Intelligent follow-up visit system for clinical test

Abstract

The invention discloses an intelligent follow-up visit system for a clinical test. The intelligent follow-up visit system comprises a follow-up visit plan management end, a follow-up visit data input end, a follow-up visit reminding and notification end, a follow-up visit data monitoring and verification end, a follow-up visit data query and analysis end and a follow-up visit report and export end. The follow-up plan management end, the follow-up data input end, the follow-up reminding and notification end, the follow-up data monitoring and verification end, the follow-up data query and analysis end and the follow-up report and export end are in data communication through a private network and a private line network. The intelligent follow-up visit system aims to improve follow-up visit efficiency, accuracy and reliability, meanwhile, the workload of researchers is relieved, the clinical test researchers can better monitor the illness state and the treatment effect of the patient through the intelligent follow-up visit system, and the quality and reliability of data are improved. Meanwhile, the patient can obtain more convenient and personalized follow-up visit and support, and the enthusiasm and treatment compliance of the patient participating in a clinical test are promoted.

Description

Technical Field

[0001] This application relates to the technical field of drug clinical trials, and in particular to an intelligent follow-up system for clinical trials. Background Technology

[0002] Currently, the trend in the pharmaceutical industry is that evidence-based medicine is gradually becoming the mainstream medical philosophy. Evidence-based medicine is defined as: the careful, accurate, and informed application of the best available research evidence, combined with the clinician's professional skills and long-term clinical experience, taking into account the patient's values ​​and wishes, to perfectly integrate these three factors and develop a specific treatment plan. Well-designed and implemented clinical trials and follow-ups are the best ways for clinicians to objectively and accurately absorb the opinions and research results of others (including experts), enhance their professional skills, and increase their clinical experience.

[0003] Clinical trials refer to any systematic study of drugs conducted on humans (patients or healthy volunteers) to confirm or reveal the effects, adverse reactions, and / or absorption, distribution, metabolism, and excretion of the investigational drug, with the aim of determining its efficacy and safety. Clinical trials are one of the key pathways to obtaining clinical evidence relevant to medical decisions. Clinical follow-up involves tracking changes in a patient's condition and treatment after discharge, including short-term and long-term efficacy evaluations, and is a core component of retrospective or prospective clinical work summaries. Clinical follow-up provides comprehensive information for clinical medical work; follow-up data is an important supplement to inpatient medical records and also provides a rich source of data for clinical research and teaching. Therefore, clinical follow-up is an important part of hospital medical, teaching, and research activities, and an extension and expansion of clinical medical services. Clinical follow-up is another key pathway to obtaining clinical evidence.

[0004] In recent years, with the rapid development of information technology, the informatization of the pharmaceutical industry has also undergone tremendous changes. Paperless office, networked medical services, and high-density information storage and interaction have become key terms in digital healthcare. Due to the rapid development of the pharmaceutical and biotechnology industry, the demand for clinical trials and clinical follow-ups based on various research purposes has increased exponentially. A single clinical trial or clinical follow-up may have a research cycle of ten or even decades, with numerous research projects at each visit site. Unplanned visits, adverse events, and other special visit site requirements may occur at any time during the visit. Data collected at various stages of the entire clinical trial and clinical follow-up study is usually mixed, analyzed, and extracted into multiple reports and files. It is essential to ensure that the collected data is accurate and reliable, stored securely and confidentially, and can be accessed and analyzed in an orderly manner in a fast, efficient, and low-cost manner.

[0005] Therefore, we propose an intelligent follow-up system for clinical trials, which utilizes artificial intelligence and technological tools to assist and improve the system for patient follow-up and monitoring during the clinical trial process. Summary of the Invention

[0006] To address the problems existing in current technologies, this application provides an intelligent follow-up system for clinical trials. This system aims to improve the efficiency, accuracy, and reliability of follow-up while reducing the workload of researchers. Through this intelligent follow-up system, clinical trial researchers can better monitor patients' conditions and treatment effects, improving the quality and reliability of data. Simultaneously, patients can receive more convenient and personalized follow-up and support, promoting their participation in clinical trials and improving treatment adherence.

[0007] To achieve the above objectives, this application adopts the following technical solution:

[0008] An intelligent follow-up system for clinical trials includes a follow-up plan management terminal, a follow-up data entry terminal, a follow-up reminder and notification terminal, a follow-up data monitoring and verification terminal, a follow-up data query and analysis terminal, and a follow-up report and export terminal;

[0009] The follow-up plan management terminal, follow-up data entry terminal, follow-up reminder and notification terminal, follow-up data monitoring and verification terminal, follow-up data query and analysis terminal, and follow-up report and export terminal communicate with each other via a dedicated network.

[0010] Preferably, the follow-up plan management terminal includes a follow-up time point setting module, a follow-up content definition module, a follow-up plan generation module, a follow-up plan adjustment module, a follow-up reminder and notification module, a follow-up plan tracking module, and a follow-up plan review and approval module;

[0011] The follow-up time point setting module includes a follow-up time point setting unit, which is used by the system to support setting the follow-up time points for patients or research subjects participating in clinical trials; and a follow-up time point setting database unit, which is used to store follow-up time point setting data information.

[0012] The follow-up content definition module includes a follow-up content definition unit, used to define the follow-up content at each follow-up time point; and a follow-up content definition database unit, used to store follow-up content definition data information.

[0013] The follow-up plan generation module includes a follow-up plan generation unit, which is used by the system to automatically generate a follow-up plan based on the set follow-up time points and follow-up content; and a follow-up plan generation database unit, which is used to store follow-up plan generation data information.

[0014] The follow-up plan adjustment module includes a follow-up plan adjustment unit, used to support the adjustment and modification of the follow-up plan; and a follow-up plan adjustment database unit, used to store follow-up plan adjustment data information.

