Clinical test source data traceability tracking operation system

Abstract

The invention provides a clinical test source data traceability tracking operation system, and relates to the technical field of drug clinical tests. Comprising a data identification and index end, a data acquisition and recording end, a data change tracking end, a data traceability and traceability end, a data verification and auditing end, a data access and authority control end, a data backup and recovery end and a data report and analysis end. The data identification and index end, the data acquisition and recording end, the data change tracking end, the data traceability and tracing end, the data verification and auditing end, the data access and authority control end, the data backup and recovery end and the data report and analysis end are in data communication through a private network and a private line network. The system aims at monitoring and managing links such as sources, acquisition, recording and change of clinical test data so as to ensure the reliability and credibility of the data.

Description

Technical Field

[0001] This invention relates to the field of drug clinical trial technology, and specifically to a clinical trial source data traceability and tracking system. Background Technology

[0002] Clinical trials are a crucial part of medical research, designed to evaluate the safety and effectiveness of new drugs, treatments, or medical devices. These trials typically involve complex design, data collection, data analysis, and reporting processes, and must adhere to strict regulatory and ethical requirements.

[0003] In clinical trials, the traditional method of tracing source data usually requires manually organizing and comparing multiple data sources, which is prone to human error and omissions. For complex experimental data, source data tracing may require a lot of time and human resources, which is time-consuming and labor-intensive. In the process of tracing source data in the traditional method, it is also difficult to accurately track the history of data modification, deletion and change, which affects the credibility and transparency of the data.

[0004] Therefore, there are areas for improvement. This invention provides a clinical trial source data tracing and tracking system. Summary of the Invention

[0005] To address the shortcomings of existing technologies, the present invention aims to propose a source data tracing and tracking system for clinical trials, the specific solution of which is as follows:

[0006] A clinical trial source data traceability and tracking system includes a data identification and indexing terminal, a data collection and recording terminal, a data change tracking terminal, a data traceability and tracing terminal, a data verification and auditing terminal, a data access and permission control terminal, a data backup and recovery terminal, and a data reporting and analysis terminal;

[0007] The data identification and indexing end, data collection and recording end, data change tracking end, data tracing and traceability end, data verification and auditing end, data access and permission control end, data backup and recovery end, and data reporting and analysis end communicate with each other via a dedicated network.

[0008] Furthermore, the data identifier and index terminal is used to assign a unique identifier to each data element and establish an index for subsequent tracing and tracking operations. The data identifier and index terminal includes a data element identifier generation module, a data element index establishment module, an associated data element module, a data element attribute recording module, and an identifier and data association module.

[0009] The data element identifier generation module generates a unique identifier for each data element. The data element index building module builds an index based on the data element identifiers to enable quick data retrieval and access. The associated data element module associates related data elements based on data relationships and dependencies. The data element attribute recording module records the attribute information of each data element. The identifier and data association module associates the identifiers of data elements with the actual data.

[0010] Furthermore, the data acquisition and recording terminal is used to collect and record source data from clinical trials. The data acquisition and recording terminal includes a data acquisition interface module, a data entry and verification module, a data recording and timestamp module, a data association and dependency module, and a data storage and backup module.

[0011] The data acquisition interface module provides a data acquisition interface for inputting source data from clinical trials. The data entry and verification module supports manual data entry and automatic verification. The data recording and timestamp module records the entry time and operator information for each data entry. The data association and dependency module identifies the relationships and dependencies between data. The data storage and backup module securely stores the collected source data and performs regular data backups.

[0012] Furthermore, the data change tracking terminal is used to track and record the change history of clinical trial source data in order to achieve the tracing and tracking of data changes. The data change tracking terminal includes a change recording module, a timestamp and version control module, an audit and verification module, a data rollback module, and a change notification and reminder module.

[0013] The change record module is used to record the details of each data change. The timestamp and version control module is used to generate a timestamp for each data change and record the version information of the change. The audit and verification module is used to support the audit and verification of data changes. The data rollback module is used to provide the function of data rollback to restore the data to a previous version or state. The change notification and reminder module is used to send notifications and reminders to relevant personnel to inform them of the data changes.

[0014] Furthermore, the data tracing and tracking terminal is used to realize the tracing and tracking of clinical trial source data. The data tracing and tracking terminal includes a data source identification module, a data link establishment module, a data tracing query module, a data association analysis module, and a data tracing report module.

[0015] The data source identification module is used to identify the source of each data item; the data link establishment module is used to establish links between data to form data flow and transmission path; the data traceability query module is used to provide query function; the data association analysis module is used to analyze and display the relationship between different data; and the data traceability report module is used to generate a data traceability report to describe the traceability information and traceability process of the data.

[0016] Furthermore, the data verification and auditing terminal is used to verify and audit clinical trial source data. The data verification and auditing terminal includes a data verification rule module, a data auditing process module, a data anomaly detection module, a data consistency check module, and a data auditing record module.

