Automatic operation system for clinical test inspection

Abstract

The invention discloses a clinical test inspection and inspection automatic operation system which comprises a task management end, a data collection and recording end, a data quality control end, a result analysis and report end and a communication and cooperation end. The task management end, the data collection and recording end, the data quality control end, the result analysis and report end and the communication and cooperation end are in data communication. The system can automatically manage and process information of examination and inspection data in clinical tests, can effectively coordinate and optimize the examination and inspection process, and improves the accuracy, consistency and efficiency of the data.

Description

Technical Field

[0001] The present invention relates to the field of drug clinical trials, and particularly to an automatic operation system for clinical trial inspections and tests. Background Art

[0002] In clinical trials, the inspection data and test data generated need to be uniformly collected and processed, and then the clinical trials are analyzed based on these inspection data and test data. In the prior art, generally, data is collected manually, then input into a data management system manually, and then various analyses and studies are carried out manually in the system. It is found during the analysis and research process that manual operations often make mistakes, resulting in low data accuracy and very low processing efficiency. Summary of the Invention

[0003] In order to solve the above problems, the present invention provides an automatic operation system for clinical trial inspections and tests.

[0004] To achieve the above object, the technical solution of the present invention is as follows:

[0005] An automatic operation system for clinical trial inspections and tests, the automatic operation system for clinical trial inspections and tests includes a task management terminal, a data collection and recording terminal, a data quality control terminal, a result analysis and reporting terminal, and a communication and collaboration terminal, and data communication is carried out among the task management terminal, the data collection and recording terminal, the data quality control terminal, the result analysis and reporting terminal, and the communication and collaboration terminal.

[0006] In a preferred embodiment of the present invention, the task management terminal includes a task generation module, a task assignment module, a task tracking module, a task priority and urgency module, a task assignment and re-assignment module, and a task notification and reminder module.

[0007] The task generation module includes:

[0008] A task generation unit, which is used to automatically generate inspection and test tasks according to the test protocol and research plan;

[0009] A task generation database unit, which is used to store task generation information.

[0010] The task assignment module includes:

[0011] A task assignment unit, which is used to assign the generated tasks to the corresponding laboratories or inspection agencies;

[0012] A task assignment database unit, which is used to store task assignment information.

[0013] The task tracking module includes:

[0014] A task tracking unit, which is used to provide a task tracking function and can monitor the progress and status of tasks in real time;

[0015] A task tracking database unit, which is used to store task tracking information,

[0016] The task priority and urgency module includes:

[0017] A task priority and urgency unit, which is used to sort and manage tasks according to their priority and urgency;

[0018] A task priority and urgency database unit, which is used to store task priority and urgency information,

[0019] The task assignment and reassignment module includes:

[0020] A task assignment and reassignment unit, which is used for the system to support task assignment and reassignment;

[0021] A task assignment and reassignment database unit, which is used to store task assignment and reassignment information,

[0022] The task notification and reminder module includes:

[0023] A task notification and reminder unit, which is used to send task notifications and reminders to relevant personnel by means of emails, text messages or internal system messages, etc.;

[0024] A task notification and reminder database unit, which is used to store task notification and reminder information.

[0025] In a preferred embodiment of the present invention, the data collection and recording end includes a data interface and integration module, a data entry and verification module, a data standardization and coding module, a data storage and management module, a data review and quality control module, and a data tracking and traceability module,

[0026] The data interface and integration module includes:

[0027] A data interface and integration unit, which is used to perform data interface and integration with laboratory equipment, medical information systems, etc., to achieve automated data collection and recording;

[0028] A data interface and integration database unit, which is used to store data interface and integration information,

[0029] The data entry and verification module includes:

[0030] A data entry and verification unit, which is used to provide a user interface for operators to manually enter inspection and test results;

[0031] A data entry and verification database unit, which is used to store data entry and verification information,

[0032] The data standardization and coding module includes:

[0033] A data standardization and coding unit, which is used to standardize and code data according to relevant standards and coding systems;

[0034] A data standardization and coding database unit, which is used to store data standardization and coding information,

[0035] The data storage and management module includes:

[0036] A data storage and management unit, which is used to provide data storage and management functions and can securely store and maintain inspection and test data;

[0037] A data storage and management database unit, which is used to store data storage and management information,

[0038] The data review and quality control module includes:

[0039] A data review and quality control unit, which is used to support data review and quality control mechanisms and can automatically or manually review and control data;

[0040] A data review and quality control database unit, which is used to store data review and quality control information,

[0041] The data tracking and traceability module includes:

[0042] A data tracking and traceability unit, which is used to track and record the change history of data, including operations such as data entry, modification, and deletion;

[0043] A data tracking and traceability database unit, which is used to store data tracking and traceability information.

