Clinical test randomization system

Abstract

The invention discloses a clinical test randomization system, and relates to the technical field of drug clinical tests. Comprising a subject grouping and randomizing end, a randomizing method and algorithm end, a grouping strategy management end, a subject distributing and tracking end, a blind method and blind solution management end, a data security and confidentiality end and a reporting and auditing function end. The subject grouping and randomization end, the randomization method and algorithm end, the grouping strategy management end, the subject distribution and tracking end, the blind method and blind solution management end, the data security and confidentiality end and the report and audit function end are in data communication through a private network and a private line network. The method has the effect of helping researchers and test management teams to implement and monitor the randomization process of the test.

Description

Technical Field

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

[0002] The Clinical Trial Randomization System is a software system specifically designed to manage the randomization process in clinical trials. It provides a centralized, automated, and reliable platform to support the grouping and random assignment of subjects in trials, ensuring the scientific integrity, reliability, and comparability of trials. In clinical trials, randomization is a common method used to randomly assign subjects to different treatment or experimental groups. The purpose of randomization is to reduce the impact of bias and confounding factors, ensure the comparability of results, and ensure the validity of statistical analyses. The Clinical Trial Randomization System helps researchers and trial management teams implement and monitor the randomization process in trials by providing a range of functions and tools. Summary of the Invention

[0003] (1) Technical problems solved

[0004] In response to the shortcomings of the existing technology, the present invention provides a clinical trial randomization system, which achieves the technical effect of helping researchers and trial management teams implement and monitor the randomization process of the trial.

[0005] (2) Technical solution

[0006] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0007] A clinical trial randomization system comprising:

[0008] Subject grouping and randomization end, including randomization method and algorithm selection module, randomization sequence generation module, subject grouping module, grouping strategy management module, blinding and unblinding management module, subject allocation and tracking module, data security and confidentiality module;

[0009] Randomization methods and algorithms, including simple randomization module, stratified randomization module, block randomization module, random area module, dynamic randomization module, and blind protection module;

[0010] The grouping strategy management end includes a grouping factor definition module, a grouping strategy setting module, a grouping ratio setting module, a pre-allocated subject management module, a randomized sequence generation module, and a grouping strategy adjustment module;

[0011] The subject allocation and tracking end includes a grouping result recording module, a subject basic information management module, a subject follow-up data management module, a grouping strategy tracking module, a treatment result recording module, and a data quality control module;

[0012] Blinding and unblinding management end, including blinding management module, blinding protection module, unblinding management module, unblinding committee management module, and post-unblinding data processing module;

[0013] Data security and confidentiality, including access control module, data encryption module, secure backup and recovery module, audit log module, data backup module, data privacy and anonymization module, and security training and awareness raising module;

[0014] The reporting and auditing function end includes a randomized reporting module, a group statistical reporting module, a safety reporting module, a progress reporting module, an auditing function module, a report archiving and version control module.

[0015] Preferably: the randomization method and algorithm selection module includes a randomization method and algorithm selection unit for providing a selection of multiple randomization methods and algorithms; a randomization method and algorithm selection database unit for storing randomization method and algorithm selection information;

[0016] The randomization sequence generation module includes a randomization sequence generation unit for generating a randomization sequence that conforms to the selected randomization method; a randomization sequence generation database unit for storing randomization sequence generation information;

[0017] The subject grouping module includes a subject grouping unit for allocating subjects to different treatment groups or test groups according to the generated randomization sequence; a subject grouping database unit for storing subject grouping information;

[0018] The grouping strategy management module includes a grouping strategy management unit for supporting the management of grouping strategies for different treatment groups or test groups; a grouping strategy management database unit for storing grouping strategy management information;

[0019] The blinding and unblinding management module includes a blinding and unblinding management unit, which is used to support the blinding management of the trial, record the blinding status and the time point of unblinding, and provide corresponding unblinding process and authority control; a blinding and unblinding management database unit, which is used to store blinding and unblinding management information;

[0020] The subject allocation and tracking module includes a subject allocation and tracking unit for recording and tracking the grouping of subjects; a subject allocation and tracking database unit for storing subject allocation and tracking information;

[0021] The data security and confidentiality module includes a data security and confidentiality unit for ensuring the security and confidentiality of subject grouping and randomization data; and a data security and confidentiality database unit for storing data security and confidentiality information.

[0022] Preferably: the simple randomization module includes a simple randomization unit, which is used for simple randomization, which is the most basic randomization method, in which subjects are randomly assigned to treatment groups or test groups, and each subject has the same chance of being assigned to any group, generating a randomization sequence that conforms to simple randomization, and assigning subjects to corresponding groups according to the sequence; a simple randomization database unit, which is used to store simple randomization information;

[0023] The stratified randomization module includes a stratified randomization unit, which is used to divide subjects into different strata by taking into account some important baseline characteristics or factors, such as gender, age, disease severity, etc., and then perform random allocation within each stratum, support the definition and management of stratification factors, and generate a randomization sequence suitable for stratified randomization; a stratified randomization database unit is used to store stratified randomization information;

[0024] The block randomization module includes a block randomization unit, which is used for dividing subjects into blocks in a certain order according to a predefined block size during the trial, and then performing random assignment within each block, supporting the definition and management of block size, and generating a randomization sequence suitable for block randomization; a block randomization database unit, which is used to store block randomization information;

[0025] The random area module includes a random area unit, which is used for some trials that may require random allocation between specific geographical areas or research centers, supports the definition and management of different random areas, and ensures the random allocation of subjects in each area; a random area database unit is used to store random area information;

[0026] The dynamic randomization module includes a dynamic randomization unit, which is used for dynamic randomization to adjust the random allocation in real time according to the progress of the trial and the allocation of subjects, and dynamically generate and adjust the randomization sequence according to pre-set rules and algorithms to adapt to the actual situation of the trial; a dynamic randomization database unit, which is used to store dynamic randomization information;

[0027] The blind protection module includes a blind protection unit, which is used for the randomization system to support blind protection of the trial, and the blind methods include double-blind, single-blind and open-blind, etc.; and a blind protection database unit, which is used to store blind protection information.

