Clinical test item inspection operation system

Abstract

The invention provides a clinical test item inspection operation system, which relates to the technical field of drug clinical tests and comprises an inspection plan management end, an inspection task distribution end, an inspection recording and reporting end, an inspection data management end, an inspection tracking and reminding end and a compliance and quality control end. The inspection plan management end, the inspection task distribution end, the inspection recording and reporting end, the inspection data management end, the inspection tracking and reminding end and the compliance and quality control end are in data communication through a private network and a private line network; the inspection plan management end is used for setting an inspection target and an inspection range of a qualified inspection plan and managing basic information and resources related to the qualified inspection plan; the system can improve the efficiency and accuracy of inspection work, ensure the compliance and quality of tests, and promote the cooperation and communication between inspectors and related personnel.

Description

Technical Field

[0001] The present invention relates to the technical field of drug clinical trials, and in particular to a clinical trial project auditing operation system. Background Art

[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 often involve complex design, data collection, analysis, and reporting processes, and must adhere to strict regulatory and ethical requirements.

[0003] In clinical trials, auditing refers to the inspection and evaluation of the clinical trial process and the implementation of the trial center to ensure the compliance of the trial, the reliability of the data, and the protection of the rights and interests of trial participants. The traditional auditing process has the following flaws:

[0004] Time-consuming: Manual auditing takes a lot of time, especially for complex test projects that require checking large amounts of documents and data.

[0005] High labor costs: Recruiting and training specialized auditors requires a lot of human resources and costs.

[0006] Omission issues: Manual audits may miss issues due to negligence or fatigue, affecting the completeness and accuracy of the data.

[0007] Lack of real-time performance: Manual audits often take time to complete and cannot monitor the test process and data in real time.

[0008] Difficulty in processing big data: For large-scale clinical trials, manual audits require processing large amounts of data and documents, making them difficult to conduct efficiently.

[0009] Human Error: Manual audits may affect the accuracy of data due to human errors such as entry errors and omissions.

[0010] Not suitable for complex data analysis: For experiments requiring complex data analysis, manual auditing is difficult to fully play its role and may miss the correlations and trends behind the data.

[0011] Difficulty in tracking the problem-solving process: In manual audits, the problem discovery and resolution process may not be transparent enough, making it difficult to effectively track the resolution of the problem.

[0012] Therefore, there is room for improvement, and the present invention provides a clinical trial project auditing system. Summary of the Invention

[0013] In view of the shortcomings of the existing technology, the present invention aims to propose a clinical trial project audit operation system, the specific scheme is as follows:

[0014] A clinical trial project audit operation system includes an audit plan management terminal, an audit task allocation terminal, an audit record and report terminal, an audit data management terminal, an audit tracking and reminder terminal, and a compliance and quality control terminal. The audit plan management terminal, the audit task allocation terminal, the audit record and report terminal, the audit data management terminal, the audit tracking and reminder terminal, and the compliance and quality control terminal communicate with each other via a dedicated network and dedicated line.

[0015] The audit plan management terminal is used to set the audit objectives and audit scope of the qualified audit plan, and manage the basic information and resources related to the qualified audit plan;

[0016] The audit task assignment end creates audit tasks with different dates and priorities for the qualified audit plans in the audit plan management end, and assigns personnel, notifies, and tracks different audit tasks.

[0017] The audit record and report terminal is used to record the data and issues of each audit task in real time and to process the audit records later;

[0018] The audit data management terminal is used to supplement the audit records and provide query and protection functions for all data in the audit records, as well as subsequent sorting;

[0019] The audit tracking and reminder terminal is used to assign and track audit tasks, and to set reminders and manage audit tasks;

[0020] The compliance and quality control end is used to conduct a comprehensive compliance review of each audit task, and to perform quality control and management on the documents and data during the audit task process.

[0021] Furthermore, the audit plan management terminal includes an audit target setting module, an audit scope determination module, an audit schedule planning module, an auditor assignment module, an audit resource management module, and an audit plan document management module;

[0022] The audit target setting module is used by users to define the goals and objectives of the audit, the audit scope determination module is used by users to determine the scope and boundaries of the audit, the audit schedule planning module is used to plan and arrange the time and cycle of the audit plan, the auditor assignment module is used by users to specify the audit team to implement subsequent allocation of audit tasks, the audit resource management module is used to help users manage the resources required for the audit, and the audit plan document management module is used to provide document management functions.