[0017] The data verification rules module is used to set a series of data verification rules to check the legality and accuracy of the data. The data audit process module is used to establish a data audit process, define the audit steps and responsible persons. The data anomaly detection module is used to automatically detect anomalies in the data. The data consistency check module is used to check the consistency between different data. The data audit record module is used to record the data audit process and results.

[0018] Furthermore, the data access and permission control terminal is used to ensure the security and confidentiality of data. The data access and permission control terminal includes a user authentication module, a user role and permission management module, a data access control module, and a data operation auditing module.

[0019] The user authentication module is used to require users to authenticate themselves; the user role and permission management module is used to set different user roles and assign specific permissions to each role; the data access control module is used to restrict users' access to data according to their roles and permissions; and the data operation audit module is used to record users' operations on data.

[0020] Furthermore, the data access and permission control terminal also includes a data encryption and decryption module, which is used to encrypt and store sensitive data using encryption algorithms.

[0021] Furthermore, the data backup and recovery terminal is used to ensure data security and recoverability. The data backup and recovery terminal includes a regular backup module, a data integrity verification module, a data storage and recovery module, a data recovery testing module, and a disaster recovery and emergency recovery plan module.

[0022] The periodic backup module is used to perform periodic backups of data according to a set time interval or a specific time point. The data integrity verification module is used to verify the integrity of the backed-up data. The data storage and recovery module is used to store the backup data on media. The data recovery test module is used to perform data recovery tests periodically. The disaster recovery and emergency recovery plan module is used to provide disaster recovery and emergency recovery plans.

[0023] Furthermore, the data reporting and analysis terminal is used to provide data visualization and analysis. The data reporting and analysis terminal includes a data report generation module, a data visualization module, a data analysis tool module, a data query and filtering module, and a data comparison and trend analysis module.

[0024] The data report generation module is used to generate various types of data reports according to user needs. The data visualization module is used to display clinical trial data in a visual form. The data analysis tool module is used to provide data analysis tools or integrate with external data analysis tools to perform various analysis tasks. The data query and filtering module is used to provide data query and filtering functions. The data comparison and trend analysis module is used to support data comparison and trend analysis between different groups or time points.

[0025] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0026] (1) The Clinical Trial Source Data Traceability System is designed to ensure the integrity, accuracy and traceability of clinical trial data. Through the cooperation of the data identification and indexing end, data collection and recording end, data change tracking end, data traceability and tracing end, and data verification and auditing end, the system aims to monitor and manage the source, collection, recording and change of clinical trial data to ensure the reliability and credibility of the data.

[0027] A clinical trial source data traceability and tracking system helps improve the quality and reliability of clinical trial data. Through data access and permission control, it strengthens data management and control; through data backup and recovery, it improves the reliability and reproducibility of clinical trials. This system plays a crucial role in ensuring data security and compliance, and through data reporting and analysis, it provides a traceable data management solution by enabling visual analysis of the data. Attached Figure Description

[0028] Figure 1 This is an architecture diagram of the data identification and indexing end of the present invention;

[0029] Figure 2 This is an architecture diagram of the data acquisition and recording terminal of the present invention;

[0030] Figure 3This is an architecture diagram of the data change tracking terminal of the present invention;

[0031] Figure 4 This is an architecture diagram of the data tracing and tracking terminal of the present invention;

[0032] Figure 5 This is an architecture diagram of the data verification and review terminal of the present invention;

[0033] Figure 6 This is an architecture diagram of the data access and permission control terminal of the present invention;

[0034] Figure 7 This is an architecture diagram of the data backup and recovery terminal of the present invention;

[0035] Figure 8 This is an architecture diagram of the data reporting and analysis terminal of the present invention.