[0015] The follow-up reminder and notification module includes a follow-up reminder and notification unit, used by the system to send follow-up reminders and notifications to patients or research subjects participating in clinical trials; and a follow-up reminder and notification database unit, used to store follow-up reminder and notification data information.

[0016] The follow-up plan tracking module includes a follow-up plan tracking unit for systematically tracking and recording the execution status of the follow-up plan; and a follow-up plan tracking database unit for storing follow-up plan tracking data information.

[0017] The follow-up plan review and approval module includes a follow-up plan review and approval unit, which is used by the system to provide the review and approval function for follow-up plans; and a follow-up plan review and approval database unit, which is used to store follow-up plan review and approval data information.

[0018] Preferably, the follow-up reminder and notification unit can automatically send reminders and notifications according to the set follow-up time points; the reminders and notifications can be sent via email, SMS or internal system messages.

[0019] Preferably, the follow-up data entry terminal includes a data entry interface module, a data field definition module, a data verification and validation module, a data dictionary management module, a multi-data type support module, a data validation rule module, and a data saving and submission module;

[0020] The data entry interface module includes a data entry interface unit, which provides an intuitive and easy-to-use data entry interface for researchers to enter data; and a data entry interface database unit, which stores data information from the data entry interface.

[0021] The data field definition module includes a data field definition unit, used by the system to define corresponding data fields according to the requirements of clinical trials; and a data field definition database unit, used to store data field definition information.

[0022] The data verification and validation module includes a data verification and validation unit for the system to verify and validate the entered data; and a data verification and validation database unit for storing data verification and validation data information.

[0023] The data dictionary management module includes a data dictionary management unit for system management and maintenance of the data dictionary, defining the meaning and value range of data fields; and a data dictionary management database unit for storing data dictionary management data information.

[0024] The multi-data type support module includes a multi-data type support unit for supporting the input of multiple data types, including text, numbers, dates, and drop-down menus; and a multi-data type support database unit for storing multi-data type support data information.

[0025] The data verification rule module includes: a data verification rule unit, used by the system to provide data verification rules to ensure that the entered data complies with the specifications and requirements of clinical trials; and a data verification rule database unit, used to store data verification rule data information.

[0026] The data saving and submission module includes: a data saving and submission unit for saving the entered data and supporting data submission; and a data saving and submission database unit for storing data saving and submission information.

[0027] Preferably, the follow-up reminder and notification terminal includes a follow-up appointment reminder module, a follow-up plan notification module, a follow-up reminder and warning module, a questionnaire completion reminder module, a follow-up result notification module, an adverse event notification module, and a communication channel flexibility module.

[0028] The follow-up appointment reminder module includes a follow-up appointment reminder unit, which is used by the system to send follow-up appointment reminders to patients or research subjects to ensure that they know the specific time, location and related arrangements for the follow-up; and a follow-up appointment reminder database unit, which is used to store follow-up appointment reminder data information.

[0029] The follow-up plan notification module includes a follow-up plan notification unit, which is used by the system to automatically send follow-up plan notifications to participants according to the set follow-up plan; and a follow-up plan notification database unit, which is used to store follow-up plan notification data information.

[0030] The follow-up reminder and warning module includes a follow-up reminder and warning unit, which is used by the system to send follow-up reminders and warnings to participants to ensure that they participate in the follow-up on time; and a follow-up reminder and warning database unit, which is used to store follow-up reminder and warning data information.

[0031] The questionnaire completion reminder module includes a questionnaire completion reminder unit, which is used when participants need to complete a questionnaire or assessment form during follow-up. The system can send reminder notifications to prompt participants to complete and submit the relevant forms; and a questionnaire completion reminder database unit, which is used to store questionnaire completion reminder data information.

[0032] The follow-up result notification module includes a follow-up result notification unit, which is used by the system to send follow-up result notifications to participants, including disease assessment results and treatment effect feedback; and a follow-up result notification database unit, which is used to store follow-up result notification data information.

[0033] The adverse event notification module includes an adverse event notification unit, which allows the system to send notifications to relevant researchers or medical personnel when a participant experiences an adverse event or side effect, in order to facilitate timely intervention and treatment; and an adverse event notification database unit, which stores adverse event notification data.

[0034] The communication channel flexibility module includes a communication channel flexibility unit, which is used by the system to select an appropriate method to send reminders and notifications based on the participants' preferences and available communication channels, and a communication channel flexibility database unit, which is used to store communication channel flexibility data information.

[0035] Preferably, the questionnaire completion reminder module includes a questionnaire link, completion instructions, and deadline information.

[0036] Preferably, the follow-up data monitoring and verification terminal includes a data monitoring module, a data verification rule module, a data logic verification module, a data range verification module, a data integrity check module, a data duplication check module, and a data quality report module;

[0037] The data monitoring module includes a data monitoring unit for real-time or periodic monitoring of follow-up data; and a data monitoring database unit for storing data monitoring data information.

[0038] The data validation rule module includes a data validation rule unit, used to define data validation rules and check the accuracy and consistency of data according to the needs and requirements of clinical trials; and a data validation rule database unit, used to store data validation rule data information.

[0039] The data logic verification module includes a data logic verification unit, which is used by the system to verify the logical relationship between data to ensure the correlation and consistency between data; and a data logic verification database unit, which is used to store data logic verification data information.

[0040] The data range verification module includes a data range verification unit, which is used by the system to verify the value range of the data to ensure the rationality and accuracy of the data; and a data range verification database unit, which is used to store data range verification data information.

[0041] The data integrity check module includes a data integrity check unit, which is used by the system to check the integrity of the data, ensuring that all required fields are filled in and no key information is missing; and a data integrity check database unit, which is used to store data integrity check data information.

[0042] The data duplication check module includes a data duplication check unit, used by the system to check the duplication of data and prevent the same data from being entered or submitted repeatedly; and a data duplication check database unit, used to store data duplication check data information.

