A research HIS system for clinical trials

Abstract

The present application discloses a research HIS system for clinical trials, which relates to the technical field of clinical trials, and includes a research participant management end, including a participant registration module, a pre-screening module, a research participant tracking module, a data collection module, an access rights management module, a research participant communication module, and a participant security and privacy protection module; a planning and scheduling management end, including a test plan module, a research center management module, a personnel task allocation module, a test schedule management module, a task tracking progress monitoring module, a resource scheduling management module, and a visit arrangement reminder module; a collaborative communication end, including a project team collaboration module, an email message notification module, a real-time chat discussion module, a file sharing collaborative editing module, a meeting schedule module, a discussion board knowledge base module, and a task allocation tracking module. The present application has the effect of facilitating the reasonable management and monitoring of clinical data in a hospital information management system.

Description

Technical Field

[0001] The present application relates to the technical field of clinical trials, and in particular to the field of clinical trials. Background Art

[0002] Clinical trial of a drug refers to any systematic study of a drug conducted on humans (patients or healthy volunteers) to confirm or discover the clinical, pharmacological and / or other pharmacodynamic effects, adverse reactions and / or absorption, distribution, metabolism and excretion of the investigational drug, with the aim of determining the safety and efficacy of the investigational drug.

[0003] Among the related technologies, Hospital Information System (HIS) is an interdisciplinary science that integrates medicine, information, management, computer and other disciplines. It has been widely used in developed countries and has created good social and economic benefits.

[0004] Hospital information management system is the necessary technical support and infrastructure for modern hospital operation. The purpose of implementing hospital information management system is to strengthen hospital management, improve hospital work efficiency, and improve medical quality in a more modern, scientific, and standardized way, thereby establishing a new image of modern hospitals. This is also the inevitable direction of future hospital development. However, in related technologies, a large amount of clinical data is always used in clinical trials. How to reasonably manage and monitor clinical data is of great significance to hospital information management system. Summary of the invention

[0005] In order to reasonably manage and monitor clinical data in a hospital information management system, the present application provides a research-type HIS system for clinical trials.

[0006] This application provides a research HIS system for clinical trials, which adopts the following technical solutions:

[0007] A research HIS system for clinical trials, including a research participant management terminal for managing participants in clinical trials, including a participant registration module, a pre-screening module, a research participant tracking module, a data collection module, an access rights management module, a research participant communication module, and a participant security and privacy protection module;

[0008] Research data management terminal, which is used to manage the data required for clinical trials, including data collection and entry module, data storage management module, data verification logic check module, data query and retrieval module, data analysis and statistics module, data export and sharing module, and data security and privacy protection module;

[0009] The trial drug management end includes the drug registration identification module, drug inventory management module, drug distribution randomization module, drug delivery tracking module, drug use management module, drug side effect safety monitoring module, and drug adjustment termination module;

[0010] The planning and scheduling management end includes the test planning module, research center management module, personnel task allocation module, test schedule management module, task tracking and progress monitoring module, resource scheduling management module, and visit arrangement reminder module;

[0011] Collaborative communication terminal, including project team collaboration module, email message notification module, real-time chat discussion module, file sharing collaborative editing module, meeting scheduling module, discussion board knowledge base module, and task assignment tracking module;

[0012] Ethics and compliance management, including ethics review management module, compliance regulations management module, informed consent management module, privacy protection data security module, compliance monitoring and reporting module, adverse event safety management module, ethics committee and regulatory agency collaboration module; and,

[0013] The report analysis end includes data report visualization module, data analysis tool module, research result report module, statistical analysis support module, data quality inspection module, statistical indicator monitoring module, and data sharing module.

[0014] Preferably, data communication is performed between the research participant management end, research data management end, trial drug management end, schedule management end, collaborative communication end, ethical compliance management end and report analysis end through a dedicated network with dedicated lines.

[0015] Preferably, the participant registration module includes a participant registration unit and a participant registration database unit, wherein the participant registration unit is used by researchers to register the information of participants participating in the clinical trial, wherein the participant information includes basic personal information, contact information, and medical insurance information; and the participant registration database unit is used to store the participant registration information;

[0016] The pre-screening module includes a pre-screening unit and a pre-screening database unit, wherein the pre-screening unit is used to screen out qualified participants according to preset screening criteria, and record and output pre-screening information; and the pre-screening database unit is used to store the pre-screening information;

[0017] The research participant tracking module includes a research participant tracking unit and a research participant tracking database unit, wherein the research participant tracking unit is used to record and track the research progress of the research participants and output the research participant tracking information; the research participant tracking database unit is used to store the research participant tracking information;

[0018] The data collection module includes a data collection unit and a data collection database unit. The data collection unit is used to collect data related to the research participants and generate data collection information; the data collection database unit is used to store the data collection information;

[0019] The access permission management module includes an access permission management unit and an access permission management database unit, wherein the access permission management unit is used to manage the access permission of the research participant data and generate access permission management information; the access permission management database unit is used to store the access permission management information;

[0020] The research participant communication module includes a research participant communication unit and a research participant communication database unit, wherein the research participant communication unit is used to provide a communication channel between the research participants and the researchers and output research participant communication information; the research participant communication database unit is used to store research participant communication information;

[0021] The participant security and privacy protection module includes a participant security and privacy protection unit and a participant security and privacy protection database unit. The participant security and privacy protection unit is used to provide research participant data security and privacy protection functions and output participant security and privacy protection information; the participant security and privacy protection database unit is used to store participant security and privacy protection information.

[0022] Preferably, the data collection and entry module includes a data collection and entry unit and a data collection and entry database unit, wherein the data collection and entry unit is used to collect and enter the data required for the clinical trial; the data collection and entry database unit is used to store data collection and entry information;

[0023] The data storage management module includes a data storage management unit and a data storage and management database unit, wherein the data storage management unit is used to store and manage research data, wherein the research data includes data of research participants and related clinical trial data; the data storage and management database unit is used to store data storage and management research data information;

[0024] The data verification logic check module includes a data verification logic check unit and a data verification logic check database unit; the data verification logic check unit is used to perform data verification and logic check to ensure the consistency and rationality of the data, automatically and / or manually verify and check the data according to preset rules and standards, and provide corresponding warnings or prompts; the data verification logic check database unit is used to store data verification and logic check information;

[0025] The data query and retrieval module includes a data query and retrieval unit and a data query and retrieval database unit. The data query and retrieval unit is used to provide data query and retrieval functions to facilitate researchers to obtain and retrieve research data as needed; the data query and retrieval database unit is used to store data query and retrieval information;

[0026] The data analysis and statistics module includes a data analysis and statistics unit and a data analysis and statistics database unit. The data analysis and statistics unit is used to analyze and count the data of the clinical trial; the data analysis and statistics database unit is used to store data analysis and statistics information;

[0027] The data export sharing module includes a data export sharing unit and a data export sharing database unit. The data export sharing unit is used to export data to other formats or systems for further analysis or sharing with other research teams; the data export sharing database unit is used to store data export sharing information;

[0028] The data security and privacy protection module includes a data security and privacy protection unit and a data security and privacy protection database unit; the data security and privacy protection unit is used to process data security and privacy, and the processing methods include data encryption, access control, and audit tracking; the data security and privacy protection database unit is used to store data security and privacy protection information.

