Intelligent auxiliary system for clinical test researchers

Abstract

The invention belongs to the technical field of medical informatization, and particularly relates to an intelligent auxiliary system for clinical test researchers, which comprises an intelligent adverse event recording module for intelligently recording adverse events; the real-time guidance and feedback module is used for automatically generating standardized suggestions and examples and carrying out automatic verification; the time management and reminding module is used for managing the time of the adverse events and reminding the adverse events needing to be continuously followed up; the data analysis module is used for providing a data analysis tool, supporting trend analysis, frequency statistics and risk assessment of the adverse events and providing decision support for researchers and managers, the problems existing in the prior art can be effectively solved, the normalization, timeliness and accuracy of adverse event recording are remarkably improved, and the working efficiency is improved. Therefore, the quality of clinical tests and the safety of subjects are guaranteed.

Description

Technical Field

[0001] The present invention relates to the technical field of medical informatization, and specifically to an intelligent assistant system for clinical trial researchers. Background Art

[0002] In recent years, the importance of Good Clinical Practice (GCP) in the drug R & D and regulatory systems has become increasingly prominent. In 2022, GCP was officially incorporated into the annual assessment index system of medical institutions by the National Health Commission. This policy measure has significantly promoted the standardized management process of clinical trials in China. However, with the continuous increase in the number of newly registered clinical trial institutions, inexperienced researchers in the new institutions have exposed many problems in the recording of adverse events. According to the "Annual Report on Adverse Drug Reaction Monitoring in 2022" released by the National Medical Products Administration, the non - standard rate of adverse event reports in newly registered institutions is about 35% higher than that in mature institutions. The main problems include: incomplete description of adverse events, non - standard use of medical terms, inaccurate grading of severity, delayed reporting time, etc. The existence of these problems not only affects the quality and reliability of clinical trial data, but also may have an adverse impact on the safety of subjects and drug evaluation. In the existing technology, although some Electronic Data Capture (EDC) systems provide adverse event recording modules, these systems generally have problems such as insufficient intelligence and lack of real - time guidance functions, and it is difficult to effectively solve the difficulties encountered by novice researchers in actual operations. In addition, in clinical trials, the difficult recruitment of subjects is a key problem that researchers urgently need to solve, mainly reflected in the following two aspects: First, the information transmission is not smooth and unequal, and the release channels are limited. The recruitment information of many clinical trials is only released in a few hospitals or professional channels, resulting in a large number of potential subjects being unable to obtain this information in a timely manner. Second, there is a lack of effective dissemination channels and the information coverage is narrow. In some areas, there is no dedicated clinical trial information release platform, or the publicity of these platforms is insufficient. Even if there is an information release platform, its coverage may be limited and it cannot reach a wider range of potential subjects. The difficult recruitment of subjects is not only extremely unfavorable to the conduct of clinical trials, but also seriously affects the rights and interests of subjects. For clinical trial projects, the recruitment cycle is extended, the trial progress is blocked, resulting in waste of resources. For subjects, they cannot timely understand the cutting - edge treatment methods and lose the opportunity to receive new therapies. For researchers, the project progress is slow, affecting the timely completion of the research plan; the research cycle is extended, and the release of scientific research results is lagged, which may miss the best publication opportunity. In the field of subject recruitment, although the existing platforms and channels can release clinical trial information, there are problems such as narrow dissemination range and lack of precise push mechanism. At the same time, some recruitment companies with high fees also have the risk of false subjects, which not only increases the cost of the sponsor, but also affects the reliability of the data, and it is difficult to effectively solve the dilemmas faced by researchers in the recruitment process. Therefore, an intelligent assistant system for clinical trial researchers is invented. Summary of the Invention

[0003] To solve the above - mentioned technical problems, according to one aspect of the present invention, the present invention provides the following technical solutions:

[0004] An intelligent assistant system for clinical trial researchers, comprising:

[0005] An intelligent adverse event recording module for intelligently recording adverse events;

[0006] A real-time guidance and feedback module for automatically generating standardized suggestions and examples and performing automatic verification;

[0007] A time management and reminder module for managing the time of adverse events and reminding of adverse events that need continuous follow-up;

[0008] A data analysis module for providing data analysis tools to support trend analysis, frequency statistics and risk assessment of adverse events, and providing decision-making support for researchers and managers;

[0009] A user-friendly interface and training support module for establishing a user-friendly interface and providing online training resources;

[0010] A compliance document management module for centrally and standardly managing documents during the clinical trial process, the documents including informed consent forms, research protocols, and ethical approval documents;

[0011] A subject management module for effectively managing subject information;

[0012] An intelligent recruitment information publishing module mainly for efficiently spreading recruitment information, expanding the information coverage, ensuring that researchers and subjects can obtain relevant information in a timely manner, and improving the recruitment efficiency and quality.