[0043] The data quality reporting module includes a data quality reporting unit, which is used to generate data quality reports, summarize and display the monitoring results and quality indicators of the data; and a data quality reporting database unit, which is used to store data quality report information.

[0044] Preferably, the validation rules in the data validation rules module include checks on logical relationships, range restrictions, and required fields.

[0045] Preferably, the follow-up data query and analysis terminal includes a data query module, a data export and import module, a data statistics and summary module, a data visualization module, a data comparison and contrast module, a data association and integration module, and a custom analysis and reporting module;

[0046] The data query module includes a data query unit, which provides the system with flexible data query functions, allowing researchers to search and extract follow-up data according to specific query conditions and screening criteria; and a data query database unit, which stores data query information.

[0047] The data export and import module includes a data export and import unit for supporting the export of follow-up data to common data formats for further processing and analysis in analysis tools; and a data export and import database unit for storing data export and import information.

[0048] The data statistics and aggregation module includes a data statistics and aggregation unit, which provides statistical and aggregation functions for the system, enabling statistical analysis of follow-up data and the generation of various statistical indicators and reports; and a data statistics and aggregation database unit, which stores data statistics and aggregation information.

[0049] The data visualization module includes a data visualization unit, which is used by the system to display and visualize follow-up data in the form of charts, graphs or visualization dashboards; and a data visualization database unit, which is used to store data visualization data information.

[0050] The data comparison and contrast module includes a data comparison and contrast unit for supporting the comparison and contrast of different follow-up data to reveal differences and trends between the data; and a data comparison and contrast database unit for storing data comparison and contrast data information.

[0051] The data association and integration module includes a data association and integration unit, which is used by the system to associate and integrate follow-up data with other relevant data to obtain a more comprehensive data view and analysis capabilities; and a data association and integration database unit, which is used to store data association and integration data information.

[0052] The custom analysis and reporting module includes a custom analysis and reporting unit, which supports researchers in performing custom data analysis and generating reports; and a custom analysis and reporting database unit, which stores custom analysis and reporting data.

[0053] Preferably, the query conditions in the data query module include patient information, follow-up time, and treatment plan.

[0054] Preferably, the data visualization module includes visualizations such as trend charts, bar charts, pie charts, as well as interactive controls and filters to support in-depth data analysis and exploration.

[0055] Preferably, the follow-up report and export terminal include a follow-up report generation module, a report customization and personalization module, a report export module, a data export module, an export data field selection module, a data filtering and export module, and a data security and privacy protection module;

[0056] The follow-up report generation module includes a follow-up report generation unit, which is used to generate detailed reports of follow-up data, including the follow-up status of participants, treatment response assessment results, and adverse event records; and a follow-up report generation database unit, which is used to store follow-up report generation data information.

[0057] The report customization and personalization module includes a report customization and personalization unit, which allows researchers to customize the content, layout, and style of follow-up reports as needed; and a report customization and personalization database unit, which stores report customization and personalization data information.

[0058] The report export module includes a report export unit, which is used by the system to export follow-up reports into common document formats for sharing, printing, or archiving; and a report export database unit, which is used to store report export data information.

[0059] The data export module includes a data export unit, which, in addition to generating follow-up reports, allows the system to export raw follow-up data to other data formats; and a data export database unit, which stores data export information.

[0060] The exported data field selection module includes an exported data field selection unit, which allows researchers to select the data fields to be exported as needed; and an exported data field selection database unit, which stores the exported data field selection data information.

[0061] The data filtering and export module includes a data filtering and export unit, which is used by the system to support filtering follow-up data according to specific filtering conditions and exporting data that meets the conditions; and a data filtering and export database unit, which is used to store data filtering and export data information.

[0062] The data security and privacy protection module includes a data security and privacy protection unit, which ensures data security and privacy protection when exporting follow-up data; and a data security and privacy protection database unit, which stores data security and privacy protection information.

[0063] Compared with the prior art, this application has the following beneficial effects:

[0064] The intelligent follow-up system for this clinical trial application utilizes artificial intelligence and technological tools to assist and improve patient follow-up and monitoring during the clinical trial process. This system aims to improve the efficiency, accuracy, and reliability of follow-up while reducing the workload of researchers. Through the intelligent follow-up system, clinical trial researchers can better monitor patients' conditions and treatment effects, improving the quality and reliability of data. Simultaneously, patients can receive more convenient and personalized follow-up and support, promoting their participation in the clinical trial and improving treatment adherence. Attached Figure Description

[0065] Figure 1 This is a system block diagram of the overall implementation of the embodiments of this application;

[0066] Figure 2 This is a schematic block diagram of the follow-up plan management terminal in an embodiment of this application;

[0067] Figure 3 This is a schematic block diagram of the follow-up data entry terminal in an embodiment of this application;

[0068] Figure 4 This is a schematic block diagram of the follow-up reminder and notification terminal in the embodiments of this application;

[0069] Figure 5 This is a schematic block diagram of the follow-up data monitoring and verification terminal in the embodiments of this application;

[0070] Figure 6 This is a schematic block diagram of the follow-up data query and analysis terminal in the embodiments of this application;

[0071] Figure 7 This is a schematic block diagram of the follow-up report and the export terminal in the embodiments of this application. Detailed Implementation

[0072] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0073] This application provides an intelligent follow-up system for clinical trials.

[0074] like Figure 1 As shown, the intelligent follow-up system for clinical trials includes a follow-up plan management terminal 1, a follow-up data entry terminal 2, a follow-up reminder and notification terminal 3, a follow-up data monitoring and verification terminal 4, a follow-up data query and analysis terminal 5, and a follow-up report and export terminal 6. The follow-up plan management terminal 1, the follow-up data entry terminal 2, the follow-up reminder and notification terminal 3, the follow-up data monitoring and verification terminal 4, the follow-up data query and analysis terminal 5, and the follow-up report and export terminal 6 communicate with each other via a dedicated network.