[0023] Furthermore, the audit plan management terminal also includes an audit plan approval and authorization module, which is used to support the approval and authorization process of the audit plan to determine the eligibility of the audit plan.

[0024] Furthermore, the audit task allocation terminal includes a task creation and definition module, an auditor allocation module, a task priority and deadline module, a task status tracking module, and a task assignment notification module;

[0025] The task creation and definition module is used by users to create audit tasks and clarify the specific content and requirements of the tasks. The auditor assignment module is used by users to select suitable auditors from the available audit teams and assign tasks. The task priority and deadline module is used by users to set the priority and deadline for each audit task. The task status tracking module is used to provide task status tracking function. The task assignment notification module is used to send task assignment notifications to relevant auditors.

[0026] Furthermore, the audit task allocation terminal also includes a task collaboration and discussion module for providing collaboration and discussion functions for audit tasks.

[0027] Furthermore, the audit record and report terminal includes an audit record creation module, an audit data entry module, an audit question management module, an audit report generation module, a report review and approval module, and an audit record query and export module;

[0028] The audit record creation module is used by users to create audit records, the audit data entry module is used to provide an audit data entry interface to input and record data collected during the audit process, the audit problem management module is used by users to record and manage problems or violations found during the audit process, the audit record query and export module is used to provide query and export functions for audit records, the audit report generation module is used to provide audit report generation functions, and the report review and approval module is used for relevant personnel to review and approve the generated audit reports.

[0029] Furthermore, the audit data management terminal includes a data entry and storage module, a data check and verification module, a data query and retrieval module, a data export and sharing module, a data review and approval module, and a data security and privacy protection module;

[0030] The data entry and storage module is used for the data secondary entry interface to input and store audit data, the data check and verification module is used to perform data check and verification, the data query and retrieval module is used to provide data query and retrieval functions, the data export and sharing module is used for users to export audit data into common file formats, the data review and approval module is used for relevant personnel to review and approve audit data, and the data security and privacy protection module is used to provide corresponding security measures.

[0031] Furthermore, the audit tracking and reminder terminal includes an audit task tracking module, a reminder and notification module, an audit plan management module, a task allocation and assignment module, and a schedule management module;

[0032] The task allocation and assignment module is used to automatically adjust and assign tasks to corresponding auditors based on the nature and requirements of the audit tasks. The audit task tracking module is used to provide audit task tracking functions. The reminder and notification module is used to send reminders and notifications to relevant personnel. The audit plan management module is used for users to create and manage audit plans and set corresponding reminders and deadlines. The schedule management module is used to provide schedule management functions to view and manage the schedule of audit tasks.

[0033] Furthermore, the compliance and quality control end includes a compliance audit module, a data quality control module, a file management and version control module, an audit and review management module, and a quality indicator and indicator monitoring module;

[0034] The compliance audit module is used to audit the compliance of the test project, the data quality control module is used to provide data quality control functions, the file management and version control module is used to provide file management and version control functions, the audit and review management module is used to support the management of the audit and review process, and the quality indicator and indicator monitoring module is used to define and track the quality indicators of the test project.

[0035] Compared with the prior art, the present invention has the following beneficial effects:

[0036] (1) The Clinical Trial Project Audit Operation System is a system specifically designed to manage and execute clinical trial project audits. It plays an important role in trial project management and oversight, helping to ensure the reliability and credibility of the trials. The system provides a centralized platform for planning, executing, recording, and managing audit activities, and supports collaboration and data management during the audit process.