[0028] Preferably: the grouping factor definition module includes a grouping factor definition unit for allowing researchers to define factors for grouping; a grouping factor definition database unit for storing grouping factor definition information;

[0029] The grouping strategy setting module includes a grouping strategy setting unit for supporting the setting of grouping strategies for different treatment groups or test groups; and a grouping strategy setting database unit for storing grouping strategy setting information.

[0030] The group ratio setting module includes a group ratio setting unit for allowing researchers to set the group ratios of different treatment groups or test groups; a group ratio setting database unit for storing group ratio setting information;

[0031] The pre-allocated subject management module includes a pre-allocated subject management unit, which is used to support the process of managing pre-allocated subjects, record and manage pre-allocated subject information, and ensure that their subsequent random allocation complies with the preset grouping strategy; and a pre-allocated subject management database unit, which is used to store pre-allocated subject management information.

[0032] The randomization sequence generation module includes a randomization sequence generation unit, which is used for grouping strategy management functions, usually combined with randomization methods and algorithms, to generate corresponding randomization sequences according to the defined grouping strategy and the selected randomization method, and the randomization sequences are used for actual random allocation of subjects; a randomization sequence generation database unit, which is used to store randomization sequence generation information;

[0033] The grouping strategy adjustment module includes a grouping strategy adjustment unit, which is used for researchers to adjust the grouping strategy according to actual conditions during the experiment; and a grouping strategy adjustment database unit, which is used to store grouping strategy adjustment information.

[0034] Preferably: the grouping result recording module includes a grouping result recording unit for accurately recording the grouping result of each subject; a grouping result recording database unit for storing grouping result record information;

[0035] The subject basic information management module includes a subject basic information management unit for researchers to record and manage the subject's basic information; a subject basic information management database unit for storing subject basic information management information;

[0036] The subject follow-up data management module includes a subject follow-up data management unit for supporting the recording and management of the subject's follow-up data; a subject follow-up data management database unit for storing subject follow-up data management information;

[0037] The grouping strategy tracking module includes a grouping strategy tracking unit for tracking and recording the execution of the grouping strategy; a grouping strategy tracking database unit for storing grouping strategy tracking information;

[0038] The treatment result recording module includes a treatment result recording unit for supporting the recording of the treatment results of the subject; a treatment result recording database unit for storing treatment result record information;

[0039] The data quality control module includes a data quality control unit for providing data quality control functions, including data entry verification, logic check and data consistency check, etc.; a data quality control database unit for storing data quality control information.

[0040] Preferably, the blind management module includes a blind management unit for supporting the definition and management of the blind method of the trial, wherein the blind method includes different types of blind methods such as double-blind, single-blind and open-blind; and a blind management database unit for storing blind management information.

[0041] The blind protection module includes a blind protection unit for supporting measures to ensure blind protection of the trial, and recording and tracking the implementation of blind protection; a blind protection database unit for storing blind protection information;

[0042] The unblinding management module includes an unblinding management unit for managing the unblinding process of the test, performing unblinding operations according to predetermined unblinding rules, and recording the time and reason of unblinding; an unblinding management database unit for storing unblinding management information;

[0043] The unblinding committee management module includes an unblinding committee management unit for supporting the management of the unblinding committee for some complex trials, including recording committee member information, recording and tracking unblinding decisions, etc.; a unblinding committee management database unit for storing unblinding committee management information;

[0044] The post-unblinding data processing module includes a post-unblinding data processing unit, which is used for data processing after unblinding and supports processing of data after unblinding, including performing subset analysis based on the unblinding results, explaining the impact of the blinding method on the test results, etc.; and a post-unblinding data processing database unit, which is used to store post-unblinding data processing information.

[0045] Preferably: the access control module includes an access control unit for implementing strict access control measures, including authentication using a username and password, setting different levels of user permissions, and restricting access to sensitive data; an access control database unit for storing access control information;

[0046] The data encryption module includes a data encryption unit for supporting encryption of test data to protect the security of data during transmission and storage; a data encryption database unit for storing data encryption information;

[0047] The security backup and recovery module includes a security backup and recovery unit for regularly backing up data and having the ability to restore data; a security backup and recovery database unit for storing security backup and recovery information;

[0048] The audit log module includes an audit log unit for recording and storing operation logs and tracking the access and modification history of test data, wherein the audit log can be used to track data change records, identify potential security risks and data tampering, and provide support for audit purposes; an audit log database unit for storing audit log information;

[0049] The data backup module includes a data backup unit for supporting regular backup and archiving of test data; a data backup database unit for storing data backup information;

[0050] The data privacy and anonymization module includes a data privacy and anonymization unit for ensuring the privacy and anonymization of test data; a data privacy and anonymization database unit for storing data privacy and anonymization information;

[0051] The security training and awareness-raising module includes a security training and awareness-raising unit, which is used to provide training and educational materials to help users understand the importance of data security and confidentiality and to improve users' awareness of protecting data security; and a security training and awareness-raising database unit, which is used to store security training and awareness-raising information.

[0052] Preferably, the randomization report module includes a randomization report unit for generating a randomization report including the subject's grouping, randomization method and results; and a randomization report database unit for storing randomization report information.

[0053] The group statistical reporting module includes a group statistical reporting unit for generating a group statistical report including information such as the number of subjects in different treatment groups or test groups, basic characteristics, treatment process and results; and a group statistical reporting database unit for storing group statistical report information;

[0054] The safety reporting module includes a safety reporting unit for the system to generate safety reports, including the incidence, severity and relevance of adverse events, and statistical analysis results of other safety indicators; a safety report database unit for storing safety report information;

[0055] The progress reporting module includes a progress reporting unit for generating trial progress reports, including recruitment status, data collection and monitoring progress, intermediate analysis results, etc.; a progress report database unit for storing progress report information;

[0056] The audit function module includes an audit function unit, which is used to provide audit functions, allowing researchers and regulatory agencies to audit and review reports and documents, including checking the consistency and accuracy of data to ensure the reliability of test data and results; and an audit function database unit, which is used to store audit function information.