[0075] like Figure 2 As shown, the follow-up plan management terminal 1 includes a follow-up time point setting module 101, a follow-up content definition module 102, a follow-up plan generation module 103, a follow-up plan adjustment module 104, a follow-up reminder and notification module 105, a follow-up plan tracking module 106, and a follow-up plan review and approval module 107.

[0076] The follow-up time point setting module 101 includes a follow-up time point setting unit 101a and a follow-up time point setting database unit 101b. The follow-up time point setting unit 101a is used by the system to support the setting of follow-up time points for patients or research subjects participating in clinical trials. Researchers can set specific follow-up time points according to the needs of the clinical trial and the research protocol, such as follow-up time after enrollment, follow-up time during treatment cycles, and follow-up time after surgery. The follow-up time point setting database unit 101b is used to store follow-up time point setting data information.

[0077] The follow-up content definition module 102 includes a follow-up content definition unit 102a and a follow-up content definition database unit 102b. The follow-up content definition unit 102a is used to systematically define the follow-up content at each follow-up time point. Researchers can set the data and information to be collected, such as disease assessment, quality of life questionnaires, and adverse event records. The follow-up content can be customized according to the specific requirements of the clinical trial. The follow-up content definition database unit 102b is used to store the follow-up content definition data.

[0078] The follow-up plan generation module 103 includes a follow-up plan generation unit 103a and a follow-up plan generation database unit 103b. The follow-up plan generation unit 103a is used by the system to automatically generate a follow-up plan based on the set follow-up time points and follow-up content. This plan may include the follow-up schedule for each patient or research subject, as well as the specific follow-up content and requirements for each follow-up time point. The follow-up plan generation database unit 103b is used to store the follow-up plan generation data information.

[0079] The follow-up plan adjustment module 104 includes a follow-up plan adjustment unit 104a and a follow-up plan adjustment database unit 104b. The follow-up plan adjustment unit 104a is used to support the adjustment and modification of the follow-up plan. During clinical trials, situations may arise where adjustments to follow-up time points or follow-up content are necessary. The system provides corresponding functions, allowing researchers to flexibly adjust the follow-up plan. The follow-up plan adjustment database unit 104b is used to store follow-up plan adjustment data.

[0080] The follow-up reminder and notification module 105 includes a follow-up reminder and notification unit 105a, used by the system to send follow-up reminders and notifications to patients or study subjects participating in clinical trials. Based on the set follow-up time points, the system can automatically send reminders and notifications to ensure patients participate in follow-ups on time. Reminders and notifications can be sent via email, SMS, or internal system messages. The follow-up reminder and notification database unit 105b is used to store follow-up reminder and notification data.

[0081] The follow-up plan tracking module 106 includes a follow-up plan tracking unit 106a and a follow-up plan tracking database unit 106b. The follow-up plan tracking unit 106a is used to track and record the execution of the follow-up plan. Researchers can view the follow-up status and completion of each patient or research subject. The system can provide corresponding reports and statistical information so that researchers can understand the follow-up progress in real time. The follow-up plan tracking database unit 106b is used to store follow-up plan tracking data.

[0082] The follow-up plan review and approval module 107 includes a follow-up plan review and approval unit 107a and a follow-up plan review and approval database unit 107b. The follow-up plan review and approval unit 107a is used by the system to provide review and approval functions for follow-up plans. The follow-up plan review and approval database unit 107b is used to store follow-up plan review and approval data.

[0083] like Figure 3As shown, the follow-up data entry terminal 2 includes a data entry interface module 201, a data field definition module 202, a data verification and validation module 203, a data dictionary management module 204, a multi-data type support module 205, a data validation rule module 206, and a data saving and submission module 207.

[0084] The data entry interface module 201 includes a data entry interface unit 201a and a data entry interface database unit 201b. The data entry interface unit 201a provides an intuitive and easy-to-use data entry interface, allowing researchers to enter data. The interface can be customized based on the complexity of the follow-up content, ranging from simple text boxes to complex questionnaires. The data entry interface database unit 201b stores the data information from the data entry interface.

[0085] The data field definition module 202 includes a data field definition unit 202a and a data field definition database unit 202b. The data field definition unit 202a is used by the system to define corresponding data fields according to the requirements of clinical trials. When entering data, researchers need to fill in the corresponding data according to the predefined data fields. Data fields can cover follow-up data such as disease assessment, treatment response, adverse events, and medication records. The data field definition database unit 202b is used to store the data field definition information.

[0086] The data verification and validation module 203 includes a data verification and validation unit 203a and a data verification and validation database unit 203b. The data verification and validation unit 203a is used by the system to verify and validate the entered data. The system can check the format, range, and reasonableness of the data and provide corresponding error messages and warnings. This helps ensure the accuracy and consistency of the data. The data verification and validation database unit 203b is used to store data verification and validation data information.

[0087] The data dictionary management module 204 includes a data dictionary management unit 204a and a data dictionary management database unit 204b. The data dictionary management unit 204a is used for system management and maintenance of the data dictionary, defining the meaning and value range of data fields. The data dictionary can provide reference and guidance, helping researchers to correctly enter data. At the same time, the use of the data dictionary also facilitates data standardization and comparative analysis. The data dictionary management database unit 204b is used to store data dictionary management information.

[0088] The multi-data type support module 205 includes a multi-data type support unit 205a and a multi-data type support database unit 205b. The multi-data type support unit 205a is used to support the input of multiple data types, including text, numbers, dates, drop-down menus, etc. This can adapt to different types of follow-up data, improving the flexibility and accuracy of data entry. The multi-data type support database unit 205b is used to store data information supported by multiple data types.

[0089] The data validation rule module 206 includes a data validation rule unit 206a and a data validation rule database unit 206b. The data validation rule unit 206a is used by the system to provide data validation rules to ensure that the entered data complies with the specifications and requirements of clinical trials. Validation rules may include logical validation, range validation, and correlation validation to ensure the rationality and consistency of the data. The data validation rule database unit 206b is used to store data validation rule data information.

