Clinical test participant report ending system

Abstract

The invention discloses a clinical test participant report ending system, and relates to the technical field of clinical tests. Comprising a result definition and management end, a data collection end, a data management end, a data analysis end, a report generation end, a data monitoring and quality management end, a security and privacy protection end and a traceability and auditing function end which are used for collecting, managing and analyzing report result data of medical participants, wherein the result definition and management end, the data collection end, the data management end, the data analysis end, the report generation end, the data monitoring and quality management end, the security and privacy protection end and the traceability and auditing function end are in data communication through a private network. The system provided by the invention can collect, manage and analyze the report outcome data of the medical participants, can help researchers and clinical test teams to effectively collect and analyze the report outcome data of the participants so as to evaluate the curative effect and safety of drugs or treatment methods, and has the advantages of improving the efficiency of data collection and analysis, reducing the cost and the like. The method has the advantages that data input and management errors are reduced, accurate and reliable results are provided, the method plays an important role in design, execution and result interpretation of clinical tests, and the quality and credibility of the clinical tests can be improved.

Description

Technical Field

[0001] The present invention relates to the technical field of clinical trials, and in particular to a system for reporting outcomes of clinical trial participants. Background Art

[0002] A clinical trial is any systematic study of a drug in humans (patients or healthy volunteers) to confirm or reveal the effects, adverse reactions, and / or absorption, distribution, metabolism, and excretion of the investigational drug. The goal is to determine the efficacy and safety of the investigational drug. Currently, evaluation of trial results is primarily categorized into two types: physician-assessed outcomes and participant-reported outcomes. Physician-assessed outcomes primarily provide a comprehensive assessment of treatment outcomes based on laboratory test indicators, instrumental test results, symptoms, and signs. Participant-reported outcomes, on the other hand, assess changes in the patient's condition based on their own experience, prioritizing improvements in symptoms and quality of life.

[0003] However, participant-reported outcomes involve a wide range of data, including data collection, data management, data analysis, and report generation. Currently, clinical trials often rely on manual data collection and recording by staff. Manual work is prone to human error and inefficient, leading to slow progress in participant-reported outcomes. Some clinical trials utilize operating systems to assist with completion, but current operating systems typically operate independently for each task and operation. For example, data collection is a separate operating system, data analysis is a separate function system, and data calculation is yet another separate operating system. These operations lack relevance, and human intervention is also required for data integration and management. Other operating systems are capable of data integration, but these systems can suffer from accuracy and consistency issues. For example, the reports and documents generated during the trial often lack consistency and accuracy, which can also slow down the trial process.

[0004] As can be seen from the above, the current clinical trial participant outcome reporting system does not provide a good comprehensive operation integration method. Based on this, the present invention provides a clinical trial participant outcome reporting system to solve the above problems. Summary of the Invention

[0005] The purpose of the present invention is to address the shortcomings of the existing technology and to propose a clinical trial participant reporting outcome system.

[0006] In order to achieve the above object, the present invention adopts the following technical solutions:

[0007] A clinical trial participant-reported outcome system includes an outcome definition and management terminal, a data collection terminal, a data management terminal, a data analysis terminal, a report generation terminal, a data monitoring and quality management terminal, a security and privacy protection terminal, and a traceability and audit function terminal for collecting, managing and analyzing medical participant-reported outcome data through a dedicated network.

[0008] Furthermore, the outcome definition and management terminal is used to define and manage the outcomes reported by participants, including an outcome selection module, a measurement tool selection module, an assessment time point determination module, an outcome measurement standard module, an outcome classification and grading module, an outcome data dictionary module, and an outcome modification and update module, wherein:

[0009] The outcome selection module is used to allow researchers to select outcomes that are appropriate to their study objectives and hypotheses from a range of possible participant-reported outcomes;

[0010] The measurement tool selection module is used to provide commonly used measurement tools and questionnaires;

[0011] The assessment time point determination module is used to allow researchers to determine the assessment time point for each outcome;

[0012] The outcome measurement standard module is used to support the definition of measurement standards and indicators for each outcome;

[0013] The outcome classification and grading module is used to allow researchers to classify and grade outcomes;

[0014] The outcome data dictionary module is used to maintain an outcome data dictionary;

[0015] The outcome modification and update module is used to allow researchers to modify and update the outcomes as needed.

[0016] Furthermore, the data collection terminal is used to collect data from participant reports, including an electronic data collection module, an adaptive questionnaire module, a data entry verification module, a multiple data type support module, a data editing and correction module, a data integrity check module, a reminder and notification function module, and a data preservation and storage module, wherein:

[0017] The electronic data collection module is used to provide an electronic platform that allows participants to electronically enter and submit their reported outcome data;

[0018] The self-adaptive questionnaire module is used to support automatic adjustment of the questionnaire content according to the participants' answers;

[0019] The data entry verification module is used to check the accuracy and completeness of the data entered by the participants;

[0020] The multiple data type support modules are used to support different types of data collection;

[0021] The data editing and correction module is used to allow researchers to edit and correct participant-reported outcome data;

[0022] The data integrity checking module is used to check the integrity of the data;

[0023] The reminder and notification function module is used to send reminders and notifications to participants;

[0024] The data saving and storage module is used to save and store participant-reported outcome data.

[0025] Furthermore, the data management terminal is used for data management of participant reports, including a data storage and organization module, a data entry and verification module, a data cleaning and processing module, a data security and confidentiality module, a data import and export module, a data backup and recovery module, and a data query and reporting module, wherein:

[0026] The data storage and organization module is used to store participant-reported outcome data and organize them into a form that is easy to access and manage;

[0027] The data entry and verification module is used to support data entry functions, allowing researchers or data managers to enter participant-reported outcome data into the system;

[0028] The data cleaning and processing module is used to provide data cleaning and processing functions;

[0029] The data security and confidentiality module is used to take corresponding security measures;

[0030] The data import and export module is used to support the import of data from external data sources, or to export participant-reported outcome data into other formats or formats recognizable by the system;

[0031] The data backup and recovery module is used for regular data backup;

[0032] The data query and reporting module is used to provide flexible data query and reporting functions.

[0033] Furthermore, the data analysis terminal is used for analyzing the data reported by participants, including a descriptive statistics analysis module, an exploratory data analysis module, a statistical hypothesis testing module, a regression analysis module, a subset analysis module, a time series analysis module, and a sensitivity analysis module, wherein:

[0034] The descriptive statistics analysis module is used to calculate and present descriptive statistics of participant-reported outcome data;

[0035] The exploratory data analysis module is used to support exploratory data analysis technology;

[0036] The statistical hypothesis testing module is used to perform various statistical hypothesis tests;

[0037] The regression analysis module is used to support regression analysis;

[0038] The subset analysis module is used to perform subset analysis;

[0039] The time series analysis module is used to perform time series analysis;

[0040] The sensitivity analysis module is used to perform sensitivity analysis.