[0057] Furthermore: the report archiving and version control module includes a report archiving and version control unit, which is used to support the archiving and version control of reports, including time stamping, storage and backup of reports, and version management of reports; a report archiving and version control database unit, which is used to store report archiving and version control information.

[0058] Preferably, data communication is performed between the subject grouping and randomization end, the randomization method and algorithm end, the grouping strategy management end, the subject allocation and tracking end, the blinding and unblinding management end, the data security and confidentiality end, and the reporting and auditing function end through a dedicated network.

[0059] (3) Beneficial effects

[0060] 1. The present invention provides a centralized, automated, and reliable platform for supporting the grouping and randomization of subjects in trials, ensuring the scientificity, reliability, and comparability of trials, by setting up a subject grouping and randomization terminal, a randomization method and algorithm terminal, a grouping strategy management terminal, a subject allocation and tracking terminal, a blinding and unblinding management terminal, a data security and confidentiality terminal, and a reporting and auditing function terminal.

[0061] 2. The clinical trial randomization system provided by the present invention helps researchers and trial management teams implement and monitor the randomization process of the trial by providing a series of functions and tools. BRIEF DESCRIPTION OF THE DRAWINGS

[0062] The above description is only an overview of the technical solution of the present invention. In order to more clearly understand the technical means of the present invention and implement it according to the contents of the specification, the following is a detailed description of the preferred embodiments of the present invention with reference to the accompanying drawings.

[0063] Figure 1 is a schematic block diagram showing the entire clinical trial randomization system in the present invention;

[0064] Figure 2 A schematic block diagram of the subject grouping and randomization end in the present invention;

[0065] Figure 3 A schematic block diagram of the randomization method and algorithm in the present invention;

[0066] Figure 4 A schematic block diagram of a grouping strategy management terminal in the present invention;

[0067] Figure 5 A schematic block diagram of the subject allocation and tracking terminal in the present invention;

[0068] Figure 6 Schematic diagram of the blinding method and unblinding management terminal in the present invention;

[0069] Figure 7 A schematic block diagram of the data security and confidentiality end of the present invention;

[0070] Figure 8 This is a schematic block diagram of the reporting and auditing functional end in the present invention.

[0071] Legend: 1. Subject grouping and randomization end;

[0072] 101. Randomization method and algorithm selection module; 101a. Randomization method and algorithm selection unit; 101b. Randomization method and algorithm selection database unit; 102. Randomization sequence generation module; 102a. Randomization sequence generation unit; 102b. Randomization sequence generation database unit; 103. Subject grouping module; 103a. Subject grouping unit; 103b. Subject grouping database unit; 104. Grouping strategy management module; 104a. Grouping strategy management unit; 104b. Grouping strategy management database unit; 105. Blinding and unblinding management module; 105a. Blinding and unblinding management unit; 105b. Blinding and unblinding management database unit; 106. Subject allocation and tracking module; 106a. Subject allocation and tracking unit; 106b. Subject allocation and tracking database unit; 107. Data security and confidentiality module; 107a. Data security and confidentiality unit; 107b. Data security and confidentiality database unit;

[0073] 2. Randomization method and algorithm;

[0074] 201, simple randomization module; 201a, simple randomization unit; 201b, simple randomization database unit; 202, stratified randomization module; 202a, stratified randomization unit; 202b, stratified randomization database unit; 203, block randomization module; 203a, block randomization unit; 203b, block randomization database unit; 204, random area module; 204a, random area unit; 204b, random area database unit; 205, dynamic randomization module; 205a, dynamic randomization unit; 205b, dynamic randomization database unit; 206, blind protection module; 206a, blind protection unit; 206b, blind protection database unit;

[0075] 3. Grouping strategy management terminal;

[0076] 301. Grouping factor definition module; 301a. Grouping factor definition unit; 301b. Grouping factor definition database unit; 302. Grouping strategy setting module; 302a. Grouping strategy setting unit; 302b. Grouping strategy setting database unit; 303. Grouping ratio setting module; 303a. Grouping ratio setting unit; 303b. Grouping ratio setting database unit; 304. Pre-allocated subject management module; 304a. Pre-allocated subject management unit; 304b. Pre-allocated subject management database unit; 305. Randomization sequence generation module; 305a. Randomization sequence generation unit; 305b. Randomization sequence generation database unit; 306. Grouping strategy adjustment module; 306a. Grouping strategy adjustment unit; 306b. Grouping strategy adjustment database unit;

[0077] 4. Subject allocation and tracking terminal;

[0078] 401. Grouping result recording module; 401a. Grouping result recording unit; 401b. Grouping result recording database unit; 402. Subject basic information management module; 402a. Subject basic information management unit; 402b. Subject basic information management database unit; 403. Subject follow-up data management module; 403a. Subject follow-up data management unit; 403b. Subject follow-up data management database unit; 404. Grouping strategy tracking module; 404a. Grouping strategy tracking unit; 404b. Grouping strategy tracking database unit; 405. Treatment result recording module; 405a. Treatment result recording unit; 405b. Treatment result recording database unit; 406. Data quality control module; 406a. Data quality control unit; 406b. Data quality control database unit;

[0079] 5. Blinding and unblinding management end;

[0080] 501, blinding management module; 501a, blinding management unit; 501b, blinding management database unit; 502, blinding protection module; 502a, blinding protection unit; 502b, blinding protection database unit; 503, unblinding management module; 503a, unblinding management unit; 503b, unblinding management database unit; 504, unblinding committee management module; 504a, unblinding committee management unit; 504b, unblinding committee management database unit; 505, post-unblinding data processing module; 505a, post-unblinding data processing unit; 505b, post-unblinding data processing database unit;