[0029] Preferably, the drug registration identification module includes a drug registration identification unit and a drug registration identification database unit, wherein the drug registration identification unit is used to record and identify the information of each test drug, including the drug name, batch number, manufacturer, and dosage; and the drug registration identification database unit is used to store drug registration and identification information;

[0030] The drug inventory management module includes a drug inventory management unit and a drug inventory management database unit. The drug inventory management unit is used to track and manage the inventory of the test drug, including the entry, exit and remaining quantity of the drug; the drug inventory management database unit is used to store drug inventory management information;

[0031] The drug distribution randomization module includes a drug distribution randomization unit and a drug distribution randomization database unit, wherein the drug distribution randomization unit is used to automatically distribute the trial drug to eligible research participants according to the trial design and randomization scheme, and record the distribution status; the drug distribution randomization database unit is used to store drug distribution and randomization information;

[0032] The drug delivery tracking module includes a drug delivery tracking unit and a drug delivery tracking database unit, wherein the drug delivery tracking unit is used to track the delivery process of the test drug, including the delivery to various research centers or clinical units; and the drug delivery tracking database unit is used to store drug delivery and tracking information;

[0033] The drug use management module includes a drug use management unit and a drug use and management database unit. The drug use management unit is used to systematically record the conditions of the study participants receiving the trial drugs, including the dosage, usage, and frequency of the drugs. The drug use and management database unit is used to store drug use and management information.

[0034] The drug side effect safety monitoring module includes a drug side effect safety monitoring unit and a drug side effect safety monitoring database unit, wherein the drug side effect safety monitoring unit is used to systematically record and monitor the side effects and safety information of the test drug; the drug side effect safety monitoring database unit is used to store the drug side effects and safety monitoring information;

[0035] The drug adjustment termination module includes a drug adjustment termination unit and a drug adjustment termination database unit; the drug adjustment termination unit is used to record the adjustment and termination of the trial drug, and adjust the drug dosage or terminate the use of the drug according to the research needs or the situation of the research participants; the drug adjustment termination database unit is used to store drug adjustment and termination information.

[0036] Preferably, the trial plan module includes a trial plan unit and a trial plan database unit, wherein the trial plan unit is used to record and manage the plan information of the clinical trial, including the objectives, research questions, research design, sample size, and follow-up plan of the trial; and the trial plan database unit is used to store the trial plan information;

[0037] The research center management module includes a research center management unit and a research center management database unit. The research center management unit is used to manage the research center information involved in the experiment, including the location, personnel composition, and equipment resources of the center; the research center management database unit is used to store the research center management information;

[0038] The personnel task allocation module includes a personnel task allocation unit and a personnel task allocation database unit. The personnel task allocation unit is used to allocate research tasks to corresponding researchers and record the status and progress of the tasks; the personnel task allocation database unit is used to store personnel and task allocation information;

[0039] The test schedule management module includes a test schedule management unit and a test schedule management database unit, wherein the test schedule management unit is used to manage the schedule and time arrangement of the clinical trial; the test schedule management database unit is used to store test schedule management information;

[0040] The task tracking and progress monitoring module includes a task tracking and progress monitoring unit and a task tracking and progress monitoring database unit. The task tracking and progress monitoring unit is used to track the progress of the task and provide corresponding monitoring and reporting functions; the task tracking and progress monitoring database unit is used to store task tracking and progress monitoring information;

[0041] The resource scheduling management module includes a resource scheduling management unit and a resource scheduling management database unit. The resource scheduling management unit is used to manage the resources required for the experiment, including equipment, personnel, materials, etc.; the resource scheduling management database unit is used to store resource scheduling and management information;

[0042] The visit arrangement reminder module includes a visit arrangement reminder unit and a visit arrangement reminder database unit. The visit arrangement reminder unit is used to arrange the time and place of the test visit and provide reminder and notification functions; the visit arrangement reminder database unit is used to store visit arrangements and reminder information.

[0043] Preferably, the project team collaboration module includes a project team collaboration unit and a project team collaboration database unit. The project team collaboration unit is used to provide a project team collaboration platform, and researchers can create project teams, add members, and share information, files and tasks with team members in the system. The project team collaboration database unit is used to store project team collaboration information.

[0044] The email message notification module includes an email message notification unit and an email message notification database unit. The email message notification unit is used to integrate email and message notification functions, so that researchers can send emails or messages to other members and receive notifications and reminders. The email message notification database unit is used to store email and message notification information.

[0045] The real-time chat discussion module includes a real-time chat discussion unit and a real-time chat discussion database unit. The real-time chat discussion unit is used to provide real-time chat and discussion functions, conduct real-time communication and discussion, share ideas, solve problems, and negotiate decisions; the real-time chat discussion database unit is used to store real-time chat and discussion information;

[0046] The file sharing collaborative editing module includes a file sharing collaborative editing unit and a file sharing collaborative editing database unit. The file sharing collaborative editing unit is used to provide file sharing and collaborative editing functions, and researchers upload and share files, perform collaborative editing and version control; the file sharing collaborative editing database unit is used to store file sharing and collaborative editing information;

[0047] The conference scheduling module includes a conference scheduling unit and a conference scheduling database unit. The conference scheduling unit is used to integrate conference and scheduling functions, create and schedule meetings, add conference schedules, and invite relevant members to participate; the conference scheduling database unit is used to store conference and scheduling information;

[0048] The discussion board knowledge base module includes a discussion board knowledge base unit and a discussion board knowledge base database unit; the discussion board knowledge base unit is used to post questions, share experiences and provide suggestions, and organize them into a knowledge base; the discussion board knowledge base database unit is used to store discussion board and knowledge base information;

[0049] The task assignment tracking module includes a task assignment tracking unit and a task assignment tracking database unit. The task assignment tracking unit is used to assign tasks to relevant members and track the completion of tasks; the task assignment tracking database unit is used to store task assignment and tracking information.