[0013] As a preferred embodiment of the intelligent assistant system for clinical trial researchers described in the present invention, wherein: the intelligent adverse event recording module includes:

[0014] An intelligent text recognition module for real-time analyzing the adverse event description input by the researcher according to natural language processing, and automatically identifying and prompting incomplete, non-standard or ambiguous expressions;

[0015] A term recommendation and automatic correction module for providing term recommendation and automatic correction functions according to an integrated medical term library and a standardized dictionary to ensure the accuracy and consistency of the adverse event description.

[0016] As a preferred embodiment of the intelligent assistant system for clinical trial researchers described in the present invention, wherein: the real-time guidance and feedback module includes:

[0017] A real-time guidance module for automatically generating standardized suggestions and examples according to the content input by the researcher to help novice researchers quickly master the standards and requirements for adverse event recording;

[0018] An instant feedback module for automatically verifying the key content of severity grading and causality assessment and prompting errors or omissions.

[0019] As a preferred solution of an intelligent assistant system for clinical trial researchers according to the present invention, wherein: the time management and reminder module includes:

[0020] An integrated time management module for automatically recording the occurrence time and reporting time of adverse events and setting reminders according to GCP requirements to ensure timely reporting;

[0021] An overdue warning module for marking and reminding adverse events that need to be continuously followed up to avoid untimely follow-up.

[0022] As a preferred solution of an intelligent assistant system for clinical trial researchers according to the present invention, wherein: the user-friendly interface and training support module includes:

[0023] A user interface design module for designing an intuitive and easy-to-use user interface, simplifying the operation process, and reducing the usage threshold;

[0024] An online training module for integrating online training resources, providing standardized operation guidelines and case analyses for adverse event recording, and helping researchers quickly improve their skills.

[0025] As a preferred solution of an intelligent assistant system for clinical trial researchers according to the present invention, wherein: the data analysis module includes:

[0026] A trend analysis module for analyzing the occurrence trend of adverse events by using data visualization technology, so that researchers and managers can intuitively understand the change of the occurrence frequency of adverse events over time and timely discover potential risks;

[0027] A frequency statistics module for statistically analyzing the frequencies of adverse events of different types and severities and generating statistical reports, so as to provide decision-making support for drug R & D and clinical trial management through the analysis of frequency data;

[0028] A risk assessment module for assessing the risks of clinical trials by adopting a risk assessment model and combining the occurrence frequency and severity factors of adverse events, and displaying the assessment results in the form of risk levels to provide a reference for researchers and managers to formulate risk response strategies.

[0029] As a preferred solution of an intelligent assistant system for clinical trial researchers according to the present invention, wherein: the compliance document management module includes:

[0030] The document classification and storage module is used to classify and store various types of compliant documents, support the upload of multiple formats, and provide a unified document access entry to facilitate researchers to quickly retrieve and obtain the required documents;

[0031] The version control module is used to track the version changes of documents, record in detail the content, time, and effective time of each revision, and avoid compliance risks caused by using the wrong version of the document;

[0032] The expiration reminder module is used to automatically set reminders for documents with expiration date restrictions to ensure the timeliness of the documents.

[0033] As a preferred solution of an intelligent assistant system for clinical trial researchers described in the present invention, wherein: the subject management module includes:

[0034] The information integration module is used to centrally store the basic information, health status, and trial participation records of subjects, form a complete subject file, and facilitate researchers to comprehensively understand the situation of subjects;

[0035] The visit plan management module is used to formulate a visit plan for subjects according to the trial protocol, and automatically remind researchers and subjects in the system to ensure that the visits are carried out on time;

[0036] The safety monitoring module is used to combine adverse event records to monitor the health status of subjects in real time. Once an abnormality is found, an early warning is issued in a timely manner to ensure the safety of subjects.

[0037] As a preferred solution of an intelligent assistant system for clinical trial researchers described in the present invention, wherein: the intelligent recruitment information release module includes:

[0038] The recruitment information push module: is used to widely release clinical trial recruitment information to ensure that researchers and subjects can obtain relevant information in a timely manner.

[0039] The real-time update and feedback module: can real-time update the status of clinical trial recruitment information, and adjust the information push strategy in a timely manner according to the feedback of potential subjects to ensure the timeliness and accuracy of the information.

