data tracking module 702, an anomaly detection and alert module 703, and a data traceability module 704.

[0089] The audit log recording module 701 includes an audit log recording unit 701a, which is used to automatically record the operations and data access records of users and record them in the audit log. These logs include users' login and logout activities, data modification or deletion operations, and other activities related to data access and operations. The audit log records the operation time of users, the specific operation content, and the identity information of the operators; it also includes an audit log recording database unit 701b, which is used to store audit log recording information.

[0090] The audit data tracing module 702 includes an audit data tracing unit 702a, which is used to enable the system to trace and record the change history of data. Each time data is modified or updated, the system records the detailed information of the change, including the values before and after the modification, the timestamp of the change, and the user information of the person making the change. This can trace the modification history of the data and can check the integrity and accuracy of the data; it also includes an audit data tracing database unit 702b, which is used to store audit data tracing information.

[0091] The anomaly detection and alert module 703 includes an anomaly detection and alert unit 703a, which is used to detect abnormal data access and operation behaviors by the system and generate corresponding alerts. For example, the system can detect abnormal situations such as access attempts by unauthorized users, unauthorized data modification or deletion operations, etc., and send alert notifications to relevant personnel so that necessary measures can be taken in a timely manner; it also includes an anomaly detection and alert database unit 703b, which is used to store anomaly detection and alert information.

[0092] The data traceability module 704 includes a data traceability unit 704a, which is used to trace the source and change history of data by the system to ensure the traceability and credibility of the data. By tracing the flow path of the data, the system can track the source of each data item, the data inputter, and the modifier, thereby improving the reliability and quality of the data; it also includes a data traceability database unit 704b, which is used to store data traceability information.

[0093] As Figure 8 , the data quality monitoring and feedback end 8 can monitor the data quality in real time, discover and handle problems in a timely manner. It can also provide feedback to help continuously improve the data quality and management. The data quality monitoring and feedback end 8 includes a data quality index monitoring module 801, a data quality anomaly detection module 802, a data quality feedback and correction module 803, and a data quality report and visualization module 804.

[0094] The data quality indicator monitoring module 801 includes a data quality indicator monitoring unit 801a, which is used to define and monitor various data quality indicators in the system, such as data integrity, accuracy, consistency, etc. The system will regularly check and evaluate the data, calculate and track the values of these quality indicators, and generate corresponding reports or indicator charts so that users can clearly understand the data quality status; it also includes a data quality indicator monitoring database unit 801b, which is used to store data quality indicator monitoring information.

[0095] The data quality anomaly detection module 802 includes a data quality anomaly detection unit 802a, which is used to enable the system to automatically detect data quality anomalies, such as missing data, outliers, data conflicts, etc. Once an anomaly is detected, the system will generate an alarm or notification and provide relevant information to help users correct and handle it; a data quality anomaly detection database unit 802b, which is used to store data quality anomaly detection information.

[0096] The data quality feedback and correction module 803 includes a data quality feedback and correction unit 803a, which is used to provide data quality feedback to users and guide users to take appropriate correction measures in the system. The system can identify the problematic data items and provide correction suggestions or guidance to help users correct data quality problems and ensure data accuracy and consistency; it also includes a data quality feedback and correction database unit 803b, which is used to store data quality feedback and correction information.

[0097] The data quality reporting and visualization module 804 includes a data quality reporting and visualization unit 804a, which is used to enable the system to generate data quality reports and visualization charts to intuitively display the data quality situation. These reports and charts can help users better understand the data quality status and take corresponding measures to improve data quality based on the feedback information; it also includes a data quality reporting and visualization database unit 804b, which is used to store data quality reporting and visualization information.

[0098] The above are only the preferred embodiments of the present invention, and the protection scope of the present invention is not limited to the above embodiments. All technical solutions falling within the idea of the present invention belong to the protection scope of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A clinical trial research medical record quality control system, characterized in that: It includes data collection and entry end (1), data verification and validation end (2), data integration and standardization end (3), data quality control end (4), data query and reporting end (5), data access and authority control end (6), data audit and tracking end (7), and data quality monitoring and feedback end (8); The data collection and input terminal (1), the data checking and verification terminal (2), the data integration and standardization terminal (3), the data quality control terminal (4), the data query and report terminal (5), the data access and authority control terminal (6), the data audit and tracking terminal (7) and the data quality monitoring and feedback terminal (8) communicate with each other through a dedicated network and dedicated line network.

2. The clinical trial research medical record quality control system according to claim 1, characterized in that: The data collection and input terminal (1) comprises a data collection form design module (101), a data input interface module (102), a data check and verification module (103), a data import and export module (104), a data check rule and business logic module (105), and a data review and verification module (106); The data collection form design module (101) is used to provide an interface and tools for designing a data collection form, the data entry interface module (102) is used to provide a data entry interface for researchers to input clinical trial data, the data check and verification module (103) is used to perform data check and verification to ensure the accuracy and completeness of the entered data, the data import and export module (104) is used to support batch import and export functions of data so as to import data and export data into a common data format, the data check rule and business logic module (105) is used to define data check rules and business logic to ensure that the entered data meets the requirements and standards of clinical trials, and the data review and verification module (106) is used to provide data review and verification functions to ensure the accuracy of the entered data.