[0090] The data saving and submission module 207 includes a data saving and submission unit 207a and a data saving and submission database unit 207b. The data saving and submission unit 207a is used to save the entered data and supports data submission. Researchers can progressively enter and save follow-up data until the data is complete and meets the submission requirements before submission. The system can record the data modification history and submission records for auditing and traceability. The data saving and submission database unit 207b is used to store data saving and submission information.

[0091] like Figure 4 As shown, the follow-up reminder and notification terminal 3 includes a follow-up appointment reminder module 301, a follow-up plan notification module 302, a follow-up reminder and warning module 303, a questionnaire completion reminder module 304, a follow-up result notification module 305, an adverse event notification module 306, and a communication channel flexibility module 307.

[0092] The follow-up appointment reminder module 301 includes a follow-up appointment reminder unit 301a and a follow-up appointment reminder database unit 301b. The follow-up appointment reminder unit 301a is used by the system to send follow-up appointment reminders to patients or research subjects to ensure they know the specific time, location, and arrangements for their follow-up appointments. Reminders can be sent via email, SMS, mobile application, or telephone. The follow-up appointment reminder database unit 301b is used to store follow-up appointment reminder data.

[0093] The follow-up plan notification module 302 includes a follow-up plan notification unit 302a and a follow-up plan notification database unit 302b. The follow-up plan notification unit 302a is used by the system to automatically send follow-up plan notifications to participants according to the set follow-up plan. These notifications can be sent a certain amount of time in advance to help participants prepare and make arrangements. The follow-up plan notification database unit 302b is used to store follow-up plan notification data.

[0094] The follow-up reminder and warning module 303 includes a follow-up reminder and warning unit 303a and a follow-up reminder and warning database unit 303b. The follow-up reminder and warning unit 303a is used by the system to send follow-up reminders and warnings to participants to ensure they participate in follow-ups on time. These reminders can be sent before the follow-up date, on the same day, or after a delay period to accommodate different follow-up schedules. The follow-up reminder and warning database unit 303b is used to store follow-up reminder and warning data.

[0095] The questionnaire completion reminder module 304 includes a questionnaire completion reminder unit 304a and a questionnaire completion reminder database unit 304b. The questionnaire completion reminder unit 304a is used to send reminder notifications when participants are required to complete a questionnaire or assessment form during follow-up, prompting them to fill out and submit the relevant forms. The reminder may include a questionnaire link, instructions for completion, and a deadline. The questionnaire completion reminder database unit 304b is used to store questionnaire completion reminder data.

[0096] The follow-up result notification module 305 includes a follow-up result notification unit 305a and a follow-up result notification database unit 305b. The follow-up result notification unit 305a is used by the system to send follow-up result notifications to participants, including disease assessment results and treatment effect feedback. This helps participants understand their health status and trial progress. The follow-up result notification database unit 305b is used to store follow-up result notification data.

[0097] The adverse event notification module 306 includes an adverse event notification unit 306a and an adverse event notification database unit 306b. The adverse event notification unit 306a is used to send notifications to relevant researchers or medical personnel if a participant experiences an adverse event or side effect, to facilitate timely intervention and treatment. The adverse event notification database unit 306b is used to store adverse event notification data.

[0098] The communication channel flexibility module 307 includes a communication channel flexibility unit 307a and a communication channel flexibility database unit 307b. The communication channel flexibility unit 307a is used by the system to select appropriate methods to send reminders and notifications based on participants' preferences and available communication channels, such as email, SMS, telephone calls, and mobile application notifications. The communication channel flexibility database unit 307b is used to store communication channel flexibility data.

[0099] like Figure 5 As shown, the follow-up data monitoring and verification terminal 4 includes a data monitoring module 401, a data verification rule module 402, a data logic verification module 403, a data range verification module 404, a data integrity check module 405, a data duplication check module 406, and a data quality report module 407.

[0100] The data monitoring module 401 includes a data monitoring unit 401a and a data monitoring database unit 401b. The data monitoring unit 401a is used for real-time or periodic monitoring of follow-up data. During monitoring, the system automatically checks the rationality, range, and logical relationships of the data to detect potential errors or anomalies. The data monitoring database unit 401b is used to store data monitoring information.

[0101] The data validation rule module 402 includes a data validation rule unit 402a and a data validation rule database unit 402b. The data validation rule unit 402a is used to define data validation rules and check the accuracy and consistency of data according to the needs and requirements of clinical trials. Validation rules may include checks on logical relationships, scope limitations, required fields, etc. The data validation rule database unit 402b is used to store data validation rule information.

[0102] The data logic verification module 403 includes a data logic verification unit 403a and a data logic verification database unit 403b. The data logic verification unit 403a is used by the system to verify the logical relationships between data, ensuring the correlation and consistency between data. For example, it checks whether the logical relationships between certain fields meet expectations, or checks the continuity and rationality of time series data. The data logic verification database unit 403b is used to store data logic verification data information.

[0103] The data range verification module 404 includes a data range verification unit 404a and a data range verification database unit 404b. The data range verification unit 404a is used by the system to verify the value range of the data, ensuring the reasonableness and accuracy of the data. According to the requirements of clinical trials, the system can check whether the data is within a predefined range or exceeds a reasonable range. The data range verification database unit 404b is used to store data range verification data information.

[0104] The data integrity check module 405 includes a data integrity check unit 405a and a data integrity check database unit 405b. The data integrity check unit 405a is used by the system to check the integrity of the data, ensuring that all required fields are filled in and that no critical information is missing. This helps prevent missing or incomplete data, improving data quality and usability. The data integrity check database unit 405b is used to store data integrity check data information.

[0105] The data duplication check module 406 includes a data duplication check unit 406a and a data duplication check database unit 406b. The data duplication check unit 406a is used by the system to check the duplication of data, preventing the same data from being entered or submitted repeatedly. This avoids data redundancy and confusion, ensuring the uniqueness and consistency of the data. The data duplication check database unit 406b is used to store data duplication check data information.