[0041] Furthermore, the report generation end is used to generate a participant report, including a custom report template module, a data summary and abstract module, a chart and visualization presentation module, an analysis result presentation module, a subset analysis report module, a result interpretation and discussion module, and a reference and citation module, wherein:

[0042] The custom report template module is used to provide a variety of report templates or report styles, allowing users to select a template that suits their needs;

[0043] The data aggregation and summary module is used to automatically aggregate and generate summary information from the collected data;

[0044] The chart and visualization rendering module is used to support the generation of charts and visualization graphics;

[0045] The analysis result presentation module is used to present the data analysis results in a report in text form;

[0046] The subset analysis reporting module is used to perform subset analysis;

[0047] The result interpretation and discussion module is used to provide a text editing tool to enable users to interpret and discuss the test results;

[0048] The reference and citation module is used to allow users to add references and citations.

[0049] Furthermore, the data monitoring and quality management terminal is used to monitor and manage the quality of the data reported by participants, including a data verification and logic check module, a data quality assessment module, a data cleaning and error correction module, a data tracking and audit module, a data security and confidentiality module, a data backup and recovery module, a data monitoring and anomaly detection module, and a data tracing and indexing module, wherein:

[0050] The data verification and logic check module is used to verify and logic check the input data;

[0051] The data quality assessment module is used to assess and monitor data quality;

[0052] The data cleaning and error correction module is used to provide data cleaning and error correction functions;

[0053] The data tracking and auditing module is used to record and track the operation history and modification records of the data;

[0054] The data security and confidentiality module is used to take appropriate security measures to protect the security and confidentiality of participant-reported outcome data;

[0055] The data backup and recovery module is used to perform regular data backup;

[0056] The data monitoring and anomaly detection module is used to perform data monitoring and anomaly detection;

[0057] The data tracing and indexing module is used to provide data tracing and indexing functions.

[0058] Furthermore, the security and privacy protection end is used to control the security and privacy of participant data, including a data encryption module, an access control module, an identity authentication module, an audit log module, a data backup and recovery module, an anonymization and desensitization module, a compliance and regulatory compliance module, and a training and awareness raising module, wherein:

[0059] The data encryption module is used to protect sensitive data using data encryption technology;

[0060] The access control module is used to implement access control measures;

[0061] The identity authentication module is used to authenticate the user;

[0062] The audit log module is used to record and track user operations and system events;

[0063] The data backup and recovery module is used to perform regular data backup;

[0064] The anonymization and desensitization module is used to anonymize or desensitize the participant data;

[0065] The Compliance and Regulatory Compliance module is used to comply with applicable laws, regulations and industry standards;

[0066] The training and awareness raising module is used to provide relevant training and awareness raising measures.

[0067] Furthermore, the traceability and audit function terminal is used to trace and audit the data in the participant report, including an operation log module, a modification record module, a data version control module, a data audit module, a data tracing module, a user rights management module, a data access control module, and an audit report module, wherein:

[0068] The operation log module is used to record user operation behaviors and system events and generate detailed operation logs;

[0069] The modification record module is used to track and record modification and update operations on data;

[0070] The data version control module is used to support the data version control function;

[0071] The data audit module is used to provide data audit functions, allowing for review and verification of data;

[0072] The data tracing module is used to support the data tracing function, allowing users to track the source and processing of data;

[0073] The user rights management module is used to implement the user rights management mechanism and set different access rights according to user roles and rights;

[0074] The data access control module is used to limit access rights to data through access control measures;

[0075] The audit report module is used to generate an audit report to summarize and display the operation and decision records during the test process.

[0076] Compared with the existing technology, the beneficial effects of the present invention are: the present invention provides a clinical trial participant-reported outcome system for collecting, managing and analyzing medical participant-reported outcome data, which can help researchers and clinical trial teams effectively collect and analyze participant-reported outcome data to evaluate the efficacy and safety of drugs or treatment methods. The use of this system can improve the efficiency of data collection and analysis, reduce data entry and management errors, and provide accurate and reliable results. It plays an important role in the design, execution and result interpretation of clinical trials, and helps to improve the quality and credibility of clinical trials. BRIEF DESCRIPTION OF THE DRAWINGS

[0077] Figure 1 This is a schematic diagram of the system for outcome definition and management in the present invention;

[0078] Figure 2 This is a system diagram of the data collection terminal in the present invention;

[0079] Figure 3 This is a system diagram of the data management terminal in the present invention;

[0080] Figure 4 This is a system diagram of the data analysis end in the present invention;

[0081] Figure 5 This is a system diagram of the report generation end in the present invention;

[0082] Figure 6 This is a system diagram of the data monitoring and quality management end in the present invention;

[0083] Figure 7 A schematic diagram of the security and privacy protection system in the present invention;

[0084] Figure 8 This is a system diagram of the traceability and audit function end in the present invention.

[0085] In the figure: 1. Outcome definition and management terminal; 101. Outcome selection module; 101a. Outcome selection unit; 101b. Outcome selection database unit; 102. Measurement tool selection module; 102a. Measurement tool selection unit; 102b. Measurement tool selection database unit; 103. Evaluation time point determination module; 103a. Evaluation time point determination unit; 103b. Evaluation time point determination database unit; 104. Outcome measurement standard module; 104a. Outcome measurement standard unit; 104b. Outcome measurement standard database unit; 105. Outcome classification and grading module; 105a. Outcome classification and grading unit; 105b. Outcome classification and grading database unit; 106. Outcome data dictionary module; 106a. Outcome data dictionary unit; 106b. Outcome data dictionary database unit; 107. Outcome modification and update module; 107a. Outcome modification and update unit; 107b. Outcome modification and update database unit;

[0086] 2. Data Collection Terminal; 201. Electronic Data Collection Module; 201a. Electronic Data Collection Unit; 201b. Electronic Data Collection Database Unit; 202. Adaptive Questionnaire Module; 202a. Adaptive Questionnaire Unit; 202b. Adaptive Questionnaire Database Unit; 203. Data Entry Verification Module; 203a. Data Entry Verification Unit; 203b. Data Entry Verification Database Unit; 204. Multiple Data Type Support Module; 204a. Multiple Data Type Support Unit; 204b. Multiple Data Type Support Database Unit; 205. Data Editing and Correction Module; 205a. Data Editing and Correction Unit; 205b. Data Editing and Correction Database Unit; 206. Data Integrity Check Module; 206a. Data Integrity Check Unit; 206b. Data Integrity Check Database Unit; 207. Reminder and Notification Function Module; 207a. Data Preservation and Storage Unit; 207b. Data Preservation and Storage Database Unit;