[0037] (2) Through the clinical trial project audit operation system, improve the efficiency and accuracy of the audit work, ensure the compliance and quality of the trial, and promote collaboration and communication between auditors and relevant personnel. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 This is a flowchart of the audit plan management end in the present invention;

[0039] Figure 2 This is a flow chart of the audit task allocation end in the present invention;

[0040] Figure 3 Schematic diagram of the process of audit record and report in the present invention;

[0041] Figure 4 Schematic diagram of the process of auditing data management terminal in the present invention;

[0042] Figure 5 Schematic diagram of the process of the audit tracking and reminder terminal in the present invention;

[0043] Figure 6 Schematic diagram of the process of compliance and quality control in the present invention.

[0044] Reference numerals: 1. Audit plan management terminal; 101. Audit target setting module; 101a. Audit target setting unit; 101b. Audit target setting database unit; 102. Audit scope determination module; 102a. Audit scope determination unit; 102b. Audit scope determination database unit; 103. Audit schedule planning module; 103a. Audit schedule planning unit; 103b. Audit schedule planning database unit; 104. Auditor dispatching module; 104a. Auditor dispatching unit; 104b. Auditor dispatching database unit; 105. Audit resource management module; 105a. Audit resource management unit; 105b. Audit resource management database unit; 106. Audit plan document management module; 106a, audit plan document management unit; 106b, audit plan document management database unit; 107, audit plan approval and authorization module; 107a, audit plan approval and authorization unit; 107b, audit plan approval and authorization database unit; 2. Audit task allocation terminal; 201, task creation and definition module; 201a, task creation and definition unit; 201b, task creation and definition database unit; 202, auditor allocation module; 202a, auditor allocation unit; 202b, auditor allocation database unit; 203, task priority and deadline module; 203a, task priority and deadline unit; 203b, task priority and deadline database unit; 204, task status Tracking module; 204a, task status tracking unit; 204b, task status tracking database unit; 205, task assignment notification module; 205a, task assignment notification unit; 205b, task assignment notification database unit; 206, task collaboration and discussion module; 206a, task collaboration and discussion unit; 206b, task collaboration and discussion database unit; 3, audit record and report terminal; 301, audit record creation module; 301a, audit record creation unit; 301b, audit record creation database unit; 302, audit data entry module; 302a, audit data entry unit; 302b, audit data entry database unit; 303, audit problem management module; 303a, audit problem management Unit; 303b, audit problem management database unit; 304, audit report generation module; 304a, audit report generation unit; 304b, audit report generation database unit; 305, report review and approval module; 305a, report review and approval unit; 305b, report review and approval database unit; 306, audit record query and export module; 306a, audit record query and export unit; 306b, audit record query and export database unit; 4, audit data management terminal; 401, data entry and storage module; 401a, data entry and storage unit; 401b, data entry and storage database unit; 402, data verification and validation module; 402a, data verification and validation unit;402b, Data Verification and Authentication Database Unit; 403, Data Query and Retrieval Module; 403a, Data Query and Retrieval Unit; 403b, Data Query and Retrieval Database Unit; 404, Data Export and Sharing Module; 404a, Data Export and Sharing Unit; 404b, Data Export and Sharing Database Unit; 405, Data Review and Approval Module; 405a, Data Review and Approval Unit; 405b, Data Review and Approval Database Unit; 406, Data Security and Privacy Protection Module; 406a, data security and privacy protection unit; 406b, data security and privacy protection database unit; 5, audit tracking and reminder terminal; 501, audit task tracking module; 501a, audit task tracking unit; 501b, audit task tracking database unit; 502, reminder and notification module; 502a, reminder and notification unit; 502b, reminder and notification database unit; 503, audit plan management module; 503a, audit plan management unit; 503b, audit plan Management database unit; 504, Task allocation and assignment module; 504a, Task allocation and assignment unit; 504b, Task allocation and assignment database unit; 505, Schedule management module; 505a, Schedule management unit; 505b, Schedule management database unit; 6, Compliance and quality control terminal; 601, Compliance audit module; 601a, Compliance audit unit; 601b, Compliance audit database unit; 602, Data quality control module; 602a, Data quality control unit; 602b, Data quality control database unit; 603, File management and version control module; 603a, File management and version control unit; 603b, File management and version control database unit; 604, Audit and review management module; 604a, Audit and review management unit; 604b, Audit and review management database unit; 605, Quality indicator and indicator monitoring module; 605a, Quality indicator and indicator monitoring unit; 605b, Quality indicator and indicator monitoring database unit. DETAILED DESCRIPTION

[0045] The present invention will be further described in detail below with reference to the embodiments and drawings, but the embodiments of the present invention are not limited thereto.