[0040] The data statistics and analysis module: monitors and analyzes the dissemination effect of recruitment information in real time, including key indicators such as the click-through rate and conversion rate of the information, provides decision-making support for researchers, and optimizes the subsequent recruitment strategy.

[0041] Compared with the prior art:

[0042] The present invention can effectively solve the problems existing in the prior art, significantly improve the standardization, timeliness and accuracy of adverse event records, thereby ensuring the quality of clinical trials and the safety of subjects; in addition, it can also efficiently disseminate recruitment information, expand the information coverage, ensure that researchers and subjects can obtain relevant information in a timely manner, and improve the recruitment efficiency and quality. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 It is a schematic flowchart of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0044] To make the objectives, technical solutions and advantages of the present invention clearer, the embodiments of the present invention will be further described in detail below with reference to the accompanying drawings.

[0045] The present invention provides an intelligent assistant system for clinical trial researchers. Please refer to Figure 1 ;

[0046] It includes: an intelligent adverse event recording module for intelligently recording adverse events; a real-time guidance and feedback module for automatically generating standardized suggestions and examples and performing automatic verification; a time management and reminder module for managing the time of adverse events and reminding adverse events that need continuous follow-up; a data analysis module for providing data analysis tools to support trend analysis, frequency statistics and risk assessment of adverse events, and providing decision-making support for researchers and managers; a user-friendly interface and training support module for establishing a user-friendly interface and providing online training resources; a compliance document management module for centrally and standardly managing documents during the clinical trial process, and the documents include informed consent forms, research protocols, and ethical approval documents; a subject management module for effectively managing subject information.

[0047] The intelligent adverse event recording module includes: an intelligent text recognition module for real-time analyzing the adverse event description input by the researcher according to natural language processing, automatically identifying and prompting incomplete, non-standard or ambiguous expressions; a term recommendation and automatic correction module for providing term recommendation and automatic correction functions according to the integrated medical terminology database and standardized dictionary to ensure the accuracy and consistency of the adverse event description.

[0048] The real-time guidance and feedback module includes: a real-time guidance module for automatically generating standardized suggestions and examples according to the content input by the researcher to help novice researchers quickly master the standards and requirements for adverse event recording; an instant feedback module for automatically verifying the key content of severity grading and causality assessment and prompting errors or omissions.

[0049] The time management and reminder module includes: an integrated time management module for automatically recording the occurrence time and reporting time of adverse events, and setting reminders according to GCP requirements to ensure timely reporting; an overdue warning module for marking and reminding adverse events that need to be continuously followed up to avoid untimely follow-up.

[0050] The user-friendly interface and training support module includes: a user interface design module for designing an intuitive and easy-to-use user interface, simplifying the operation process, and reducing the usage threshold; an online training module for integrating online training resources, providing standardized operation guidelines and case analyses for adverse event recording to help researchers quickly improve their skills.

[0051] The data analysis module includes: a trend analysis module for analyzing the occurrence trend of adverse events using data visualization technology, enabling researchers and managers to intuitively understand the change in the occurrence frequency of adverse events over time and timely discover potential risks; a frequency statistics module for statistically analyzing the frequencies of adverse events of different types and severities, generating statistical reports, and providing decision-making support for drug R & D and clinical trial management through the analysis of frequency data; a risk assessment module for assessing the risks of clinical trials using a risk assessment model and combining factors such as the occurrence frequency and severity of adverse events, and presenting the assessment results in the form of risk levels to provide reference for researchers and managers to formulate risk response strategies.

[0052] The compliance document management module includes: a document classification and storage module for classifying and storing various compliance documents, supporting the upload of multiple formats, and providing a unified document access entrance to facilitate researchers to quickly retrieve and obtain the required documents; a version control module for tracking the version changes of documents, detailedly recording the content, time, and effective date of each revision to avoid compliance risks caused by using the wrong version of documents; an expiration reminder module for automatically setting reminders for documents with expiration date restrictions to ensure the timeliness of documents; by setting up the compliance document management module, it can greatly improve the efficiency of compliance document management, reduce the chaos of document management, effectively avoid compliance risks caused by poor document management, and help clinical trials smoothly pass regulatory reviews.