[0087] 3. Data Management Terminal; 301. Data Storage and Organization Module; 301a. Data Storage and Organization Unit; 301b. Data Storage and Organization Database Unit; 302. Data Entry and Verification Module; 302a. Data Entry and Verification Unit; 302b. Data Entry and Verification Database Unit; 303. Data Cleansing and Processing Module; 303a. Data Cleansing and Processing Unit; 303b. Data Cleansing and Processing Database Unit; 304. Data Security and Confidentiality Module; 304a. Data Security and Confidentiality Unit; 304b. Data Security and Confidentiality Database Unit; 305. Data Import and Export Module; 305a. Data Import and Export Unit; 305b. Data Import and Export Database Unit; 306. Data Backup and Recovery Module; 306a. Data Backup and Recovery Unit; 306b. Data Backup and Recovery Database Unit; 307. Data Query and Report Module; 307a. Data Query and Report Unit; 307b. Data Query and Report Database Unit;

[0088] 4. Data Analysis Terminal; 401. Descriptive Statistics Analysis Module; 401a. Descriptive Statistics Analysis Unit; 401b. Descriptive Statistics Analysis Database Unit; 402. Exploratory Data Analysis Module; 402a. Exploratory Data Analysis Unit; 402b. Exploratory Data Analysis Database Unit; 403. Statistical Hypothesis Testing Module; 403a. Statistical Hypothesis Testing Unit; 403b. Statistical Hypothesis Testing Database Unit; 404. Regression Analysis Module; 404a. Regression Analysis Unit; 404b. Regression Analysis Database Unit; 405. Subset Analysis Module; 405a. Subset Analysis Unit; 405b. Subset Analysis Database Unit; 406. Time Series Analysis Module; 406a. Time Series Analysis Unit; 406b. Time Series Analysis Database Unit; 407. Sensitivity Analysis Module; 407a. Sensitivity Analysis Unit; 407b. Sensitivity Analysis Database Unit;

[0089] 5. Report generation end; 501. Custom report template module; 501a. Custom report template unit; 501b. Custom report template database unit; 502. Data summary and abstract module; 502a. Data summary and abstract unit; 502b. Data summary and abstract database unit; 503. Chart and visualization presentation module; 503a. Chart and visualization presentation unit; 503b. Chart and visualization presentation database unit; 504. Analysis result presentation module; 504a. Analysis result presentation unit; 504b. Analysis result presentation database unit; 505. Subset analysis report module; 505a. Subset analysis report unit; 505b. Subset analysis report database unit; 506. Result interpretation and discussion module; 506a. Result interpretation and discussion unit; 506b. Result interpretation and discussion database unit; 507. Reference and citation module; 507a. Reference and citation unit; 507b. Reference and citation database unit;

[0090] 6. Data monitoring and quality management terminal; 601. Data verification and logic check module; 601a. ​​Data verification and logic check unit; 601b. Data verification and logic check database unit; 602. Data quality assessment module; 602a. Data quality assessment unit; 602b. Data quality assessment database unit; 603. Data cleaning and error correction module; 603a. Data cleaning and error correction unit; 603b. Data cleaning and error correction database unit; 604. Data tracking and audit module; 604a. Data tracking and audit unit; 604b. Data tracking and audit data Library unit; 605, data security and confidentiality module; 605a, data security and confidentiality unit; 605b, data security and confidentiality database unit; 606, data backup and recovery module; 606a, data backup and recovery unit; 606b, data backup and recovery database unit; 607, data monitoring and anomaly detection module; 607a, data monitoring and anomaly detection unit; 607b, data monitoring and anomaly detection database unit; 608, data tracing and indexing module; 608a, data tracing and indexing unit; 608b, data tracing and indexing database unit;

[0091] 7. Security and privacy protection terminal; 701. Data encryption module; 701a. Data encryption unit; 701b. Data encryption database unit; 702. Access control module; 702a. Access control unit; 702b. Access control database unit; 703. Identity authentication module; 703a. Identity authentication unit; 703b. Identity authentication database unit; 704. Audit log module; 704a. Audit log unit; 704b. Audit log database unit; 705. Data backup and recovery module Block; 705a, data backup and recovery unit; 705b, data backup and recovery database unit; 706, anonymization and desensitization module; 706a, anonymization and desensitization unit; 706b, anonymization and desensitization database unit; 707, compliance and regulatory compliance module; 707a, compliance and regulatory compliance unit; 707b, compliance and regulatory compliance database unit; 708, training and awareness raising module; 708a, training and awareness raising unit; 708b, training and awareness raising database unit;

[0092] 8. Traceability and audit function end; 801. Operation log module; 801a. Operation log unit; 801b. Operation log database unit; 802. Modification record module; 802a. Modification record unit; 802b. Modification record database unit; 803. Data version control module; 803a. Data version control unit; 803b. Data version control database unit; 804. Data audit module; 804a. Data audit unit; 804b. Data audit database unit; 805. Data tracing module; 805a. Data tracing unit; 805b. Data tracing database unit; 806. User authority management module; 806a. User authority management unit; 806b. User authority management database unit; 807. Data access control module; 807a. Data access control unit; 807b. Data access control database unit; 808. Audit report module; 808a. Audit report unit; 808b. Audit report database unit. DETAILED DESCRIPTION

[0093] The technical solutions in the embodiments of the present invention will be clearly and completely described 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.

[0094] based on

[0095] A clinical trial participant-reported outcome system includes an outcome definition and management terminal 1, a data collection terminal 2, a data management terminal 3, a data analysis terminal 4, a report generation terminal 5, a data monitoring and quality management terminal 6, a security and privacy protection terminal 7, and a traceability and audit function terminal 8 for collecting, managing, and analyzing medical participant-reported outcome data through a dedicated network.

[0096] Among them, the outcome definition and management terminal 1 is used to define and manage the outcomes reported by participants, the data collection terminal 2 is used to collect data in participant reports, the data management terminal 3 is used to manage data reported by participants, the data analysis terminal 4 is used to analyze data reported by participants, the report generation terminal 5 is used to generate participant reports, the data monitoring and quality management terminal 6 is used to monitor and manage the quality of data in participant reports, the security and privacy protection terminal 7 is used to control the security and privacy of participant data, and the traceability and audit function terminal 8 is used to trace and audit data in participant reports.