[0046] The present invention provides a clinical trial project audit operation system, including an audit plan management terminal 1, an audit task allocation terminal 2, an audit record and report terminal 3, an audit data management terminal 4, an audit tracking and reminder terminal 5, and a compliance and quality control terminal 6. The audit plan management terminal 1, the audit task allocation terminal 2, the audit record and report terminal 3, the audit data management terminal 4, the audit tracking and reminder terminal 5, and the compliance and quality control terminal 6 communicate data through a dedicated network and a dedicated line network.

[0047] like Figure 1The audit plan management terminal 1 is used to set the audit objectives and audit scope of the qualified audit plan, and manage the basic information and resources related to the qualified audit plan; the audit plan management terminal 1 includes an audit objective setting module 101, an audit scope determination module 102, an audit schedule planning module 103, an auditor assignment module 104, an audit resource management module 105, and an audit plan document management module 106.

[0048] The audit target setting module 101 includes an audit target setting unit 101a, which allows the system to allow users to define audit goals and objectives. These may include confirming that the test complies with regulatory requirements, verifying the accuracy of test data, and evaluating the compliance of the test process. It also includes an audit target setting database unit 101b, which is used to store audit target setting information.

[0049] The audit scope determination module 102 includes an audit scope determination unit 102a, which allows the system to allow users to determine the scope and boundaries of the audit, clearly identifying the test steps, data sources, and files that need to be audited. This helps ensure the comprehensiveness and accuracy of the audit work; and an audit scope determination database unit 102b, which stores audit scope determination information.

[0050] The audit schedule planning module 103 includes an audit schedule planning unit 103a, which provides a system schedule function for planning and scheduling audit activities. Users can set the start and end dates of audit tasks and specify the required audit frequency. It also includes an audit schedule planning database unit 103b, which stores audit schedule planning information.

[0051] The auditor assignment module 104 includes an auditor assignment unit 104a, which allows the system user to designate an audit team and assign audit tasks to corresponding personnel. This can be achieved through the role allocation and task distribution mechanism within the system; and an auditor assignment database unit 104b, which stores auditor assignment information.

[0052] The audit resource management module 105 includes an audit resource management unit 105a, which helps users manage the resources needed for audits, such as auditor qualifications and training, audit tools and equipment, etc. Users can record and track auditor information and ensure that they have the appropriate capabilities and knowledge. It also includes an audit resource management database unit 105b, which is used to store audit resource management information.

[0053] The audit plan document management module 106 includes an audit plan document management unit 106a, which provides system document management functionality and is used to store and manage audit plan-related documents and files. Users can upload, share, and update audit plan documents for access and reference by team members and relevant stakeholders. It also includes an audit plan document management database unit 106b, which stores audit plan document management information.

[0054] The audit plan management terminal 1 also includes an audit plan approval and authorization module 107, which is used to support the audit plan approval and authorization process to determine the eligibility of the audit plan. The module includes an audit plan approval and authorization unit 107a, which is used to systemically support the audit plan approval and authorization process. Relevant personnel can review and approve the audit plan to ensure its compliance and effectiveness; and an audit plan approval and authorization database unit 107b, which is used to store audit plan approval and authorization information.

[0055] like Figure 2 The audit task allocation terminal 2 creates audit tasks with different dates and priorities for the qualified audit plans in the audit plan management terminal 1, and assigns personnel, notifies and tracks different audit tasks; the audit task allocation terminal 2 includes a task creation and definition module 201, an auditor allocation module 202, a task priority and deadline module 203, a task status tracking module 204, a task assignment notification module 205, and a task collaboration and discussion module 206.

[0056] The task creation and definition module 201 includes a task creation and definition unit 201a, which allows users to create audit tasks and specify the specific content and requirements of the tasks. Users can specify task information such as the title, description, audit object, and audit criteria to ensure the accuracy and clarity of the tasks. It also includes a task creation and definition database unit 201b, which stores task creation and definition information.