[0050] Preferably, the ethics review management module includes an ethics review management unit and an ethics review management database unit, wherein the ethics review management unit is used to submit an ethics review application and track the review process of the application; the ethics review management database unit is used to store ethics review management information;

[0051] The compliance regulations management module includes a compliance regulations management unit and a compliance regulations management database unit, wherein the compliance regulations management unit contains laws and regulations related to research compliance; the compliance regulations management database unit is used to store compliance regulations management information;

[0052] The informed consent management module includes an informed consent management unit and an informed consent management database unit. The informed consent management unit is used to store and manage the informed consent documents and processes of the research participants, and track the signing and updating of the informed consent to ensure that the informed consent process of the research participants complies with ethical and regulatory requirements; the informed consent management database unit is used to store informed consent management information;

[0053] The privacy protection data security module includes a privacy protection data security unit and a privacy protection data security database unit, wherein the privacy protection data security unit is used to provide privacy protection and data security functions to ensure the security of the personal information and research data of the research participants; the privacy protection data security database unit is used to store privacy protection and data security information;

[0054] The compliance monitoring and reporting module includes a compliance monitoring and reporting unit and a compliance monitoring and reporting database unit, which are used for system support to monitor and report the compliance of research projects; the compliance monitoring and reporting database unit is used to store compliance monitoring and reporting information;

[0055] The adverse event safety management module includes an adverse event safety management unit and an adverse event safety management database unit, wherein the adverse event safety management unit is used to report and record adverse events and safety issues occurring in the study; and the adverse event safety management database unit is used to store adverse events and safety management information;

[0056] The ethics committee regulatory body collaboration module includes an ethics committee regulatory body collaboration unit and an ethics committee regulatory body collaboration database unit. The ethics committee regulatory body collaboration unit is used for collaboration and communication between the ethics committee and the regulatory body; the ethics committee regulatory body collaboration database unit is used to store collaboration information between the ethics committee and the regulatory body.

[0057] Preferably, the data report visualization module includes a data report visualization unit and a data report visualization database unit, wherein the data report visualization unit is used to generate various reports and charts for displaying the summary and trend of the research data; the data report visualization database unit is used to store data reports and visualization information;

[0058] The data analysis tool module includes a data analysis tool unit and a data analysis tool database unit. The data analysis tool unit is used to perform statistical analysis and inference analysis on the research data, perform data mining, modeling and prediction to reveal potential associations and trends; the data analysis tool database unit is used to store data analysis tool information;

[0059] The research result report module includes a research result report unit and a research result report database unit. The research result report unit is used to generate research reports, academic articles or other forms of results according to the research design and analysis results; the research result report database unit is used to store research results and report information;

[0060] The statistical analysis support module includes a statistical analysis support unit and a statistical analysis support database unit. The statistical analysis support unit is used to provide support for statistical analysis, including statistical methods and algorithms, and to perform data analysis based on built-in statistical tools, or to export data to external statistical software for further analysis. The statistical analysis support database unit is used to store statistical analysis support information.

[0061] The data quality check module includes a data quality check unit and a data quality check database unit, wherein the data quality check unit is used to identify and correct errors and inconsistencies in the data; the data quality check database unit is used to store data quality check information;

[0062] The statistical indicator monitoring module includes a statistical indicator monitoring unit and a statistical indicator monitoring database unit. The statistical indicator monitoring unit is used to provide a series of statistical indicators and monitoring functions for evaluating the progress and effect of the research project and tracking the changes of key indicators. The statistical indicator monitoring database unit is used to store statistical indicators and indicator monitoring information;

[0063] The data sharing module includes a data sharing unit and a data sharing database unit. The data sharing unit is used for system support of data export and sharing; the data sharing database unit is used for storing data export and sharing information.

[0064] In summary, the present application includes at least one of the following beneficial technical effects:

[0065] 1. Research HIS systems can centrally manage and store various clinical data required for clinical trials, including basic patient information, medical records, test results, laboratory data, etc. Such a system can provide a unified data storage and management platform to facilitate researchers to access and analyze trial data. The system can support the process management of clinical trials, including trial planning, trial process and tracking of trial results. It can record the various stages of the trial, the allocation and completion of trial tasks, and the recording and archiving of trial results. This helps researchers better control the progress of the trial and ensure the smooth progress of the trial;

[0066] 2. The research HIS system has strict data security and privacy protection measures to ensure the confidentiality and integrity of the test data. The system should adopt measures such as data encryption, access control, and identity authentication to limit access to and modification of test data, and ensure the security of data during transmission and storage. The system should have data export and analysis functions so that researchers can export test data to statistical analysis software for further data processing and statistical analysis. This helps researchers extract useful information from test data and draw scientific conclusions;

[0067] 3. The system can support licensing and compliance management in clinical trial research, including research ethics review, informed consent management, etc. It can help researchers track and record the informed consent status of trial participants to ensure that the trial meets ethical and regulatory requirements. Through the research-based HIS system, clinical trial researchers can better manage and utilize clinical data, support the management and monitoring of trial processes, improve data security and reliability, and promote the analysis and research of trial results. This helps promote the conduct of clinical trials and the development of scientific research. BRIEF DESCRIPTION OF THE DRAWINGS

[0068] Figure 1 It is a block diagram of a research HIS system mainly embodied in an embodiment of the present application for clinical trials.

[0069] Figure 2 It is a schematic block diagram of the research participant management terminal mainly embodied in the embodiment of the present application.

[0070] Figure 3 It is a schematic block diagram of the research data management terminal mainly embodied in the embodiment of the present application.

[0071] Figure 4 It is a schematic block diagram of the test drug management end mainly embodied in the embodiment of the present application.

[0072] Figure 5 It is a schematic block diagram of the plan scheduling management end mainly embodied in the embodiment of the present application.

[0073] Figure 6 It is a schematic block diagram of a collaborative communication terminal mainly embodied in an embodiment of the present application.

[0074] Figure 7 It is a schematic block diagram of the ethics and compliance management end mainly embodied in the embodiment of the present application.

[0075] Figure 8 It is a schematic block diagram of the report analysis end mainly embodied in the embodiment of the present application.

[0076] Explanation of the accompanying drawings: 1. Research participant management end; 11. Participant registration module; 12. Pre-screening module; 13. Research participant tracking module; 14. Data collection module; 15. Access rights management module; 16. Research participant communication module; 17. Participant security and privacy protection module; 2. Research data management end; 21. Data collection and entry module; 22. Data storage management module; 23. Data verification logic check module; 24. Data query and retrieval module; 25. Data analysis and statistics module; 26. Data export and sharing module; 27. Data security and privacy protection module; 3. Trial drug management end; 31. Drug registration identification module; 32. Drug inventory management module; 33. Drug distribution randomization module; 34. Drug distribution tracking module; 35. Drug use management module; 36. Drug side effect safety monitoring module; 37. Drug adjustment termination module; 4. Planning and scheduling management end; 41. Trial planning module; 42. Research center management module; 43. Personnel task allocation module; 44. Experimental schedule management module; 45. Task tracking and progress monitoring module; 46. Resource scheduling management module; 47. Visit arrangement reminder module; 5. Collaborative communication terminal; 51. Project team collaboration module; 52. Email message notification module; 53. Real-time chat discussion module; 54. File sharing and collaborative editing module; 55. Meeting schedule module; 56. Discussion board knowledge base module; 57. Task assignment tracking module; 6. Ethics and compliance management terminal; 61. Ethics review management module; 62. Compliance regulations management module; 63. Informed consent management module; 64. Privacy protection data security module; 65. Compliance monitoring report module; 66. Adverse event safety management module; 67. Ethics committee and regulatory agency collaboration module; 7. Report analysis terminal; 71. Data report visualization module; 72. Data analysis tool module; 73. Research results reporting module; 74. Statistical analysis support module; 75. Data quality inspection module; 76. Statistical indicator monitoring module; 77. Data sharing module. DETAILED DESCRIPTION

[0077] The following is combined with Figure 1-8 This application is described in further detail.