[0097] After the outcome definition and management terminal 1 defines and manages the outcomes reported by the participants, the data collection terminal 2 collects the data, the collected data is managed by the data management terminal 3, and analyzed by the data analysis terminal 4. The report generation terminal then generates the participant report, and the relevant data of the participant report outcomes is monitored and quality managed by the data monitoring and quality management terminal 6. The security and privacy protection terminal 7 ensures data security and privacy, and the traceability and audit function terminal 8 traces and audits the data. The various terminals work together to ultimately achieve the purpose of integration.

[0098] The outcome definition and management end 1, the data collection end 2, the data management end 3, the data analysis end 4, the report generation end 5, the data monitoring and quality management end 6, the security and privacy protection end 7, and the traceability and audit function end 8 respectively implement different functions and are integrated and coordinated with each other on the basis of their respective functions, so that the entire system becomes an important tool for clinical trial participants to report outcomes and promote the efficiency, safety and reliability of clinical research.

[0099] The following sections describe each component of a clinical trial participant-reported outcomes system in detail:

[0100] First, as Figure 1 As shown, the outcome definition and management terminal 1 includes an outcome selection module 101, a measurement tool selection module 102, an evaluation time point determination module 103, an outcome measurement standard module 104, an outcome classification and grading module 105, an outcome data dictionary module 106, and an outcome modification and update module 107.

[0101] Specifically, in one possible embodiment:

[0102] The outcome selection module 101 includes an outcome selection unit 101a and an outcome selection database unit 101b. The outcome selection unit 101a allows researchers to select outcomes that suit their research objectives and hypotheses from a range of possible participant-reported outcomes. These outcomes can include aspects such as a patient's symptoms, quality of life, psychological well-being, and functional status. The outcome selection database unit 101b stores outcome selection information.

[0103] The measurement tool selection module 102 includes a measurement tool selection unit 102a and a measurement tool selection database unit 102b. The measurement tool selection unit 102a provides commonly used measurement tools and questionnaires for researchers to select appropriate tools for assessing each outcome. These tools may include standardized questionnaires, scales, or customized assessment tools. The measurement tool selection database unit 102b stores measurement tool selection information.

[0104] The assessment timing determination module 103 includes an assessment timing determination unit 103a and an assessment timing determination database unit 103b. The assessment timing determination unit 103a allows researchers to determine the assessment timing for each outcome, i.e., the time point or time range for data collection. This helps determine the schedule and frequency of data collection. The assessment timing determination database unit 103b stores this information.

[0105] The outcome measurement standard module 104 includes an outcome measurement standard unit 104a and an outcome measurement standard database unit 104b. The outcome measurement standard unit 104a supports the definition of measurement standards and indicators for each outcome. Researchers can clearly describe how to measure outcomes, including measurement methods, calculation formulas, and data collection requirements. The outcome measurement standard database unit 104b stores this information.

[0106] The outcome classification and grading module 105 includes an outcome classification and grading unit 105a and an outcome classification and grading database unit 105b. The outcome classification and grading unit 105a is used to allow researchers to classify and grade outcomes to better organize and analyze data. This can include classifying outcomes into primary and secondary outcomes, or into different clinical endpoints. The outcome classification and grading database unit 105b stores the outcome classification and grading information.

[0107] The outcome data dictionary module 106 includes an outcome data dictionary unit 106a and an outcome data dictionary database unit 106b. The outcome data dictionary unit 106a is used to maintain an outcome data dictionary containing the definition, measurement tools, and indicators for each outcome. This helps maintain consistency and accuracy in outcome definitions. The outcome data dictionary database unit 106b stores the outcome data dictionary information.

[0108] The outcome modification and update module 107 includes an outcome modification and update unit 107a and an outcome modification and update database unit 107b. The outcome modification and update unit 107a allows researchers to modify and update outcomes as needed. This may include adding new outcomes, modifying measurement tools, or adjusting assessment timing. The outcome modification and update database unit 107b stores this information.

[0109] Second, if Figure 2 As shown, the data collection terminal 2 includes an electronic data collection module 201, an adaptive questionnaire module 202, a data entry verification module 203, a multiple data type support module 204, a data editing and correction module 205, a data integrity check module 206, a reminder and notification function module 207, and a data preservation and storage module.

[0110] Specifically, in one possible embodiment:

[0111] The electronic data collection module 201 includes an electronic data collection unit 201a and an electronic data collection database unit 201b. The electronic data collection unit 201a provides an electronic platform that allows participants to electronically input and submit their reported outcome data. This can be done through online surveys, mobile applications, or emails. The electronic data collection database unit 201b stores the electronic data collection information.

[0112] The adaptive questionnaire module 202 includes an adaptive questionnaire unit 202a and an adaptive questionnaire database unit 202b. The adaptive questionnaire unit 202a is used to automatically adjust the questionnaire content based on the participant's responses. This means that the questionnaire can select the next relevant question based on the participant's previous answers, improving the efficiency and accuracy of data collection. The adaptive questionnaire database unit 202b stores the adaptive questionnaire information.

[0113] The data entry verification module 203 includes a data entry verification unit 203a and a data entry verification database unit 203b. The data entry verification unit 203a is used to check the accuracy and completeness of data entered by participants. It ensures data validity through logical rules, range checks, and data type verification. The data entry verification database unit 203b stores data entry verification information.

[0114] The multiple data type support module 204 includes a multiple data type support unit 204a and a multiple data type support database unit 204b, wherein the multiple data type support unit 204a is used to support different types of data collection, including quantitative data (such as scores, points), qualitative data (such as text descriptions), multiple-choice questions, single-choice questions, etc.; and the multiple data type support database unit 204b stores multiple data type support information.

[0115] The data editing and correction module 205 includes a data editing and correction unit 205a and a data editing and correction database unit 205b. The data editing and correction unit 205a allows researchers to edit and correct participant-reported outcome data. This can correct data entry errors, missing data, or other inaccuracies. The data editing and correction database unit 205b stores the data editing and correction information.

[0116] The data integrity check module 206 includes a data integrity check unit 206a and a data integrity check database unit 206b. The data integrity check unit 206a is used to check data integrity, ensuring that all necessary data for each participant is collected and recorded. If any data is missing or incomplete, the system can provide corresponding warnings or prompts. The data integrity check database unit 206b stores the data integrity check information.

[0117] The reminder and notification module 207 includes a reminder and notification unit and a reminder and notification database unit. The reminder and notification unit is used to send reminders and notifications to participants, prompting them to promptly complete and submit their reported outcome data. This helps ensure timely data collection and updating. The reminder and notification database unit stores reminder and notification information.

[0118] The data storage module includes a data storage unit 207a and a data storage database unit 207b. The data storage unit 207a is used to store and preserve participant-reported outcome data and ensure data security and confidentiality. It may employ data encryption, backup, and storage security measures to prevent data loss or leakage. The data storage database unit 207b stores data storage information.

