Clinical test ethical examination system

Abstract

The invention discloses a clinical test ethical examination system which comprises a submission application end, an examination process management end, a file management end, an examination cooperation end, an examination recording and tracking end, a notification and reminding end, an ethical examination report generation end, a data analysis and statistics end and a privacy and security end which are in data communication through a private network and a private line network. The clinical test ethical examination system aims at simplifying and optimizing management and processes of ethical examination, researchers can more effectively manage and track the ethical examination process through the clinical test ethical examination system, it is ensured that tests meet ethical principles and related regulation requirements, the rights and interests of test participants are protected, and the clinical test ethical examination system has the advantages that the research efficiency is improved, and the research cost is reduced. And the proceeding and development of scientific research are promoted.

Description

Technical Field

[0001] The present application relates to the technical field of drug clinical trials, and in particular to a clinical trial ethics review system. Background Art

[0002] The clinical trial ethics review system is a system used to manage and coordinate the clinical trial ethics review process. Ethical review is an important link in protecting the rights and interests of trial participants and ensuring that the trial complies with ethical principles.

[0003] At present, there are mainly the following situations in the ethical review of clinical trial participating units: the ethics committees of some participating units in clinical trials completely rely on the lead unit to implement ethical review, and the participating units directly file for record without conducting a review; the ethics committees of some participating units conduct ethical review regardless of whether the lead unit conducts a review; some ethics committees conduct a quick review based on an assessment and approval of the work quality of the ethics committee of the lead unit.

[0004] In summary, the existing ethical review management method is too complicated, inconvenient to manage, and cannot effectively manage and track the ethical review process. Therefore, there is room for improvement. Summary of the invention

[0005] In order to solve the problems existing in the prior art, this application provides a clinical trial ethics review system.

[0006] In order to achieve the above objectives, this application adopts the following technical solutions:

[0007] A clinical trial ethics review system includes an application submission end, a review process management end, a document management end, a review collaboration end, a review record and tracking end, a notification and reminder end, an ethics review report generation end, a data analysis and statistics end, and a privacy and security end. Data communication between the various parts is carried out through a dedicated network.

[0008] The application submission terminal includes an application form module, a file upload module, a supplementary material module, a contact information module, and a submission confirmation module;

[0009] The review process management terminal includes an application allocation module, a review progress tracking module, a review opinion recording module, a decision recording module, a notification and feedback module, a time limit management module, and a transparency and traceability module;

[0010] The file management terminal includes an application file management module, a file version control module, a file classification and labeling module, a file authority management module, a file sharing and collaboration module, a file audit and recording module, and a file export and printing module;

[0011] The review collaboration end includes a task assignment and tracking module, a review collaboration module, a comment and discussion module, a document sharing and version control module, a reminder and notification module, a meeting and conference management module, and a file audit and recording module;

[0012] The review record and tracking terminal includes an application record module, a review process record module, a review opinion record module, a decision record module, a notification and reminder record module, and a file modification record module;

[0013] The notification and reminder terminal includes an application receiving notification module, a review progress reminder module, a material supplement reminder module, a review decision notification module, and a meeting notification module;

[0014] The ethics review report generation end includes a report template design module, a report generation module, a report editing and modification module, a report approval and signing module, and a report distribution and archiving module;

[0015] The data analysis and statistics end includes a data sorting and cleaning module, a data visualization module, a statistical analysis module, a report generation module, and an advanced analysis function module;

[0016] The privacy and security end includes a data encryption module, an access control module, an audit log module, a data backup and recovery module, a user rights management module, a security review and vulnerability management module, and a regulatory compliance module.

[0017] Further, the application form module includes an application form unit, which is used for the ethics review system to provide a corresponding application form or online form;

[0018] The file upload module includes a file upload unit, which is used for researchers to upload relevant files through the ethics review system;

[0019] The supplementary materials module includes a supplementary materials unit, which is used for researchers to submit supplementary materials according to the requirements of the ethics review committee;

[0020] The contact information module includes a contact information unit, which is used for researchers to provide their own contact information so that the ethics review committee can communicate with them and provide feedback;

[0021] The submission confirmation module includes a submission confirmation unit, which is used for researchers to complete the application filling and file uploading.

[0022] Further, the application allocation module includes an application allocation unit, which is used for the ethics review system to automatically or manually allocate the submitted application to the corresponding review committee member or expert for review;

[0023] The examination progress tracking module includes an examination progress tracking unit, which is used to systematically record and track the examination progress of each application;

[0024] The review opinion recording module includes a review opinion recording unit, which is used for review committee members to record their review opinions and suggestions in the system;

[0025] The decision recording module includes a decision recording unit, which is used by the review committee to make a review decision based on the review opinions and the researchers’ responses;

[0026] The notification and feedback module includes a notification and feedback unit, which is used for the system to automatically generate notifications and feedback to researchers;

[0027] The time limit management module includes a time limit management unit, which is used to set and manage the time limits of each link in the review process;

[0028] The transparency and traceability module includes a transparency and traceability unit, which is used for the review process management function to ensure the transparency and traceability of the review process.

[0029] Further, the application document management module includes an application document management unit, which is used in the ethics review system to allow researchers to upload ethics review application documents to the system for management;

[0030] The file version control module includes a file version control unit, which is used to modify and update the application documents during the ethics review process. The file management function can support the version control of the files to ensure that each modification has corresponding records and traceability;

[0031] The document classification and labeling module includes a document classification and labeling unit for better organizing and managing ethics review documents;

[0032] The file authority module includes a file authority management unit for ethics review documents that usually contain sensitive research data and personal information;

[0033] The file sharing and collaboration module includes a file sharing and collaboration unit, which is used in the ethical review process and may require sharing files with review committee members, research teams or other relevant parties and conducting collaborative editing;

[0034] The file audit and record module includes a file audit and record unit, which is used to systematically record the operation and access records of ethics review files;

[0035] The file export and printing module includes a file export and printing unit. The results of ethical review usually need to be exported or printed in the form of files for researchers and related parties to review.