[0036] Figure reference numerals: 1. Data Identifier and Index End; 101. Data Element Identifier Generation Module; 101a. Data Element Identifier Generation Unit; 101b. Data Element Identifier Generation Database Unit; 102. Data Element Index Establishment Module; 102a. Data Element Index Establishment Unit; 102b. Data Element Index Establishment Database Unit; 103. Associated Data Element Module; 103a. Associated Data Element Unit; 103b. Associated Data Element Database Unit; 104. Data Element Attribute Recording Module; 104a. Data Element Attribute Recording Unit; 104b. Data Element Attribute Recording Database Unit; 105. Identifier and Data Association Module; 105a. Identifier and Data Association Unit; 105 b. Identifier and Data Association Database Unit; 2. Data Acquisition and Recording Terminal; 201. Data Acquisition Interface Module; 201a. Data Acquisition Interface Unit; 201b. Data Acquisition Interface Database Unit; 202. Data Input and Verification Module; 202a. Data Input and Verification Unit; 202b. Data Input and Verification Database Unit; 203. Data Recording and Timestamp Module; 203a. Data Recording and Timestamp Unit; 203b. Data Recording and Timestamp Database Unit; 204. Data Association and Dependency Module; 204a. Data Association and Dependency Unit; 204b. Data Association and Dependency Database Unit; 205. Data Storage and Backup Module; 205a. Data Storage and Backup Unit; 2 05b. Data storage and backup database unit; 3. Data change tracking terminal; 301. Change record module; 301a. Change record unit; 301b. Change record database unit; 302. Timestamp and version control module; 302a. Timestamp and version control unit; 302b. Timestamp and version control database unit; 303. Audit and verification module; 303a. Audit and verification unit; 303b. Audit and verification database unit; 304. Data rollback module; 304a. Data rollback unit; 304b. Data rollback database unit; 305. Change notification and reminder module; 305a. Change notification and reminder unit; 305b. Change notification and reminder database unit; 4. Data traceability and Traceability Terminal; 401, Data Source Identification Module; 401a, Data Source Identification Unit; 401b, Data Source Identification Database Unit; 402, Data Link Establishment Module; 402a, Data Link Establishment Unit; 402b, Data Link Establishment Database Unit; 403, Data Traceability Query Module; 403a, Data Traceability Query Unit; 403b, Data Traceability Query Database Unit; 404, Data Association Analysis Module; 404a, Data Association Analysis Unit; 404b, Data Association Analysis Database Unit; 405, Data Traceability Report Module; 405a, Data Traceability Report Unit; 405b, Data Traceability Report Database Unit; 5, Data Verification and Audit Terminal; 501, Data Verification Rules Module;501a. Data Validation Rule Unit; 501b. Data Validation Rule Database Unit; 502. Data Audit Process Module; 502a. Data Audit Process Unit; 502b. Data Audit Process Database Unit; 503. Data Anomaly Detection Module; 503a. Data Anomaly Detection Unit; 503b. Data Anomaly Detection Database Unit; 504. Data Consistency Check Module; 504a. Data Consistency Check Unit; 504b. Data Consistency Check Database Unit; 505. Data Audit Record Module; 505a. Data Audit Record Unit; 505b. Data Audit Record Database Unit; 6. Data Access and Permission Control Terminal; 601. User Authentication Modules: 601a, User Authentication Unit; 601b, User Authentication Database Unit; 602, User Role and Permission Management Module; 602a, User Role and Permission Management Unit; 602b, User Role and Permission Management Database Unit; 603, Data Access Control Module; 603a, Data Access Control Unit; 603b, Data Access Control Database Unit; 604, Data Operation Audit Module; 604a, Data Operation Audit Unit; 604b, Data Operation Audit Database Unit; 605, Data Encryption and Decryption Module; 605a, Data Encryption and Decryption Unit; 605b, Data Encryption and Decryption Database Unit; 7, Data Backup and Recovery Terminal; 7 701. Regular Backup Module; 701a. Regular Backup Unit; 701b. Regular Backup Database Unit; 702. Data Integrity Verification Module; 702a. Data Integrity Verification Unit; 702b. Data Integrity Verification Database Unit; 703. Data Storage and Recovery Module; 703a. Data Storage and Recovery Unit; 703b. Data Storage and Recovery Database Unit; 704. Data Recovery Testing Module; 704a. Data Recovery Testing Unit; 704b. Data Recovery Testing Database Unit; 705. Disaster Recovery and Emergency Recovery Plan Module; 705a. Disaster Recovery and Emergency Recovery Plan Unit; 705b. Disaster Recovery and Emergency Recovery Plan Database Unit; 8. Data Reporting Analysis module; 801, Data Report Generation Module; 801a, Data Report Generation Unit; 801b, Data Report Generation Database Unit; 802, Data Visualization Module; 802a, Data Visualization Unit; 802b, Data Visualization Database Unit; 803, Data Analysis Tool Module; 803a, Data Analysis Tool Unit; 803b, Data Analysis Tool Database Unit; 804, Data Query and Filtering Module; 804a, Data Query and Filtering Unit; 804b, Data Query and Filtering Database Unit; 805, Data Comparison and Trend Analysis Module; 805a, Data Comparison and Trend Analysis Unit; 805b, Data Comparison and Trend Analysis Database Unit. Detailed Implementation

[0037] The present invention will be further described in detail below with reference to the embodiments and accompanying drawings, but the embodiments of the present invention are not limited thereto.

[0038] A clinical trial source data traceability and tracking system includes a data identification and indexing terminal 1, a data collection and recording terminal 2, a data change tracking terminal 3, a data traceability and tracing terminal 4, a data verification and auditing terminal 5, a data access and permission control terminal 6, a data backup and recovery terminal 7, and a data reporting and analysis terminal 8.