[0119] Third, if Figure 3 As shown, the data management terminal 3 includes a data storage and organization module 301, a data entry and verification module 302, a data cleaning and processing module 303, a data security and confidentiality module 304, a data import and export module 305, a data backup and recovery module 306, and a data query and reporting module 307.

[0120] Specifically, in one possible embodiment:

[0121] The data storage and organization module 301 includes a data storage and organization unit 301a and a data storage and organization database unit 301b. The data storage and organization unit 301a is used to store participant-reported outcome data and organize it into a format that is easily accessible and manageable. Data can be stored in a database or file system to ensure data security and reliability. The data storage and organization database unit 301b stores data storage and organization information.

[0122] The data entry and verification module 302 includes a data entry and verification unit 302a and a data entry and verification database unit 302b. The data entry and verification unit 302a supports data entry, allowing researchers or data managers to enter participant-reported outcome data into the system. The system may also include a data verification function to check the accuracy and legitimacy of the data. The data entry and verification database unit 302b stores data entry and verification information.

[0123] The data cleaning and processing module 303 includes a data cleaning and processing unit 303a and a data cleaning and processing database unit 303b. The data cleaning and processing unit 303a provides data cleaning and processing functions to check and correct errors, missing values, or abnormal values ​​in the data. This includes operations such as data cleaning, filling missing values, and handling outliers to ensure data consistency and reliability. The data cleaning and processing database unit 303b stores data cleaning and processing information.

[0124] The data security and confidentiality module 304 includes a data security and confidentiality unit 304a and a data security and confidentiality database unit 304b. The data security and confidentiality unit 304a is responsible for implementing appropriate security measures to ensure the security and confidentiality of participant-reported outcome data. These measures may include data encryption, access control, and identity verification to prevent unauthorized access and data leakage. The data security and confidentiality database unit 304b stores data security and confidentiality information.

[0125] The data import and export module 305 includes a data import and export unit 305a and a data import and export database unit 305b. The data import and export unit 305a supports importing data from external data sources or exporting participant-reported outcome data into other formats or system-recognizable formats. This facilitates data integration and sharing, supporting cross-system data flow. The data import and export database unit 305b stores data import and export information.

[0126] The data backup and recovery module 306 includes a data backup and recovery unit 306a and a data backup and recovery database unit 306b. The data backup and recovery unit 306a is used to regularly back up data to prevent data loss or corruption. The system also provides a data recovery function to restore accidentally deleted or damaged data when needed. The data backup and recovery database unit 306b stores data backup and recovery information.

[0127] The data query and reporting module 307 includes a data query and reporting unit 307a and a data query and reporting database unit 307b. The data query and reporting unit 307a provides flexible data query and reporting capabilities, enabling researchers to retrieve and generate specific data reports as needed. This facilitates rapid acquisition of required data to support data analysis and results presentation. The data query and reporting database unit 307b stores data query and reporting information.

[0128] Fourth, if Figure 4 As shown, the data analysis terminal 4 includes a descriptive statistics analysis module 401, an exploratory data analysis module 402, a statistical hypothesis testing module 403, a regression analysis module 404, a subset analysis module 405, a time series analysis module 406, and a sensitivity analysis module 407.

[0129] Specifically, in one possible embodiment:

[0130] The descriptive statistics analysis module 401 includes a descriptive statistics analysis unit 401a and a descriptive statistics analysis database unit 401b. The descriptive statistics analysis unit 401a is used to calculate and present descriptive statistics of participant-reported outcome data, such as mean, median, standard deviation, percentage, etc. This helps describe the basic characteristics and distribution of the data. The descriptive statistics analysis database unit 401b stores the descriptive statistics analysis information.

[0131] The exploratory data analysis module 402 includes an exploratory data analysis unit 402a and an exploratory data analysis database unit 402b. The exploratory data analysis unit 402a is used to support exploratory data analysis techniques, such as data visualization and chart generation, to help researchers discover patterns, associations, and trends in the data. This may include plotting histograms, scatter plots, boxplots, etc. The exploratory data analysis database unit 402b stores exploratory data analysis information.

[0132] The statistical hypothesis testing module 403 includes a statistical hypothesis testing unit 403a and a statistical hypothesis testing database unit 403b. The statistical hypothesis testing unit 403a is used to perform various statistical hypothesis tests to assess whether the differences between participant-reported outcome data are statistically significant. Common hypothesis testing methods include t-tests, analysis of variance, and chi-square tests. The statistical hypothesis testing database unit 403b stores statistical hypothesis test information.

[0133] Regression analysis module 404 includes a regression analysis unit 404a and a regression analysis database unit 404b. Regression analysis unit 404a is used to support regression analysis to explore the relationship between participant-reported outcomes and other factors. This includes methods such as linear regression, logistic regression, and survival analysis, which can help researchers identify potential predictive and influencing factors. Regression analysis database unit 404b stores regression analysis information.

[0134] The subset analysis module 405 includes a subset analysis unit 405a and a subset analysis database unit 405b. The subset analysis unit 405a is used to perform subset analysis, which groups and analyzes participant-reported outcome data according to specific factors or characteristics. This helps identify possible subgroup differences and heterogeneity of effects. The subset analysis database unit 405b stores the subset analysis information.

[0135] The time series analysis module 406 includes a time series analysis unit 406a and a time series analysis database unit 406b. If the participant-reported outcome data involves changes over time, the time series analysis unit 406a is used to perform time series analysis to evaluate trends and patterns over time; and the time series analysis database unit 406b stores the time series analysis information.

[0136] The sensitivity analysis module 407 includes a sensitivity analysis unit 407a and a sensitivity analysis database unit 407b, wherein the sensitivity analysis unit 407a is used to perform sensitivity analysis, and can evaluate the impact of these changes on the results and conclusions by changing assumptions, parameters or methods in the analysis; and the sensitivity analysis database unit 407b stores the sensitivity analysis information.

[0137] Fifth, if Figure 5 As shown, the report generation terminal 5 includes a custom report template module 501, a data aggregation and summary module 502, a chart and visualization presentation module 503, an analysis result presentation module 504, a subset analysis report module 505, a result interpretation and discussion module 506, and a reference and citation module 507.

[0138] Specifically, in one possible embodiment:

[0139] The custom report template module 501 includes a custom report template unit 501a and a custom report template database unit 501b. The custom report template unit 501a provides a variety of report templates or report styles, allowing users to select a template that suits their needs. Users can customize the appearance and layout of reports, including titles, fonts, colors, borders, and more. The custom report template database unit 501b stores custom report template information.

