Clinical test case file management device
By designing a clinical trial case archive management device with multiple modules, the problems of unstandard data collection and classification and time-consuming retrieval in the prior art are solved, and data efficiency, safety and compliance management are achieved.
Patent Information
- Application Number
- CN202411919776.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-25
- Publication Date
- 2025-05-16
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
The existing clinical trial case archive management devices rely on manual entry or paper recording, and lack standardization and automation, which makes it difficult to ensure data accuracy and completeness, inconsistent classification standards, cumbersome archiving process, and retrieval and access specific cases may take a long time, affecting work efficiency.
A clinical trial case archive management device is designed, including data acquisition module, data encryption module, case classification module, permission management module, data analysis module, report generation module and user interaction module. The device supports multiple data input methods, real-time data verification, uses deep learning algorithms for intelligent classification, and provides flexible classification standards and labeling systems to ensure data security and compliance.
Through intelligent data collection and classification, the accuracy and completeness of the data are ensured, the archiving and retrieval process is simplified, work efficiency is improved, and data security and compliance are enhanced through encryption and permission management.
Smart Images
Figure CN120015211A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of clinical trial case file management equipment, and in particular to a clinical trial case file management device. Background Art
[0002] A clinical trial case file management device is a system or device specifically designed to collect, manage, protect and utilize case data generated in clinical trials.
[0003] Existing clinical trial case file management devices generally rely on manual entry or paper records, which may lack standardization and automation, making it difficult to ensure data accuracy and completeness. At the same time, they rely on manual operations, have inconsistent classification standards, and have a cumbersome filing process. Retrieving and accessing specific cases may take a long time, affecting work efficiency.
[0004] In view of the problems that the existing clinical trial case file management device relies on manual operation, has inconsistent classification standards, has a cumbersome filing process, and may take a long time to retrieve and access specific cases, which affects work efficiency, this clinical trial case file management device supports multiple data input methods, improves the efficiency and accuracy of data collection, and at the same time, the case classification module provides flexible classification standards and labeling systems, supports automatic or manual classification. After classification is completed, the case data will be archived in the corresponding classification directory, and a standardized case report form will be generated, simplifying the data collation and analysis process. Summary of the invention
[0005] In order to overcome the problems that existing clinical trial case file management devices generally rely on manual entry or paper records, which may lack standardization and automation, making it difficult to ensure data accuracy and completeness, and rely on manual operations, with inconsistent classification standards, cumbersome filing processes, and retrieval and access to specific cases may take a long time, affecting work efficiency.
[0006] The technical solution of the present invention is: a clinical trial case file management device, comprising:
[0007] Data collection module: used to collect all relevant data generated in clinical trials;
[0008] Data encryption module: used to perform multiple encryption processing on the collected case data;
[0009] Case classification module: used to classify and archive cases according to collected case characteristics;
[0010] Permission management module: used for real-time and strict permission allocation and access control policies;
[0011] Data analysis module: used to analyze and count the data collected by the data acquisition module;
[0012] Report generation module: used to generate detailed compliance reports and recommendations;
[0013] User interaction module: used to provide an interactive interface for users.
[0014] Preferably, the data acquisition module is responsible for collecting all relevant data generated in the clinical trial, including but not limited to basic patient information, trial process records, examination results, and drug use records. The module supports multiple data input methods, including but not limited to manual entry, spreadsheet import, and medical device interface docking, and ensures the accuracy and completeness of the data. During the data entry process, the module performs real-time data verification, including format verification, logical consistency check, and comparison with existing data. When errors or omissions are found, feedback is provided immediately to ensure the integrity and accuracy of the data.
[0015] Preferably, the data encryption module is used to perform advanced encryption processing on all collected case data to ensure the security of the data during transmission and storage. The data encryption module protects the data from unauthorized access, leakage or tampering by utilizing encryption algorithms and security protocols that meet industry standards. In addition, the data encryption module is also responsible for the data backup and recovery mechanism to prevent data loss.
[0016] Preferably, the data encryption module comprises the following steps when operating:
[0017] S11: First, receive clinical trial case data transmitted from the data collection and input module, including but not limited to basic patient information, trial process records, examination results, and drug use records;
[0018] S12: The received data will be processed by advanced encryption before being stored or transmitted. During the encryption process, the data will be converted into a format that is difficult to understand and interpret. Only people or systems with corresponding decryption keys can restore the data;
[0019] S13: The encrypted data will be stored in an encrypted database or cloud storage service, and a backup and recovery mechanism will be implemented to prevent data loss or damage;
[0020] S14: When an authorized user needs to access encrypted data, the data encryption module will cooperate with the authority management and access control module to decrypt the data using the corresponding decryption key.