[0044] In a preferred embodiment of the present invention, the data quality control end includes a data verification and validation module, a data logic check module, a data integrity check module, a data consistency check module, a data anomaly detection module, and a data review and audit module.

[0045] The data verification and validation module includes:

[0046] A data verification and validation unit for verifying and validating data, checking aspects such as the format, range, and legality of the data;

[0047] A data verification and validation database unit for storing data verification and validation information.

[0048] The data logic check module includes:

[0049] A data logic check unit for performing data logic checks and verifying the relationships and consistency between data;

[0050] A data logic check database unit for storing data logic check information.

[0051] The data integrity check module includes:

[0052] A data integrity check unit for checking the integrity of data to ensure that all required data items are filled or recorded;

[0053] A data integrity check database unit for storing data integrity check information.

[0054] The data consistency check module includes:

[0055] A data consistency check unit for checking the consistency of data to ensure that data for the same patient or sample remains consistent at different time points or in different examinations;

[0056] A data consistency check database unit for storing data consistency check information.

[0057] The data anomaly detection module includes:

[0058] A data anomaly detection unit for detecting outliers or abnormal patterns in data to help identify potential data problems or abnormal situations;

[0059] A data anomaly detection database unit for storing data anomaly detection information.

[0060] The data review and audit module includes:

[0061] A data review and audit unit, which is used to provide data review and audit functions, record the change history, operation logs, and audit trails of the data;

[0062] A data review and audit database unit, which is used to store data review and audit information.

[0063] In a preferred embodiment of the present invention, the result analysis and reporting end includes a data statistics and summary module, a result interpretation and explanation module, a result trend analysis module, an anomaly detection and alert module, and a result report generation module.

[0064] The data statistics and summary module includes:

[0065] A data statistics and summary unit, which is used to perform statistics and summary on inspection and test data;

[0066] A data statistics and summary database unit, which is used to store data statistics and summary information.

[0067] The result interpretation and explanation module includes:

[0068] A result interpretation and explanation unit, which is used to interpret and explain the inspection and test results according to preset algorithms or rules;

[0069] A result interpretation and explanation database unit, which is used to store result interpretation and explanation information.

[0070] The result trend analysis module includes:

[0071] A result trend analysis unit, which is used to perform trend analysis on the multiple inspection or test results of a patient to help users observe and evaluate the change trend of the data;

[0072] A result trend analysis database unit, which is used to store result trend analysis information.

[0073] The anomaly detection and alert module includes:

[0074] An anomaly detection and alert unit, which is used to automatically detect and identify abnormal values or abnormal patterns in the inspection and test results and provide corresponding alerts or prompts;

[0075] Anomaly detection and alert database unit, which is used to store anomaly detection and alert information,

[0076] The result report generation module includes:

[0077] Result report generation unit, which is used to generate inspection and test result reports that meet the requirements according to the needs and settings of users;

[0078] Result report generation database unit, which is used to store result report generation information.

[0079] In a preferred embodiment of the present invention, the communication and collaboration end includes an internal communication module, a multi-user collaboration module, a file sharing and collaborative editing module, a task assignment and tracking module, and a reminder and notification module,

[0080] The internal communication module includes:

[0081] Internal communication unit, which is used to provide an internal communication channel for the automatic operation system of clinical trial inspection, enabling users to conduct instant messaging and communication within the automatic operation system of clinical trial inspection;

[0082] Internal communication database unit, which is used to store internal communication information,

[0083] The multi-user collaboration module includes:

[0084] Multi-user collaboration unit, which is used to support multi-user simultaneous use and collaboration, enabling team members to jointly participate in the management and processing of inspection and test tasks;

[0085] Multi-user collaboration database unit, which is used to store multi-user collaboration information,

[0086] The file sharing and collaborative editing module includes:

[0087] File sharing and collaborative editing unit, which is used to allow users to share and collaboratively edit files and documents in inspection and test tasks;

[0088] File sharing and collaborative editing database unit, which is used to store file sharing and collaborative editing information,

[0089] The task assignment and tracking module includes:

[0090] Task assignment and tracking unit, which is used to provide task assignment and tracking functions;

[0091] A task assignment and tracking database unit for storing task assignment and tracking information,

[0092] The reminder and notification module includes:

[0093] A reminder and notification unit for providing reminder and notification functions to send task-related reminders, notifications, and important information to users;

[0094] A reminder and notification database unit for storing reminder and notification information.

[0095] In a preferred embodiment of the present invention, data communication is carried out between the task management end, the data collection and recording end, the data quality control end, the result analysis and reporting end, and the communication and collaboration end through a dedicated private network.