[0057] The auditor assignment module 202 includes an auditor assignment unit 202a, which allows the system user to select appropriate auditors from a list of available auditors and assign tasks to them. Users can assign auditors based on factors such as their experience, ability, and availability to ensure the quality and efficiency of task completion. It also includes an auditor assignment database unit 202b, which stores auditor assignment information.

[0058] The task priority and deadline module 203 includes a task priority and deadline unit 203a, which allows the system user to set a priority and deadline for each audit task. This helps auditors understand the urgency and completion time of tasks, helping them optimize work planning and time management. It also includes a task priority and deadline database unit 203b, which stores task priority and deadline information.

[0059] The task status tracking module 204 includes a task status tracking unit 204a, which provides task status tracking functionality, allowing users and auditors to track task progress in real time. Users can view the current status, progress, and completion of tasks, as well as related notes and updates. It also includes a task status tracking database unit 204b, which stores task status tracking information.

[0060] The task assignment notification module 205 includes a task assignment notification unit 205a, which is used by the system to send task assignment notifications to relevant auditors, notifying them of the new audit task they have been assigned. This can be achieved through the system's internal notification mechanism, email, or other appropriate communication methods; and a task assignment notification database unit 205b, which is used to store task assignment notification information.

[0061] The task collaboration and discussion module 206 is used to provide collaboration and discussion functions for audit tasks. It includes a task collaboration and discussion unit 206a, which supports the collaboration and discussion functions of audit tasks, allowing auditors to communicate and exchange ideas on task-related matters. This helps improve the efficiency of team collaboration and problem solving. It also includes a task collaboration and discussion database unit 206b, which stores task collaboration and discussion information.

[0062] like Figure 3 The audit record and report terminal 3 is used to make real-time audit records of data and issues for each audit task, and to perform subsequent processing of the audit records; the audit record and report terminal 3 includes an audit record creation module 301, an audit data entry module 302, an audit problem management module 303, an audit report generation module 304, a report review and approval module 305, and an audit record query and export module 306.

[0063] The audit record creation module 301 includes an audit record creation unit 301a, which allows users to create audit records to record key information and findings during the audit process. Users can enter information such as the audit date, location, participants, audit items, audit standards, and issues found. It also includes an audit record creation database unit 301b, which stores audit record creation information.

[0064] The audit data entry module 302 includes an audit data entry unit 302a, which provides an audit data entry interface for the system, allowing users to conveniently enter and record data collected during the audit process. This can include records of audit activities such as subject visits, data collection, and document review; and an audit data entry database unit 302b, which stores the audit data entry information.

[0065] The audit issue management module 303 includes an audit issue management unit 303a, which allows users to record and manage issues or violations discovered during the audit process. Users can describe the nature and severity of the issue, relevant evidence, and suggested solutions for subsequent tracking and processing. It also includes an audit issue management database unit 303b, which stores audit issue management information.

[0066] The audit record query and export module 306 includes an audit record query and export unit 306a, which provides audit record query and export functionality, allowing users to retrieve and export audit record data on demand. This facilitates analysis and tracking of audit work and meets relevant audit and compliance requirements. It also includes an audit record query and export database unit 306b, which stores audit record query and export information.

[0067] The audit report generation module 304 includes an audit report generation unit 304a, which provides the system with audit report generation functionality and automatically generates audit reports summarizing the results and findings of audit work. The reports may include an overview of the audit activities, a summary of issues, recommended measures, and improvement plans for sharing with relevant stakeholders. The module also includes an audit report generation database unit 304b, which stores audit report generation information.

[0068] The report review and approval module 305 includes a report review and approval unit 305a, which allows relevant personnel to review and approve the generated audit report. Reviewers can view the report content and provide feedback, and approvers can confirm the accuracy and completeness of the report. It also includes a report review and approval database unit 305b, which stores report review and approval information.

[0069] like Figure 4 The audit data management terminal 4 is used to supplement the audit records, and provide query and protection functions for all data in the audit records, as well as subsequent sorting; the audit data management terminal 4 includes a data entry and storage module 401, a data check and verification module 402, a data query and retrieval module 403, a data export and sharing module 404, a data review and approval module 405, and a data security and privacy protection module 406.