[0081] 6. Data security and confidentiality;

[0082] 601, access control module; 601a, access control unit; 601b, access control database unit; 602, data encryption module; 602a, data encryption unit; 602b, data encryption database unit; 603, security backup and recovery module; 603a, security backup and recovery unit; 603b, security backup and recovery database unit; 604, audit log module; 604a, audit log unit; 604b, audit log database unit; 605, data backup module; 605a, data backup unit; 605b, data backup database unit; 606, data privacy and anonymization module; 606a, data privacy and anonymization unit; 606b, data privacy and anonymization database unit; 607, security training and awareness-raising module; 607a, security training and awareness-raising unit; 607b, security training and awareness-raising database unit;

[0083] 7. Reporting and auditing function end;

[0084] 701. Randomization report module; 701a. Randomization report unit; 701b. Randomization report database unit; 702. Group statistics report module; 702a. Group statistics report unit; 702b. Group statistics report database unit; 703. Security report module; 703a. Security report unit; 703b. Security report database unit; 704. Progress report module; 704a. Progress report unit; 704b. Progress report database unit; 705. Audit function module; 705a. Audit function unit; 705b. Audit function database unit; 706. Report archiving and version control module; 706a. Report archiving and version control unit; 706b. Report archiving and version control database unit. DETAILED DESCRIPTION

[0085] The embodiments of the present application achieve the technical effect of helping researchers and trial management teams implement and monitor the randomization process of trials by providing a clinical trial randomization system.

[0086] Example

[0087] like Figure 1-8 As shown, the overall idea of ​​the technical solution in the embodiment of the present application is as follows:

[0088] In response to the problems existing in the prior art, the present invention provides a clinical trial randomization system, comprising: a subject grouping and randomization terminal 1, a randomization method and algorithm terminal 2, a grouping strategy management terminal 3, a subject allocation and tracking terminal 4, a blinding and unblinding management terminal 5, a data security and confidentiality terminal 6, and a reporting and auditing function terminal 7, and data communication is carried out between them through a dedicated network.

[0089] Among them, the subject grouping and randomization end 1 includes a randomization method and algorithm selection module 101, a randomization sequence generation module 102, a subject grouping module 103, a grouping strategy management module 104, a blinding and unblinding management module 105, a subject allocation and tracking module 106, and a data security and confidentiality module 107.

[0090] Specifically, the randomization method and algorithm selection module 101 includes a randomization method and algorithm selection unit 101a, which is used to provide a variety of randomization methods and algorithms for selection, such as simple randomization, stratified randomization, block randomization, etc. Researchers can select an appropriate randomization method based on the design and requirements of the experiment; a randomization method and algorithm selection database unit 101b, which is used to store randomization method and algorithm selection information;

[0091] The randomization sequence generation module 102 includes a randomization sequence generation unit 102a, which is used to enable the system to generate randomization sequences that conform to the selected randomization method. These sequences can be generated and stored in advance, or generated in real time to ensure the reliability and randomness of the randomization; a randomization sequence generation database unit 102b, which is used to store randomization sequence generation information;

[0092] The subject grouping module 103 includes a subject grouping unit 103a, which is used to assign subjects to different treatment groups or experimental groups according to the generated randomization sequence. Each subject is assigned to a corresponding group according to the allocation result; a subject grouping database unit 103b, which is used to store subject grouping information;

[0093] The grouping strategy management module 104 includes a grouping strategy management unit 104a, which is used to support the management of grouping strategies for different treatment groups or experimental groups. Researchers can define and set different grouping strategies, such as grouping by gender, age, disease severity, etc., to ensure comparability and balance between groups; a grouping strategy management database unit 104b, which is used to store grouping strategy management information;

[0094] The blinding and unblinding management module 105 includes a blinding and unblinding management unit 105a, which is used to support the blinding management of the trial, including double-blind, single-blind, and open-blind. It can record the blinding status and the time point of unblinding, and provide corresponding unblinding processes and authority control to ensure the integrity of the blinding of the trial; a blinding and unblinding management database unit 105b, which is used to store blinding and unblinding management information;

[0095] The subject allocation and tracking module 106 includes a subject allocation and tracking unit 106a, which enables the system to record and track the subject grouping, including grouping results, basic subject information, and follow-up data. This helps researchers track the subject's treatment process and trial results; a subject allocation and tracking database unit 106b, which is used to store subject allocation and tracking information;

[0096] The data security and confidentiality module 107 includes a data security and confidentiality unit 107a, which is used to systematically ensure the security and confidentiality of subject grouping and randomization data to prevent information leakage and the generation of potential bias; and a data security and confidentiality database unit 107b, which is used to store data security and confidentiality information.

[0097] The randomization method and algorithm end 2 includes a simple randomization module 201, a layered randomization module 202, a block randomization module 203, a random area module 204, a dynamic randomization module 205, and a blind protection module 206.

[0098] Specifically, the simple randomization module 201 includes a simple randomization unit 201a, which is used for simple randomization, the most basic randomization method, in which subjects are randomly assigned to treatment groups or experimental groups, and each subject has an equal chance of being assigned to either group. The system can generate a randomization sequence that conforms to simple randomization and assign subjects to corresponding groups according to the sequence; a simple randomization database unit 201b, which is used to store simple randomization information;

[0099] The stratified randomization module 202 includes a stratified randomization unit 202a, which is used to divide subjects into different strata based on some important baseline characteristics or factors, such as gender, age, disease severity, etc., and then perform random assignment within each stratum. The system supports the definition and management of stratification factors and generates a randomization sequence suitable for stratified randomization; a stratified randomization database unit 202b, which is used to store stratified randomization information;