[0039] Data communication between the data identification and indexing end 1, data collection and recording end 2, data change tracking end 3, data tracing and traceability end 4, data verification and auditing end 5, data access and access control end 6, data backup and recovery end 7, and data reporting and analysis end 8 is conducted via a dedicated network.

[0040] like Figure 1 The data identification and indexing module 1 includes a data element identifier generation module 101, a data element index building module 102, a data element association module 103, a data element attribute recording module 104, and an identifier and data association module 105. The data identification and indexing module 1 of the clinical trial source data traceability and tracking system primarily assigns a unique identifier to each data element and establishes an index for subsequent traceability and tracking operations. Through the data identification and indexing function, the clinical trial source data traceability and tracking system can uniquely identify and index clinical trial data, thereby achieving efficient data management and traceability. This provides fundamental support for subsequent data analysis, quality control, and safety auditing. The following are some specific details of this function:

[0041] The data element identifier generation module 101 includes a data element identifier generation unit 101a, which generates a unique identifier for each data element, which can be a number, a letter, or a combination thereof. This identifier will be associated with the data element and serve as a unique identifier for the data. It also includes a data element identifier generation database unit 101b, used to store data element identifier generation information.

[0042] The data element indexing module 102 includes a data element indexing unit 102a, which builds an index based on the identifier of the data element to enable quick data retrieval and access. The index can be implemented based on a database or other data storage mechanism to ensure efficient data retrieval and querying; it also includes a data element indexing database unit 102b, which stores data element indexing information.

[0043] The associated data element module 103 includes an associated data element unit 103a, which associates related data elements based on their relationships and dependencies. This allows for searching and analysis based on these relationships during data tracing and tracking. It also includes an associated data element database unit 103b, used to store associated data element information.

[0044] The data element attribute recording module 104 includes a data element attribute recording unit 104a, which records the attribute information of each data element, including data type, data format, and data range. This attribute information helps in the effective management and verification of data. It also includes a data element attribute recording database unit 104b, which is used to store the data element attribute recording information.

[0045] The identifier and data association module 105 includes an identifier and data association unit 105a, which associates the identifier of a data element with the actual data to ensure a one-to-one correspondence between the data and the identifier, so as to facilitate subsequent traceability and tracking operations; it also includes an identifier and data association database unit 105b, which is used to store identifier and data association information.

[0046] like Figure 2 The data acquisition and recording terminal 2 includes a data acquisition interface module 201, a data entry and verification module 202, a data recording and timestamp module 203, a data association and dependency module 204, and a data storage and backup module 205. The data acquisition and recording terminal 2 of the clinical trial source data traceability and tracking system aims to effectively collect and record source data from clinical trials, ensuring data integrity, accuracy, and traceability. Through its data acquisition and recording functions, the clinical trial source data traceability and tracking system can effectively manage source data from clinical trials, guaranteeing data integrity and accuracy, and providing a reliable foundation for subsequent data analysis, auditing, and reporting. The following are some specific details of this function:

[0047] The data acquisition interface module 201 includes a data acquisition interface unit 201a, which provides a user-friendly data acquisition interface for inputting source data from clinical trials. The interface can be customized according to the specific needs of the trial to ensure the integrity and consistency of the data; it also includes a data acquisition interface database unit 201b for storing data acquisition interface information.

[0048] The data entry and verification module 202 includes a data entry and verification unit 202a, which supports manual data entry and automatic verification. During data entry, the system performs a series of verifications and checks, including data format, range, and logical relationships, to ensure the accuracy and legality of the data. It also includes a data entry and verification database unit 202b, used to store data entry and verification information.

[0049] The data recording and timestamp module 203 includes a data recording and timestamp unit 203a, where the system records the entry time and operator information for each piece of data for traceability and auditing. Each modification or update of data generates a corresponding timestamp to ensure data traceability and version control; it also includes a data recording and timestamp database unit 203b, used to store data recording and timestamp information.

[0050] The data association and dependency module 204 includes a data association and dependency unit 204a, which enables the system to identify the relationships and dependencies between data, ensuring data integrity and consistency. For example, some data may need to be calculated or automatically populated based on the values ​​of other data; it also includes a data association and dependency database unit 204b, which is used to store data association and dependency information.

[0051] The data storage and backup module 205 includes a data storage and backup unit 205a, which securely stores the collected source data and performs regular data backups to prevent data loss or damage; it also includes a data storage and backup database unit 205b, which stores data storage and backup information.

[0052] like Figure 3 The data change tracking terminal 3 includes a change recording module 301, a timestamp and version control module 302, an audit and verification module 303, a data rollback module 304, and a change notification and reminder module 305. The data change tracking terminal 3 of the clinical trial source data tracing and tracking system aims to track and record the change history of clinical trial source data to achieve traceability and tracking of data changes. Through the data change tracking function, the clinical trial source data tracing and tracking system can ensure the traceability and integrity of data, effectively manage and control the change process of clinical trial data, and provide a reliable data change history to support data auditing, analysis, and verification. The following are some specific details of this function:

[0053] The change log module 301 includes a change log unit 301a, which records in detail each data change, including the value before modification, the value after modification, the change time, and the operator information. This allows for accurate tracking of the change history of each data item. It also includes a change log database unit 301b, which stores the change log information.