[0078] The embodiment of the present application discloses a research-type HIS system for clinical trials.

[0079] Reference Figure 1A research HIS system for clinical trials includes a research participant management terminal 1, a research data management terminal 2, a trial drug management terminal 3, a plan scheduling management terminal 4, a collaborative communication terminal 5, an ethics compliance management terminal 6, and a report analysis terminal 7. The research participant management terminal 1, the research data management terminal 2, the trial drug management terminal 3, the plan scheduling management terminal 4, the collaborative communication terminal 5, the ethics compliance management terminal 6, and the report analysis terminal 7 communicate data through a dedicated network.

[0080] Reference Figure 2 The research participant management terminal 1 is used to manage the participants of the clinical trial, including a participant registration module 11, a pre-screening module 12, a research participant tracking module 13, a data collection module 14, an access rights management module 15, a research participant communication module 16, and a participant security and privacy protection module 17.

[0081] Specifically, the participant registration module 11 includes a participant registration unit and a participant registration database unit. The participant registration unit is used by researchers to register participant information participating in clinical trials, where the participant information includes basic personal information, contact information, and medical insurance information; the participant registration database unit is used to store participant registration information.

[0082] The pre-screening module 12 includes a pre-screening unit and a pre-screening database unit. The pre-screening unit is used to screen out qualified participants according to preset screening criteria, and record and output pre-screening information; the pre-screening database unit is used to store pre-screening information;

[0083] The research participant tracking module 13 includes a research participant tracking unit and a research participant tracking database unit. The research participant tracking unit is used to record and track the research progress of research participants and output research participant tracking information, such as recording the follow-up status of participants, participation in research activities, etc.; the research participant tracking database unit is used to store research participant tracking information.

[0084] The data collection module 14 includes a data collection unit and a data collection database unit. The data collection unit is used to collect data related to the research participants and generate data collection information, including medical records, laboratory results, imaging data, etc. The system can record and store this data and ensure its security and privacy protection. The data collection database unit is used to store data collection information.

[0085] The access rights management module 15 includes an access rights management unit and an access rights management database unit. The access rights management unit is used to manage the access rights of the research participants' data and generate access rights management information to ensure that only authorized personnel can view and process the relevant data. The access rights management database unit is used to store the access rights management information.

[0086] The research participant communication module 16 includes a research participant communication unit and a research participant communication database unit. The research participant communication unit is used to provide a communication channel between research participants and researchers and output research participant communication information, including message notifications, appointment reminders, questionnaires, etc. The research participant communication database unit is used to store research participant communication information.

[0087] The participant security and privacy protection module 17 includes a participant security and privacy protection unit and a participant security and privacy protection database unit. The participant security and privacy protection unit is used to provide research participant data security and privacy protection functions and output participant security and privacy protection information, including data encryption, access control, audit tracking and other security measures to comply with relevant laws and regulations and ethical requirements. The participant security and privacy protection database unit is used to store participant security and privacy protection information.

[0088] Reference Figure 3 The research data management terminal 2 is used to manage the data required for clinical trials, including a data collection and entry module 21, a data storage management module 22, a data verification logic check module 23, a data query and retrieval module 24, a data analysis and statistics module 25, a data export and sharing module 26, and a data security and privacy protection module 27.

[0089] Specifically, the data collection and entry module 21 includes a data collection and entry unit and a data collection and entry database unit. The data collection and entry unit is used to collect and enter the data required for the clinical trial, including medical record data, laboratory results, imaging data, questionnaire data, etc. The data collection and entry database unit is used to store data collection and entry information.

[0090] The data storage management module 22 includes a data storage management unit and a data storage and management database unit. The data storage management unit is used to store and manage research data, wherein the research data includes the data of research participants and related clinical trial data, and appropriate data structures and database management functions should be provided to ensure the security, reliability and accessibility of the data. The data storage and management database unit is used to store data storage and management research data information.

[0091] The data verification logic check module 23 includes a data verification logic check unit and a data verification logic check database unit; the data verification logic check unit is used to perform data verification and logic check to ensure the consistency and rationality of the data, automatically and / or manually verify and check the data according to preset rules and standards, and provide corresponding warnings or prompts. The data verification logic check database unit is used to store data verification and logic check information.

[0092] The data query and retrieval module 24 includes a data query and retrieval unit and a data query and retrieval database unit. The data query and retrieval unit is used to provide data query and retrieval functions, including advanced query, data filtering and sorting based on specific conditions, so as to facilitate researchers to obtain and retrieve research data as needed. The data query and retrieval database unit is used to store data query and retrieval information.

[0093] The data analysis and statistics module 25 includes a data analysis and statistics unit and a data analysis and statistics database unit. The data analysis and statistics unit is used to analyze and count the data of the clinical trial; the data analysis and statistics database unit is used to store data analysis and statistics information.

[0094] The data export sharing module 26 includes a data export sharing unit and a data export sharing database unit. The data export sharing unit is used to export data to other formats or systems and provide a secure data export and sharing mechanism for further analysis or sharing with other research teams. The data export sharing database unit is used to store data export sharing information.

[0095] The data security and privacy protection module 27 includes a data security and privacy protection unit and a data security and privacy protection database unit; the data security and privacy protection unit is used to process data security and privacy, and the processing methods include data encryption, access control, audit tracking and other security measures to comply with relevant laws and regulations and ethical requirements. The data security and privacy protection database unit is used to store data security and privacy protection information.

[0096] Reference Figure 4 The trial drug management terminal 3 includes a drug registration identification module 31, a drug inventory management module 32, a drug distribution randomization module 33, a drug delivery tracking module 34, a drug use management module 35, a drug side effect safety monitoring module 36, and a drug adjustment termination module 37.

[0097] Specifically, the drug registration identification module 31 includes a drug registration identification unit and a drug registration identification database unit. The drug registration identification unit is used to record and identify the information of each test drug, including the drug name, batch number, manufacturer, and dosage. Each test drug should have a unique identifier for tracking and identification. The drug registration identification database unit is used to store drug registration and identification information;

[0098] The drug inventory management module 32 includes a drug inventory management unit and a drug inventory management database unit. The drug inventory management unit is used to track and manage the inventory of the test drugs, including the entry, exit, and remaining quantity of the drugs, and can provide real-time inventory information so that researchers can understand the availability and quantity of the test drugs. The drug inventory management database unit is used to store drug inventory management information;

[0099] The drug distribution randomization module 33 includes a drug distribution randomization unit and a drug distribution randomization database unit. The drug distribution randomization unit is used to automatically distribute the trial drug to the eligible research participants according to the trial design and randomization scheme, and record the distribution. The drug distribution randomization database unit is used to store drug distribution and randomization information.