[0096] In a preferred embodiment of the present invention, the clinical trial inspection and testing automatic operation system includes a background terminal, and the background terminal is respectively connected to the task management end, the data collection and recording end, the data quality control end, the result analysis and reporting end, and the communication and collaboration end.

[0097] The beneficial effects of the present invention are:

[0098] The present invention can automatically manage and process the information of inspection and testing data in clinical trials, effectively coordinate and optimize the inspection and testing process, and improve the accuracy, consistency, and efficiency of data.

[0099] The present invention can significantly improve the efficiency and quality of clinical trials, reduce the workload and error rate of manual operations, and at the same time improve the accuracy and consistency of data. It helps to speed up the trial progress, improve the reliability and availability of data, provide more accurate results and conclusions for researchers, and promote the development and innovation of clinical research. BRIEF DESCRIPTION OF THE DRAWINGS

[0100] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0101] Figure 1 It is a schematic structural diagram of the task management end;

[0102] Figure 2 It is a schematic structural diagram of the data collection and recording end;

[0103] Figure 3 It is a schematic structural diagram of the data quality control terminal;

[0104] Figure 4 It is a schematic structural diagram of the result analysis and reporting terminal;

[0105] Figure 5 It is a schematic structural diagram of the communication and collaboration terminal. Specific implementation manners

[0106] In order to make the technical means, creative features, achieved purposes and effects realized by the present invention easy to understand, the present invention will be further described below.

[0107] Refer to Figures 1 to 5 The automatic operation system for clinical trial inspection and testing provided by the present invention includes a task management terminal 1, a data collection and recording terminal 2, a data quality control terminal 3, a result analysis and reporting terminal 4, and a communication and collaboration terminal 5.

[0108] Data communication is realized among the task management terminal 1, the data collection and recording terminal 2, the data quality control terminal 3, the result analysis and reporting terminal 4, and the communication and collaboration terminal 5 through data communication.

[0109] Specifically, data communication among the task management terminal 1, the data collection and recording terminal 2, the data quality control terminal 3, the result analysis and reporting terminal 4, and the communication and collaboration terminal 5 can be carried out through a dedicated network and dedicated line, which can improve the security and efficiency of data communication.

[0110] In addition, the present invention may further include a background terminal, which is respectively connected to the task management terminal 1, the data collection and recording terminal 2, the data quality control terminal 3, the result analysis and reporting terminal 4, and the communication and collaboration terminal 5. The background terminal can control the work of the task management terminal 1, the data collection and recording terminal 2, the data quality control terminal 3, the result analysis and reporting terminal 4, and the communication and collaboration terminal 5, and can accept the data sent by the task management terminal 1, the data collection and recording terminal 2, the data quality control terminal 3, the result analysis and reporting terminal 4, and the communication and collaboration terminal 5 for storage and archiving, which is convenient for subsequent traceability.

[0111] Refer to Figure 1 The task management terminal 1 is used to effectively generate, allocate and track the inspection and testing tasks related to clinical trials, enabling researchers and clinicians to better organize and manage the inspection and testing tasks related to clinical trials, improving the execution efficiency and accuracy of tasks. It provides a real-time task tracking and notification mechanism to ensure that tasks can be completed on time and promote the smooth progress of clinical trials.

[0112] The task management terminal 1 may specifically include a task generation module 101, a task assignment module 102, a task tracking module 103, a task priority and urgency module 104, a task assignment and reassignment module 105, and a task notification and reminder module 106.

[0113] The task generation module 101 includes a task generation unit 101a and a task generation database unit 101b.

[0114] The task generation unit 101a is used to enable the system to automatically generate inspection and testing tasks according to the test protocol and research plan. It can automatically create corresponding tasks according to specified time points, frequencies, or event trigger conditions.

[0115] The task generation database unit 101b is used to store task generation information and can send the stored information to the background terminal.

[0116] The task assignment module 102 includes a task assignment unit 102a and a task assignment database unit 102b.

[0117] The task assignment unit 102a is used to enable the system to assign the generated tasks to the corresponding laboratories or inspection agencies. The task assignment can be optimized based on factors such as the capabilities of the laboratories, geographical locations, and equipment availability to ensure that the tasks can be completed in a timely manner.

[0118] The task assignment database unit 102b is used to store task assignment information and can send the stored information to the background terminal.

[0119] The task tracking module 103 includes a task tracking unit 103a and a task tracking database unit 103b.

[0120] The task tracking unit 103a is used to provide the system with a task tracking function, which can monitor the progress and status of tasks in real time. Researchers and clinicians can view the task list, understand the task completion situation, and take necessary actions in a timely manner.

[0121] The task tracking database unit 103b is used to store task tracking information and can send the stored information to the background terminal.