[0070] The data entry and storage module 401 includes a data entry and storage unit 401a, which provides a secondary data entry interface for the system, allowing auditors to conveniently enter and store audit data. If auditors fail to enter audit data in a timely manner in the audit data entry module 302 of the audit record and report terminal 3, the data entry and storage module 401 can re-enter audit-related data, including subject visit data, data collection forms, document review results, and other data. The module also includes a data entry and storage database unit 401b, which is used to store data entry and storage information.

[0071] The data verification and validation module 402 includes a data verification and validation unit 402a, which is used by the system to perform data verification and validation to ensure that the input data meets predetermined specifications and requirements. This may include checking data ranges, verifying data formats, confirming logical relationships, etc.; and a data verification and validation database unit 402b, which is used to store data verification and validation information.

[0072] The data query and retrieval module 403 includes a data query and retrieval unit 403a, which provides data query and retrieval functionality, allowing users to quickly find required audit data based on specific query criteria. Users can query based on audit date, audit item, subject information, etc. to obtain specific audit data sets. It also includes a data query and retrieval database unit 403b, which stores data query and retrieval information.

[0073] The data export and sharing module 404 includes a data export and sharing unit 404a, which allows users to export audit data into common file formats (such as Excel, CSV, etc.) for further analysis and sharing. The exported data can be used for report generation, statistical analysis, data cleaning, etc.; and a data export and sharing database unit 404b, which is used to store data export and sharing information.

[0074] The data review and approval module 405 includes a data review and approval unit 405a, which allows relevant personnel to review and approve audit data. Reviewers can check the accuracy, completeness, and consistency of the data and provide feedback and corrective suggestions. Approval personnel can confirm the credibility and usability of the data. It also includes a data review and approval database unit 405b, which is used to store data review and approval information.

[0075] The data security and privacy protection module 406 includes a data security and privacy protection unit 406a, which is used to ensure that the system has appropriate security measures to protect the security and privacy of audit data. This may include security measures such as data encryption, access control, and data backup to ensure data confidentiality and integrity. It also includes a data security and privacy protection database unit 406b, which is used to store data security and privacy protection information.

[0076] like Figure 5 The audit tracking and reminder terminal 5 is used to allocate and track audit tasks, and to set reminders and management of audit tasks; the audit tracking and reminder terminal 5 includes an audit task tracking module 501, a reminder and notification module 502, an audit plan management module 503, a task allocation and assignment module 504, and a schedule management module 505.

[0077] The task allocation and assignment module 504 includes a task allocation and assignment unit 504a, which allows the system to automatically assign tasks to appropriate auditors based on the nature and requirements of the audit task. The task assignment function ensures that each audit task is assigned to a dedicated person and can be adjusted as needed. It also includes a task allocation and assignment database unit 504b, which is used to store task allocation and assignment information.

[0078] The audit task tracking module 501 includes an audit task tracking unit 501a, which provides the system with audit task tracking functionality, allowing users to clearly understand the status and progress of each audit task. Users can view completed audit tasks, ongoing audit tasks, and pending audit tasks. It also includes an audit task tracking database unit 501b, which stores audit task tracking information.

[0079] The reminder and notification module 502 includes a reminder and notification unit 502a, which is used by the system to send reminders and notifications to relevant personnel to ensure that audit tasks are completed on time. This can include sending emails, text messages, or internal system notifications to remind relevant personnel to perform specific audit tasks or address specific issues. It also includes a reminder and notification database unit 502b, which is used to store reminder and notification information.

[0080] The audit plan management module 503 includes an audit plan management unit 503a, which allows users to create and manage audit plans and set corresponding reminders and deadlines. The system can automatically remind users of upcoming audit tasks or plans to ensure that tasks are completed as planned. It also includes an audit plan management database unit 503b, which is used to store audit plan management information.

[0081] The schedule management module 505 includes a schedule management unit 505a, which provides schedule management functionality and allows users to view and manage the schedule of audit tasks. Users can view the start time, end time, and deadline of each audit task, as well as any conflicts with other tasks. It also includes a schedule management database unit 505b, which stores schedule management information.