[0100] The drug delivery tracking module 34 includes a drug delivery tracking unit and a drug delivery tracking database unit. The drug delivery tracking unit is used to track the delivery process of the test drug, including the delivery to each research center or clinical unit, record the delivery time, recipient, quantity and other information, and ensure the safety and correctness of the drug. The drug delivery tracking database unit is used to store drug delivery and tracking information.

[0101] The drug use management module 35 includes a drug use management unit and a drug use and management database unit. The drug use management unit is used to systematically record the conditions of the study participants receiving the trial drugs, including the dosage, usage, and frequency of the drugs, and can provide reminder and warning functions to ensure that the study participants use the drugs correctly according to the specified drug use plan. The drug use and management database unit is used to store drug use and management information.

[0102] The drug side effect safety monitoring module 36 includes a drug side effect safety monitoring unit and a drug side effect safety monitoring database unit. The drug side effect safety monitoring unit is used to systematically record and monitor the side effects and safety information of the test drug. Researchers can report and record the adverse drug events and adverse reactions of the research participants and perform necessary safety monitoring and reporting. The drug side effect safety monitoring database unit is used to store drug side effects and safety monitoring information.

[0103] The drug adjustment termination module 37 includes a drug adjustment termination unit and a drug adjustment termination database unit. The drug adjustment termination unit is used to record the adjustment and termination of the trial drug, and adjust the drug dosage or terminate the use of the drug according to the research needs or the conditions of the research participants. The drug adjustment termination database unit is used to store drug adjustment and termination information.

[0104] Reference Figure 5 The planning and scheduling management terminal 4 includes a test planning module 41, a research center management module 42, a personnel task allocation module 43, a test schedule management module 44, a task tracking and progress monitoring module 45, a resource scheduling management module 46, and a visit arrangement reminder module 47.

[0105] Specifically, the trial plan module 41 includes a trial plan unit and a trial plan database unit. The trial plan unit is used to record and manage the plan information of the clinical trial, including the objectives, research questions, research design, sample size, and follow-up plan of the trial. Researchers can formulate and update the trial plan in the system and ensure that the plan is consistent with the research objectives and ethical requirements. The trial plan database unit is used to store the trial plan information.

[0106] The research center management module 42 includes a research center management unit and a research center management database unit. The research center management unit is used to manage the research center information involved in the experiment, including the location, personnel composition, and equipment resources of the center. Researchers can create and maintain the information of the research center in the system and assign corresponding tasks and responsibilities. The research center management database unit is used to store the research center management information.

[0107] The personnel task allocation module 43 includes a personnel task allocation unit and a personnel task allocation database unit. The personnel task allocation unit is used to allocate research tasks to corresponding researchers and record the status and progress of the tasks. Researchers can view their own task lists and understand the tasks they are responsible for and the time schedule. The personnel task allocation database unit is used to store personnel and task allocation information.

[0108] The trial schedule management module 44 includes a trial schedule management unit and a trial schedule management database unit. The trial schedule management unit is used to manage the schedule and time arrangement of the clinical trial. Researchers can create a trial schedule and set key milestones, visit time points, etc. to help researchers complete corresponding tasks and visits in a timely manner. The trial schedule management database unit is used to store trial schedule management information.

[0109] The task tracking and progress monitoring module 45 includes a task tracking and progress monitoring unit and a task tracking and progress monitoring database unit. The task tracking and progress monitoring unit is used to track the progress of the task and provide corresponding monitoring and reporting functions. Researchers can view the status, progress and completion of the task and make corresponding management and adjustments. The task tracking and progress monitoring database unit is used to store task tracking and progress monitoring information.

[0110] The resource scheduling management module 46 includes a resource scheduling management unit and a resource scheduling management database unit. The resource scheduling management unit is used to manage the resources required for the experiment, including equipment, personnel, materials, etc. Researchers can reserve and arrange the use of resources and ensure the reasonable allocation and utilization of resources. The resource scheduling management database unit is used to store resource scheduling and management information.

[0111] The visit arrangement reminder module 47 includes a visit arrangement reminder unit and a visit arrangement reminder database unit. The visit arrangement reminder unit is used to arrange the time and place of the trial visit and provide reminder and notification functions. Researchers and research participants can view the visit arrangements and reminders in the system and attend the corresponding visits on time. The visit arrangement reminder database unit is used to store visit arrangements and reminder information.

[0112] Reference Figure 6 The collaborative communication terminal 5 includes a project team collaboration module 51, an email message notification module 52, a real-time chat discussion module 53, a file sharing collaborative editing module 54, a meeting scheduling module 55, a discussion board knowledge base module 56, and a task assignment tracking module 57.

[0113] Specifically, the project team collaboration module 51 includes a project team collaboration unit and a project team collaboration database unit. The project team collaboration unit is used to provide a project team collaboration platform. Researchers create project teams, add members, and share information, files, and tasks with team members in the system. Team members can collaborate, discuss issues, share progress, etc. in real time through the system. The project team collaboration database unit is used to store project team collaboration information.

[0114] The email message notification module 52 includes an email message notification unit and an email message notification database unit. The email message notification unit is used to integrate email and message notification functions. Researchers can send emails or messages to other members and receive notifications and reminders, so as to facilitate and timely communication. The email message notification database unit is used to store email and message notification information.

[0115] The real-time chat discussion module 53 includes a real-time chat discussion unit and a real-time chat discussion database unit. The real-time chat discussion unit is used to provide real-time chat and discussion functions, conduct real-time communication and discussion, share ideas, solve problems, and negotiate decisions. The real-time chat discussion database unit is used to store real-time chat and discussion information.

[0116] The file sharing and collaborative editing module 54 includes a file sharing and collaborative editing unit and a file sharing and collaborative editing database unit. The file sharing and collaborative editing unit is used to provide file sharing and collaborative editing functions. Researchers upload and share files, perform collaborative editing and version control, and ensure document management and collaboration efficiency among team members. The file sharing and collaborative editing database unit is used to store file sharing and collaborative editing information.

[0117] The conference scheduling module 55 includes a conference scheduling unit and a conference scheduling database unit. The conference scheduling unit is used to integrate conference and scheduling functions, create and schedule meetings, add conference schedules, and invite relevant members to participate. It can provide reminder and notification functions to ensure that participants attend the meeting on time. The conference scheduling database unit is used to store conference and scheduling information.

[0118] The discussion board knowledge base module 56 includes a discussion board knowledge base unit and a discussion board knowledge base database unit. The discussion board knowledge base unit is used to post questions, share experiences, and provide suggestions, and organize them into a knowledge base for other researchers to refer to and learn from. The discussion board knowledge base database unit is used to store discussion board and knowledge base information.

[0119] The task assignment tracking module 57 includes a task assignment tracking unit and a task assignment tracking database unit. The task assignment tracking unit is used to assign tasks to relevant members and track the completion of tasks. Researchers can view the task list, update the task status, and perform corresponding collaboration and communication in the system. The task assignment tracking database unit is used to store task assignment and tracking information.