[0122] The task priority and urgency module 104 includes a task priority and urgency unit 104a and a task priority and urgency database unit 104b.

[0123] The task priority and urgency unit 104a is used to enable the system to sort and manage tasks according to their priorities and urgencies. Urgent tasks can be processed preferentially to ensure the safety of patients and the progress of clinical trials.

[0124] The task priority and urgency database unit 104b is used to store task priority and urgency information and can send the stored information to the background terminal.

[0125] The task assignment and reassignment module 105 includes a task assignment and reassignment unit 105a and a task assignment and reassignment database unit 105b.

[0126] The task assignment and reassignment unit 105a is used for the assignment and reassignment of tasks supported by this system. If a certain laboratory or inspection agency is unable to complete a task, the system can reassign the task to other available laboratories or agencies.

[0127] The task assignment and reassignment database unit 105b is used to store task assignment and reassignment information and can send the stored information to the background terminal.

[0128] The task notification and reminder module 106 includes a task notification and reminder unit 106a and a task notification and reminder database unit 106b.

[0129] The task notification and reminder unit 106a is used for this system to send task notifications and reminders to relevant personnel via email, text message, or internal system message, etc. This helps ensure that tasks are discovered and processed in a timely manner.

[0130] The task notification and reminder database unit 106b is used to store task notification and reminder information and can send the stored information to the background terminal.

[0131] See Figure 2 , the data collection and recording terminal 2, which is used for the collection and recording process of inspection and test data in automated and standardized clinical trials. The data collection and recording function enables the inspection and test data in clinical trials to be collected and recorded more efficiently and accurately. Through automated and standardized data processing procedures, the risk of data errors and omissions can be reduced, and the quality and reliability of the data can be improved. At the same time, the system's data management and auditing mechanism can strengthen the control and supervision of data to ensure the integrity and accuracy of the data.

[0132] The data collection and recording terminal 2 may specifically include a data interface and integration module 201, a data entry and verification module 202, a data standardization and coding module 203, a data storage and management module 204, a data auditing and quality control module 205, and a data tracking and traceability module 206.

[0133] The data interface and integration module 201 includes a data interface and integration unit 201a and a data interface and integration database unit 201b.

[0134] The data interface and integration unit 201a enables the system to interface and integrate with laboratory equipment, medical information systems, etc., achieving automated data collection and recording. It can obtain the raw data generated by the equipment and automatically import it into the system.

[0135] The data interface and integration database unit 201b is used to store data interface and integration information and can send the stored information to the background terminal.

[0136] The data entry and verification module 202 includes a data entry and verification unit 202a and a data entry and verification database unit 202b.

[0137] The data entry and verification unit 202a provides a user interface for the system for operators to manually enter inspection and test results. The data entry interface can be configured according to the test protocol and data requirements to ensure the accuracy and consistency of the data. The system can also perform data verification to check the integrity and legality of the data.

[0138] The data entry and verification database unit 202b is used to store data entry and verification information and can send the stored information to the background terminal.

[0139] The data standardization and coding module 203 includes a data standardization and coding unit 203a and a data standardization and coding database unit 203b.

[0140] The data standardization and coding unit 203a enables the system to standardize and code data according to relevant standards and coding systems. This helps to improve the comparability and consistency of the data and facilitates subsequent data analysis and reporting.

[0141] The data standardization and coding database unit 203b is used to store data standardization and coding information and can send the stored information to the background terminal.

[0142] The data storage and management module 204 includes a data storage and management unit 204a and a data storage and management database unit 204b.

[0143] The data storage and management unit 204a provides data storage and management functions for the system, which can securely store and maintain inspection and test data. The data storage can be based on a database or cloud storage to ensure the security and accessibility of the data.

[0144] The data storage and management database unit 204b is used to store data storage and management information and can send the stored information to the background terminal.

[0145] The data review and quality control module 205 includes a data review and quality control unit 205a and a data review and quality control database unit 205b.

[0146] The data review and quality control unit 205a is used for the system to support data review and quality control mechanisms, and can automatically or manually review and control the quality of data. It can check the legality, consistency and anomalies of data, and provide corresponding warnings or correction suggestions.

[0147] The data review and quality control database unit 205b is used to store data review and quality control information, and can send the stored information to the background terminal.

[0148] The data tracking and traceability module 206 includes a data tracking and traceability unit 206a and a data tracking and traceability database unit 206b.

[0149] The data tracking and traceability unit 206a is used for the system to track and record the change history of data, including operations such as data entry, modification and deletion. This helps to ensure the traceability of data and the auditability of data operations.

[0150] The data tracking and traceability database unit 206b is used to store data tracking and traceability information, and can send the stored information to the background terminal.