[0100] The block randomization module 203 includes a block randomization unit 203a, which is used to divide subjects into blocks according to a certain order according to pre-defined block sizes during the trial, and then randomly assign subjects within each block. This helps ensure that each treatment group or experimental group is evenly assigned within each block. The system supports the definition and management of block sizes and generates a randomization sequence suitable for block randomization; a block randomization database unit 203b, which is used to store block randomization information;

[0101] The randomization area module 204 includes a randomization area unit 204a, which is used for randomization between specific geographical areas or research centers in some trials. The system can support the definition and management of different randomization areas and ensure the randomization of subjects within each area; a randomization area database unit 204b, which is used to store randomization area information;

[0102] The dynamic randomization module 205 includes a dynamic randomization unit 205a, which is used for dynamic randomization, i.e., adjusting random allocation in real time according to the progress of the trial and the allocation of subjects. The system can dynamically generate and adjust the randomization sequence according to pre-set rules and algorithms to adapt to the actual situation of the trial; a dynamic randomization database unit 205b, which is used to store dynamic randomization information;

[0103] The blinding protection module 206 includes a blinding protection unit 206a, which is used to enable the randomization system to support trial blinding protection, including double-blind, single-blind, and open-blind. This ensures that during the randomization process, researchers and subjects cannot know or influence the grouping results in advance; and a blinding protection database unit 206b, which is used to store blinding protection information.

[0104] The grouping strategy management terminal 3 includes a grouping factor definition module 301 , a grouping strategy setting module 302 , a grouping ratio setting module 303 , a pre-allocated subject management module 304 , a randomization sequence generation module 305102 , and a grouping strategy adjustment module 306 .

[0105] Specifically, the grouping factor definition module 301 includes a grouping factor definition unit 301a, which allows researchers to define factors for grouping. These factors can be baseline characteristics or other important trial-related factors, such as gender, age, disease severity, etc. Defining grouping factors can help ensure comparability and balance between groups; a grouping factor definition database unit 301b, which is used to store grouping factor definition information;

[0106] The grouping strategy setting module 302 includes a grouping strategy setting unit 302a, which supports setting grouping strategies for different treatment or experimental groups. Researchers can define and adjust grouping strategies for different groups based on the needs of the experimental design. For example, they can set stratification based on a specific factor, set ratios, etc.; and a grouping strategy setting database unit 302b, which is used to store grouping strategy setting information.

[0107] The group ratio setting module 303 includes a group ratio setting unit 303a, which allows researchers to set the group ratios of different treatment groups or experimental groups. According to the requirements of the experimental design, the proportion of subjects in different groups can be set to ensure the rationality of sample distribution and statistical effectiveness; a group ratio setting database unit 303b, which is used to store group ratio setting information;

[0108] The pre-assigned subject management module 304 includes a pre-assigned subject management unit 304a, which supports the management of pre-assigned subjects. Pre-assignment is the process of assigning subjects to groups based on specific rules or needs before randomization. The system records and manages pre-assigned subject information and ensures that subsequent randomization complies with the pre-defined grouping strategy. A pre-assigned subject management database unit 304b is used to store pre-assigned subject management information.

[0109] The randomization sequence generation module 305 includes a randomization sequence generation unit 305a, which is used for grouping strategy management and is usually combined with randomization methods and algorithms. The system can generate corresponding randomization sequences based on the defined grouping strategy and the selected randomization method. These sequences will be used for the actual random allocation of subjects; a randomization sequence generation database unit 305b, which is used to store randomization sequence generation information;

[0110] The grouping strategy adjustment module 306 includes a grouping strategy adjustment unit 306a, which is used to adjust the grouping strategy based on actual conditions as the researcher may need during the experiment. The system should support flexible grouping strategy adjustment functions to meet the needs of the experiment and ensure the rationality and scientificity of randomization; and a grouping strategy adjustment database unit 306b, which is used to store grouping strategy adjustment information.

[0111] The subject allocation and tracking terminal 4 includes a grouping result recording module 401 , a subject basic information management module 402 , a subject follow-up data management module 403 , a grouping strategy tracking module 404 , a treatment result recording module 405 , and a data quality control module 406 .

[0112] Specifically, the grouping result recording module 401 includes a grouping result recording unit 401a, which is used to accurately record the grouping result of each subject, that is, which treatment group or experimental group they were assigned to. This includes associating subjects with corresponding groups and storing and managing this information in the system; a grouping result recording database unit 401b, which is used to store the grouping result record information;

[0113] The subject basic information management module 402 includes a subject basic information management unit 402a, which allows researchers to record and manage the subject's basic information, such as name, age, gender, and disease status. This information is helpful for subsequent data analysis and result evaluation; a subject basic information management database unit 402b, which is used to store subject basic information management information;

[0114] The subject follow-up data management module 403 includes a subject follow-up data management unit 403a, which is used to support the recording and management of subject follow-up data. This includes various observations and measurements during the treatment process, such as clinical indicators, symptom assessments, and laboratory test results. The management of follow-up data can help researchers track the subject's treatment process and trial results; a subject follow-up data management database unit 403b, which is used to store subject follow-up data management information;

[0115] The grouping strategy tracking module 404 includes a grouping strategy tracking unit 404a, which is used to enable the system to track and record the implementation of the grouping strategy, including the random assignment of subjects according to the preset grouping strategy. This can help researchers evaluate the implementation of the trial and the rationality of the grouping strategy; a grouping strategy tracking database unit 404b, which is used to store grouping strategy tracking information;

[0116] The treatment result recording module 405 includes a treatment result recording unit 405a, which is used to support the system to record the treatment results of the subject, including information such as the duration, dosage, and efficacy evaluation of the treatment. This helps to analyze and evaluate the efficacy and safety of different treatment groups or trial groups; a treatment result recording database unit 405b, which is used to store the treatment result record information;

[0117] The data quality control module 406 includes a data quality control unit 406a, which is used to provide data quality control functions for the system, including data entry verification, logic checks, and data consistency checks. This helps ensure the accuracy and completeness of subject data; and a data quality control database unit 406b, which is used to store data quality control information.