[0120] Reference Figure 7 The ethics and compliance management terminal 6 includes an ethics review management module 61, a compliance regulations management module 62, an informed consent management module 63, a privacy protection data security module 64, a compliance monitoring report module 65, an adverse event safety management module 66, and an ethics committee and regulatory agency collaboration module 67.

[0121] Specifically, the ethics review management module 61 includes an ethics review management unit and an ethics review management database unit, wherein the ethics review management unit is used to submit an ethics review application and track the review process of the application. The ethics review management database unit is used to store ethics review management information.

[0122] The compliance management module 62 includes a compliance management unit and a compliance management database unit. The compliance management unit contains laws and regulations related to research compliance, records the opinions and decisions of the ethics review committee, and associates them with relevant documents and notifications. The compliance management database unit is used to store compliance management information.

[0123] The informed consent management module 63 includes an informed consent management unit and an informed consent management database unit. The informed consent management unit is used to store and manage the informed consent documents and processes of the research participants. Researchers can check these regulations in the system and ensure that the research project meets the corresponding requirements, and track the signing and updating of informed consent to ensure that the informed consent process of the research participants meets ethical and regulatory requirements. The informed consent management database unit is used to store informed consent management information.

[0124] The privacy protection data security module 64 includes a privacy protection data security unit and a privacy protection data security database unit. The privacy protection data security unit is used to provide privacy protection and data security functions to ensure the security of the personal information of the research participants and the research data, and take appropriate security measures, such as data encryption, access control and audit logs, to protect the confidentiality and integrity of the data. The privacy protection data security database unit is used to store privacy protection and data security information.

[0125] The compliance monitoring and reporting module 65 includes a compliance monitoring and reporting unit and a compliance monitoring and reporting database unit, which are used for system support for monitoring and reporting of compliance of research projects. Researchers can record and track the compliance of research activities, such as recruitment process, data collection and reporting requirements. The system can generate compliance reports and indicators for monitoring the compliance of research projects. The compliance monitoring and reporting database unit is used to store compliance monitoring and reporting information.

[0126] The adverse event safety management module 66 includes an adverse event safety management unit and an adverse event safety management database unit. The adverse event safety management unit is used to report and record adverse events and safety issues that occur during research, and can help researchers track and handle adverse events and ensure proper reporting, investigation, and notification. The adverse event safety management database unit is used to store adverse events and safety management information.

[0127] The ethics committee regulatory body collaboration module 67 includes an ethics committee regulatory body collaboration unit and an ethics committee regulatory body collaboration database unit. The ethics committee regulatory body collaboration unit is used for collaboration and communication between the ethics committee and the regulatory body, and researchers submit necessary documents and reports and communicate with relevant agencies. The ethics committee regulatory body collaboration database unit is used to store the collaboration information between the ethics committee and the regulatory body.

[0128] Reference Figure 8 The report analysis end 7 includes a data report visualization module 71, a data analysis tool module 72, a research result report module 73, a statistical analysis support module 74, a data quality check module 75, a statistical indicator monitoring module 76, and a data sharing module 77.

[0129] Specifically, the data report visualization module 71 includes a data report visualization unit and a data report visualization database unit. The data report visualization unit is used to generate various reports and charts to display the summary and trend of the research data. These reports and charts may include the recruitment of research participants, the completion of data collection, the results of treatment effect evaluation, etc. Visualization tools can help researchers better understand and interpret data. The data report visualization database unit is used to store data reports and visualization information.

[0130] The data analysis tool module 72 includes a data analysis tool unit and a data analysis tool database unit. The data analysis tool unit is used to perform statistical analysis and inference analysis on the research data, perform data mining, modeling and prediction to reveal potential associations and trends. The data analysis tool database unit is used to store data analysis tool information.

[0131] The research result report module 73 includes a research result report unit and a research result report database unit. The research result report unit is used to generate research reports, academic articles or other forms of results based on the research design and analysis results, and can provide templates and custom options to meet the reporting requirements of different research projects. The research result report database unit is used to store research results and report information.

[0132] The statistical analysis support module 74 includes a statistical analysis support unit and a statistical analysis support database unit. The statistical analysis support unit is used to provide support for statistical analysis, including statistical methods and algorithms, and to perform data analysis based on built-in statistical tools, or to export data to external statistical software for further analysis. The statistical analysis support database unit is used to store statistical analysis support information.

[0133] The data quality check module 75 includes a data quality check unit and a data quality check database unit. The data quality check unit is used to identify and correct errors and inconsistencies in the data, help researchers ensure the accuracy and reliability of the data, and provide a reliable basis in the process of data analysis and result interpretation. The data quality check database unit is used to store data quality check information.

[0134] The statistical indicator monitoring module 76 includes a statistical indicator monitoring unit and a statistical indicator monitoring database unit. The statistical indicator monitoring unit is used to provide a series of statistical indicators and monitoring functions for evaluating the progress and effect of the research project and tracking the changes in key indicators. Researchers can track the changes in key indicators, such as recruitment speed, data collection quality, treatment effect, etc., and take corresponding adjustment measures in time. The statistical indicator monitoring database unit is used to store statistical indicators and indicator monitoring information.

[0135] The data sharing module 77 includes a data sharing unit and a data sharing database unit. The data sharing unit is used to support the export and sharing of data in the system, and can provide export options in different data formats to meet the needs of different research partners. The data sharing database unit is used to store data export and sharing information.

[0136] The above are all preferred embodiments of the present application, and the protection scope of the present application is not limited thereto. Therefore, any equivalent changes made according to the structure, shape, and principle of the present application should be included in the protection scope of the present application.

Claims

1. A research HIS system for clinical trials, characterized in that: include: A research participant management terminal (1), used for managing participants of clinical trials, including a participant registration module (11), a pre-screening module (12), a research participant tracking module (13), a data collection module (14), an access rights management module (15), a research participant communication module (16), and a participant security and privacy protection module (17); A research data management terminal (2), which is used to manage the data required for clinical trials, and includes a data collection and entry module (21), a data storage management module (22), a data verification logic check module (23), a data query and retrieval module (24), a data analysis and statistics module (25), a data export and sharing module (26), and a data security and privacy protection module (27); The trial drug management terminal (3) includes a drug registration identification module (31), a drug inventory management module (32), a drug distribution randomization module (33), a drug delivery tracking module (34), a drug use management module (35), a drug side effect safety monitoring module (36), and a drug adjustment termination module (37); The planning and scheduling management terminal (4) includes a test planning module (41), a research center management module (42), a personnel task allocation module (43), a test schedule management module (44), a task tracking and progress monitoring module (45), a resource scheduling management module (46), and a visit arrangement reminder module (47); A collaborative communication terminal (5), including a project team collaboration module (51), an email message notification module (52), a real-time chat discussion module (53), a file sharing collaborative editing module (54), a meeting schedule module (55), a discussion board knowledge base module (56), and a task assignment tracking module (57); Ethics and compliance management (6), including ethics review management module (61), compliance regulations management module (62), informed consent management module (63), privacy protection data security module (64), compliance monitoring report module (65), adverse event safety management module (66), ethics committee and regulatory agency collaboration module (67); and, The report analysis end (7) includes a data report visualization module (71), a data analysis tool module (72), a research result report module (73), a statistical analysis support module (74), a data quality check module (75), a statistical indicator monitoring module (76), and a data sharing module (77).