[0036] Further, the task assignment and tracking module includes a task assignment and tracking unit for the system to allow supervisors or administrators to assign review tasks to different committee members and track the progress and completion of tasks;

[0037] The review collaboration module includes a review collaboration unit, which is used to provide a collaborative review function for the system, allowing committee members to review the same document and provide opinions and suggestions;

[0038] The review and discussion module includes a review and discussion unit, and the review collaboration function in the system generally includes a review and discussion tool, so that committee members can discuss and communicate on documents and the review process within the system;

[0039] The document sharing and version control module includes a document sharing and version control unit, which is used for review committee members to share review documents, reports, opinions and suggestions in the system, ensuring that all relevant personnel can obtain and understand the latest review materials in a timely manner;

[0040] The reminder and notification module includes a reminder and notification unit, which is used for the system to send reminders and notifications to committee members, including the assignment of new tasks, deadlines for tasks, and submission of review comments;

[0041] The conference and meeting management module includes a conference and meeting management unit for holding regular review committee meetings if necessary;

[0042] The file audit and record module includes file audit, which is used to systematically record and review operations and access records during the collaboration process, including comments, discussions, and file modifications.

[0043] Further, the application record module includes an application record unit for systematically recording detailed information of each submitted application, including basic information such as the applicant's name, organization, and application date, as well as the version and modification record of the application document;

[0044] The review process recording module includes a review process recording unit, which is used to systematically record the important links and time nodes in the review process of each application, including the receipt of the application, the allocation to the committee members, the submission of the review opinions, and the notification of the review decision;

[0045] The review opinion recording module includes a review opinion recording unit, which is used to systematically record the review opinions and suggestions of each committee member on the application, including the content of the review opinion, submission time, and reviewer information;

[0046] The decision recording module includes a decision recording unit, which is used to systematically record the review decision of each application, including whether it is approved, the conditions for approval, and the reasons for rejection;

[0047] The notification and reminder recording module includes a notification and reminder recording unit, which is used to systematically record notifications and reminders sent to applicants and related personnel, including notifications of application receipt, notifications of examination results, and requests for supplementary materials;

[0048] The file modification record module includes a file modification record unit, which is used to systemically record the modification records of application files, including the modification time, modification content, and information of the modifier.

[0049] Further, the application receiving notification module includes an application receiving notification unit, which is used for the system to send a notification to the applicant to confirm that the ethics review application has been received and started to be processed;

[0050] The review progress reminder module includes a review progress reminder unit, which is used for the system to send reminders to relevant committee members and applicants according to the set review schedule and process to ensure that the review progress is carried out as planned;

[0051] The material supplement reminder module includes a material supplement reminder unit, which is used to prompt the applicant to provide additional materials or further explanations if the examination process requires the applicant to provide additional materials or further explanations;

[0052] The examination decision notification module includes an examination decision notification unit, which is used for the system to send a notification of the examination decision to the applicant;

[0053] The meeting notification module includes a meeting notification unit, which is used if the ethics review committee needs to hold a meeting for discussion and decision-making.

[0054] Further, the report template design module includes a report template design unit, which is used for the ethics review system to provide a predefined report template, including the format and structure of review results, decisions, opinions and suggestions;

[0055] The report generation module includes a report generation unit, which is used for the system to automatically generate an ethics review report based on the information collected during the review process and the decision of the committee;

[0056] The report editing and modification module includes a report editing and modification unit, which is used to generate reports that can usually be edited and modified in the system so that the reviewer can make precise and accurate adjustments to the report content;

[0057] The report approval and signing module includes a report approval and signing unit, which is used to provide approval and signing functions after the report is generated and modified to ensure the accuracy and compliance of the report;

[0058] The report distribution and archiving module includes a report distribution and archiving unit, which is used to distribute and archive the generated ethical review report in the system. The system can provide an email notification function to send the report to relevant personnel.

[0059] Furthermore, the data sorting and cleaning module includes a data sorting and cleaning unit, which is used by the ethics review system to sort and clean the collected ethics review data to ensure the accuracy and consistency of the data;

[0060] The data visualization module includes a data visualization unit, which is used to provide various visualization tools and charts for the system to present the ethics review data in an intuitive and easy-to-understand manner;

[0061] The statistical analysis module includes a statistical analysis unit for system support of statistical analysis of ethical review data to reveal potential patterns, associations and trends;

[0062] The report generation module includes a report generation unit, which is used for the system to automatically generate a report and summary of the ethics review data analysis;

[0063] The advanced analysis function module includes an advanced analysis function unit, which may also provide more advanced data analysis functions for the ethics review system.

[0064] Further, the data encryption module includes a data encryption unit, which is used for the system to encrypt sensitive data using encryption technology to prevent unauthorized access and data leakage;

[0065] The access control module includes an access control unit, which is used to implement a strict access control mechanism in the system to ensure that only authorized personnel can access sensitive data;

[0066] The audit log module includes an audit log unit, which is used to systematically record the user's operation activities and data access logs for auditing and tracing;

[0067] The data backup and recovery module includes a data backup and recovery unit, which is used for the system to regularly perform data backup to prevent data loss or damage;

[0068] The user rights management module includes a user rights management unit, which is used to set different levels of user rights in the system to ensure that only authorized personnel can view and process specific data and files;

[0069] The security review and vulnerability management module includes a security review and vulnerability management unit, which is used for the system to perform regular security reviews and vulnerability management to identify and resolve potential security vulnerabilities and risks;

[0070] The regulatory compliance module includes a regulatory compliance unit for the system to comply with applicable privacy and data protection regulations.