[0054] The timestamp and version control module 302 includes a timestamp and version control unit 302a, which generates a timestamp for each data change and records the version information of the change. This allows the system to trace the data change process based on the timestamp and version number and to manage and control the data version. It also includes a timestamp and version control database unit 302b, which is used to store timestamp and version control information.

[0055] The audit and verification module 303 includes an audit and verification unit 303a, which supports the audit and verification of data changes. Auditors can view the data change records and review and verify the changes to ensure the accuracy and compliance of the data; it also includes an audit and verification database unit 303b, which is used to store audit and verification information.

[0056] The data rollback module 304 includes a data rollback unit 304a, which provides the function of data rollback, that is, data can be restored to a previous version or state when necessary. This is very useful for correcting errors or recovering data problems caused by misoperation; it also includes a data rollback database unit 304b, which is used to store data rollback information.

[0057] The change notification and reminder module 305 includes a change notification and reminder unit 305a, which allows the system to send notifications and reminders to relevant personnel informing them of data changes. This ensures timely awareness of data changes and enables the system to take appropriate measures for tracking and processing. It also includes a change notification and reminder database unit 305b, used to store change notification and reminder information.

[0058] like Figure 4 The data traceability and tracing terminal 4 includes a data source identification module 401, a data link establishment module 402, a data traceability query module 403, a data correlation analysis module 404, and a data traceability report module 405. The data traceability and tracing terminal 4 of the clinical trial source data traceability and tracking system aims to achieve the traceability and tracing of clinical trial source data, ensuring the traceability and integrity of the data source. Through the data traceability and tracing function, the clinical trial source data traceability and tracking system can ensure the traceability of the data source, help guarantee the accuracy and integrity of the data, and provide reliable data traceability evidence, meeting the needs of clinical trial data management. The following are some specific details of this function:

[0059] The data source identification module 401 includes a data source identification unit 401a, which identifies the source of each data item, including information such as the data collection point, the data input personnel, or the data transmission channel. This allows for accurate tracking of the source of each data item. It also includes a data source identification database unit 401b, which stores the data source identification information.

[0060] The data link establishment module 402 includes a data link establishment unit 402a, which establishes links between data, forming a data flow and transmission path. By establishing data links, the data transmission process can be traced from the source to the end, ensuring data integrity and accuracy. It also includes a data link establishment database unit 402b, which stores data link establishment information.

[0061] The data traceability query module 403 includes a data traceability query unit 403a, which provides query functionality and supports data traceability queries based on keywords, time ranges, data identifiers, and other conditions. Users can query the traceability information of specific data as needed to understand the source and flow of the data; it also includes a data traceability query database unit 403b, which is used to store data traceability query information.

[0062] The data correlation analysis module 404 includes a data correlation analysis unit 404a, which enables the system to analyze and display the correlation relationships between different data. Through correlation analysis, the logical relationships and dependencies between data can be revealed, and the source and transmission path of the data can be traced further. It also includes a data correlation analysis database unit 404b, which is used to store data correlation analysis information.

[0063] The data traceability report module 405 includes a data traceability report unit 405a, which can generate a data traceability report that describes in detail the traceability information and process of the data. This provides reliable evidence of data traceability and supports data auditing and verification. It also includes a data traceability report database unit 405b, which is used to store data traceability report information.

[0064] like Figure 5 The data verification and auditing module 5 includes a data verification rules module 501, a data auditing process module 502, a data anomaly detection module 503, a data consistency check module 504, and a data auditing record module 505. The data verification and auditing module 5 of the clinical trial source data traceability and tracking system aims to verify and audit clinical trial source data to ensure its accuracy, completeness, and consistency. Through the data verification and auditing function, the clinical trial source data traceability and tracking system can rigorously verify and audit data, ensuring its accuracy and consistency and improving its quality and credibility. Simultaneously, the system can also record the auditing process and results, providing support for data auditing and verification. The following are some specific details of this function:

[0065] The data validation rule module 501 includes a data validation rule unit 501a, which sets a series of data validation rules to check the legality and accuracy of the data. These rules may include checks on data format, value range, logical relationships, etc., to ensure that the data meets predetermined specifications and requirements; it also includes a data validation rule database unit 501b, which stores data validation rule information.

[0066] The data review process module 502 includes a data review process unit 502a, which establishes a data review process and defines the review steps and responsible persons. After data is entered or updated, the system triggers the corresponding review process, and reviewers review the data according to the prescribed review standards. It also includes a data review process database unit 502b, which is used to store data review process information.