[0106] The data quality reporting module 407 includes a data quality reporting unit 407a and a data quality reporting database unit 407b. The data quality reporting unit 407a is used by the system to generate data quality reports, summarizing and displaying data monitoring results and quality indicators. The report may include a list of errors and abnormal data, statistical information on data quality indicators, etc., to help researchers identify and resolve data quality problems. The data quality reporting database unit 407b is used to store data quality report data information.

[0107] like Figure 6 As shown, the follow-up data query and analysis terminal 5 includes a data query module 501, a data export and import module 502, a data statistics and summary module 503, a data visualization module 504, a data comparison and contrast module 505, a data association and integration module 506, and a custom analysis and reporting module 507.

[0108] The data query module 501 includes a data query unit 501a and a data query database unit 501b. The data query unit 501a provides flexible data query functionality, allowing researchers to search and extract follow-up data based on specific query conditions and screening criteria. Query conditions may include patient information, follow-up time, treatment plan, etc., to meet the specific needs of researchers. The data query database unit 501b stores the data query information.

[0109] The data export and import module 502 includes a data export and import unit 502a and a data export and import database unit 502b. The data export and import unit 502a is used to support the export of follow-up data to common data formats (such as Excel, CSV, etc.) for further processing and analysis in other analytical tools. Simultaneously, the system can also support the import of external data into the system for integrated analysis. The data export and import database unit 502b is used to store data export and import information.

[0110] The data statistics and summary module 503 includes a data statistics and summary unit 503a and a data statistics and summary database unit 503b. The data statistics and summary unit 503a provides statistical and summary functions for the system, enabling statistical analysis of follow-up data and generating various statistical indicators and reports. For example, it can calculate patient follow-up rates, changes in disease condition, and treatment effectiveness evaluations. The data statistics and summary database unit 503b stores statistical and summary data information.

[0111] The data visualization module 504 includes a data visualization unit 504a and a data visualization database unit 504b. The data visualization unit 504a is used by the system to display and visualize follow-up data through charts, graphs, or visualization dashboards to help researchers understand and analyze the data more intuitively. Visualizations may include trend charts, bar charts, pie charts, and interactive controls and filters to support in-depth data analysis and exploration. The data visualization database unit 504b is used to store data visualization information.

[0112] The data comparison and contrast module 505 includes a data comparison and contrast unit 505a and a data comparison and contrast database unit 505b. The data comparison and contrast unit 505a is used by the system to support the comparison and contrast of different follow-up data to reveal differences and trends between the data. Researchers can compare and analyze data from different patient groups, treatment regimens, or time periods to evaluate treatment effectiveness or validate research hypotheses. The data comparison and contrast database unit 505b is used to store data comparison and contrast information.

[0113] The data association and integration module 506 includes a data association and integration unit 506a and a data association and integration database unit 506b. The data association and integration unit 506a is used by the system to associate and integrate follow-up data with other relevant data (such as clinical indicators, laboratory results, etc.) to obtain a more comprehensive data view and analytical capabilities. This helps to comprehensively consider information from different data sources and provide a more comprehensive clinical trial analysis. The data association and integration database unit 506b is used to store the data association and integration information.

[0114] The custom analysis and reporting module 507 includes a custom analysis and reporting unit 507a and a custom analysis and reporting database unit 507b. The custom analysis and reporting unit 507a supports researchers in performing custom data analysis and generating reports. Researchers can use built-in analysis tools or external analysis software to conduct more in-depth and advanced data analysis based on their needs and hypotheses. The custom analysis and reporting database unit 507b stores custom analysis and reporting data.

[0115] like Figure 7 As shown, the follow-up report and export module 6 includes a follow-up report generation module 601, a report customization and personalization module 602, a report export module 603, a data export module 604, an export data field selection module 605, a data filtering and export module 606, and a data security and privacy protection module 607.

[0116] The follow-up report generation module 601 includes a follow-up report generation unit 601a and a follow-up report generation database unit 601b. The follow-up report generation unit 601a is used to generate detailed reports of follow-up data, including participant follow-up status, treatment response assessment results, adverse event records, etc. The reports can be generated according to preset templates and formats, and include necessary charts, tables, and explanatory text. The follow-up report generation database unit 601b is used to store the follow-up report generation data information.

[0117] The report customization and personalization module 602 includes a report customization and personalization unit 602a and a report customization and personalization database unit 602b. The report customization and personalization unit 602a allows researchers to customize the content, layout, and style of follow-up reports as needed. Researchers can select the fields, metrics, and charts to include, as well as customize the report's title, header, footer, etc., to meet research needs and standards. The report customization and personalization database unit 602b stores the report customization and personalization data.

[0118] The report export module 603 includes a report export unit 603a and a report export database unit 603b. The report export unit 603a is used by the system to export follow-up reports to common document formats, such as PDF, Word, or HTML, for sharing, printing, or archiving. The exported report retains the format and layout of the original report, ensuring data readability and consistency. The report export database unit 603b is used to store the exported report data.

[0119] The data export module 604 includes a data export unit 604a and a data export database unit 604b. The data export unit 604a, in addition to generating follow-up reports, allows the system to export raw follow-up data to other data formats, such as Excel and CSV. This enables researchers to use the data for further statistical analysis, chart creation, or other data processing tasks. The data export database unit 604b stores the data export information.

[0120] The export data field selection module 605 includes an export data field selection unit 605a and an export data field selection database unit 605b. The export data field selection unit 605a allows researchers to select the data fields to export as needed. This allows researchers to export only the fields required for their analysis, simplifying subsequent data processing and analysis. The export data field selection database unit 605b stores the export data field selection information.