[0071] Compared with the prior art, this application has the following beneficial effects:

[0072] This application clinical trial ethics review system aims to simplify and optimize the management and process of ethical review. Through the clinical trial ethics review system, researchers can more effectively manage and track the ethical review process to ensure that the trial complies with ethical principles and relevant regulatory requirements, which helps protect the rights and interests of trial participants and promotes the conduct and development of scientific research. BRIEF DESCRIPTION OF THE DRAWINGS

[0073] Figure 1 A schematic block diagram of the overall system of this application;

[0074] Figure 2 This is a schematic block diagram of the application submission end in this application;

[0075] Figure 3 This is a schematic diagram of the review process management end in this application;

[0076] Figure 4 This is a schematic block diagram of the file management terminal in this application;

[0077] Figure 5 A schematic block diagram of the review collaboration end in this application;

[0078] Figure 6 A schematic block diagram of the review record and tracking end in this application;

[0079] Figure 7 This is a schematic block diagram of the notification and reminder terminal in this application;

[0080] Figure 8 This is a schematic diagram of the ethical review report generation end in this application;

[0081] Fig. 9 A schematic diagram of the data analysis and statistics end in this application;

[0082] Fig.10 This is a schematic block diagram of the privacy and security ends in this application. DETAILED DESCRIPTION

[0083] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments.

[0084] This application provides a clinical trial ethics review system.

[0085] Reference Figures 1 to 10 The clinical trial ethics review system includes application submission terminal 1, review process management terminal 2, document management terminal 3, review collaboration terminal 4, review record and tracking terminal 5, notification and reminder terminal 6, ethics review report generation terminal 7, data analysis and statistics terminal 8, privacy and security terminal 9. Data communication is carried out between each part through a dedicated network.

[0086] Reference Figure 2 The application submission terminal 1 includes an application form module 101 , a file upload module 102 , a supplementary material module 103 , a contact information module 104 , and a submission confirmation module 105 .

[0087] The application form module 101 includes an application form unit 101a and an application form database unit 101b. The application form unit 101a is used to provide the ethics review system with a corresponding application form or online form. Researchers need to fill in and submit the application form, which usually contains basic information of the trial, research plan, trial design, subject protection plan, etc. The application form database unit 101b is used to store application form information.

[0088] The file upload module 102 includes a file upload unit 102a and a file upload database unit 102b. The file upload unit 102a is used for researchers to upload relevant files through the ethics review system, such as trial protocols, research plans, informed consent forms, questionnaires, etc. The system supports various common file formats, such as PDF, Word, Excel, etc. The file upload database unit 102b is used to store file upload information.

[0089] The supplementary material module 103 includes a supplementary material unit 103a and a supplementary material database unit 103b. The supplementary material unit 103a is used for researchers to submit supplementary materials, such as laboratory test results, data management plans, statistical analysis plans, etc., according to the requirements of the ethics review committee. These materials can be uploaded to the system as additional documents supporting the application. The supplementary material database unit 103b is used to store supplementary material information.

[0090] The contact information module 104 includes a contact information unit 104a and a contact information database unit 104b. The contact information unit 104a is used for researchers to provide their contact information so that the ethics review committee can communicate and provide feedback to them, including name, contact number, email address, etc. The contact information database unit 104b is used to store contact information.

[0091] The submission confirmation module 105 includes a submission confirmation unit 105a and a submission confirmation database unit 105b. The submission confirmation unit 105a is used for researchers to complete the application filling and file upload. They need to submit the application through the system and confirm it; after submission, the application will be sent to the ethics review committee for further review. The submission confirmation database unit 105b is used to store submission confirmation information.

[0092] Reference Figure 3 The review process management terminal 2 includes an application allocation module 201, a review progress tracking module 202, a review opinion recording module 203, a decision recording module 204, a notification and feedback module 205, a time limit management module 206, and a transparency and traceability module 207.

[0093] The application allocation module 201 includes an application allocation unit 201a and an application allocation database unit 201b. The application allocation unit 201a is used for the ethics review system to automatically or manually allocate submitted applications to corresponding review committee members or experts for review. According to the regulations of the review committee and the allocation algorithm, the system will reasonably allocate the application to the appropriate reviewer. The application allocation database unit 201b is used to store application allocation information.

[0094] The review progress tracking module 202 includes a review progress tracking unit 202a and a review progress tracking database unit 202b. The review progress tracking unit 202a is used to systematically record and track the review progress of each application, including the review start time, progress, reviewer's comments and suggestions, etc. Researchers and the review committee can view and monitor the review progress through the system. The review progress tracking database unit 202b is used to store the review progress tracking information.

[0095] The review opinion recording module 203 includes a review opinion recording unit 203a and a review opinion recording database unit 203b. The review opinion recording unit 203a is used for review committee members to record their review opinions and suggestions in the system. These opinions usually include evaluations on the compliance of the research plan, subject protection measures, risk assessment, etc. The recorded review opinions can be used for subsequent decision-making and review report generation. The review opinion recording database unit 203b is used to store review opinion record information.

[0096] The decision record module 204 includes a decision record unit 204a and a decision record database unit 204b. The decision record unit 204a is used by the review committee to make review decisions based on the review opinions and the responses of the researchers. These decisions may include approval, modification requirements, suspension of review, rejection, etc. The system can record and archive these decisions for future reference and tracing. The decision record database unit 204b is used to store decision record information.