[0067] The data anomaly detection module 503 includes a data anomaly detection unit 503a, which can automatically detect anomalies in the data, such as values ​​outside the expected range, duplicate data, and missing data. Anomaly data is marked and relevant personnel are notified for processing and confirmation. It also includes a data anomaly detection database unit 503b, which is used to store data anomaly detection information.

[0068] The data consistency check module 504 includes a data consistency check unit 504a, which checks the consistency between different data to ensure the correctness of the relationships and logical connections between the data. For example, it ensures the consistency between case data and examination data. It also includes a data consistency check database unit 504b, which stores data consistency check information.

[0069] The data audit record module 505 includes a data audit record unit 505a, which records the data audit process and results, including information such as the auditor, audit time, and audit comments. This enables the traceability of data audits and provides a basis for subsequent data audits. It also includes a data audit record database unit 505b, which stores data audit record information.

[0070] like Figure 6 The data access and access control terminal 6 includes a user authentication module 601, a user role and access management module 602, a data access control module 603, a data operation audit module 604, and a data encryption and decryption module 605. The data access and access control terminal 6 of the clinical trial source data traceability and tracking system aims to ensure data security and confidentiality, ensuring that only authorized personnel can access and process relevant data. Through data access and access control functions, the clinical trial source data traceability and tracking system can effectively manage user access permissions, ensuring that data is only accessed and processed by authorized personnel, preventing unauthorized access and data leakage, and protecting the security and privacy of clinical trial data. The following are some specific details of this function:

[0071] The user authentication module 601 includes a user authentication unit 601a, which requires users to authenticate themselves, such as by entering a username and password or using two-factor authentication, to ensure that only authorized users can log in to the system; it also includes a user authentication database unit 601b, which stores user authentication information.

[0072] The user role and permission management module 602 includes a user role and permission management unit 602a, where the system sets different user roles and assigns specific permissions to each role. For example, administrators have the highest permissions and can manage users and configure system settings; data entry clerks can only perform data entry operations and cannot modify other users' data; it also includes a user role and permission management database unit 602b, which is used to store user role and permission management information.

[0073] The data access control module 603 includes a data access control unit 603a, which restricts user access to data based on user roles and permissions. Only users with the corresponding permissions can access specific data. For example, certain sensitive data can only be accessed by authorized users, while other users are not authorized to view it. It also includes a data access control database unit 603b, which stores data access control information.

[0074] The data operation audit module 604 includes a data operation audit unit 604a, which records user operations on data, including the time, user, and specific operation content of data access, modification, deletion, etc. This forms an audit log of data operations, facilitating the traceability and monitoring of data access. It also includes a data operation audit database unit 604b, which stores data operation audit information.

[0075] The data encryption and decryption module 605 includes a data encryption and decryption unit 605a, which can use encryption algorithms to encrypt and store sensitive data, and use secure communication protocols during data transmission to ensure data confidentiality and prevent data leakage; it also includes a data encryption and decryption database unit 605b, which is used to store data encryption and decryption information.

[0076] like Figure 7 The data backup and recovery terminal 7 includes a regular backup module 701, a data integrity verification module 702, a data storage and recovery module 703, a data recovery testing module 704, and a disaster recovery and emergency recovery plan module 705. The data backup and recovery terminal 7 of the clinical trial source data traceability and tracking system is a crucial component in ensuring data security and recoverability. It involves regularly backing up data and restoring it when needed to prevent data loss or corruption. Through the data backup and recovery functions, the clinical trial source data traceability and tracking system can guarantee data security and recoverability. Even in the event of an unexpected event, system administrators can perform timely data recovery based on backup data, ensuring the integrity and availability of clinical trial data. The following are some of the main components of this function:

[0077] The periodic backup module 701 includes a periodic backup unit 701a, which performs periodic backups of data at set time intervals or specific time points. The backup frequency can be set according to specific needs, such as daily backups, weekly backups, etc.; it also includes a periodic backup database unit 701b, which is used to store periodic backup information.

[0078] The data integrity verification module 702 includes a data integrity verification unit 702a, which performs integrity verification on the backed-up data during the backup process to ensure the accuracy and integrity of the backup data. Common verification methods include hash checksums and checksums. It also includes a data integrity verification database unit 702b, used to store data integrity verification information.

[0079] The data storage and recovery module 703 includes a data storage and recovery unit 703a, where backup data is typically stored on reliable media such as disk arrays, tape libraries, or cloud storage. When data recovery is required, the system can restore the data to its original state from the backup media. It also includes a data storage and recovery database unit 703b, which stores data storage and recovery information.

[0080] The data recovery testing module 704 includes a data recovery testing unit 704a, which performs data recovery tests periodically to ensure the availability of backup data. These tests verify the integrity of the backup data and ensure successful data recovery when needed. It also includes a data recovery testing database unit 704b, which stores data recovery test information.