[0118] The blinding and unblinding management terminal 5 includes a blinding management module 501 , a blinding protection module 502 , an unblinding management module 503 , an unblinding committee management module 504 , and a post-unblinding data processing module 505 .

[0119] Specifically, the blind management module 501 includes a blind management unit 501a, which is used to support the definition and management of the blinding method of the trial. This includes different types of blinding methods such as double-blind, single-blind, and open-blind. Researchers can specify the blinding method of the trial in the system and adjust it as needed; a blind management database unit 501b, which is used to store blinding management information;

[0120] The blind protection module 502 includes a blind protection unit 502a, which is used to support the system in taking measures to ensure the blind protection of the trial. This may include appropriate isolation of subjects and researchers to prevent them from obtaining information about the subject grouping. The system can record and track the implementation of blind protection; a blind protection database unit 502b, which is used to store blind protection information;

[0121] The unblinding management module 503 includes an unblinding management unit 503a, which is used to manage the unblinding process of the trial. Unblinding is the process of revealing the treatment group or experimental group to which the subject belongs at the end of the trial or under specific circumstances. The system allows researchers to perform unblinding operations according to predetermined unblinding rules and record the time and reason for unblinding; an unblinding management database unit 503b, which is used to store unblinding management information;

[0122] The unblinding committee management module 504 includes an unblinding committee management unit 504a, which is used to set up an unblinding committee to make unblinding decisions for some complex trials. The system supports the management of the unblinding committee, including recording committee member information, recording and tracking unblinding decisions, etc.; the unblinding committee management database unit 504b is used to store unblinding committee management information;

[0123] The post-unblinding data processing module 505 includes a post-unblinding data processing unit 505a, which is used to process the post-unblinding data and analyze and interpret it based on the unblinding results. The system can support the processing of post-unblinding data, including subset analysis based on the unblinding results and interpretation of the impact of blinding on the test results; and a post-unblinding data processing database unit 505b, which is used to store post-unblinding data processing information.

[0124] The data security and confidentiality end 6 includes an access control module 601, a data encryption module 602, a security backup and recovery module 603, an audit log module 604, a data backup module 605, a data privacy and anonymization module 606, and a security training and awareness raising module 607.

[0125] Specifically, the access control module 601 includes an access control unit 601a, which is used to implement strict access control measures in the system to ensure that only authorized personnel can access test data. This includes using usernames and passwords for authentication, setting different levels of user permissions, and restricting access to sensitive data; an access control database unit 601b, which is used to store access control information;

[0126] The data encryption module 602 includes a data encryption unit 602a, which supports the encryption of test data to protect the security of data during transmission and storage. Encryption technology can prevent unauthorized access to sensitive data and increase the security of data transmission; a data encryption database unit 602b, which is used to store data encryption information;

[0127] The security backup and recovery module 603 includes a security backup and recovery unit 603a, which is used to regularly perform data backup and recovery. This allows for rapid recovery of test data in the event of accidental data corruption, system failure, or other emergency situations, ensuring data integrity and availability. A security backup and recovery database unit 603b is used to store security backup and recovery information.

[0128] The audit log module 604 includes an audit log unit 604a, which is used to record and store operation logs and track the access and modification history of test data. The audit log can be used to track data changes, identify potential security risks and data tampering, and provide support for audit purposes; an audit log database unit 604b, which is used to store audit log information;

[0129] The data backup module 605 includes a data backup unit 605a, which is used to support the system to regularly back up and archive test data. In this way, in the event of data loss or damage, the backup data can be used for recovery and reconstruction; a data backup database unit 605b, which is used to store data backup information;

[0130] The data privacy and anonymization module 606 includes a data privacy and anonymization unit 606a, which is used to ensure the privacy and anonymization of the test data. Sensitive information such as the subject's personal identity information and medical record number is desensitized or encrypted in the system to protect the subject's privacy; a data privacy and anonymization database unit 606b, which is used to store data privacy and anonymization information;

[0131] The security training and awareness raising module 607 includes a security training and awareness raising unit 607a, which is used to provide training and educational materials to the system to help users understand the importance of data security and confidentiality and improve users' awareness of protecting data security; and a security training and awareness raising database unit 607b, which is used to store security training and awareness raising information.

[0132] The reporting and auditing function terminal 7 includes a randomized reporting module 701 , a group statistical reporting module 702 , a security reporting module 703 , a progress reporting module 704 , an auditing function module 705 , and a report archiving and version control module 706 .

[0133] Specifically, the randomization report module 701 includes a randomization report unit 701a, which is used to generate a randomization report, including the subject grouping, randomization method, and results. These reports can be provided to the research team and regulatory agencies to ensure that the randomization process of the trial complies with regulatory and ethical requirements; a randomization report database unit 701b, which is used to store randomization report information;

[0134] The group statistical reporting module 702 includes a group statistical reporting unit 702a, which is used to enable the system to generate group statistical reports, including information such as the number of subjects, basic characteristics, treatment process and results of different treatment groups or experimental groups. These reports help researchers evaluate the differences and trends between different groups and the overall effectiveness of the trial; a group statistical report database unit 702b, which is used to store group statistical report information;

[0135] The safety reporting module 703 includes a safety reporting unit 703a, which is used to generate safety reports, including the incidence, severity, and relevance of adverse events, as well as statistical analysis results of other safety indicators. These reports are used to monitor the safety of the trial and take necessary safety measures and adjustments in a timely manner; a safety report database unit 703b, which is used to store safety report information;

[0136] The progress reporting module 704 includes a progress reporting unit 704a, which enables the system to generate trial progress reports, including recruitment status, data collection and monitoring progress, and intermediate analysis results. These reports are used to track the progress of the trial and promptly identify and resolve potential problems and challenges; a progress report database unit 704b, which is used to store progress report information;

[0137] The audit module 705 includes an audit function unit 705a, which provides system audit functionality, allowing researchers and regulatory agencies to review and examine reports and documents. This includes checking data consistency and accuracy to ensure the reliability of trial data and results; and an audit function database unit 705b, which stores audit function information.