[0097] The notification and feedback module 205 includes a notification and feedback unit 205a and a notification and feedback database unit 205b. The notification and feedback unit 205a is used for the system to automatically generate notifications and feedback to researchers, including review opinions, decisions and modification requirements, etc. These notifications can be sent to relevant parties through internal system messages, emails or other communication channels to ensure timely communication and feedback. The notification and feedback database unit 205b is used to store notification and feedback information.

[0098] The time limit management module 206 includes a time limit management unit 206a and a time limit management database unit 206b. The time limit management unit 206a is used to set and manage the time limits of each link in the review process, which helps to ensure that the review process is carried out on time and prevent delays and procrastination. The time limit management database unit 206b is used to store time limit management information.

[0099] The transparency and traceability module 207 includes a transparency and traceability unit 207a and a transparency and traceability database unit 207b. The transparency and traceability unit 207a is used for the review process management function to ensure the transparency and traceability of the review process, and the system records and archives all key information and decisions in the review process for future audit and verification. The transparency and traceability database unit 207b is used to store transparency and traceability information.

[0100] Reference Figure 4 The file management terminal 3 includes an application file management module 301, a file version control module 302, a file classification and labeling module 303, a file permission management module 304, a file sharing and collaboration module 305, a file audit and recording module 306, and a file export and printing module 307.

[0101] The application document management module 301 includes an application document management unit 301a and an application document management database unit 301b. The application document management unit 301a is used in the ethics review system to allow researchers to upload ethics review application documents to the system for management. These documents may include research plans, informed consent forms, questionnaires, data collection tools, recruitment materials, etc. The system provides functions for uploading, storing and classifying these documents. The application document management database unit 301b is used to store application document management information.

[0102] The file version control module 302 includes a file version control unit 302a and a file version control database unit 302b. The file version control unit 302a is used to modify and update the application documents during the ethical review process. The file management function can support the version control of the documents to ensure that each modification has corresponding records and traceability, which helps the review committee members understand the evolution and modification history of the documents. The file version control database unit 302b is used to store the file version control information.

[0103] The file classification and labeling module 303 includes a file classification and labeling unit 303a and a file classification and labeling database unit 303b. The file classification and labeling unit 303a is used to better organize and manage ethical review documents. The system usually provides file classification and labeling functions. Researchers can create folders, subfolders or use labels to classify files as needed to make them easier to manage and retrieve. The file classification and labeling database unit 303b is used to store file classification and labeling information.

[0104] The file permission module 304 includes a file permission management unit 304a and a file permission management database unit 304b. The file permission management unit 304a is used for ethical review. Files usually contain sensitive research data and personal information. In order to ensure the security and confidentiality of files, the file management function provides a permission management function. Only authorized users can access and view files, and different access rights can be set for different users. The file permission management database unit 304b is used to store file permission management information.

[0105] The file sharing and collaboration module 305 includes a file sharing and collaboration unit 305a and a file sharing and collaboration database unit 305b. The file sharing and collaboration unit 305a is used in the ethical review process. It may be necessary to share files with review committee members, research teams or other relevant parties and conduct collaborative editing; the file management function allows users to share files in the system and provides collaborative tools for real-time collaboration and feedback. The file sharing and collaboration database unit 305b is used to store file sharing and collaboration information.

[0106] The file audit and record module 306 includes a file audit and record unit 306a and a file audit and record database unit 306b. The file audit and record unit 306a is used to systematically record the operation and access records of the ethics review file, including operations such as uploading, downloading, editing, and deleting, which helps to audit and track the use of the file and ensure the integrity and security of the file. The file audit and record database unit 306b is used to store file audit and record information.

[0107] The file export and print module 307 includes a file export and print unit 307a and a file export and print database unit 307b. The file export and print unit 307a is used for the results of ethical review, which usually need to be exported or printed in the form of files for researchers and related parties to consult. The file management function provides the option of exporting and printing files to meet these needs. The file export and print database unit 307b is used to store file export and print information.

[0108] Reference Figure 5 The review collaboration terminal 4 includes a task allocation and tracking module 401, a review collaboration module 402, a comment and discussion module 403, a document sharing and version control module 404, a reminder and notification module 405, a meeting and conference management module 406, and a file audit and recording module 407.

[0109] The task allocation and tracking module 401 includes a task allocation and tracking unit 401a and a task allocation and tracking database unit 401b. The task allocation and tracking unit 401a is used for the system to allow supervisors or administrators to allocate review tasks to different committee members and track the progress and completion of tasks, so as to ensure the timely implementation and monitoring of review work. The task allocation and tracking database unit 401b is used to store task allocation and tracking information.

[0110] The review collaboration module 402 includes a review collaboration unit 402a and a review collaboration database unit 402b. The review collaboration unit 402a is used to provide a collaborative review function for the system, allowing committee members to review the same document and provide opinions and suggestions, so that multiple people can independently evaluate the same application document, thereby improving the accuracy and comprehensiveness of the review. The review collaboration database unit 402b is used to store review collaboration information.

[0111] The review and discussion module 403 includes a review and discussion unit 403a and a review and discussion database unit 403b. The review and discussion unit 403a is used for the review collaboration function in the system and generally includes review and discussion tools, which enable committee members to discuss and exchange information on documents and the review process within the system, which helps to communicate opinions, clarify issues, resolve doubts, and promote cooperation and consensus among committee members. The review and discussion database unit 403b is used to store review and discussion information.

[0112] The document sharing and version control module 404 includes a document sharing and version control unit 404a and a document sharing and version control database unit 404b. The document sharing and version control unit 404a is used for review committee members to share review documents, reports, opinions and suggestions in the system, ensuring that all relevant personnel can obtain and understand the latest review materials in a timely manner; at the same time, the system provides a version control function for the file to ensure the integrity and traceability of the file. The document sharing and version control database unit 404b is used to store document sharing and version control information.