2. A research HIS system for clinical trials according to claim 1, characterized in that: The research participant management terminal (1), the research data management terminal (2), the trial drug management terminal (3), the plan management terminal (4), the collaborative communication terminal (5), the ethics and compliance management terminal (6) and the report analysis terminal (7) communicate with each other through a dedicated network.

3. A research HIS system for clinical trials according to claim 1, characterized in that: The participant registration module (11) comprises a participant registration unit and a participant registration database unit, wherein the participant registration unit is used by researchers to register information of participants participating in the clinical trial, wherein the participant information includes basic personal information, contact information, and medical insurance information; and the participant registration database unit is used to store the participant registration information; The pre-screening module (12) comprises a pre-screening unit and a pre-screening database unit, wherein the pre-screening unit is used to screen out qualified participants according to a preset screening standard, and record and output pre-screening information; and the pre-screening database unit is used to store the pre-screening information; The research participant tracking module (13) comprises a research participant tracking unit and a research participant tracking database unit, wherein the research participant tracking unit is used to record and track the research progress of the research participants and output the research participant tracking information; the research participant tracking database unit is used to store the research participant tracking information; The data collection module (14) includes a data collection unit and a data collection database unit, wherein the data collection unit is used to collect data related to the research participants and generate data collection information; the data collection database unit is used to store the data collection information; The access permission management module (15) comprises an access permission management unit and an access permission management database unit, wherein the access permission management unit is used to manage the access permission of the research participant data and generate access permission management information; the access permission management database unit is used to store the access permission management information; The research participant communication module (16) comprises a research participant communication unit and a research participant communication database unit, wherein the research participant communication unit is used to provide a communication channel between the research participants and the researchers and output research participant communication information; the research participant communication database unit is used to store research participant communication information; The participant security and privacy protection module (17) comprises a participant security and privacy protection unit and a participant security and privacy protection database unit. The participant security and privacy protection unit is used to provide the function of data security and privacy protection for research participants and output participant security and privacy protection information; the participant security and privacy protection database unit is used to store participant security and privacy protection information.

4. A research HIS system for clinical trials according to claim 1, characterized in that: The data collection and entry module (21) comprises a data collection and entry unit and a data collection and entry database unit, wherein the data collection and entry unit is used to collect and enter data required for clinical trials; The data collection and entry database unit is used to store data collection and entry information; The data storage management module (22) comprises a data storage management unit and a data storage and management database unit, wherein the data storage management unit is used to store and manage research data, wherein the research data comprises data of research participants and related clinical trial data; and the data storage and management database unit is used to store data storage and management research data information; The data verification logic check module (23) comprises a data verification logic check unit and a data verification logic check database unit; the data verification logic check unit is used to perform data verification and logic check to ensure the consistency and rationality of the data, automatically and / or manually verify and check the data according to preset rules and standards, and provide corresponding warnings or prompts; the data verification logic check database unit is used to store data verification and logic check information; The data query and retrieval module (24) comprises a data query and retrieval unit and a data query and retrieval database unit. The data query and retrieval unit is used to provide data query and retrieval functions to facilitate researchers to obtain and retrieve research data as needed; the data query and retrieval database unit is used to store data query and retrieval information; The data analysis and statistics module (25) comprises a data analysis and statistics unit and a data analysis and statistics database unit, wherein the data analysis and statistics unit is used to analyze and count the data of the clinical trial; and the data analysis and statistics database unit is used to store data analysis and statistics information; The data export sharing module (26) comprises a data export sharing unit and a data export sharing database unit, wherein the data export sharing unit is used to export data to other formats or systems for further analysis or sharing with other research teams; the data export sharing database unit is used to store data export sharing information; The data security and privacy protection module (27) comprises a data security and privacy protection unit and a data security and privacy protection database unit; the data security and privacy protection unit is used to process data security and privacy, and the processing method includes data encryption, access control, and audit tracking; the data security and privacy protection database unit is used to store data security and privacy protection information.

5. The research HIS system for clinical trials according to claim 1, characterized in that: The drug registration identification module (31) comprises a drug registration identification unit and a drug registration identification database unit, wherein the drug registration identification unit is used to record and identify the information of each test drug, including the drug name, batch number, manufacturer, and dosage; and the drug registration identification database unit is used to store drug registration and identification information; The drug inventory management module (32) includes a drug inventory management unit and a drug inventory management database unit, wherein the drug inventory management unit is used to track and manage the inventory status of the test drug, including the entry, exit and remaining quantity of the drug; The drug inventory management database unit is used to store drug inventory management information; The drug distribution randomization module (33) comprises a drug distribution randomization unit and a drug distribution randomization database unit, wherein the drug distribution randomization unit is used to automatically distribute the test drug to the qualified research participants according to the test design and the randomization scheme, and record the distribution situation; the drug distribution randomization database unit is used to store the drug distribution and randomization information; The drug delivery tracking module (34) includes a drug delivery tracking unit and a drug delivery tracking database unit, wherein the drug delivery tracking unit is used to track the delivery process of the test drug, including the delivery to various research centers or clinical units; and the drug delivery tracking database unit is used to store drug delivery and tracking information; The drug use management module (35) comprises a drug use management unit and a drug use and management database unit, wherein the drug use management unit is used to systematically record the conditions of the study participants receiving the test drug, including the dosage, usage and frequency of the drug; and the drug use and management database unit is used to store drug use and management information; The drug side effect safety monitoring module (36) comprises a drug side effect safety monitoring unit and a drug side effect safety monitoring database unit, wherein the drug side effect safety monitoring unit is used to systematically record and monitor the side effects and safety information of the test drug; and the drug side effect safety monitoring database unit is used to store the drug side effects and safety monitoring information; The drug adjustment termination module (37) comprises a drug adjustment termination unit and a drug adjustment termination database unit; The drug adjustment and termination unit is used to record the adjustment and termination of the trial drug, and to adjust the drug dosage or terminate the use of the drug according to the research needs or the conditions of the research participants; the drug adjustment and termination database unit is used to store drug adjustment and termination information.