[0138] The report archiving and version control module 706 includes a report archiving and version control unit 706a, which supports the archiving and version control of reports, ensuring the integrity and traceability of reports. This includes time stamping, storing, and backing up reports, as well as versioning reports to facilitate subsequent review and traceability; and a report archiving and version control database unit 706b, which stores report archiving and version control information.

[0139] Finally, it should be noted that the above embodiments are merely examples for the purpose of illustrating the present invention and are not intended to limit the embodiments. Those skilled in the art will readily appreciate that other variations or modifications based on the above description are possible. It is not necessary and impossible to provide an exhaustive list of all embodiments. However, obvious variations or modifications arising therefrom remain within the scope of protection of the present invention.

Claims

1. A clinical trial randomization system, characterized in that: include: Subject grouping and randomization end, including randomization method and algorithm selection module, randomization sequence generation module, subject grouping module, grouping strategy management module, blinding and unblinding management module, subject allocation and tracking module, data security and confidentiality module; Randomization methods and algorithms, including simple randomization module, stratified randomization module, block randomization module, random area module, dynamic randomization module, and blind protection module; The grouping strategy management end includes a grouping factor definition module, a grouping strategy setting module, a grouping ratio setting module, a pre-allocated subject management module, a randomized sequence generation module, and a grouping strategy adjustment module; The subject allocation and tracking end includes a grouping result recording module, a subject basic information management module, a subject follow-up data management module, a grouping strategy tracking module, a treatment result recording module, and a data quality control module; Blinding and unblinding management end, including blinding management module, blinding protection module, unblinding management module, unblinding committee management module, and post-unblinding data processing module; Data security and confidentiality, including access control module, data encryption module, secure backup and recovery module, audit log module, data backup module, data privacy and anonymization module, and security training and awareness raising module; The reporting and auditing function end includes a randomized reporting module, a group statistical reporting module, a safety reporting module, a progress reporting module, an auditing function module, a report archiving and version control module.

2. A clinical trial randomization system according to claim 1, characterized in that: The randomization method and algorithm selection module includes a randomization method and algorithm selection unit for providing a selection of multiple randomization methods and algorithms; a randomization method and algorithm selection database unit for storing randomization method and algorithm selection information; The randomization sequence generation module includes a randomization sequence generation unit, which is used to generate a randomization sequence that complies with the selected randomization method; A randomized sequence generation database unit, used for storing randomized sequence generation information; The subject grouping module includes a subject grouping unit for allocating subjects to different treatment groups or test groups according to the generated randomization sequence; a subject grouping database unit for storing subject grouping information; The grouping strategy management module includes a grouping strategy management unit for supporting the management of grouping strategies for different treatment groups or test groups; A grouping policy management database unit, used for storing grouping policy management information; The blinding and unblinding management module includes a blinding and unblinding management unit, which is used to support the blinding management of the trial, record the blinding status and the time point of unblinding, and provide corresponding unblinding process and authority control; a blinding and unblinding management database unit, which is used to store blinding and unblinding management information; The subject allocation and tracking module includes a subject allocation and tracking unit for recording and tracking the grouping of subjects; a subject allocation and tracking database unit for storing subject allocation and tracking information; The data security and confidentiality module includes a data security and confidentiality unit for ensuring the security and confidentiality of subject grouping and randomization data; and a data security and confidentiality database unit for storing data security and confidentiality information.

3. A clinical trial randomization system according to claim 1, characterized in that: The simple randomization module includes a simple randomization unit, which is used for simple randomization, which is the most basic randomization method, in which subjects are randomly assigned to treatment groups or test groups, and each subject has an equal chance of being assigned to any group. A randomization sequence that conforms to simple randomization is generated, and subjects are assigned to corresponding groups according to the sequence; A simple randomization database unit, used for storing simple randomization information; The stratified randomization module includes a stratified randomization unit, which is used to divide subjects into different strata by taking into account some important baseline characteristics or factors, such as gender, age, disease severity, etc., and then perform random allocation within each stratum, support the definition and management of stratification factors, and generate a randomization sequence suitable for stratified randomization; a stratified randomization database unit is used to store stratified randomization information; The block randomization module includes a block randomization unit, which is used for block randomization. During the trial, the subjects are divided into blocks in a certain order according to a pre-defined block size, and then random allocation is performed within each block. It supports the definition and management of block size and generates a randomization sequence suitable for block randomization; A block randomization database unit, used to store block randomization information; The random area module includes a random area unit, which is used for some trials that may require random allocation between specific geographical areas or research centers, supports the definition and management of different random areas, and ensures the random allocation of subjects in each area; a random area database unit is used to store random area information; The dynamic randomization module includes a dynamic randomization unit, which is used for dynamic randomization to adjust the random allocation in real time according to the progress of the trial and the allocation of subjects, and dynamically generate and adjust the randomization sequence according to pre-set rules and algorithms to adapt to the actual situation of the trial; a dynamic randomization database unit, which is used to store dynamic randomization information; The blind protection module includes a blind protection unit, which is used for the randomization system to support the blind protection of the trial, including double-blind, single-blind and open-blind, etc. The blind protection database unit is used to store blind protection information.