[0113] The reminder and notification module 405 includes a reminder and notification unit 405a and a reminder and notification database unit 405b. The reminder and notification unit 405a is used for the system to send reminders and notifications to committee members, including the allocation of new tasks, the deadline of tasks, the submission of review opinions, etc., which helps to remind committee members to perform tasks and participate in collaborative work in a timely manner. The reminder and notification database unit 405b is used to store reminder and notification information.

[0114] The meeting and conference management module 406 includes a meeting and conference management unit 406a and a meeting and conference management database unit 406b. The meeting and conference management unit 406a is used to provide meeting management functions, including meeting schedules, meeting notices, meeting minutes, etc., to support the organization and coordination of meetings if regular review committee meetings are required. The meeting and conference management database unit 406b is used to store meeting and conference management information.

[0115] The file audit and record module 407 includes a file audit and record unit 407a and a file audit and record database unit 407b. The file audit and record unit 407a is used to systematically record and review the operations and access records during the collaboration process, including comments, discussions, file modifications, etc. This helps to audit and track the operations during the collaboration process and ensure the transparency and traceability of the collaboration. The file audit and record database unit 407b is used to store file audit and record information.

[0116] Reference Figure 6 The review record and tracking terminal 5 includes an application record module 501, a review process record module 502, a review opinion record module 503, a decision record module 504, a notification and reminder record module 505, and a file modification record module 506.

[0117] The application record module 501 includes an application record unit 501a and an application record database unit 501b. The application record unit 501a is used to systematically record the detailed information of each submitted application, including basic information such as the applicant's name, organization, application date, and the version and modification records of the application documents, etc. These records are helpful in tracking and managing the application process of ethical review. The application record database unit 501b is used to store application record information.

[0118] The review process record module 502 includes a review process record unit 502a and a review process record database unit 502b. The review process record unit 502a is used to systematically record the important links and time nodes in the review process of each application, including the receipt of the application, the allocation to the committee members, the submission of the review opinions, the notification of the review decision, etc. These records are helpful to track the timeline and progress of the review process. The review process record database unit 502b is used to store the review process record information.

[0119] The review opinion recording module 503 includes a review opinion recording unit 503a and a review opinion recording database unit 503b. The review opinion recording unit 503a is used to systematically record the review opinions and suggestions of each committee member on the application, including the content of the review opinion, submission time, reviewer and other information. These records are helpful to track the opinions of each committee member and provide reference for subsequent decision-making. The review opinion recording database unit 503b is used to store the review opinion record information.

[0120] The decision record module 504 includes a decision record unit 504a and a decision record database unit 504b. The decision record unit 504a is used to systematically record the review decision of each application, including whether to approve, the conditions for approval, the reasons for rejection, etc. These records are helpful to record the final results and decisions of the ethical review and provide clear feedback to the applicant and related personnel. The decision record database unit 504b is used to store decision record information.

[0121] The notification and reminder record module 505 includes a notification and reminder record unit 505a and a notification and reminder record database unit 505b. The notification and reminder record unit 505a is used to systematically record notifications and reminders sent to applicants and related personnel, including notifications of application acceptance, notifications of examination results, requirements for supplementary materials, etc. These records help track the sending and receiving of notifications and ensure timely communication and exchanges. The notification and reminder record database unit 505b is used to store notification and reminder record information.

[0122] The file modification record module 506 includes a file modification record unit 506a and a file modification record database unit 506b. The file modification record unit 506a is used to systematically record the modification records of the application documents, including the modification time, modification content, and modification person, etc. These records are helpful to track the modification history and version control of the documents, and ensure the transparency and traceability of the review process. The file modification record database unit 506b is used to store the file modification record information.

[0123] Reference Figure 7 The notification and reminder terminal 6 includes an application receiving notification module 601, a review progress reminder module 602, a material supplement reminder module 603, a review decision notification module 604, and a meeting notification module 605.

[0124] The application receiving notification module 601 includes an application receiving notification unit 601a and an application receiving notification database unit 601b. The application receiving notification unit 601a is used for the system to send a notification to the applicant to confirm that the ethics review application has been received and has begun to be processed. This notification may include information such as the unique identification of the application, the estimated review time, and the materials that need to be provided later, so that the applicant can understand the status of the application and the subsequent steps. The application receiving notification database unit 601b is used to store the application receiving notification information.

[0125] The review progress reminder module 602 includes a review progress reminder unit 602a and a review progress reminder database unit 602b. The review progress reminder unit 602a is used to send reminders to relevant committee members and applicants according to the set review schedule and process to ensure that the review progress is carried out as planned. These reminders may include information such as the time and place of the review meeting, the deadline for submitting review opinions, and the next action plan. The review progress reminder database unit 602b is used to store the review progress reminder information.

[0126] The material supplement reminder module 603 includes a material supplement reminder unit 603a and a material supplement reminder database unit 603b. The material supplement reminder unit 603a is used to send reminders to the applicant if the applicant needs to supplement materials or provide further explanations during the review process to ensure that the required materials are supplemented in time. These reminders may include the specific content of the required supplementary materials, the deadline, etc. The material supplement reminder database unit 603b is used to store material supplement reminder information.

[0127] The examination decision notification module 604 includes an examination decision notification unit 604a and an examination decision notification database unit 604b. The examination decision notification unit 604a is used for the system to send a notification of the examination decision to the applicant, including the examination result, the conditions for approval (if any), the reasons for rejection, etc. This notification can be automatically generated by the system and sent to the applicant at a specified time to ensure that the examination result is notified to the applicant in a timely manner. The examination decision notification database unit 604b is used to store the examination decision notification information.