[0151] See Figure 3 , the data quality control terminal 3, which is used to ensure the accuracy, consistency and integrity of the inspection and test data collected and recorded. The data quality control function can help ensure the accuracy and reliability of the inspection and test data in clinical trials. Through automated and standardized data quality checks and validations, data errors and inconsistencies can be reduced, data quality can be improved, and trust in data quality can be increased. This helps to ensure the reliability and repeatability of research results, and provides a reliable basis for subsequent data analysis and interpretation.

[0152] The data quality control terminal 3 may specifically include a data verification and validation module 301, a data logic check module 302, a data integrity check module 303, a data consistency check module 304, a data anomaly detection module 305, and a data review and audit module 306.

[0153] The data verification and validation module 301 includes a data verification and validation unit 301a and a data verification and validation database unit 301b.

[0154] The data verification and validation unit 301a is used for the system to verify and validate data, checking aspects such as the format, range, and legality of the data. It can automatically identify incorrect or abnormal data and give corresponding warnings or error messages for timely correction.

[0155] The data verification and validation database unit 301b is used to store data verification and validation information and can send the stored information to the background terminal.

[0156] The data logic check module 302 includes a data logic check unit 302a and a data logic check database unit 302b.

[0157] The data logic check unit 302a is used for the system to perform data logic checks to verify the relationships and consistency among data. For example, for hemoglobin and red blood cell count in a blood test, the system can check whether the relationship between them is reasonable and issue warnings or error messages to indicate potential data problems.

[0158] The data logic check database unit 302b is used to store data logic check information and can send the stored information to the background terminal.

[0159] The data integrity check module 303 includes a data integrity check unit 303a and a data integrity check database unit 303b.

[0160] The data integrity check unit 303a is used for the system to check the integrity of data to ensure that all required data items are filled or recorded. It can identify missing data and prompt the user to supplement it to ensure the integrity of the data set.

[0161] The data integrity check database unit 303b is used to store data integrity check information and can send the stored information to the background terminal.

[0162] The data consistency check module 304 includes a data consistency check unit 304a and a data consistency check database unit 304b.

[0163] The data consistency check unit 304a is used for the system to check the consistency of data to ensure that data for the same patient or sample remains consistent at different time points or in different examinations. It can compare historical data or reference data to check for potential consistency problems and give corresponding warnings or error messages.

[0164] The data consistency check database unit 304b is used to store data consistency check information and can send the stored information to the background terminal.

[0165] The data anomaly detection module 305 includes a data anomaly detection unit 305a and a data anomaly detection database unit 305b.

[0166] The data anomaly detection unit 305a is used for the system to detect outliers or abnormal patterns in the data to help identify potential data problems or abnormal situations. It can use statistical methods, rule engines, or machine learning algorithms, etc. to perform anomaly detection and provide corresponding warnings or error prompts.

[0167] The data anomaly detection database unit 305b is used to store data anomaly detection information and can send the stored information to the background terminal.

[0168] The data review and audit module 306 includes a data review and audit unit 306a and a data review and audit database unit 306b.

[0169] The data review and audit unit 306a is used for the system to provide data review and audit functions, record the change history, operation logs, and audit trails of the data. This helps to trace the source and operation process of the data and provide reliable data review and audit evidence.

[0170] The data review and audit database unit 306b is used to store data review and audit information and can send the stored information to the background terminal.

[0171] The result analysis and reporting terminal 4 is used to help users analyze the collected inspection and test data and generate corresponding reports. The result analysis and reporting functions can improve the understanding and application of inspection and test data in clinical trials. They can help researchers and medical staff better understand and interpret the data, support the analysis and interpretation of research results, and provide strong evidence for clinical decision-making and further research. In addition, the generated result reports can also be used to share data results with other team members, research institutions, or regulatory agencies, and promote communication and cooperation in research.

[0172] The result analysis and reporting terminal 4 may specifically include a data statistics and summary module 401, a result interpretation and analysis module 402, a result trend analysis module 403, an anomaly detection and alarm module 404, and a result report generation module 405.

[0173] The data statistics and summary module 401 includes a data statistics and summary unit 401a and a data statistics and summary database unit 401b.

[0174] The data statistics and summary unit 401a is used for the system to perform statistics and summary on the inspection and test data, such as calculating the average value, standard deviation, percentage, etc. These statistical data can provide an overview of the overall characteristics of the data set and help users understand the distribution of the data.

[0175] The data statistics and summary database unit 401b is used to store data statistics and summary information and can send the stored information to the background terminal.

[0176] The result interpretation and analysis module 402 includes a result interpretation and analysis unit 402a and a result interpretation and analysis database unit 402b.