[0053] The subject management module includes: an information integration module for centrally storing the basic information, health status, and trial participation records of subjects to form a complete subject file, facilitating researchers to comprehensively understand the situation of subjects; a visit plan management module for formulating a visit plan for subjects according to the trial protocol and automatically reminding researchers and subjects in the system to ensure that visits are carried out on time; a safety monitoring module for combining adverse event records to monitor the health status of subjects in real time, and once an abnormality is found, giving an early warning in a timely manner to ensure the safety of subjects. By setting up the subject management module, it is possible to improve the refinement level of subject management, enhance communication and collaboration between researchers and subjects, reduce the subject dropout rate, and ensure the integrity and reliability of clinical trial data.

[0054] The intelligent recruitment information release module includes: a recruitment information push module for widely releasing clinical trial recruitment information to ensure that researchers and subjects can obtain relevant information in a timely manner; a real-time update module capable of real-time updating the status of clinical trial recruitment information to ensure the timeliness and accuracy of the information; a feedback and optimization module for receiving feedback information from potential subjects and optimizing the information push strategy according to the feedback results to improve the recruitment efficiency and quality.

[0055] In specific use, the operation steps of those skilled in the art are as follows:

[0056] Step 1: Through the intelligent text recognition module, analyze the adverse event description input by the researcher in real time according to natural language processing, automatically identify and prompt incomplete, non-standard or ambiguous expressions. Then, the term recommendation and automatic correction module will provide term recommendation and automatic correction functions according to the integrated medical term library and standardized dictionary to ensure the accuracy and consistency of the adverse event description.

[0057] Step 2: Through the real-time guidance module, automatically generate standardized suggestions and examples according to the content input by the researcher to help novice researchers quickly master the standards and requirements for adverse event recording. Then, the instant feedback module will automatically verify the key content of severity grading and causality assessment and prompt errors or omissions.

[0058] Step 3: Through the integrated time management module, automatically record the occurrence time and reporting time of adverse events, and set reminders according to GCP requirements to ensure timely reporting. Then, the overdue warning module will mark and remind adverse events that need to be continuously followed up to avoid untimely follow-up.

[0059] Step 4: Through the data analysis module, provide data analysis tools to support trend analysis, frequency statistics, and risk assessment of adverse events, providing decision-making support for researchers and managers.

[0060] Step 5: Design an intuitive and user-friendly user interface through the user interface design module to simplify the operation process and lower the usage threshold. Then, integrate online training resources through the online training module to provide standardized operation guidelines and case analyses for adverse event records, helping researchers quickly improve their skills;

[0061] Step 6: First, classify and store various compliance documents through the document classification and storage module, support the upload of multiple formats, and provide a unified document access entrance to facilitate researchers to quickly retrieve and obtain the required documents. Then, use the version control module to track the version changes of the documents, record in detail the content, time, and effective date of each revision, and avoid compliance risks caused by using the wrong version of the documents. After that, set reminders automatically for documents with expiration date restrictions through the expiration reminder module to ensure the timeliness of the documents;

[0062] Step 7: First, centrally store the basic information, health status, and trial participation records of the subjects through the information integration module to form a complete subject file, facilitating researchers to comprehensively understand the subjects' situations. Then, formulate a visit plan for the subjects according to the trial protocol through the visit plan management module and automatically remind the researchers and subjects in the system to ensure that the visits are carried out on time. After that, combine the adverse event records through the safety monitoring module to monitor the health status of the subjects in real time. Once an abnormality is found, an early warning will be issued in a timely manner to ensure the safety of the subjects.

[0063] Step 8: First, widely publish the recruitment information of the clinical trial project through the recruitment information push module to ensure that researchers and subjects can obtain relevant information in a timely manner. Then, through the real-time update module, the status of the clinical trial recruitment information can be updated in real time to ensure the timeliness and accuracy of the information. After that, use the feedback and optimization module to receive feedback information from potential subjects and optimize the information push strategy according to the feedback results to improve the recruitment efficiency and quality.

[0064] Although the present invention has been described above with reference to the embodiments, various improvements can be made to it and its components can be replaced with equivalents without departing from the scope of the present invention. In particular, as long as there is no structural conflict, the various features in the embodiments disclosed in the present invention can be combined with each other in any way. The reason for not exhaustively describing the situations of these combinations in this specification is only to save space and resources. Therefore, the present invention is not limited to the specific embodiments disclosed in the text, but includes all technical solutions falling within the scope of the claims.