[0128] The meeting notification module 605 includes a meeting notification unit 605a and a meeting notification database unit 605b. The meeting notification unit 605a is used for sending meeting notifications to committee members if the ethics review committee needs to hold a meeting for discussion and decision-making, including information such as the time, location, and agenda of the meeting. These notifications can be sent in advance and provide access links to relevant materials and documents so that committee members can prepare for the meeting. The meeting notification database unit 605b is used to store meeting notification unit information.

[0129] Reference Figure 8 The ethics review report generation terminal 7 includes a report template design module 701, a report generation module 702, a report editing and modification module 703, a report approval and signing module 704, and a report distribution and archiving module 705.

[0130] The report template design module 701 includes a report template design unit 701a and a report template design database unit 701b. The report template design unit 701a is used in the ethics review system to provide predefined report templates, including the format and structure of review results, decisions, opinions and suggestions. These templates usually meet the standard format and requirements of ethics review to ensure the consistency and standardization of the report. The report template design database unit 701b is used to store report template design information.

[0131] The report generation module 702 includes a report generation unit 702a and a report generation database unit 702b. The report generation unit 702a is used for the system to automatically generate an ethics review report based on the information collected during the review process and the decision of the committee, which includes arranging relevant data and opinions into various parts of the report, such as background information, research plan overview, discussion of ethical issues, decisions and suggestions, etc. The report generation database unit 702b is used to store report generation information.

[0132] The report editing and modification module 703 includes a report editing and modification unit 703a and a report editing and modification database unit 703b. The report generated by the report editing and modification unit 703a can usually be edited and modified in the system so that the reviewer can make precise and accurate adjustments to the report content, including modifying decision results, adding or modifying opinions and suggestions, updating project information, etc. The report editing and modification database unit 703b is used to store report editing and modification information.

[0133] The report approval and signing module 704 includes a report approval and signing unit 704a and a report approval and signing database unit 704b. The report approval and signing unit 704a is used to provide the system with the functions of approval and signing after the report is generated and modified to ensure the accuracy and compliance of the report. Relevant personnel can review the report in the system and sign or authorize it electronically to confirm the accuracy and validity of its content. The report approval and signing database unit 704b is used to store the report approval and signing information.

[0134] The report distribution and archiving module 705 includes a report distribution and archiving unit 705a and a report distribution and archiving database unit 705b. The ethical review report generated by the report distribution and archiving unit 705a can be distributed and archived in the system. The system can provide an email notification function to send the report to relevant personnel, such as research team members, applicants, committee members, etc. At the same time, the system also provides a report archiving and filing function to ensure the long-term preservation and traceability of the report. The report distribution and archiving database unit 705b is used to store report distribution and archiving information.

[0135] Reference Fig. 9 The data analysis and statistics terminal 8 includes a data sorting and cleaning module 801, a data visualization module 802, a statistical analysis module 803, a report generation module 804, and an advanced analysis function module 805.

[0136] The data sorting and cleaning module 801 includes a data sorting and cleaning unit 801a and a data sorting and cleaning database unit 801b. The data sorting and cleaning unit 801a is used by the ethics review system to sort and clean the collected ethics review data to ensure the accuracy and consistency of the data, which may involve operations such as data deduplication, format conversion, and filling in missing values ​​for subsequent analysis and statistics. The data sorting and cleaning database unit 801b is used to store data sorting and cleaning information.

[0137] The data visualization module 802 includes a data visualization unit 802a and a data visualization database unit 802b. The data visualization unit 802a is used to provide the system with various visualization tools and charts to present the ethics review data in an intuitive and easy-to-understand manner; for example, bar charts, pie charts, line charts, etc. can be used to display the proportions, trends, and distribution of different review results. The data visualization database unit 802b is used to store data visualization information.

[0138] The statistical analysis module 803 includes a statistical analysis unit 803a and a statistical analysis database unit 803b. The statistical analysis unit 803a is used to support the system to perform statistical analysis on the ethical review data to reveal potential patterns, associations and trends. Common statistical analysis methods include descriptive statistics, frequency analysis, correlation analysis, and difference analysis, which can help the review committee and managers to deeply understand the review results and activities. The statistical analysis database unit 803b is used to store statistical analysis information.

[0139] The report generation module 804 includes a report generation unit 804a and a report generation database unit 804b. The report generation unit 804a is used for the system to automatically generate reports and summaries of ethical review data analysis, which usually include key indicators, statistical results, data charts and interpretations, as well as discussions and suggestions on problems and trends in the review process. The report generation database unit 804b is used to store report generation information.

[0140] The advanced analysis function module 805 includes an advanced analysis function unit 805a and an advanced analysis function database unit 805b. The advanced analysis function unit 805a is used in the ethics review system and may also provide more advanced data analysis functions, such as regression analysis, survival analysis, cluster analysis, etc. These analysis methods can be used for deeper data mining and insight, and discover more complex relationships and patterns hidden in the data. The advanced analysis function database unit 805b is used to store advanced analysis function information.

[0141] Reference Fig.10 The privacy and security end 9 includes a data encryption module 901, an access control module 902, an audit log module 903, a data backup and recovery module 904, a user rights management module 905, a security review and vulnerability management module 906, and a regulatory compliance module 907.

[0142] The data encryption module 901 includes a data encryption unit 901a and a data encryption database unit 901b. The data encryption unit 901a is used for the system to encrypt sensitive data using encryption technology, including personal identification information and medical records of research participants. Encryption can prevent unauthorized access and data leakage, and ensure the confidentiality of data. The data encryption database unit 901b is used to store data encryption information.

[0143] The access control module 902 includes an access control unit 902a and an access control database unit 902b. The access control unit 902a is used to implement a strict access control mechanism in the system to ensure that only authorized personnel can access sensitive data, including identity authentication, authority management and role allocation, to limit the access and operation scope of data. The access control database unit 902b is used to store access control information.