[0082] like Figure 6 The compliance and quality control terminal 6 is used to conduct a comprehensive compliance review of each audit task, and to perform quality control and management on the documents and data during the audit task. The compliance and quality control terminal 6 includes a compliance review module 601, a data quality control module 602, a file management and version control module 603, an audit and review management module 604, and a quality indicator and indicator monitoring module 605.

[0083] The compliance audit module 601 includes a compliance audit unit 601a, which is used to audit the compliance of trial projects, including the trial plan, trial documents, subject recruitment process, data collection and management, etc. The system can check whether the trial complies with applicable regulations, guidelines, and standards and provide necessary guidance and suggestions. It also includes a compliance audit database unit 601b, which is used to store compliance audit information.

[0084] The data quality control module 602 includes a data quality control unit 602a, which provides data quality control functions for the system and monitors the accuracy, completeness, and consistency of test data. The system can perform data validation and logic checks, and identify potential data issues and anomalies. Furthermore, the system can generate data quality reports to help users identify and resolve data quality issues. It also includes a data quality control database unit 602b, which stores data quality control information.

[0085] The file management and version control module 603 includes a file management and version control unit 603a, which provides file management and version control functionality for managing test files and related documents. Users can upload, share, and update test files, ensuring that each version of the file is properly managed and controlled. This helps ensure the consistency and timely updating of test files. It also includes a file management and version control database unit 603b, which stores file management and version control information.

[0086] The audit and review management module 604 includes an audit and review management unit 604a, which supports the management of the audit and review process, including the generation and management of audit plans, audit records, and audit reports. The system can record audit and review results and track the implementation of relevant corrective and preventive measures, helping to ensure compliance and quality control of the test project. It also includes an audit and review management database unit 604b, which stores audit and review management information.

[0087] The quality indicator and indicator monitoring module 605 includes a quality indicator and indicator monitoring unit 605a, which allows the system to define and track quality indicators for test items to evaluate test execution and results. The system can generate quality indicator reports to help users understand the quality status of the test and take necessary measures to improve it. It also includes a quality indicator and indicator monitoring database unit 605b, which is used to store quality indicator and indicator monitoring 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 embodiment. All technical solutions based on the concept of the present invention are within the scope of protection of the present invention. It should be noted that for those skilled in the art, various improvements and modifications that do not depart 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 project audit system, characterized by: The system comprises an audit plan management terminal (1), an audit task allocation terminal (2), an audit record and report terminal (3), an audit data management terminal (4), an audit tracking and reminder terminal (5), and a compliance and quality control terminal (6), wherein data communication is performed among the audit plan management terminal (1), the audit task allocation terminal (2), the audit record and report terminal (3), the audit data management terminal (4), the audit tracking and reminder terminal (5), and the compliance and quality control terminal (6) via a dedicated network and dedicated line. Audit plan management terminal (1) is used to set the audit objectives and audit scope of the qualified audit plan, and manage the basic information and resources related to the qualified audit plan; The audit task assignment terminal (2) creates audit tasks with different dates and priorities for the qualified audit plans in the audit plan management terminal (1), and assigns personnel, notifies, and tracks different audit tasks; The audit record and report terminal (3) is used to record the data and issues of each audit task in real time and to process the audit records later; The audit data management terminal (4) is used to supplement the audit records and provide query and protection functions for all data in the audit records as well as subsequent sorting; The audit tracking and reminder terminal (5) is used to assign and track audit tasks, and to set reminders and manage audit tasks; The compliance and quality control terminal (6) is used to conduct a comprehensive compliance review of each audit task and to perform quality control and management on the documents and data during the audit task process.

2. The clinical trial project auditing system according to claim 1, characterized in that: The audit plan management terminal (1) includes an audit target setting module (101), an audit scope determination module (102), an audit schedule planning module (103), an auditor assignment module (104), an audit resource management module (105), and an audit plan document management module (106); The audit target setting module (101) is used by the user to define the goals and objectives of the audit, the audit scope determination module (102) is used by the user to determine the scope and boundaries of the audit, the audit schedule planning module (103) is used to plan and arrange the time and cycle of the audit plan, the auditor assignment module (104) is used by the user to specify the audit team to implement the subsequent allocation of audit tasks, the audit resource management module (105) is used to help the user manage the resources required for the audit, and the audit plan document management module (106) is used to provide document management functions.