[0021] Preferably, the case classification module is used to automatically or manually classify and archive cases according to the type, stage, and patient characteristics of the clinical trial. The case classification module adopts a deep learning algorithm to automatically learn and optimize the classification model based on multi-dimensional information such as the complexity of the clinical trial, disease type, and patient characteristics. When the pathology classification module is classifying, in addition to the preset classification standards, the module supports users to customize classification labels according to specific trial needs to achieve refined management of cases. At the same time, the system can automatically recommend or adjust classification standards based on data characteristics to improve the flexibility and practicality of classification.
[0022] Preferably, the case classification module comprises the following steps when operating:
[0023] S21: When the pathology classification module receives the clinical trial related data collected by the data acquisition module, it will perform a series of pre-processing operations such as cleaning, formatting and data integration on the data;
[0024] S22: Based on factors such as the type and stage of the clinical trial and patient characteristics, the pathology classification module will pre-establish a set of classification criteria, including but not limited to the classification of diseases, the division of trial stages, and the classification of patient age or gender;
[0025] S23: The case classification module can automatically classify cases using machine learning or artificial intelligence algorithms, and analyze and classify case data according to preset classification standards and labeling systems;
[0026] S24: After the classification is completed, the module will archive the case data into the corresponding classification directory, and generate a standardized case report form CRF according to the classification results. The CRF form will contain key information of the case, including but not limited to basic information of the patient, test process records, and examination results, and will be presented in a standardized format;
[0027] S25: The archived case data can be quickly accessed through the retrieval function provided by the pathology classification module.
[0028] Preferably, the case classification module not only provides preset classification standards, but also allows for custom settings based on the specific needs of clinical trials, and automatically or manually classifies and archives cases, making data management more orderly and efficient. This helps researchers quickly find the required case data, thereby saving time and energy and improving research efficiency. At the same time, through strict classification standards and labeling systems, the accuracy and integrity of case data are ensured, and in conjunction with the data encryption module and the authority management module, case data is encrypted and access controlled, thereby enhancing data security and compliance.
[0029] Preferably, the permission management module is used to implement strict permission allocation and access control policies to ensure that only authorized personnel can access specific case data. The permission management module supports role-based access control and assigns different data access rights according to the user's role. The permission management module also records all access and operation logs for easy auditing and tracking.
[0030] Preferably, the data analysis module is used to provide data analysis tools and visualization interfaces to help researchers deeply analyze clinical trial data and identify trends, outliers and correlations. The data analysis module supports a variety of statistical analysis methods, including but not limited to descriptive statistics, hypothesis testing, survival analysis, and can generate charts, reports and dashboards to intuitively display the analysis results.
[0031] Preferably, the report generation module is used to automatically check whether the clinical trial case files comply with relevant regulations and ethical requirements. The report generation module identifies potential compliance issues through a preset rule base and algorithm, and generates detailed compliance reports and recommendations. The report generation module can also assist in preparing documents for submission to regulatory agencies or ethics committees.
[0032] Preferably, the user interaction module is used to provide a user-friendly interface and interactive experience, so that researchers, data managers and other stakeholders can easily use the management device. The user interaction module supports multi-language and multi-device access, and provides real-time help documents, online support and user feedback channels. By collecting user feedback and suggestions, it can be continuously optimized and improved to meet changing needs.