[0081] The disaster recovery and emergency recovery plan module 705 includes a disaster recovery and emergency recovery plan unit 705a. The clinical trial source data traceability and tracking system may also include disaster recovery and emergency recovery plans to deal with unexpected events or disasters. These plans typically include offline storage of backup data, failover of backup equipment, disaster recovery testing, etc.; it also includes a disaster recovery and emergency recovery plan database unit 705b for storing disaster recovery and emergency recovery plan information.

[0082] like Figure 8The data reporting and analysis module 8 includes a data report generation module 801, a data visualization module 802, a data analysis tool module 803, a data query and filtering module 804, and a data comparison and trend analysis module 805. The data reporting and analysis module 8 of the clinical trial source data tracing and tracking system aims to provide data visualization and analysis, helping researchers and managers better understand and utilize clinical trial data. Through its data reporting and analysis functions, the clinical trial source data tracing and tracking system can provide rich data display and analysis tools, helping users to deeply understand clinical trial data, discover potential correlations and trends, and make data-driven decisions and optimizations. This helps strengthen the monitoring and management of clinical trials and provides strong support for further research and decision-making. The following are some of the main features of this function:

[0083] The data report generation module 801 includes a data report generation unit 801a, which can generate various types of data reports according to user needs, including data summary reports, statistical reports, trend charts, etc. Reports can be customized based on specific indicators and variables to meet the needs of different users. It also includes a data report generation database unit 801b, used to store data report generation information.

[0084] The data visualization module 802 includes a data visualization unit 802a, which allows the system to display clinical trial data in a visual format, such as charts, graphs, and heatmaps. This data visualization method helps users intuitively understand and analyze the data, and discover patterns, trends, and anomalies. It also includes a data visualization database unit 802b, which is used to store data visualization information.

[0085] The data analysis tool module 803 includes a data analysis tool unit 803a, which may provide some built-in data analysis tools or integrate with external data analysis tools to perform various analysis tasks. These tools can support methods such as statistical analysis, data mining, and machine learning to help users explore data, discover correlations, make predictions, and build models; it also includes a data analysis tool database unit 803b for storing data analysis tool information.

[0086] The data query and filtering module 804 includes a data query and filtering unit 804a, which provides data query and filtering functions for the system. Users can quickly retrieve and filter the required data subsets for analysis based on specific conditions and needs. These query and filtering conditions can be set based on variables, time ranges, subject attributes, etc.; it also includes a data query and filtering database unit 804b, which stores data query and filtering information.

[0087] The data comparison and trend analysis module 805 includes a data comparison and trend analysis unit 805a, which supports data comparison and trend analysis between different groups or time points. Users can compare data differences between different treatment groups or analyze the data change trends of the same group at different time points to evaluate the effectiveness and progress of clinical trials; it also includes a data comparison and trend analysis database unit 805b for storing data comparison and trend analysis information.

[0088] The above description is merely a preferred embodiment of the present invention. The scope of protection of the present invention is not limited to the above embodiments. All technical solutions falling within the scope of the present invention's concept are within the scope of protection of the present invention. It should be noted that for those skilled in the art, any improvements and modifications made without departing from the principles of the present invention should also be considered within the scope of protection of the present invention.

Claims

1. A clinical trial source data traceability and tracking system, characterized in that, Data identification and indexing end (1), data collection and recording end (2), data change tracking end (3), data tracing and traceability end (4), data verification and auditing end (5), data access and access control end (6), data backup and recovery end (7), data reporting and analysis end (8); The data identification and indexing end (1), data collection and recording end (2), data change tracking end (3), data tracing and tracking end (4), data verification and auditing end (5), data access and permission control end (6), data backup and recovery end (7), and data reporting and analysis end (8) communicate with each other via a dedicated network.

2. The clinical trial source data traceability system according to claim 1, characterized in that, The data identifier and index terminal (1) is used to assign a unique identifier to each data element and establish an index for subsequent tracing and tracking operations. The data identifier and index terminal (1) includes a data element identifier generation module (101), a data element index establishment module (102), an associated data element module (103), a data element attribute recording module (104), and an identifier and data association module (105). The data element identifier generation module is used to generate a unique identifier for each data element. The data element index building module (102) is used to build an index based on the identifier of the data element so as to quickly find and access the data. The associated data element module (103) is used to associate related data elements according to the relationship and dependency of the data. The data element attribute recording module (104) is used to record the attribute information of each data element. The identifier and data association module (105) is used to associate the identifier of the data element with the actual data.