[0140] The data aggregation and summary module 502 includes a data aggregation and summary unit 502a and a data aggregation and summary database unit 502b. The data aggregation and summary unit 502a is used to automatically aggregate and generate summary information from the collected data, such as the number of participants, the distribution of reported outcomes, and major statistical results. This allows for a quick understanding of the overall situation of the trial. The data aggregation and summary database unit 502b stores the data aggregation and summary information.

[0141] The chart and visualization module 503 includes a chart and visualization unit 503a and a chart and visualization database unit 503b. The chart and visualization unit 503a is used to generate charts and visualizations to intuitively display data and analysis results. These may include bar charts, line charts, pie charts, radar charts, etc., which help better understand and communicate test results. The chart and visualization database unit 503b stores chart and visualization information.

[0142] The analysis result presentation module 504 includes an analysis result presentation unit 504a and an analysis result presentation database unit 504b. The analysis result presentation unit 504a is used to present the data analysis results in text form in a report. This includes explanations of key statistical indicators, descriptions of effect sizes, and reports of significance levels to help readers understand the meaning of the experimental results. The analysis result presentation database unit 504b stores the analysis result presentation information.

[0143] The subset analysis reporting module 505 includes a subset analysis reporting unit 505a and a subset analysis report database unit 505b. The subset analysis reporting unit 505a is used to perform subset analysis. The system can generate corresponding subset analysis reports, detailing the differences and trends in the results of different subsets. This helps further explore the heterogeneity of experimental effects. The subset analysis report database unit 505b stores the subset analysis report information.

[0144] The result interpretation and discussion module 506 includes a result interpretation and discussion unit 506a and a result interpretation and discussion database unit 506b. The result interpretation and discussion unit 506a provides a text editing tool that allows users to interpret and discuss the test results. Users can state conclusions, propose hypotheses, and discuss potential mechanisms to promote a deeper understanding of the test results. The result interpretation and discussion database unit 506b stores the result interpretation and discussion information.

[0145] The reference and citation module 507 includes a reference and citation unit 507a and a reference and citation database unit 507b. The reference and citation unit 507a allows users to add references and citations to support the arguments and evidence in the report. Users can insert references and link to related documents or attachments to provide more comprehensive information support. The reference and citation database unit 507b stores the reference and citation information.

[0146] Sixth, such as Figure 6 As shown, the data monitoring and quality management terminal 6 includes a data verification and logic check module 601, a data quality assessment module 602, a data cleaning and error correction module 603, a data tracking and audit module 604, a data security and confidentiality module 605, a data backup and recovery module 606, a data monitoring and anomaly detection module 607, and a data tracing and indexing module 608.

[0147] Specifically, in one possible embodiment:

[0148] The data validation and logic check module 601 includes a data validation and logic check unit 601a and a data validation and logic check database unit 601b. The data validation and logic check unit 601a is used to perform validation and logic checks on input data to ensure its legitimacy and consistency. This includes checking the data's range, type, and format, and providing warnings or prompts for errors or abnormal data. The data validation and logic check database unit 601b stores this data validation and logic check information.

[0149] The data quality assessment module 602 includes a data quality assessment unit 602a and a data quality assessment database unit 602b. The data quality assessment unit 602a is used to assess and monitor data quality, including checking metrics such as data loss rate, error rate, and consistency. This data quality assessment allows for timely identification and correction of data quality issues. The data quality assessment database unit 602b stores data quality assessment information.

[0150] The data cleaning and error correction module 603 includes a data cleaning and error correction unit 603a and a data cleaning and error correction database unit 603b. The data cleaning and error correction unit 603a provides data cleaning and error correction functions to address errors, missing values, or outliers in the data. This includes operations such as removing duplicate data, filling missing values, and handling outliers to ensure data consistency and accuracy. The data cleaning and error correction database unit 603b stores data cleaning and error correction information.

[0151] The data tracking and audit module 604 includes a data tracking and audit unit 604a and a data tracking and audit database unit 604b. The data tracking and audit unit 604a is used to record and track data operation history and modification records. This facilitates data audits, tracking data sources, modifications, and processing, ensuring data traceability and reliability. The data tracking and audit database unit 604b stores data tracking and audit information.

[0152] The data security and confidentiality module 605 includes a data security and confidentiality unit 605a and a data security and confidentiality database unit 605b. The data security and confidentiality unit 605a is used to implement appropriate security measures to protect the security and confidentiality of participant-reported outcome data. These measures may include data encryption, access control, and identity verification to prevent unauthorized access and data leakage. The data security and confidentiality database unit 605b stores data security and confidentiality information.

[0153] The data backup and recovery module 606 includes a data backup and recovery unit 606a and a data backup and recovery database unit 606b. The data backup and recovery unit 606a is used to perform regular data backups to prevent data loss or corruption. Furthermore, the system provides a data recovery function to restore accidentally deleted or damaged data when needed. The data backup and recovery database unit 606b stores data backup and recovery information.

[0154] The data monitoring and anomaly detection module 607 includes a data monitoring and anomaly detection unit 607a and a data monitoring and anomaly detection database unit 607b. The data monitoring and anomaly detection unit 607a is used to perform data monitoring and anomaly detection, promptly identifying anomalies or inconsistencies in the data. This includes examining data trends, statistical indicators, and data distribution to identify potential issues or data quality risks. The data monitoring and anomaly detection database unit 607b stores the data monitoring and anomaly detection information.

[0155] The data tracing and indexing module 608 includes a data tracing and indexing unit 608a and a data tracing and indexing database unit 608b. The data tracing and indexing unit 608a provides data tracing and indexing functionality, enabling users to trace the source and processing of data. This helps verify data reliability and supports data review and verification. The data tracing and indexing database unit 608b stores data tracing and indexing information.

[0156] Seventh, such as Figure 7 As shown, the security and privacy protection end 7 includes a data encryption module 701, an access control module 702, an identity authentication module 703, an audit log module 704, a data backup and recovery module 705, an anonymization and desensitization module 706, a compliance and regulatory compliance module 707, and a training and awareness raising module 708.

[0157] Specifically, in one possible embodiment:

[0158] The data encryption module 701 includes a data encryption unit 701a and a data encryption database unit 701b. The data encryption unit 701a uses encryption technology to protect sensitive data, preventing unauthorized access and data leakage. Encryption can be applied during data transmission and storage to ensure data confidentiality during transmission and storage. The data encryption database unit 701b stores the encrypted data information.

[0159] Access control module 702 includes an access control unit 702a and an access control database unit 702b. Access control unit 702a is used to implement access control measures to restrict access to sensitive data. Only authorized users can access participant data and other sensitive information. Access control can be managed based on roles, permissions, and authentication. Access control database unit 702b stores access control information.