[0177] The result interpretation and analysis unit 402a is used for the system to interpret and analyze the examination and test results according to preset algorithms or rules. For example, for each index in a blood test, the system can judge whether the result is normal according to clinical standards or reference ranges and provide corresponding explanations and suggestions.

[0178] The result interpretation and analysis database unit 402b is used to store result interpretation and analysis information and can send the stored information to the background terminal.

[0179] The result trend analysis module 403 includes a result trend analysis unit 403a and a result trend analysis database unit 403b.

[0180] The result trend analysis unit 403a is used for the system to perform trend analysis on the multiple examination or test results of a patient to help the user observe and evaluate the change trend of the data. This can be used to monitor the patient's health status or the change of the drug treatment effect and timely detect potential abnormalities or trends.

[0181] The result trend analysis database unit 403b is used to store result trend analysis information and can send the stored information to the background terminal.

[0182] The anomaly detection and alarm module 404 includes an anomaly detection and alarm unit 404a and an anomaly detection and alarm database unit 404b.

[0183] The anomaly detection and alarm unit 404a is used for the system to automatically detect and identify abnormal values or abnormal patterns in the examination and test results and provide corresponding alarms or prompts. This helps to timely discover and handle abnormal situations and take necessary measures for further investigation or intervention.

[0184] The anomaly detection and alarm database unit 404b is used to store anomaly detection and alarm information and can send the stored information to the background terminal.

[0185] The result report generation module 405 includes a result report generation unit 405a and a result report generation database unit 405b.

[0186] The result report generation unit 405a is used for the system to generate examination and test result reports that meet the requirements according to the user's needs and settings. The reports can include forms such as charts, tables, and text descriptions to present the data results in an intuitive and clear manner and help the user interpret and report the results.

[0187] The result report generation database unit 405b is used to store result report generation information and can send the stored information to the background terminal.

[0188] See Figure 5 , the communication and collaboration end 5, which is used to facilitate communication, collaboration, and information sharing among users. These communication and collaboration functions can enhance the cooperation and synergy capabilities among users of the clinical trial inspection and testing automated operation system. Through effective communication and information sharing, team members can better coordinate their work, improve efficiency, and ensure the accurate and timely completion of tasks. In addition, these functions also promote knowledge sharing and learning among teams, enhancing the overall capabilities and work quality of the entire team.

[0189] The communication and collaboration end 5 specifically includes an internal communication module 501, a multi-user collaboration module 502, a file sharing and collaborative editing module 503, a task assignment and tracking module 504, and a reminder and notification module 505.

[0190] The internal communication module 501 includes an internal communication unit 501a and an internal communication database unit 501b.

[0191] The internal communication unit 501a is used to provide an internal communication channel for the system, enabling users to conduct instant messaging and communication within the system. Users can send and receive messages, discuss, ask questions, reply, etc. through the message function within the system to promote cooperation and communication among team members.

[0192] The internal communication database unit 501b is used to store internal communication information and can send the stored information to the background terminal.

[0193] The multi-user collaboration module 502 includes a multi-user collaboration unit 502a and a multi-user collaboration database unit 502b.

[0194] The multi-user collaboration unit 502a is used to support multi-user simultaneous use and collaboration in the system, enabling team members to jointly participate in the management and processing of inspection and testing tasks. Users can assign tasks, appoint responsibilities, share resources and information in the system, and collaborate to complete work, improving efficiency and quality.

[0195] The multi-user collaboration database unit 502b is used to store multi-user collaboration information and can send the stored information to the background terminal.

[0196] The file sharing and collaborative editing module 503 includes a file sharing and collaborative editing unit 503a and a file sharing and collaborative editing database unit 503b.

[0197] The file sharing and collaborative editing unit 503a enables the system to allow users to share and collaboratively edit files and documents during inspection and verification tasks. Users can upload, store, and share relevant documents, such as inspection reports, images, interpretations, etc., so that team members can view, modify, and comment together, improving work efficiency and accuracy.

[0198] The file sharing and collaborative editing database unit 503b is used to store file sharing and collaborative editing information and can send the stored information to the background terminal.

[0199] The task assignment and tracking module 504 includes a task assignment and tracking unit 504a and a task assignment and tracking database unit 504b.

[0200] The task assignment and tracking unit 504a provides the system with task assignment and tracking functions, enabling users to assign inspection and verification tasks to specific team members and track the progress and completion status of the tasks. This helps ensure the timely completion of tasks and provides visualization and monitoring of task execution.

[0201] The task assignment and tracking database unit 504b is used to store task assignment and tracking information and can send the stored information to the background terminal.

[0202] The reminder and notification module 505 includes a reminder and notification unit 505a and a reminder and notification database unit 505b.