3. The clinical trial source data traceability system according to claim 1, characterized in that, The data acquisition and recording terminal (2) is used to collect and record source data of clinical trials. The data acquisition and recording terminal (2) includes a data acquisition interface module (201), a data entry and verification module (202), a data recording and timestamp module (203), a data association and dependency module (204), and a data storage and backup module (205). The data acquisition interface module (201) is used to provide a data acquisition interface for inputting source data of clinical trials. The data entry and verification module (202) is used to support manual data entry and automatic verification. The data recording and timestamp module (203) is used to record the entry time and operator information of each data. The data association and dependency module (204) is used to identify the association and dependency between data. The data storage and backup module (205) is used to securely store the collected source data and perform data backup regularly.

4. The clinical trial source data traceability and tracking system according to claim 3, characterized in that, The data change tracking terminal (3) is used to track and record the change history of clinical trial source data in order to achieve the source tracing and tracking of data changes. The data change tracking terminal (3) includes a change record module (301), a timestamp and version control module (302), an audit and verification module (303), a data rollback module (304), and a change notification and reminder module (305). The change record module (301) is used to record the details of each data change. The timestamp and version control module (302) is used to generate a timestamp for each data change and record the version information of the change. The audit and verification module (303) is used to support the audit and verification of data changes. The data rollback module (304) is used to provide the function of data rollback to restore the data to a previous version or state. The change notification and reminder module (305) is used to send notifications and reminders to relevant personnel to inform them of the data change.

5. The clinical trial source data traceability and tracking system according to claim 4, characterized in that, The data tracing and tracking terminal (4) is used to realize the tracing and tracking of clinical trial source data. The data tracing and tracking terminal (4) includes a data source identification module (401), a data link establishment module (402), a data tracing query module (403), a data association analysis module (404), and a data tracing report module (405). The data source identification module (401) is used to identify the source of each data item. The data link establishment module (402) is used to establish links between data to form data flow and transmission path. The data traceability query module (403) is used to provide query function. The data association analysis module (404) is used to analyze and display the association relationship between different data. The data traceability report module (405) is used to generate a data traceability report to describe the traceability information and traceability process of the data.

6. The clinical trial source data traceability and tracking system according to claim 5, characterized in that, The data verification and auditing terminal (5) is used to verify and audit the source data of clinical trials. The data verification and auditing terminal (5) includes a data verification rule module (501), a data auditing process module (502), a data anomaly detection module (503), a data consistency check module (504), and a data auditing record module (505). The data verification rule module (501) is used to set a series of data verification rules to check the legality and accuracy of the data. The data audit process module (502) is used to establish a data audit process, define the audit links and responsible persons. The data anomaly detection module (503) is used to automatically detect anomalies in the data. The data consistency check module (504) is used to check the consistency between different data. The data audit record module (505) is used to record the data audit process and results.

7. The clinical trial source data traceability system according to claim 1, characterized in that, The data access and permission control terminal (6) is used to ensure the security and confidentiality of data. The data access and permission control terminal (6) includes a user authentication module (601), a user role and permission management module (602), a data access control module (603), and a data operation audit module (604). The user authentication module (601) is used to require users to authenticate themselves. The user role and permission management module (602) is used to set different user roles and assign specific permissions to each role. The data access control module (603) is used to restrict users' access to data according to their roles and permissions. The data operation audit module (604) is used to record users' operations on data.

8. The clinical trial source data traceability and tracking system according to claim 7, characterized in that, The data access and permission control terminal (6) also includes a data encryption and decryption module (605), which is used to encrypt and store sensitive data using an encryption algorithm.

9. The clinical trial source data traceability system according to claim 1, characterized in that, The data backup and recovery terminal (7) is used to ensure data security and recoverability. The data backup and recovery terminal (7) includes a regular backup module (701), a data integrity verification module (702), a data storage and recovery module (703), a data recovery test module (704), and a disaster recovery and emergency recovery plan module (705). The periodic backup module (701) is used to perform periodic backups of data according to a set time interval or a specific time point. The data integrity verification module (702) is used to perform integrity verification on the backed-up data. The data storage and recovery module (703) is used to store the backup data on media. The data recovery test module (704) is used to perform data recovery tests periodically. The disaster recovery and emergency recovery plan module (705) is used to provide disaster recovery and emergency recovery plans.

10. The clinical trial source data traceability system according to claim 9, characterized in that, The data reporting and analysis terminal (8) is used to provide data visualization and analysis. The data reporting and analysis terminal (8) includes a data report generation module (801), a data visualization module (802), a data analysis tool module (803), a data query and filtering module (804), and a data comparison and trend analysis module (805). The data report generation module (801) is used to generate various types of data reports according to user needs. The data visualization module (802) is used to display clinical trial data in a visual form. The data analysis tool module (803) is used to provide data analysis tools or integrate with external data analysis tools to perform various analysis tasks. The data query and filtering module (804) is used to provide data query and filtering functions. The data comparison and trend analysis module (805) is used to support data comparison and trend analysis between different groups or time points.

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