[0160] The authentication module 703 includes an authentication unit 703a and an authentication database unit 703b. The authentication unit 703a is used to authenticate users, ensuring that only authorized users can access the system and sensitive data. Common authentication methods include username and password, two-factor authentication, etc. The authentication database unit 703b stores authentication information.

[0161] The audit log module 704 includes an audit log unit 704a and an audit log database unit 704b. The audit log unit 704a is used to record and track user operations and system events, generating audit logs. This helps monitor and inspect system usage and identify potential security issues and violations. The audit log database unit 704b stores the audit log information.

[0162] The data backup and recovery module 705 includes a data backup and recovery unit 705a and a data backup and recovery database unit 705b. The data backup and recovery unit 705a is used to perform regular data backups to prevent data loss or corruption. The backup data can be used to restore the system and data, ensuring data availability and integrity in the event of an emergency. The data backup and recovery database unit 705b stores data backup and recovery information.

[0163] The anonymization and desensitization module 706 includes an anonymization and desensitization unit 706a and an anonymization and desensitization database unit 706b. The anonymization and desensitization unit 706a is used to anonymize or desensitize participant data to reduce the risk of individual identification. Anonymization can remove or replace identifying information, making the data unattributable to a specific individual. Desensitization can utilize technical means such as data generalization, shielding, and noise addition to protect individual privacy. The anonymization and desensitization database unit 706b stores the anonymized and desensitized information.

[0164] The compliance and regulatory compliance module 707 includes a compliance and regulatory compliance unit 707a and a compliance and regulatory compliance database unit 707b. The compliance and regulatory compliance unit 707a is used to comply with applicable laws, regulations, and industry standards to ensure that data processing and privacy protection comply with relevant regulations. This may include compliance with privacy protection regulations such as the European General Data Protection Regulation (GDPR). The compliance and regulatory compliance database unit 707b stores compliance and regulatory compliance information.

[0165] The training and awareness-raising module 708 includes a training and awareness-raising unit 708a and a training and awareness-raising database unit 708b, wherein the training and awareness-raising unit 708a is used to provide relevant training and awareness-raising measures to ensure that users understand the importance of data security and privacy protection and follow the system's security policies and best practices; and the training and awareness-raising database unit 708b stores training and awareness-raising information.

[0166] Eighth, such as Figure 8As shown, the traceability and audit function terminal 8 includes an operation log module 801, a modification record module 802, a data version control module 803, a data audit module 804, a data tracing module 805, a user authority management module 806, a data access control module 807, and an audit report module 808.

[0167] Specifically, in one possible embodiment:

[0168] The operation log module 801 includes an operation log unit 801a and an operation log database unit 801b. The operation log unit 801a is used to record user operations and system events, generating detailed operation logs. This includes information such as the time, user, type, and results of operations such as user login, data modification, data access, and report generation. The operation log database unit 801b stores the operation log information.

[0169] The modification record module 802 includes a modification record unit 802a and a modification record database unit 802b. The modification record unit 802a is used to track and record data modification and update operations, including data additions, deletions, and modifications. Each modification records relevant information, such as the modification time, modifier, and modification content, to ensure traceability and transparency of data modifications. The modification record database unit 802b stores the modification record information.

[0170] The data version control module 803 includes a data version control unit 803a and a data version control database unit 803b. The data version control unit 803a supports data version control, tracking and managing different versions of data. Each time data is modified, a new version is generated, and a record of the previous version is retained for comparison, backtracking, and recovery when needed. The data version control database unit 803b stores data version control information.

[0171] The data audit module 804 includes a data audit unit 804a and a data audit database unit 804b. The data audit unit 804a provides data audit functionality, allowing for the review and verification of data. The audit functionality can check the integrity, consistency, and accuracy of data to ensure that it meets specified standards and requirements. The data audit database unit 804b stores data audit information.

[0172] The data tracing module 805 includes a data tracing unit 805a and a data tracing database unit 805b. The data tracing unit 805a supports data tracing, allowing users to track the source and processing of data. Users can view the original data input, modification records, data processing flow, etc. to understand the data generation and change process. The data tracing database unit 805b stores data tracing information.

[0173] The user rights management module 806 includes a user rights management unit 806a and a user rights management database unit 806b. The user rights management unit 806a is used to implement a user rights management mechanism, setting different access rights based on user roles and permissions. Only authorized users can access and manipulate relevant data, ensuring data security and traceability. The user rights management database unit 806b stores user rights management information.

[0174] The data access control module 807 includes a data access control unit 807a and a data access control database unit 807b. The data access control unit 807a is used to restrict access to data through access control measures. Only authorized users can access sensitive data, while other users can only access data for which they have permission, ensuring data confidentiality and privacy. The data access control database unit 807b stores data access control information.

[0175] The audit report module 808 includes an audit report unit 808a and an audit report database unit 808b. The audit report unit 808a is used to generate an audit report that summarizes and displays the operations and decision-making records during the test. The audit report provides an overview and details of the test process, including operation logs, data modification records, and access rights changes, for review and verification. The audit report database unit 808b stores the audit report information.

[0176] The above description is only a preferred specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any technician familiar with the technical field, within the technical scope disclosed by the present invention, who makes equivalent replacements or changes based on the technical solution and inventive concept of the present invention, should be covered by the scope of protection of the present invention.

Claims

1. A clinical trial participant-reported outcome system, characterized in that: It includes an outcome definition and management terminal (1) that communicates data through a dedicated network, a data collection terminal (2), a data management terminal (3), a data analysis terminal (4), a report generation terminal (5), a data monitoring and quality management terminal (6), a security and privacy protection terminal (7), and a traceability and audit function terminal (8), which are used to collect, manage and analyze medical participant-reported outcome data.

2. A clinical trial participant-reported outcome system according to claim 1, characterized in that: The outcome definition and management terminal (1) is used to define and manage the outcomes reported by participants, including an outcome selection module (101), a measurement tool selection module (102), an assessment time point determination module (103), an outcome measurement standard module (104), an outcome classification and grading module (105), an outcome data dictionary module (106), and an outcome modification and update module (107), wherein: The outcome selection module (101) is used to allow researchers to select outcomes that are suitable for their research objectives and hypotheses from a range of possible participant-reported outcomes; The measurement tool selection module (102) is used to provide commonly used measurement tools and questionnaires; The assessment time point determination module (103) is used to allow researchers to determine the assessment time point for each outcome; The outcome measurement standard module (104) is used to support the definition of measurement standards and indicators for each outcome; The outcome classification and grading module (105) is used to allow researchers to classify and grade outcomes; The outcome data dictionary module (106) is used to maintain an outcome data dictionary; The outcome modification and update module (107) is used to allow researchers to modify and update the outcomes as needed.