[0203] The reminder and notification unit 505a enables the system to send task-related reminders, notifications, and important information to users. Users can receive notifications such as task assignments, deadline reminders, task status updates, etc., to ensure the timely handling of tasks and the communication of key information.

[0204] The reminder and notification database unit 505b is used to store reminder and notification information and can send the stored information to the background terminal.

[0205] The above shows and describes the basic principles, main features, and advantages of the present invention. Those skilled in the art of this industry should understand that the present invention is not limited by the above embodiments. What is described in the above embodiments and the specification only illustrates the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention will have various changes and improvements, and these changes and improvements all fall within the scope of the present invention claimed. The scope of protection claimed by the present invention is defined by the appended claims and their equivalents.

Claims

1. A clinical trial inspection and testing automatic operation system, characterized in that: The clinical trial inspection and testing automatic operation system includes a task management end, a data collection and recording end, a data quality control end, a result analysis and reporting end, and a communication and collaboration end, and data communication is carried out between the task management end, the data collection and recording end, the data quality control end, the result analysis and reporting end, and the communication and collaboration end.

2. According to claim 1, a clinical trial inspection and testing automatic operation system is characterized in that: The task management terminal includes a task generation module, a task allocation module, a task tracking module, a task priority and urgency module, a task allocation and reallocation module, and a task notification and reminder module. The task generation module includes: A task generation unit, the task generation unit is used to automatically generate inspection and testing tasks according to the test protocol and research plan; A task generation database unit, the task generation unit is used to store task generation information, The task allocation module includes: A task allocation unit, which is used to allocate the generated tasks to corresponding laboratories or inspection agencies; A task allocation database unit, wherein the task allocation database unit is used to store task allocation information, The task tracking module includes: A task tracking unit, which is used to provide a task tracking function and can monitor the progress and status of the task in real time; A task tracking database unit, wherein the task tracking database unit is used to store task tracking information, The task priority and urgency module includes: A task priority and urgency unit, wherein the task priority and urgency unit is used to sort and manage tasks according to their priorities and urgency; a task priority and urgency database unit, the task priority and urgency database unit being used to store task priority and urgency information, The task allocation and reallocation module includes: A task allocation and reallocation unit, used for allocation and reallocation of system support tasks; a task allocation and reallocation database unit, wherein the task allocation and reallocation database unit is used to store task allocation and reallocation information, The task notification and reminder module includes: A task notification and reminder unit, which is used to send task notifications and reminders to relevant personnel via email, text messages, or system internal messages; The task notification and reminder database unit is used to store task notification and reminder information.

3. The clinical trial inspection and testing automatic operation system according to claim 1 is characterized in that: The data collection and recording end includes a data interface and integration module, a data entry and verification module, a data standardization and coding module, a data storage and management module, a data review and quality control module, and a data tracking and tracing module. The data interface and integration module include: Data interface and integration unit, which is used to interface and integrate with laboratory equipment, medical information systems, etc. to achieve automated data collection and recording; a data interface and integrated database unit, the data interface and integrated database unit being used to store data interface and integrated information, The data entry and verification module includes: A data entry and verification unit, the data entry and verification unit is used to provide a user interface for operators to manually enter inspection and test results; a data entry and verification database unit, the data entry and verification database unit being used to store data entry and verification information, The data standardization and encoding module includes: A data standardization and coding unit, which is used to standardize and code data according to relevant standards and coding systems; a data standardization and coding database unit, wherein the data standardization and coding database unit is used to store data standardization and coding information, The data storage and management module includes: A data storage and management unit, the data storage and management unit is used to provide data storage and management functions, and can safely store and maintain inspection and test data; A data storage and management database unit, wherein the data storage and management database unit is used to store data storage and management information, The data review and quality control module includes: A data review and quality control unit, which is used to support a data review and quality control mechanism and can automatically or manually review and control the quality of data; A data review and quality control database unit, wherein the data review and quality control database unit is used to store data review and quality control information, The data tracking and tracing module includes: A data tracking and tracing unit, which is used to track and record the change history of data, including operations such as data entry, modification and deletion; A data tracking and tracing database unit, wherein the data tracking and tracing database unit is used to store data tracking and tracing information.