[0033] Beneficial effects of the present invention:
[0034] 1. Compared with traditional clinical trial case file management devices, which generally rely on manual entry or paper records, may lack standardization and automation, making it difficult to ensure data accuracy and completeness. At the same time, they rely on manual operations, have inconsistent classification standards, and the filing process is cumbersome. Retrieving and accessing specific cases may take a long time, affecting work efficiency. This clinical trial case file management device can automatically learn and optimize the classification model based on multi-dimensional information such as the complexity of the clinical trial, disease type, and patient characteristics, and realize intelligent and precise case classification. At the same time, the module also supports users to customize classification labels according to specific trial needs, and can automatically recommend or adjust classification standards according to data characteristics, further improving the flexibility and practicality of classification, and providing researchers with a more orderly and efficient data management environment;
[0035] 2. The archive management device can support multiple data input methods. During the data entry process, data verification is performed in real time, including format verification, logical consistency check and comparison with existing data, and errors or omissions are fed back immediately. At the same time, deep learning algorithms are used to automatically learn and optimize classification models based on multi-dimensional information of clinical trials, thereby realizing refined and intelligent classification of cases. After classification is completed, it automatically archives and generates standardized case report forms, which simplifies the operating procedures of researchers and shortens data sorting time. BRIEF DESCRIPTION OF THE DRAWINGS
[0036] Figure 1 Shown is a first three-dimensional structural schematic diagram of a clinical trial case file management device of the present invention;
[0037] Figure 2 What is shown is a flow chart of the structure of a clinical trial case file management device of the present invention;
[0038] Figure 3 Shown is a schematic diagram of the workflow of a pathology classification module of a clinical trial case file management device of the present invention. DETAILED DESCRIPTION
[0039] The present invention will be further described below in conjunction with the accompanying drawings and embodiments.
[0040] See also Figure 1-Figure 3 The present invention provides an embodiment: a clinical trial case file management device, comprising:
[0041] Data collection module: used to collect all relevant data generated in clinical trials;
[0042] Data encryption module: used to perform multiple encryption processing on the collected case data;
[0043] Case classification module: used to classify and archive cases according to collected case characteristics;
[0044] Permission management module: used for real-time and strict permission allocation and access control policies;
[0045] Data analysis module: used to analyze and count the data collected by the data acquisition module;
[0046] Report generation module: used to generate detailed compliance reports and recommendations;
[0047] User interaction module: used to provide an interactive interface for users.
[0048] Preferably, the data acquisition module is responsible for collecting all relevant data generated in the clinical trial, including but not limited to basic patient information, trial process records, examination results, and drug use records. The module supports multiple data input methods, including but not limited to manual entry, spreadsheet import, and medical device interface docking, and ensures the accuracy and completeness of the data. During the data entry process, the module performs real-time data verification, including format verification, logical consistency check, and comparison with existing data. When errors or omissions are found, feedback is provided immediately to ensure the integrity and accuracy of the data.
[0049] Preferably, the data encryption module is used to perform advanced encryption processing on all collected case data to ensure the security of the data during transmission and storage. The data encryption module protects the data from unauthorized access, leakage or tampering by utilizing encryption algorithms and security protocols that meet industry standards. In addition, the data encryption module is also responsible for the data backup and recovery mechanism to prevent data loss.
[0050] Preferably, the data encryption module comprises the following steps when operating:
[0051] S11: First, receive clinical trial case data transmitted from the data collection and input module, including but not limited to basic patient information, trial process records, examination results, and drug use records;
[0052] S12: The received data will be processed by advanced encryption before being stored or transmitted. During the encryption process, the data will be converted into a format that is difficult to understand and interpret. Only people or systems with corresponding decryption keys can restore the data;
[0053] S13: The encrypted data will be stored in an encrypted database or cloud storage service, and a backup and recovery mechanism will be implemented to prevent data loss or damage;
[0054] S14: When an authorized user needs to access encrypted data, the data encryption module will cooperate with the authority management and access control module to decrypt the data using the corresponding decryption key.
[0055] Preferably, the case classification module is used to automatically or manually classify and archive cases according to the type, stage, and patient characteristics of the clinical trial. The case classification module provides flexible classification standards and labeling systems to facilitate rapid retrieval and access to specific cases. At the same time, it can also generate standardized case report forms to simplify the data collation and analysis process.
[0056] Preferably, the case classification module is used to automatically or manually classify and archive cases according to the type, stage, and patient characteristics of the clinical trial. The case classification module adopts a deep learning algorithm to automatically learn and optimize the classification model based on multi-dimensional information such as the complexity of the clinical trial, disease type, and patient characteristics. When the pathology classification module is classifying, in addition to the preset classification standards, the module supports users to customize classification labels according to specific trial needs to achieve refined management of cases. At the same time, the system can automatically recommend or adjust classification standards based on data characteristics to improve the flexibility and practicality of classification.