3. The clinical trial project auditing system according to claim 2, characterized in that: The audit plan management terminal (1) further comprises an audit plan approval and authorization module (107), wherein the audit plan approval and authorization module (107) is used to support the audit plan approval and authorization process to determine the eligibility of the audit plan.

4. The clinical trial project auditing system according to claim 1, characterized in that: The audit task allocation terminal (2) includes a task creation and definition module (201), an auditor allocation module (202), a task priority and deadline module (203), a task status tracking module (204), and a task assignment notification module (205); The task creation and definition module (201) is used by users to create audit tasks and clarify the specific content and requirements of the tasks. The auditor allocation module (202) is used by users to select suitable auditors from the available audit teams and assign tasks. The task priority and deadline module (203) is used by users to set the priority and deadline for each audit task. The task status tracking module (204) is used to provide a task status tracking function. The task assignment notification module (205) is used to send task assignment notifications to relevant auditors.

5. The clinical trial project auditing system according to claim 4, characterized in that: The audit task distribution terminal (2) also includes a task collaboration and discussion module (206) for providing collaboration and discussion functions for audit tasks.

6. The clinical trial project auditing system according to claim 1, characterized in that: The audit record and report terminal (3) includes an audit record creation module (301), an audit data entry module (302), an audit problem management module (303), an audit report generation module (304), a report review and approval module (305), and an audit record query and export module (306); The audit record creation module (301) is used for users to create audit records, the audit data entry module (302) is used to provide an audit data entry interface for inputting and recording data collected during the audit process, the audit problem management module (303) is used for users to record and manage problems or violations found during the audit process, the audit record query and export module (306) is used to provide the query and export functions of audit records, the audit report generation module (304) is used to provide the audit report generation function, and the report review and approval module (305) is used for relevant personnel to review and approve the generated audit report.

7. The clinical trial project auditing system according to claim 6, characterized in that: The audit data management terminal (4) includes a data entry and storage module (401), a data check and verification module (402), a data query and retrieval module (403), a data export and sharing module (404), a data review and approval module (405), and a data security and privacy protection module (406); The data entry and storage module (401) is used for the data secondary entry interface to input and store audit data, the data check and verification module (402) is used to perform data check and verification, the data query and retrieval module (403) is used to provide data query and retrieval functions, the data export and sharing module (404) is used for users to export audit data into common file formats, the data review and approval module (405) is used for relevant personnel to review and approve audit data, and the data security and privacy protection module (406) is used to provide corresponding security measures.

8. The clinical trial project auditing system according to claim 4, characterized in that: The audit tracking and reminder terminal (5) includes an audit task tracking module (501), a reminder and notification module (502), an audit plan management module (503), a task allocation and assignment module (504), and a schedule management module (505); The task allocation and assignment module (504) is used to automatically adjust and assign tasks to corresponding auditors based on the nature and requirements of the audit tasks. The audit task tracking module (501) is used to provide audit task tracking functions. The reminder and notification module (502) is used to send reminders and notifications to relevant personnel. The audit plan management module (503) is used for users to create and manage audit plans and set corresponding reminders and deadlines. The schedule management module (505) is used to provide a schedule management function to view and manage the schedule of audit tasks.

9. The clinical trial project auditing system according to claims 1-8, characterized in that: The compliance and quality control terminal (6) includes a compliance audit module (601), a data quality control module (602), a file management and version control module (603), an audit and review management module (604), and a quality indicator and indicator monitoring module (605); The compliance audit module (601) is used to audit the compliance of the test project, the data quality control module (602) is used to provide data quality control functions, the file management and version control module (603) is used to provide file management and version control functions, the audit and review management module (604) is used to support the management of the audit and review process, and the quality indicator and indicator monitoring module (605) is used to define and track the quality indicators of the test project.

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