Claims

1. An intelligent assistant system for clinical trial researchers, characterized in that, Including: An intelligent adverse event recording module for intelligently recording adverse events; A real-time guidance and feedback module for automatically generating standardized suggestions and examples and performing automatic verification; A time management and reminder module for managing the time of adverse events and reminding of adverse events that need continuous follow-up; A data analysis module for providing data analysis tools to support trend analysis, frequency statistics and risk assessment of adverse events, and providing decision-making support for researchers and managers; A user-friendly interface and training support module for establishing a user-friendly interface and providing online training resources; A compliance document management module for centrally and standardly managing documents during the clinical trial process, and the documents include informed consent forms, research protocols, and ethical approval documents; A subject management module for effectively managing subject information; An intelligent recruitment information publishing module mainly for efficiently disseminating recruitment information, expanding the information coverage, ensuring that researchers and subjects can timely obtain relevant information, and improving the recruitment efficiency and quality.

2. The intelligent assistant system for clinical trial researchers according to claim 1, wherein The intelligent adverse event recording module includes: An intelligent text recognition module for real-time analyzing the adverse event description input by the researcher according to natural language processing, automatically identifying and prompting incomplete, non-standard or ambiguous expressions; A term recommendation and automatic correction module for providing term recommendation and automatic correction functions according to the integrated medical terminology library and standardized dictionary to ensure the accuracy and consistency of the adverse event description.

3. An intelligent assistant system for clinical trial researchers according to claim 1, characterized in that, The real-time guidance and feedback module includes: A real-time guidance module for automatically generating standardized suggestions and examples according to the content input by the researcher to help novice researchers quickly master the standards and requirements for adverse event recording; An instant feedback module for automatically verifying the key content of severity grading and causality assessment and prompting errors or omissions.

4. An intelligent assistant system for clinical trial researchers according to claim 1, characterized in that, The time management and reminder module includes: An integrated time management module for automatically recording the occurrence time and reporting time of adverse events and setting reminders according to GCP requirements to ensure timely reporting; An overdue warning module for marking and reminding of adverse events that need continuous follow-up to avoid untimely follow-up.

5. The intelligent assistant system for clinical trial researchers according to claim 1, wherein The user-friendly interface and training support module includes: A user interface design module for designing an intuitive and easy-to-use user interface, simplifying the operation process and reducing the usage threshold; An online training module for integrating online training resources, providing standardized operation guides and case analyses for adverse event recording to help researchers quickly improve their skills.

6. The intelligent auxiliary system for clinical trial researchers according to claim 1, wherein The data analysis module includes: A trend analysis module for analyzing the occurrence trend of adverse events by using data visualization technology, so that researchers and managers can intuitively understand the change of the occurrence frequency of adverse events over time and timely discover potential risks; A frequency statistics module for statistically analyzing the frequencies of different types and severities of adverse events and generating statistical reports, so as to provide decision-making support for drug R & D and clinical trial management through the analysis of frequency data; A risk assessment module, which is used to adopt a risk assessment model and combine factors such as the occurrence frequency and severity of adverse events to assess the risks of clinical trials. The assessment results are presented in the form of risk levels, providing a reference for researchers and managers to formulate risk response strategies.

7. An intelligent assistant system for clinical trial researchers according to claim 1, wherein, The compliance document management module includes: A document classification and storage module, which is used to classify and store various compliance documents, support the upload of multiple formats, and provide a unified document access entrance to facilitate researchers to quickly retrieve and obtain the required documents; A version control module, which is used to track the version changes of documents, record in detail the content, time, and effective time of each revision, and avoid compliance risks caused by using the wrong version of documents; An expiration reminder module, which is used to automatically set reminders for documents with validity period restrictions to ensure the timeliness of documents.

8. An intelligent auxiliary system for clinical trial researchers according to claim 1, characterized in that, The subject management module includes: An information integration module, which is used to centrally store the basic information, health status, and trial participation records of subjects to form a complete subject file, facilitating researchers to comprehensively understand the situation of subjects; A visit plan management module, which is used to formulate a visit plan for subjects according to the trial protocol and automatically remind researchers and subjects in the system to ensure that the visits are carried out on time; A safety monitoring module, which is used to combine adverse event records to monitor the health status of subjects in real time. Once an abnormality is found, an early warning is issued in a timely manner to ensure the safety of subjects.

9. An intelligent assistant system for clinical trial researchers according to claim 1, characterized in that, The intelligent recruitment information release module includes: A recruitment information push module, which is used to widely release clinical trial recruitment information to ensure that researchers and subjects can obtain relevant information in a timely manner; A real-time update module, which can real-time update the status of clinical trial recruitment information to ensure the timeliness and accuracy of information; A feedback and optimization module, which is used to receive feedback information from potential subjects and optimize the information push strategy according to the feedback results to improve the recruitment efficiency and quality.

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