[0057] Preferably, the case classification module comprises the following steps when operating:
[0058] S21: When the pathology classification module receives the clinical trial related data collected by the data acquisition module, it will perform a series of pre-processing operations such as cleaning, formatting and data integration on the data;
[0059] S22: Based on factors such as the type and stage of the clinical trial and patient characteristics, the pathology classification module will pre-establish a set of classification criteria, including but not limited to the classification of diseases, the division of trial stages, and the classification of patient age or gender;
[0060] S23: The case classification module can automatically classify cases using machine learning or artificial intelligence algorithms, and analyze and classify case data according to preset classification standards and labeling systems;
[0061] S24: After the classification is completed, the module will archive the case data into the corresponding classification directory, and generate a standardized case report form CRF according to the classification results. The CRF form will contain key information of the case, including but not limited to basic information of the patient, test process records, and examination results, and will be presented in a standardized format;
[0062] S25: The archived case data can be quickly accessed through the retrieval function provided by the pathology classification module.
[0063] Preferably, the case classification module not only provides preset classification standards, but also allows for custom settings based on the specific needs of clinical trials, and automatically or manually classifies and archives cases, making data management more orderly and efficient. This helps researchers quickly find the required case data, thereby saving time and energy and improving research efficiency. At the same time, through strict classification standards and labeling systems, the accuracy and integrity of case data are ensured, and in conjunction with the data encryption module and the authority management module, case data is encrypted and access controlled, thereby enhancing data security and compliance.
[0064] Preferably, the permission management module is used to implement strict permission allocation and access control policies to ensure that only authorized personnel can access specific case data. The permission management module supports role-based access control and assigns different data access rights according to the user's role. The permission management module also records all access and operation logs for easy auditing and tracking.
[0065] Preferably, the data analysis module is used to provide data analysis tools and visualization interfaces to help researchers deeply analyze clinical trial data and identify trends, outliers and correlations. The data analysis module supports a variety of statistical analysis methods, including but not limited to descriptive statistics, hypothesis testing, survival analysis, and can generate charts, reports and dashboards to intuitively display the analysis results.
[0066] Preferably, the report generation module is used to automatically check whether the clinical trial case files comply with relevant regulations and ethical requirements. The report generation module identifies potential compliance issues through a preset rule base and algorithm, and generates detailed compliance reports and recommendations. The report generation module can also assist in preparing documents for submission to regulatory agencies or ethics committees.
[0067] Preferably, the user interaction module is used to provide a user-friendly interface and interactive experience, so that researchers, data managers and other stakeholders can easily use the management device. The user interaction module supports multi-language and multi-device access, and provides real-time help documents, online support and user feedback channels. By collecting user feedback and suggestions, it can be continuously optimized and improved to meet changing needs.
[0068] Example 1
[0069] In a clinical trial project of a large pharmaceutical company, in order to ensure efficient, safe and compliant management of case data, a clinical trial case file management device is used as follows:
[0070] S31: Collect data generated in clinical trials from multiple sources through the data collection module, including basic information of patients, trial process records, examination results, and drug use records;
[0071] S32: During the data entry process, the data acquisition module automatically performs data verification to check the integrity, accuracy and consistency of the data to prevent the entry of erroneous or missing information;
[0072] S33: After receiving the data from the data collection module, the case classification module first performs a series of pre-processing operations such as data cleaning, formatting and data integration to ensure the quality and consistency of the data;
[0073] S34: The case classification module pre-establishes a set of detailed classification criteria based on the type, stage and patient characteristics of the clinical trial;
[0074] S35: Using machine learning or artificial intelligence algorithms, the case classification module automatically classifies the preprocessed data, and classifies the cases into different disease groups according to the classification standards of the diseases; and classifies the cases into corresponding trial stages according to the division of the trial stages, etc.;
[0075] S36: After the classification is completed, the case data is archived into the corresponding classification directory. At the same time, the case classification module provides a flexible retrieval function, and researchers can quickly access specific case data based on classification criteria, tags or keywords;
[0076] S37: Based on the classification results, the case classification module automatically generates a standardized case report form. Researchers can use the CRF form to organize and analyze data, simplifying the data processing process.
[0077] The embodiments of the present invention are described in detail above with reference to the accompanying drawings, but the present invention is not limited to the above embodiments, and various changes can be made within the knowledge scope of those skilled in the art without departing from the spirit of the present invention.
Claims
1. A clinical trial case file management device; characterized by: Included are: Data collection module: used to collect all relevant data generated in clinical trials; Data encryption module: used to perform multiple encryption processing on the collected case data; Case classification module: used to classify and archive cases according to collected case characteristics; Permission management module: used for real-time and strict permission allocation and access control policies; Data analysis module: used to analyze and count the data collected by the data acquisition module; Report generation module: used to generate detailed compliance reports and recommendations; User interaction module: used to provide an interactive interface for users.