3. A clinical trial participant-reported outcome system according to claim 2, characterized in that: The data collection terminal (2) is used for collecting data in the participant's report, and includes an electronic data collection module (201), an adaptive questionnaire module (202), a data entry verification module (203), a multiple data type support module (204), a data editing and correction module (205), a data integrity check module (206), a reminder and notification function module (207), and a data preservation and storage module, wherein: The electronic data collection module (201) is used to provide an electronic platform that allows participants to electronically input and submit their reported outcome data; The self-adaptive questionnaire module (202) is used to support automatic adjustment of the questionnaire content according to the participants' answers; The data entry verification module (203) is used to check the accuracy and completeness of the data entered by the participants; The multiple data type support module (204) is used to support different types of data collection; The data editing and correction module (205) is used to allow researchers to edit and correct participant-reported outcome data; The data integrity checking module (206) is used to check the integrity of the data; The reminder and notification function module (207) is used to send reminders and notifications to participants; The data saving and storage module is used to save and store participant-reported outcome data.

4. A clinical trial participant-reported outcome system according to claim 3, characterized in that: The data management terminal (3) is used for data management of participant reports, including a data storage and organization module (301), a data entry and verification module (302), a data cleaning and processing module (303), a data security and confidentiality module (304), a data import and export module (305), a data backup and recovery module (306), and a data query and reporting module (307), wherein: The data storage and organization module (301) is used to store participant-reported outcome data and organize it into a form that is easy to access and manage; The data entry and verification module (302) is used to support data entry functions, allowing researchers or data managers to enter participant-reported outcome data into the system; The data cleaning and processing module (303) is used to provide data cleaning and processing functions; The data security and confidentiality module (304) is used to take corresponding security measures; The data import and export module (305) is used to support the import of data from external data sources, or to export participant-reported outcome data into other formats or formats recognizable by the system; The data backup and recovery module (306) is used for regular data backup; The data query and reporting module (307) is used to provide flexible data query and reporting functions.

5. A clinical trial participant-reported outcome system according to claim 4, characterized in that: The data analysis terminal (4) is used for analyzing data reported by participants, and includes a descriptive statistics analysis module (401), an exploratory data analysis module (402), a statistical hypothesis testing module (403), a regression analysis module (404), a subset analysis module (405), a time series analysis module (406), and a sensitivity analysis module (407), wherein: The descriptive statistics analysis module (401) is used to calculate and present descriptive statistics of participant-reported outcome data; The exploratory data analysis module (402) is used to support exploratory data analysis techniques; The statistical hypothesis testing module (403) is used to perform various statistical hypothesis tests; The regression analysis module (404) is used to support regression analysis; The subset analysis module (405) is used to perform subset analysis; The time series analysis module (406) is used to perform time series analysis; The sensitivity analysis module (407) is used to perform sensitivity analysis.

6. A clinical trial participant-reported outcome system according to claim 5, characterized in that: The report generation terminal (5) is used to generate a participant report, including a custom report template module (501), a data summary and abstract module (502), a chart and visualization presentation module (503), an analysis result presentation module (504), a subset analysis report module (505), a result interpretation and discussion module (506), and a reference and citation module (507), wherein: The custom report template module (501) is used to provide a variety of report templates or report styles, allowing users to select a template that suits their needs; The data aggregation and summary module (502) is used to automatically aggregate and generate summary information from the collected data; The chart and visualization presentation module (503) is used to support the generation of charts and visualization graphics; The analysis result presentation module (504) is used to present the data analysis results in a report in text form; The subset analysis reporting module (505) is used to perform subset analysis; The result interpretation and discussion module (506) is used to provide a text editing tool to enable users to interpret and discuss the test results; The reference and citation module (507) is used to allow users to add references and citations.

7. A clinical trial participant-reported outcome system according to claim 6, characterized in that: The data monitoring and quality management terminal (6) is used to monitor and manage the quality of the data in the participant report, including a data verification and logic check module (601), a data quality assessment module (602), a data cleaning and error correction module (603), a data tracking and auditing module (604), a data security and confidentiality module (605), a data backup and recovery module (606), a data monitoring and anomaly detection module (607), and a data tracing and indexing module (608), wherein: The data verification and logic check module (601) is used to verify and logic check the input data; The data quality assessment module (602) is used to assess and monitor data quality; The data cleaning and error correction module (603) is used to provide data cleaning and error correction functions; The data tracking and auditing module (604) is used to record and track the operation history and modification records of the data; The data security and confidentiality module (605) is used to take appropriate security measures to protect the security and confidentiality of the participant-reported outcome data; The data backup and recovery module (606) is used to perform regular data backup; The data monitoring and anomaly detection module (607) is used to perform data monitoring and anomaly detection; The data tracing and indexing module (608) is used to provide data tracing and indexing functions.

8. A clinical trial participant-reported outcome system according to claim 7, characterized in that: The security and privacy protection terminal (7) is used to control the security and privacy of participant data, and includes a data encryption module (701), an access control module (702), an identity authentication module (703), an audit log module (704), a data backup and recovery module (705), an anonymization and desensitization module (706), a compliance and regulatory compliance module (707), and a training and awareness raising module (708), wherein: The data encryption module (701) is used to protect sensitive data using data encryption technology; The access control module (702) is used to implement access control measures; The identity authentication module (703) is used to authenticate the user; The audit log module (704) is used to record and track user operation behaviors and system events; The data backup and recovery module (705) is used to perform regular data backup; The anonymization and desensitization module (706) is used to anonymize or desensitize the participant data; The compliance and regulatory compliance module (707) is used to comply with applicable laws, regulations and industry standards; The training and awareness raising module (708) is used to provide relevant training and awareness raising measures.

9. A clinical trial participant-reported outcome system according to claim 8, characterized in that: The traceability and audit function terminal (8) is used to trace and audit the data in the participant report, including an operation log module (801), a modification record module (802), a data version control module (803), a data audit module (804), a data tracing module (805), a user authority management module (806), a data access control module (807), and an audit report module (808), wherein: The operation log module (801) is used to record user operation behaviors and system events and generate detailed operation logs; The modification record module (802) is used to track and record modification and update operations on data; The data version control module (803) is used to support the data version control function; The data audit module (804) is used to provide data audit functionality, allowing for review and verification of data; The data tracing module (805) is used to support the data tracing function, allowing users to track the source and processing of data; The user rights management module (806) is used to implement the user rights management mechanism and set different access rights according to user roles and rights; The data access control module (807) is used to limit access rights to data through access control measures; The audit report module (808) is used to generate an audit report to summarize and display the operation and decision records during the test process.

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