6. A research HIS system for clinical trials according to claim 1, characterized in that: The trial planning module (41) includes a trial planning unit and a trial planning database unit, wherein the trial planning unit is used to record and manage the planning information of the clinical trial, including the objectives, research questions, research design, sample size, and follow-up plan of the trial; and the trial planning database unit is used to store the trial planning information; The research center management module (42) includes a research center management unit and a research center management database unit. The research center management unit is used to manage the research center information involved in the experiment, including the location, personnel composition, and equipment resources of the center; and the research center management database unit is used to store the research center management information. The personnel task allocation module (43) comprises a personnel task allocation unit and a personnel task allocation database unit, wherein the personnel task allocation unit is used to allocate research tasks to corresponding researchers and record the status and progress of the tasks; the personnel task allocation database unit is used to store personnel and task allocation information; The test schedule management module (44) comprises a test schedule management unit and a test schedule management database unit, wherein the test schedule management unit is used to manage the schedule and time arrangement of the clinical trial; and the test schedule management database unit is used to store test schedule management information; The task tracking and progress monitoring module (45) comprises a task tracking and progress monitoring unit and a task tracking and progress monitoring database unit, wherein the task tracking and progress monitoring unit is used to track the progress of the task and provide corresponding monitoring and reporting functions; the task tracking and progress monitoring database unit is used to store task tracking and progress monitoring information; The resource scheduling management module (46) includes a resource scheduling management unit and a resource scheduling management database unit. The resource scheduling management unit is used to manage resources required for the experiment, including equipment, personnel, materials, etc.; the resource scheduling management database unit is used to store resource scheduling and management information; The visit arrangement reminder module (47) comprises a visit arrangement reminder unit and a visit arrangement reminder database unit. The visit arrangement reminder unit is used to arrange the time and place of the test visit and provide reminder and notification functions; the visit arrangement reminder database unit is used to store visit arrangement and reminder information.

7. A research HIS system for clinical trials according to claim 1, characterized in that: The project team collaboration module (51) includes a project team collaboration unit and a project team collaboration database unit. The project team collaboration unit is used to provide a project team collaboration platform. Researchers can create project teams, add members, and share information, files, and tasks with team members in the system. The project team collaboration database unit is used to store project team collaboration information. The email message notification module (52) comprises an email message notification unit and an email message notification database unit, wherein the email message notification unit is used to integrate email and message notification functions, so that researchers can send emails or messages to other members and receive notifications and reminders; and the email message notification database unit is used to store email and message notification information; The real-time chat discussion module (53) comprises a real-time chat discussion unit and a real-time chat discussion database unit, wherein the real-time chat discussion unit is used to provide real-time chat and discussion functions, to conduct real-time communication and discussion, to share ideas, solve problems, and negotiate decisions; The real-time chat discussion database unit is used to store real-time chat and discussion information; The file sharing collaborative editing module (54) comprises a file sharing collaborative editing unit and a file sharing collaborative editing database unit. The file sharing collaborative editing unit is used to provide file sharing and collaborative editing functions, and researchers upload and share files, perform collaborative editing and version control; the file sharing collaborative editing database unit is used to store file sharing and collaborative editing information; The conference schedule module (55) comprises a conference schedule unit and a conference schedule database unit, wherein the conference schedule unit is used to integrate conference and schedule functions, create and schedule meetings, add conference schedules, and invite relevant members to participate; the conference schedule database unit is used to store conference and schedule information; The discussion board knowledge base module (56) comprises a discussion board knowledge base unit and a discussion board knowledge base database unit; the discussion board knowledge base unit is used to post questions, share experiences and provide suggestions, and organize them into a knowledge base; the discussion board knowledge base database unit is used to store discussion board and knowledge base information; The task assignment tracking module (57) comprises a task assignment tracking unit and a task assignment tracking database unit. The task assignment tracking unit is used to assign tasks to relevant members and track the completion of tasks. The task assignment tracking database unit is used to store task assignment and tracking information.

8. The research HIS system for clinical trials according to claim 1, characterized in that: The ethics review management module (61) comprises an ethics review management unit and an ethics review management database unit, wherein the ethics review management unit is used to submit an ethics review application and track the review process of the application; the ethics review management database unit is used to store ethics review management information; The compliance regulations management module (62) includes a compliance regulations management unit and a compliance regulations management database unit, wherein the compliance regulations management unit contains laws and regulations related to research compliance; the compliance regulations management database unit is used to store compliance regulations management information; The informed consent management module (63) includes an informed consent management unit and an informed consent management database unit, wherein the informed consent management unit is used to store and manage the informed consent documents and processes of the research participants, and to track the signing and updating of the informed consent to ensure that the informed consent process of the research participants complies with ethical and regulatory requirements; the informed consent management database unit is used to store informed consent management information; The privacy protection data security module (64) comprises a privacy protection data security unit and a privacy protection data security database unit, wherein the privacy protection data security unit is used to provide privacy protection and data security functions to ensure the security of the personal information of the research participants and the research data; the privacy protection data security database unit is used to store privacy protection and data security information; The compliance monitoring and reporting module (65) includes a compliance monitoring and reporting unit and a compliance monitoring and reporting database unit, which are used for system support to monitor and report the compliance of research projects; the compliance monitoring and reporting database unit is used to store compliance monitoring and reporting information; The adverse event safety management module (66) includes an adverse event safety management unit and an adverse event safety management database unit, wherein the adverse event safety management unit is used to report and record adverse events and safety issues occurring during the study; and the adverse event safety management database unit is used to store adverse events and safety management information; The ethics committee regulatory body collaboration module (67) includes an ethics committee regulatory body collaboration unit and an ethics committee regulatory body collaboration database unit. The ethics committee regulatory body collaboration unit is used for collaboration and communication between the ethics committee and the regulatory body; the ethics committee regulatory body collaboration database unit is used to store collaboration information between the ethics committee and the regulatory body.

9. A research HIS system for clinical trials according to claim 1, characterized in that: The data report visualization module (71) comprises a data report visualization unit and a data report visualization database unit, wherein the data report visualization unit is used to generate various reports and charts for displaying the summary and trend of the research data; and the data report visualization database unit is used to store data reports and visualization information; The data analysis tool module (72) comprises a data analysis tool unit and a data analysis tool database unit, wherein the data analysis tool unit is used to perform statistical analysis and inference analysis on the research data, perform data mining, modeling and prediction to reveal potential associations and trends; and the data analysis tool database unit is used to store data analysis tool information; The research result reporting module (73) comprises a research result reporting unit and a research result reporting database unit, wherein the research result reporting unit is used to generate a research report, academic article or other forms of results according to the research design and analysis results; The research result report database unit is used to store research results and report information; The statistical analysis support module (74) includes a statistical analysis support unit and a statistical analysis support database unit. The statistical analysis support unit is used to provide support for statistical analysis, including statistical methods and algorithms, and to perform data analysis based on built-in statistical tools, or to export data to external statistical software for further analysis. The statistical analysis support database unit is used to store statistical analysis support information. The data quality check module (75) comprises a data quality check unit and a data quality check database unit, wherein the data quality check unit is used to identify and correct errors and inconsistencies in the data; and the data quality check database unit is used to store data quality check information; The statistical indicator monitoring module (76) comprises a statistical indicator monitoring unit and a statistical indicator monitoring database unit, wherein the statistical indicator monitoring unit is used to provide a series of statistical indicators and monitoring functions for evaluating the progress and effect of the research project and tracking the changes of key indicators; the statistical indicator monitoring database unit is used to store statistical indicators and indicator monitoring information; The data sharing module (77) comprises a data sharing unit and a data sharing database unit. The data sharing unit is used for the system to support the export and sharing of data; the data sharing database unit is used for storing data export and sharing information.

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