2. A clinical trial case file management device according to claim 1, characterized in that: The data collection module is responsible for collecting all relevant data generated in clinical trials, including but not limited to basic patient information, trial process records, examination results, and drug use records. The module supports multiple data input methods, including but not limited to manual entry, spreadsheet import, and medical device interface docking, and ensures the accuracy and completeness of the data. During the data entry process, the module performs real-time data verification, including format verification, logical consistency check, and comparison with existing data. When errors or omissions are found, feedback is provided immediately to ensure the integrity and accuracy of the data.
3. A clinical trial case file management device according to claim 2, characterized in that: The data encryption module is used to perform advanced encryption processing on all collected case data to ensure the security of data during transmission and storage. The data encryption module protects data from unauthorized access, leakage or tampering by utilizing encryption algorithms and security protocols that meet industry standards. In addition, the data encryption module is also responsible for the data backup and recovery mechanism to prevent data loss.
4. A clinical trial case file management device according to claim 3, characterized in that: When the data encryption module is working, the following steps are included: S11: First, receive clinical trial case data transmitted from the data collection and input module, including but not limited to basic patient information, trial process records, examination results, and drug use records; S12: The received data will be processed by advanced encryption before being stored or transmitted. During the encryption process, the data will be converted into a format that is difficult to understand and interpret. Only people or systems with corresponding decryption keys can restore the data; S13: The encrypted data will be stored in an encrypted database or cloud storage service, and a backup and recovery mechanism will be implemented to prevent data loss or damage; S14: When an authorized user needs to access encrypted data, the data encryption module will cooperate with the authority management and access control module to decrypt the data using the corresponding decryption key.
5. A clinical trial case file management device according to claim 4, characterized in that: The case classification module is used to automatically or manually classify and archive cases according to the type, stage, and patient characteristics of the clinical trial. The case classification module provides flexible classification standards and labeling systems to facilitate rapid retrieval and access to specific cases. At the same time, it can also generate standardized case report forms to simplify the data collation and analysis process.
6. A clinical trial case file management device according to claim 5, characterized in that: The case classification module includes the following steps when working: S21: When the pathology classification module receives the clinical trial related data collected by the data acquisition module, it will perform a series of pre-processing operations such as cleaning, formatting and data integration on the data; S22: Based on factors such as the type and stage of the clinical trial and patient characteristics, the pathology classification module will pre-establish a set of classification criteria, including but not limited to the classification of diseases, the division of trial stages, and the classification of patient age or gender; S23: The case classification module can automatically classify cases using machine learning or artificial intelligence algorithms, and analyze and classify case data according to preset classification standards and labeling systems; S24: After the classification is completed, the module will archive the case data into the corresponding classification directory, and generate a standardized case report form CRF according to the classification results. The CRF form will contain key information of the case, including but not limited to basic information of the patient, test process records, and examination results, and will be presented in a standardized format; S25: The archived case data can be quickly accessed through the retrieval function provided by the pathology classification module.
7. A clinical trial case file management device according to claim 6, characterized in that: The permission management module is used to implement strict permission allocation and access control strategies to ensure that only authorized personnel can access specific case data. The permission management module supports role-based access control and assigns different data access rights according to the user's role. At the same time, the permission management module also records all access and operation logs for easy auditing and tracking.
8. A clinical trial case file management device according to claim 7, characterized in that: The data analysis module is used to provide data analysis tools and visualization interfaces to help researchers deeply analyze clinical trial data and identify trends, outliers and correlations. The data analysis module supports a variety of statistical analysis methods, including but not limited to descriptive statistics, hypothesis testing, survival analysis, and can generate charts, reports and dashboards to intuitively display the analysis results.
9. A clinical trial case file management device according to claim 8, characterized in that: The report generation module is used to automatically check whether clinical trial case files comply with relevant regulations and ethical requirements. The report generation module identifies potential compliance issues through preset rule bases and algorithms, and generates detailed compliance reports and recommendations. The report generation module can also assist in preparing documents for submission to regulatory agencies or ethics committees.
10. A clinical trial case file management device according to claim 9, characterized in that: The user interaction module is used to provide a user-friendly interface and interactive experience, so that researchers, data managers and other stakeholders can easily use the management device. The user interaction module supports multi-language and multi-device access, and provides real-time help documents, online support and user feedback channels. By collecting user feedback and suggestions, it can be continuously optimized and improved to meet changing needs.