[0144] The audit log module 903 includes an audit log unit 903a and an audit log database unit 903b. The audit log unit 903a is used to record the user's operation activities and data access logs in the system for auditing and tracing. The audit log can track the modification, access and export of data to help discover and prevent unauthorized behavior. The audit log database unit 903b is used to store audit log information.

[0145] The data backup and recovery module 904 includes a data backup and recovery unit 904a and a data backup and recovery database unit 904b. The data backup and recovery unit 904a is used for the system to regularly perform data backup to prevent data loss or damage; the backup data can be used for data recovery in emergency situations to ensure data availability and integrity. The data backup and recovery database unit 904b is used to store data backup and recovery information.

[0146] The user rights management module 905 includes a user rights management unit 905a and a user rights management database unit 905b. The user rights management unit 905a is used to set different levels of user rights in the system to ensure that only authorized personnel can view and process specific data and files, which can reduce the risk of abuse and misuse of data. The user rights management database unit 905b is used to store user rights management information.

[0147] The security review and vulnerability management module 906 includes a security review and vulnerability management unit 906a and a security review and vulnerability management database unit 906b. The security review and vulnerability management unit 906a is used to perform regular security review and vulnerability management on the system to identify and resolve potential security vulnerabilities and risks, including measures such as assessing the security of the system and network, patching vulnerabilities, and updating security patches. The security review and vulnerability management database unit 906b is used to store security review and vulnerability management information.

[0148] The regulatory compliance module 907 includes a regulatory compliance unit 907a and a regulatory compliance database unit 907b. The regulatory compliance unit 907a is used for the system to comply with applicable privacy and data protection regulations, such as the European General Data Protection Regulation (GDPR) and the U.S. Health Insurance Portability and Accountability Act (HIPAA). The requirements of privacy regulations are considered during system design and operation to ensure that data processing complies with the provisions of relevant laws and regulations. The regulatory compliance database unit 907b is used to store regulatory compliance information.

[0149] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A clinical trial ethics review system, characterized in that: It includes application submission end, review process management end, document management end, review collaboration end, review record and tracking end, notification and reminder end, ethics review report generation end, data analysis and statistics end, and privacy and security end. Data communication between each part is carried out through a dedicated network and dedicated line network; The application submission terminal includes an application form module, a file upload module, a supplementary material module, a contact information module, and a submission confirmation module; The review process management terminal includes an application allocation module, a review progress tracking module, a review opinion recording module, a decision recording module, a notification and feedback module, a time limit management module, and a transparency and traceability module; The file management terminal includes an application file management module, a file version control module, a file classification and labeling module, a file authority management module, a file sharing and collaboration module, a file audit and recording module, and a file export and printing module; The review collaboration end includes a task assignment and tracking module, a review collaboration module, a comment and discussion module, a document sharing and version control module, a reminder and notification module, a meeting and conference management module, and a file audit and recording module; The review record and tracking terminal includes an application record module, a review process record module, a review opinion record module, a decision record module, a notification and reminder record module, and a file modification record module; The notification and reminder terminal includes an application receiving notification module, a review progress reminder module, a material supplement reminder module, a review decision notification module, and a meeting notification module; The ethics review report generation end includes a report template design module, a report generation module, a report editing and modification module, a report approval and signing module, and a report distribution and archiving module; The data analysis and statistics end includes a data sorting and cleaning module, a data visualization module, a statistical analysis module, a report generation module, and an advanced analysis function module; The privacy and security end includes a data encryption module, an access control module, an audit log module, a data backup and recovery module, a user rights management module, a security review and vulnerability management module, and a regulatory compliance module.

2. A clinical trial ethics review system according to claim 1, characterized in that: The application form module includes an application form unit, which is used for the ethics review system to provide a corresponding application form or online form; The file upload module includes a file upload unit, which is used for researchers to upload relevant files through the ethics review system; The supplementary materials module includes a supplementary materials unit, which is used for researchers to submit supplementary materials according to the requirements of the ethics review committee; The contact information module includes a contact information unit, which is used for researchers to provide their own contact information so that the ethics review committee can communicate with them and provide feedback; The submission confirmation module includes a submission confirmation unit, which is used for researchers to complete the application filling and file uploading.

3. A clinical trial ethics review system according to claim 1, characterized in that: The application allocation module includes an application allocation unit, which is used for the ethics review system to automatically or manually allocate submitted applications to corresponding review committee members or experts for review; The examination progress tracking module includes an examination progress tracking unit, which is used to systematically record and track the examination progress of each application; The review opinion recording module includes a review opinion recording unit, which is used for review committee members to record their review opinions and suggestions in the system; The decision recording module includes a decision recording unit, which is used by the review committee to make a review decision based on the review opinions and the researchers’ responses; The notification and feedback module includes a notification and feedback unit, which is used for the system to automatically generate notifications and feedback to researchers; The time limit management module includes a time limit management unit, which is used to set and manage the time limits of each link in the review process; The transparency and traceability module includes a transparency and traceability unit, which is used for the review process management function to ensure the transparency and traceability of the review process.

4. A clinical trial ethics review system according to claim 1, characterized in that: The application document management module includes an application document management unit, which is used in the ethics review system to allow researchers to upload ethics review application documents to the system for management; The file version control module includes a file version control unit, which is used to modify and update the application documents during the ethics review process. The file management function can support the version control of the files to ensure that each modification has corresponding records and traceability; The document classification and labeling module includes a document classification and labeling unit for better organizing and managing ethics review documents; The file authority module includes a file authority management unit for ethics review documents that usually contain sensitive research data and personal information; The file sharing and collaboration module includes a file sharing and collaboration unit, which is used in the ethical review process and may require sharing files with review committee members, research teams or other relevant parties and conducting collaborative editing; The file audit and record module includes a file audit and record unit, which is used to systematically record the operation and access records of ethics review files; The file export and printing module includes a file export and printing unit. The results of ethical review usually need to be exported or printed in the form of files for researchers and related parties to review.