3. The clinical trial research medical record quality control system according to claim 2, characterized in that: The data checking and verification end (2) comprises a format checking module (201), a range checking module (202), a logic relationship checking module (203), a required field checking module (204), a data consistency checking module (205), and a logic rule checking module (206); The format verification module (201) is used to check whether the format of the data complies with the prescribed format requirements, the range verification module (202) is used to verify whether the data is within the prescribed range, the logical relationship verification module (203) is used to check whether the logical relationship between the data is reasonable, the required field verification module (204) is used to check whether there are any required fields that are not filled in, the data consistency verification module (205) is used to check the consistency between the data, and the logical rule verification module (206) is used to define and apply custom logical rules to verify the legality and consistency of the data.

4. The clinical trial research medical record quality control system according to claim 2, characterized in that: The data integration and standardization end (3) includes a data integration module (301), a data cleaning and conversion module (302), a data standardization module (303), a term mapping module (304), and a data quality assessment module (305); The data integration module (301) is used to obtain clinical medical record data from different data sources and integrate them into a centralized database. The data cleaning and conversion module (302) is used to clean and convert the collected clinical medical record data. The data standardization module (303) is used to convert the clinical medical record data into a unified standard format and coding. The term mapping module (304) performs term mapping in the system to map the terms and codes in different data sources into a unified standard terminology system. The data quality assessment module (305) is used to perform quality assessment on the integrated and standardized data to check the integrity, consistency and accuracy of the data.

5. The clinical trial research medical record quality control system according to claim 4, characterized in that: The data quality control end (4) includes a data verification and validation module (401), a data consistency check module (402), a missing data processing module (403), a data normalization module (404), and a data quality reporting module (405); The data verification and validation module (401) is used to verify and validate the collected clinical medical record data, the data consistency check module (402) is used to perform consistency check on the clinical medical record data in different data sources, the missing data processing module (403) is used to detect and process missing values ​​in the clinical medical record data, the data normalization module (404) is used to normalize the clinical medical record data and unify the format and unit of the data, and the data quality report module (405) is used to generate a data quality report to summarize and display the quality indicators and statistical information of the data.

6. The clinical trial research medical record quality control system according to claim 5, characterized in that: The data quality control terminal (4) also includes a data review and audit module (406), which is used to provide data review and audit functions and track data modifications and change records.

7. The clinical trial research medical record quality control system according to claim 1, characterized in that: The data query and report terminal (5) comprises a data query module (501), a custom report module (502), a data export module (503), a data visualization module (504), and a data statistics and summary module (505); The data query module (501) is used to provide a flexible data query function, allowing the user to retrieve data according to various conditions and parameters. The custom report module (502) is used to allow the user to create a custom report according to needs. The data export module (503) is used to allow the query results or report data to be exported to a common data format. The data visualization module (504) is used to provide a data visualization function to display clinical medical record data in the form of charts, graphs, etc. The data statistics and summary module (505) is used to be able to count and summarize clinical medical record data and generate various statistical indicators and summary information.

8. The clinical trial research medical record quality control system according to claim 7, characterized in that: The data access and authority control terminal (6) includes a user identity authentication module (601), a role and authority management module (602), a data access control module (603), a data encryption and secure transmission module (604), and an audit log module (605); The user identity authentication module (601) is used to require the user to authenticate, the role and authority management module (602) is used to manage data access rights by defining different user roles and authority levels, the data access control module (603) is used to limit the user's access rights to specific data, the data encryption and secure transmission module (604) is used to adopt data encryption technology to ensure that data will be encrypted during the data transmission process, and the audit log module (605) is used to systemically record user operations and data access records and generate audit logs.

9. The clinical trial research medical record quality control system according to claim 8, characterized in that: The data audit and tracking terminal (7) includes an audit log recording module (701), an audit data tracking module (702), an anomaly detection and alarm module (703), and a data tracing module (704); The audit log recording module (701) is used to automatically record the user's operations and data access records and record them in the audit log. The audit data tracking module (702) is used to track and record the data change history. The anomaly detection and alarm module (703) is used to detect abnormal data access and operation behaviors and generate corresponding alarms. The data tracing module (704) is used to trace the source and change history of the data.

10. The clinical trial research medical record quality control system according to claim 9, characterized in that: The data quality monitoring and feedback end (8) includes a data quality indicator monitoring module (801), a data quality anomaly detection module (802), a data quality feedback and correction module (803), and a data quality report and visualization module (804); The data quality indicator monitoring module (801) is used to define and monitor various data quality indicators, the data quality anomaly detection module (802) is used to automatically detect abnormal data quality conditions, the data quality feedback and correction module (803) is used to provide data quality feedback to users and guide users to take appropriate corrective measures, and the data quality report and visualization module (804) is used to generate data quality reports and visualization charts.

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