4. A clinical trial randomization system according to claim 1, characterized in that: The grouping factor definition module includes a grouping factor definition unit for allowing researchers to define factors for grouping; A grouping factor definition database unit, used for storing grouping factor definition information; The grouping strategy setting module includes a grouping strategy setting unit for supporting the setting of grouping strategies for different treatment groups or test groups; and a grouping strategy setting database unit for storing grouping strategy setting information. The group ratio setting module includes a group ratio setting unit for allowing researchers to set the group ratios of different treatment groups or test groups; A group ratio setting database unit, used for storing group ratio setting information; The pre-allocated subject management module includes a pre-allocated subject management unit, which is used to support the process of managing pre-allocated subjects, record and manage pre-allocated subject information, and ensure that their subsequent random allocation complies with the preset grouping strategy; The pre-assigned subject management database unit is used to store pre-assigned subject management information. The randomization sequence generation module includes a randomization sequence generation unit, which is used for grouping strategy management functions, usually combined with randomization methods and algorithms, to generate corresponding randomization sequences according to the defined grouping strategy and the selected randomization method, and the randomization sequence is used for actual random allocation of subjects; A randomized sequence generation database unit, used for storing randomized sequence generation information; The grouping strategy adjustment module includes a grouping strategy adjustment unit, which is used for researchers to adjust the grouping strategy according to actual conditions during the experiment; The grouping strategy adjustment database unit is used to store grouping strategy adjustment information.

5. A clinical trial randomization system according to claim 1, characterized in that: The grouping result recording module includes a grouping result recording unit for accurately recording the grouping result of each subject; A grouping result record database unit, used for storing grouping result record information; The subject basic information management module includes a subject basic information management unit for researchers to record and manage the subject's basic information; a subject basic information management database unit for storing subject basic information management information; The subject follow-up data management module includes a subject follow-up data management unit for supporting the recording and management of the subject's follow-up data; a subject follow-up data management database unit for storing subject follow-up data management information; The grouping strategy tracking module includes a grouping strategy tracking unit for tracking and recording the execution of the grouping strategy; A grouping strategy tracking database unit, used for storing grouping strategy tracking information; The treatment result recording module includes a treatment result recording unit for supporting the recording of the treatment results of the subject; A treatment result record database unit, used for storing treatment result record information; The data quality control module includes a data quality control unit for providing data quality control functions, including data entry verification, logic check and data consistency check, etc.; a data quality control database unit for storing data quality control information.

6. A clinical trial randomization system according to claim 1, characterized in that: The blind management module includes a blind management unit for supporting the definition and management of the blind method of the trial, wherein the blind method includes different types of blind methods such as double-blind, single-blind and open-blind; A blind management database unit, used for storing blind management information; The blind protection module includes a blind protection unit, which is used to support measures to ensure blind protection of the trial and record and track the implementation of blind protection; A blind protection database unit, used for storing blind protection information; The unblinding management module includes an unblinding management unit, which is used to manage the unblinding process of the test, perform unblinding operations according to predetermined unblinding rules, and record the time and reason of unblinding; An unblinding management database unit, used for storing unblinding management information; The unblinding committee management module includes an unblinding committee management unit for supporting the management of the unblinding committee for some complex trials, including recording committee member information, recording and tracking unblinding decisions, etc.; a unblinding committee management database unit for storing unblinding committee management information; The post-unblinding data processing module includes a post-unblinding data processing unit, which is used for data processing after unblinding and supports processing of data after unblinding, including performing subset analysis based on the unblinding results, explaining the impact of the blinding method on the test results, etc.; and a post-unblinding data processing database unit, which is used to store post-unblinding data processing information.

7. A clinical trial randomization system according to claim 1, characterized in that: The access control module includes an access control unit for implementing strict access control measures, which include using usernames and passwords for authentication, setting different levels of user permissions, and restricting access to sensitive data; an access control database unit, for storing access control information; The data encryption module includes a data encryption unit for supporting encryption of test data to protect the security of data during transmission and storage; a data encryption database unit for storing data encryption information; The secure backup and recovery module includes a secure backup and recovery unit for regularly backing up data and having the ability to restore data; A security backup and recovery database unit, used for storing security backup and recovery information; The audit log module includes an audit log unit for recording and storing operation logs and tracking the access and modification history of test data, wherein the audit log can be used to track data change records, identify potential security risks and data tampering, and provide support for audit purposes; an audit log database unit for storing audit log information; The data backup module includes a data backup unit for supporting regular backup and archiving of test data; a data backup database unit for storing data backup information; The data privacy and anonymization module includes a data privacy and anonymization unit for ensuring the privacy and anonymization of test data; a data privacy and anonymization database unit for storing data privacy and anonymization information; The security training and awareness-raising module includes a security training and awareness-raising unit, which is used to provide training and educational materials to help users understand the importance of data security and confidentiality and to improve users' awareness of protecting data security; and a security training and awareness-raising database unit, which is used to store security training and awareness-raising information.

8. The clinical trial randomization system according to claim 1, wherein: The randomization report module includes a randomization report unit for generating a randomization report including the subject's grouping, randomization method and results; a randomization report database unit for storing randomization report information; The group statistical reporting module includes a group statistical reporting unit for generating a group statistical report, which includes information such as the number of subjects in different treatment groups or test groups, basic characteristics, treatment process and results; A group statistics report database unit, used to store group statistics report information; The safety reporting module includes a safety reporting unit for the system to generate safety reports, including the incidence, severity and relevance of adverse events, and statistical analysis results of other safety indicators; A safety report database unit, used for storing safety report information; The progress reporting module includes a progress reporting unit for generating trial progress reports, including recruitment status, data collection and monitoring progress, intermediate analysis results, etc.; a progress report database unit for storing progress report information; The audit function module includes an audit function unit, which is used to provide audit functions, allowing researchers and regulatory agencies to audit and review reports and documents, including checking the consistency and accuracy of data to ensure the reliability of test data and results; and an audit function database unit, which is used to store audit function information.

9. A clinical trial randomization system according to claim 8, characterized in that: The report archiving and version control module includes a report archiving and version control unit for supporting report archiving and version control, including time stamping, storage and backup of reports, and version management of reports; and a report archiving and version control database unit for storing report archiving and version control information.

10. A clinical trial randomization system according to any one of claims 1 to 9, characterized in that: Data communication is carried out between the subject grouping and randomization end, the randomization method and algorithm end, the grouping strategy management end, the subject allocation and tracking end, the blinding and unblinding management end, the data security and confidentiality end, and the reporting and auditing function end through a dedicated network.

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