4. The clinical trial inspection and testing automatic operation system according to claim 1 is characterized in that: The data quality control end includes a data verification and validation module, a data logic check module, a data integrity check module, a data consistency check module, a data anomaly detection module, and a data review and audit module. The data verification and validation module includes: A data verification and validation unit, which is used to verify and validate the data, and check the format, scope, legality, etc. of the data; a data verification and validation database unit, the data verification and validation database unit being used to store data verification and validation information, The data logic checking module comprises: A data logic checking unit, the data logic checking unit is used to perform data logic checking to verify the relationship and consistency between data; a data logic check database unit, wherein the data logic check database unit is used to store data logic check information, The data integrity checking module comprises: A data integrity checking unit, the data integrity checking unit is used to check the integrity of the data to ensure that all necessary data items are filled in or recorded; a data integrity check database unit, the data integrity check database unit being used to store data integrity check information, The data consistency checking module comprises: A data consistency checking unit, which is used to check the consistency of data to ensure that the data of the same patient or sample remain consistent at different time points or in different examinations; A data consistency check database unit, wherein the data consistency check database unit is used to store data consistency check information, The data anomaly detection module includes: A data anomaly detection unit, the data anomaly detection unit is used to detect abnormal values ​​or abnormal patterns in the data to help identify potential data problems or abnormal situations; a data anomaly detection database unit, wherein the data anomaly detection database unit is used to store data anomaly detection information, The data review and audit module includes: A data review and audit unit, which is used to provide data review and audit functions and record data change history, operation logs and audit trails; A data review and audit database unit is used to store data review and audit information.

5. The clinical trial inspection and testing automatic operation system according to claim 1 is characterized in that: The result analysis and reporting end includes a data statistics and summary module, a result explanation and interpretation module, a result trend analysis module, an anomaly detection and alarm module, and a result report generation module.

6. The clinical trial inspection and testing automatic operation system according to claim 5 is characterized in that: The data statistics and summary module includes: A data statistics and summary unit, which is used to count and summarize the inspection and test data; A data statistics and summary database unit, wherein the data statistics and summary database unit is used to store data statistics and summary information, The result interpretation and explanation module includes: A result interpretation and explanation unit, which is used to interpret and explain the inspection and test results according to a preset algorithm or rule; A result interpretation and explanation database unit, wherein the result interpretation and explanation database unit is used to store result interpretation and explanation information, The result trend analysis module includes: A result trend analysis unit, which is used to perform trend analysis on multiple examination or test results of a patient to help the user observe and evaluate the change trend of the data; A result trend analysis database unit, wherein the result trend analysis database unit is used to store result trend analysis information, The anomaly detection and alarm module includes: An anomaly detection and alarm unit, which is used to automatically detect and identify abnormal values ​​or abnormal patterns in inspection and test results and provide corresponding alarms or prompts; an anomaly detection and alarm database unit, the anomaly detection and alarm database unit is used to store anomaly detection and alarm information, The result report generating module comprises: A result report generating unit, which is used to generate an inspection and test result report that meets the requirements according to the needs and settings of the user; A result report generation database unit is used to store result report generation information.

7. The clinical trial inspection and testing automatic operation system according to claim 1 is characterized in that: The communication and collaboration end includes an internal communication module, a multi-user collaboration module, a file sharing and collaborative editing module, a task allocation and tracking module, and a reminder and notification module.

8. The automatic operation system for clinical trial inspection and testing according to claim 7 is characterized in that: The internal communication module comprises: An internal communication unit, which is used to provide an internal communication channel for the clinical trial inspection and testing automatic operation system, so that users can perform instant messaging and communication within the clinical trial inspection and testing automatic operation system; an internal communication database unit, the internal communication database unit being used to store internal communication information, The multi-user collaboration module comprises: A multi-user collaboration unit, which is used to support simultaneous use and collaboration by multiple users, so that team members can jointly participate in the management and processing of inspection and testing tasks; A multi-user collaboration database unit, wherein the multi-user collaboration database unit is used to store multi-user collaboration information, The file sharing and collaborative editing module includes: A file sharing and collaborative editing unit, which is used to allow users to share and collaboratively edit files and documents in inspection and testing tasks; A file sharing and collaborative editing database unit, wherein the file sharing and collaborative editing database unit is used to store file sharing and collaborative editing information. The task allocation and tracking module includes: A task allocation and tracking unit, wherein the task allocation and tracking unit is used to provide task allocation and tracking functions; a task allocation and tracking database unit, the task allocation and tracking database unit is used to store task allocation and tracking information, The reminder and notification module includes: A reminder and notification unit, which is used to provide reminder and notification functions to send task-related reminders, notifications and important information to users; The reminder and notification database unit is used to store reminder and notification information.

9. The clinical trial inspection and testing automatic operation system according to claim 1 is characterized in that: The task management end, data collection and recording end, data quality control end, result analysis and reporting end, and communication and collaboration end communicate with each other through a dedicated network and dedicated line network.

10. The clinical trial inspection and testing automatic operation system according to claim 1, characterized in that: The clinical trial inspection and testing automatic operation system includes a background terminal, which is respectively connected to a task management terminal, a data collection and recording terminal, a data quality control terminal, a result analysis and reporting terminal, and a communication and collaboration terminal.

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