[0121] The data filtering and export module 606 includes a data filtering and export unit 606a and a data filtering and export database unit 606b. The data filtering and export unit 606a is used by the system to support filtering follow-up data according to specific filtering criteria and exporting data that meets the criteria. This helps researchers extract specific subsets from large amounts of data for more accurate analysis and reporting. The data filtering and export database unit 606b is used to store the data filtering and export information.

[0122] The data security and privacy protection module 607 includes a data security and privacy protection unit 607a and a data security and privacy protection database unit 607b. The data security and privacy protection unit 607a ensures data security and privacy protection when exporting follow-up data. The system can adopt appropriate encryption measures and access control to protect the confidentiality and integrity of the data. The data security and privacy protection database unit 607b stores data security and privacy protection information.

[0123] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. An intelligent follow-up system for clinical trials, characterized in that, It includes a follow-up plan management terminal, a follow-up data entry terminal, a follow-up reminder and notification terminal, a follow-up data monitoring and verification terminal, a follow-up data query and analysis terminal, and a follow-up report and export terminal; The follow-up plan management terminal, follow-up data entry terminal, follow-up reminder and notification terminal, follow-up data monitoring and verification terminal, follow-up data query and analysis terminal, and follow-up report and export terminal communicate with each other via a dedicated network. 2.The intelligent follow-up system for clinical trials of claim 1, wherein, The follow-up plan management terminal includes a follow-up time point setting module, a follow-up content definition module, a follow-up plan generation module, a follow-up plan adjustment module, a follow-up reminder and notification module, a follow-up plan tracking module, and a follow-up plan review and approval module; The follow-up time point setting module includes a follow-up time point setting unit, which is used by the system to support setting the follow-up time points for patients or research subjects participating in clinical trials; and a follow-up time point setting database unit, which is used to store follow-up time point setting data information. The follow-up content definition module includes a follow-up content definition unit, which is used to define the follow-up content at each follow-up time point in the system; The follow-up content definition database unit is used to store follow-up content definition data information; The follow-up plan generation module includes a follow-up plan generation unit, which is used by the system to automatically generate a follow-up plan based on the set follow-up time points and follow-up content. The follow-up plan generation database unit is used to store the data information generated by the follow-up plan; The follow-up plan adjustment module includes a follow-up plan adjustment unit, which is used to support the adjustment and modification of the follow-up plan in the system. The follow-up plan adjustment database unit is used to store follow-up plan adjustment data information; The follow-up reminder and notification module includes a follow-up reminder and notification unit, used by the system to send follow-up reminders and notifications to patients or research subjects participating in clinical trials; and a follow-up reminder and notification database unit, used to store follow-up reminder and notification data information. The follow-up plan tracking module includes a follow-up plan tracking unit for systematically tracking and recording the execution status of the follow-up plan; and a follow-up plan tracking database unit for storing follow-up plan tracking data information. The follow-up plan review and approval module includes a follow-up plan review and approval unit, which is used by the system to provide the review and approval function for follow-up plans; and a follow-up plan review and approval database unit, which is used to store follow-up plan review and approval data information.

3. The intelligent follow-up system for clinical trials according to claim 2, characterized in that, The follow-up reminder and notification unit can automatically send reminders and notifications based on the set follow-up time points; reminders and notifications can be sent via email, SMS or internal system messages. 4.The intelligent follow-up system for clinical trials of claim 1, wherein, The follow-up data entry terminal includes a data entry interface module, a data field definition module, a data verification and validation module, a data dictionary management module, a multi-data type support module, a data validation rule module, and a data saving and submission module; The data entry interface module includes a data entry interface unit, which provides the system with an intuitive and easy-to-use data entry interface, allowing researchers to enter data through the interface. The data entry interface database unit is used to store data information from the data entry interface. The data field definition module includes a data field definition unit, which is used by the system to define corresponding data fields according to the requirements of clinical trials; Data field definitions are database units used to store data field definition information; The data verification and validation module includes a data verification and validation unit for the system to verify and validate the entered data; and a data verification and validation database unit for storing data verification and validation data information. The data dictionary management module includes a data dictionary management unit, which is used for system management and maintenance of the data dictionary, and to define the meaning and value range of data fields. The data dictionary management database unit is used to store data dictionary management data information; The multi-data type support module includes a multi-data type support unit, which is used to support the input of multiple data types, including text, numbers, dates, and drop-down menus. A database unit that supports multiple data types is used to store data information that supports multiple data types. The data verification rule module includes: a data verification rule unit, used by the system to provide data verification rules to ensure that the entered data complies with the specifications and requirements of clinical trials; and a data verification rule database unit, used to store data verification rule data information. The data saving and submission module includes: a data saving and submission unit for saving the entered data and supporting data submission; and a data saving and submission database unit for storing data saving and submission information. 5.The intelligent follow-up system for clinical trials of claim 1, wherein, The follow-up reminder and notification module includes a follow-up appointment reminder module, a follow-up plan notification module, a follow-up reminder and warning module, a questionnaire completion reminder module, a follow-up result notification module, an adverse event notification module, and a communication channel flexibility module. The follow-up appointment reminder module includes a follow-up appointment reminder unit, which is used by the system to send follow-up appointment reminders to patients or research subjects to ensure that they know the specific time, location and related arrangements for the follow-up; and a follow-up appointment reminder database unit, which is used to store follow-up appointment reminder data information. The follow-up plan notification module includes a follow-up plan notification unit, which is used by the system to automatically send follow-up plan notifications to participants according to the set follow-up plan; and a follow-up plan notification database unit, which is used to store follow-up plan notification data information. The follow-up reminder and warning module includes a follow-up reminder and warning unit, which is used by the system to send follow-up reminders and warnings to participants to ensure that they participate in the follow-up on time; and a follow-up reminder and warning database unit, which is used to store follow-up reminder and warning data information. The questionnaire completion reminder module includes a questionnaire completion reminder unit, which is used when participants need to complete a questionnaire or assessment form during follow-up. The system can send reminder notifications to prompt participants to complete and submit the relevant forms; and a questionnaire completion reminder database unit, which is used to store questionnaire completion reminder data information. The follow-up result notification module includes a follow-up result notification unit, which is used by the system to send follow-up result notifications to participants, including disease assessment results and treatment effect feedback; The follow-up result notification database unit is used to store follow-up result notification data information; The adverse event notification module includes an adverse event notification unit, which allows the system to send notifications to relevant researchers or medical personnel when a participant experiences an adverse event or side effect, in order to facilitate timely intervention and treatment; and an adverse event notification database unit, which stores adverse event notification data. The communication channel flexibility module includes a communication channel flexibility unit, which is used by the system to select an appropriate method to send reminders and notifications based on the participants' preferences and available communication channels, and a communication channel flexibility database unit, which is used to store communication channel flexibility data information. 6.The intelligent follow-up system for clinical trials of claim 1, wherein, The follow-up data monitoring and verification terminal includes a data monitoring module, a data verification rule module, a data logic verification module, a data range verification module, a data integrity check module, a data duplication check module, and a data quality report module; The data monitoring module includes a data monitoring unit, which is used for the system to monitor follow-up data in real time or periodically. The data monitoring database unit is used to store data monitoring data information; The data validation rule module includes a data validation rule unit, which is used to define data validation rules in the system and check the accuracy and consistency of the data according to the needs and requirements of clinical trials. The data validation rule database unit is used to store data validation rule data information; The data logic verification module includes a data logic verification unit, which is used by the system to verify the logical relationship between data to ensure the correlation and consistency between data. The data logic verification database unit is used to store data logic verification data information; The data range verification module includes a data range verification unit, which is used by the system to verify the value range of the data to ensure the rationality and accuracy of the data; and a data range verification database unit, which is used to store data range verification data information. The data integrity check module includes a data integrity check unit, which is used to check the integrity of the data in the system, ensuring that all required fields are filled in and that no key information is missing. The data integrity check database unit is used to store data integrity check data information; The data duplication check module includes a data duplication check unit, which is used by the system to check the duplication of data and prevent the same data from being entered or submitted repeatedly. The data duplication check database unit is used to store data duplication check data information; The data quality reporting module includes a data quality reporting unit, which is used to generate data quality reports, summarize and display the monitoring results and quality indicators of the data; and a data quality reporting database unit, which is used to store data quality report information.