5. A clinical trial ethics review system according to claim 1, characterized in that: The task assignment and tracking module includes a task assignment and tracking unit, which is used for the system to allow supervisors or administrators to assign review tasks to different committee members and track the progress and completion of tasks; The review collaboration module includes a review collaboration unit, which is used to provide a collaborative review function for the system, allowing committee members to review the same document and provide opinions and suggestions; The review and discussion module includes a review and discussion unit, and the review collaboration function in the system generally includes a review and discussion tool, so that committee members can discuss and communicate on documents and the review process within the system; The document sharing and version control module includes a document sharing and version control unit, which is used for review committee members to share review documents, reports, opinions and suggestions in the system, ensuring that all relevant personnel can obtain and understand the latest review materials in a timely manner; The reminder and notification module includes a reminder and notification unit, which is used for the system to send reminders and notifications to committee members, including the assignment of new tasks, deadlines for tasks, and submission of review comments; The conference and meeting management module includes a conference and meeting management unit for holding regular review committee meetings if necessary; The file audit and record module includes file audit, which is used to systematically record and review operations and access records during the collaboration process, including comments, discussions, and file modifications.

6. A clinical trial ethics review system according to claim 1, characterized in that: The application record module includes an application record unit, which is used to systematically record the detailed information of each submitted application, including the applicant's name, organization, application date basic information, and the version and modification record of the application document; The review process recording module includes a review process recording unit, which is used to systematically record the important links and time nodes in the review process of each application, including the receipt of the application, the allocation to the committee members, the submission of the review opinions, and the notification of the review decision; The review opinion recording module includes a review opinion recording unit, which is used to systematically record the review opinions and suggestions of each committee member on the application, including the content of the review opinion, submission time, and reviewer information; The decision recording module includes a decision recording unit, which is used to systematically record the review decision of each application, including whether it is approved, the conditions for approval, and the reasons for rejection; The notification and reminder recording module includes a notification and reminder recording unit, which is used to systematically record notifications and reminders sent to applicants and related personnel, including notifications of application receipt, notifications of examination results, and requests for supplementary materials; The file modification record module includes a file modification record unit, which is used to systemically record the modification records of application files, including the modification time, modification content, and information of the modifier.

7. A clinical trial ethics review system according to claim 1, characterized in that: The application receiving notification module includes an application receiving notification unit, which is used for the system to send a notification to the applicant to confirm that the ethics review application has been received and has started processing; The review progress reminder module includes a review progress reminder unit, which is used for the system to send reminders to relevant committee members and applicants according to the set review schedule and process to ensure that the review progress is carried out as planned; The material supplement reminder module includes a material supplement reminder unit, which is used to prompt the applicant to provide additional materials or further explanations if the examination process requires the applicant to provide additional materials or further explanations; The examination decision notification module includes an examination decision notification unit, which is used for the system to send a notification of the examination decision to the applicant; The meeting notification module includes a meeting notification unit, which is used if the ethics review committee needs to hold a meeting for discussion and decision-making.

8. A clinical trial ethics review system according to claim 1, characterized in that: The report template design module includes a report template design unit, which is used for the ethics review system to provide a predefined report template, including the format and structure of review results, decisions, opinions and suggestions; The report generation module includes a report generation unit, which is used for the system to automatically generate an ethics review report based on the information collected during the review process and the decision of the committee; The report editing and modification module includes a report editing and modification unit, which is used to generate reports that can usually be edited and modified in the system so that the reviewer can make precise and accurate adjustments to the report content; The report approval and signing module includes a report approval and signing unit, which is used to provide approval and signing functions after the report is generated and modified to ensure the accuracy and compliance of the report; The report distribution and archiving module includes a report distribution and archiving unit, which is used to distribute and archive the generated ethical review report in the system. The system can provide an email notification function to send the report to relevant personnel.

9. A clinical trial ethics review system according to claim 1, characterized in that: The data sorting and cleaning module includes a data sorting and cleaning unit, which is used by the ethics review system to sort and clean the collected ethics review data to ensure the accuracy and consistency of the data; The data visualization module includes a data visualization unit, which is used to provide various visualization tools and charts for the system to present the ethics review data in an intuitive and easy-to-understand manner; The statistical analysis module includes a statistical analysis unit for system support of statistical analysis of ethical review data to reveal potential patterns, associations and trends; The report generation module includes a report generation unit, which is used for the system to automatically generate a report and summary of the ethics review data analysis; The advanced analysis function module includes an advanced analysis function unit, which may also provide more advanced data analysis functions for the ethics review system.

10. A clinical trial ethics review system according to claim 1, characterized in that: The data encryption module includes a data encryption unit, which is used for the system to encrypt sensitive data using encryption technology to prevent unauthorized access and data leakage; The access control module includes an access control unit, which is used to implement a strict access control mechanism in the system to ensure that only authorized personnel can access sensitive data; The audit log module includes an audit log unit, which is used to systematically record the user's operation activities and data access logs for auditing and tracing; The data backup and recovery module includes a data backup and recovery unit, which is used for the system to regularly perform data backup to prevent data loss or damage; The user rights management module includes a user rights management unit, which is used to set different levels of user rights in the system to ensure that only authorized personnel can view and process specific data and files; The security review and vulnerability management module includes a security review and vulnerability management unit, which is used for the system to perform regular security reviews and vulnerability management to identify and resolve potential security vulnerabilities and risks; The regulatory compliance module includes a regulatory compliance unit for the system to comply with applicable privacy and data protection regulations.

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