7. The intelligent follow-up system for clinical trials according to claim 6, characterized in that, The data validation rules module includes checks on logical relationships, scope restrictions, and required fields. 8.The intelligent follow-up system of clinical trials of claim 1, wherein, The follow-up data query and analysis terminal includes a data query module, a data export and import module, a data statistics and summary module, a data visualization module, a data comparison and contrast module, a data association and integration module, and a custom analysis and reporting module; The data query module includes a data query unit, which provides the system with flexible data query functions, allowing researchers to search and extract follow-up data according to specific query conditions and screening criteria. The data query database unit is used to store data query information; The data export and import module includes a data export and import unit, which enables the system to support the export of follow-up data to common data formats for further processing and analysis in analysis tools. The data export and import database unit is used to store data export and import information; The data statistics and aggregation module includes a data statistics and aggregation unit, which provides statistical and aggregation functions for the system, enabling statistical analysis of follow-up data and the generation of various statistical indicators and reports; and a data statistics and aggregation database unit, which stores data statistics and aggregation information. The data visualization module includes a data visualization unit, which is used by the system to display and visualize follow-up data in the form of charts, graphs or visualization dashboards; and a data visualization database unit, which is used to store data visualization data information. The data comparison and contrast module includes a data comparison and contrast unit, which is used by the system to support the comparison and contrast of different follow-up data in order to reveal the differences and trends between the data; A data comparison and contrast database unit, used to store data comparison and contrast information; The data association and integration module includes a data association and integration unit, which is used by the system to associate and integrate follow-up data with other relevant data to obtain a more comprehensive data view and analysis capabilities. Data association and integration database unit, used to store data association and integration information; The custom analysis and reporting module includes a custom analysis and reporting unit, which supports researchers in performing custom data analysis and generating reports; and a custom analysis and reporting database unit, which stores custom analysis and reporting data.

9. The intelligent follow-up system for clinical trials according to claim 8, characterized in that, The query criteria in the data query module include patient information, follow-up time, and treatment plan. 10.The intelligent follow-up system of clinical trials of claim 1, wherein, The follow-up report and export module include a follow-up report generation module, a report customization and personalization module, a report export module, a data export module, an export data field selection module, a data filtering and export module, and a data security and privacy protection module. The follow-up report generation module includes a follow-up report generation unit, which is used to generate detailed reports of follow-up data, including the follow-up status of participants, treatment response assessment results, and adverse event records; and a follow-up report generation database unit, which is used to store follow-up report generation data information. The report customization and personalization module includes a report customization and personalization unit, which allows researchers to customize the content, layout, and style of follow-up reports as needed; and a report customization and personalization database unit, which stores report customization and personalization data information. The report export module includes a report export unit, which is used by the system to export the follow-up report into common document formats for sharing, printing or archiving. The report export database unit is used to store report export data information; The data export module includes a data export unit, which, in addition to generating follow-up reports, also supports exporting the original follow-up data to other data formats. The data export database unit is used to store data export information; The exported data field selection module includes an exported data field selection unit, which allows researchers to select the data fields to be exported as needed. The exported data field selection database cell is used to store the exported data field selection information; The data filtering and export module includes a data filtering and export unit, which is used by the system to support the filtering of follow-up data according to specific filtering conditions and to export the data that meets the conditions. Data filtering and export database unit, used to store data filtering and export information; The data security and privacy protection module includes a data security and privacy protection unit, which ensures data security and privacy protection when exporting follow-up data; and a data security and privacy protection database unit, which stores data security and privacy protection information.

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