Blind bottom file automatic generation and blind state maintenance method and system for drug clinical blind test, and storage medium

Abstract

The invention discloses a method for automatically generating a blind bottom file and keeping a blind state of a drug clinical blind test, which comprises the following steps of: selecting a specific random algorithm, configuring a self-defined parameter, generating a logic condition containing an SAS (Serial Attached SCSI) algorithm code structure, assembling according to the logic condition, and automatically generating an SAS code. Generating an executable SAS random algorithm file by calling the SAS algorithm macro file, transmitting the SAS random algorithm file to a random algorithm server, and calling SAS software to execute the SAS random algorithm file to generate a blind bottom file; the random algorithm server pushes information generated by the blind bottom file to the WEB system server, and the WEB system server receives the blind bottom file and audits the blind bottom file on the WEB system server; after the blind bottom file passes the audit, an encryption key is added to the blind bottom file, the encryption key cannot be stored in a database in the WEB system server, and blind state maintenance is achieved. The problems of tedious process and low efficiency caused by dependence on manual design and uploading of blind bottom files in the prior art are solved.

Description

Technical Field

[0001] The present invention relates to the technical field of drug treatment scheme analysis, and in particular to a method, system and storage medium for automatically generating and maintaining a blind bottom file for a blind clinical trial of a drug. Background Art

[0002] Blinding, also known as blinding, refers to keeping the subjects and / or researchers (sponsors and their entrusted institutions, clinical trial institutions, other relevant institutions, etc.) unaware of the treatment group information in drug clinical trials. It is an important measure to control trial bias. If blinding is not set during the clinical trial, the trial-related personnel know the treatment group information, which may intentionally or unintentionally produce psychological differences, leading to bias in the trial results. For example, researchers may tend to select subjects for inclusion, subjects may have different reactions other than the treatment effect depending on the inclusion situation, and evaluators may have subjective biases when evaluating effectiveness and safety. The impact of this bias on the trial results is extremely difficult to assess. Therefore, for randomized clinical trials, blinding is often combined with random grouping and acts on the entire process of the trial to avoid possible trial bias caused by "knowing the random grouping information."

[0003] Common blinding measures include allocation concealment, treatment simulation, drug coding, blinding of study participants, blinded data review and independent evaluation.

[0004] Existing blinding measures have problems of low efficiency and high risk of leakage. For example, the patent with publication number CN113889218A discloses a traditional method of generating random tables, which still relies on manually uploading blind files. This process is not only cumbersome and inefficient, but also fails to integrate modern technical means for automatically generating blind files online. The disadvantage of this technical solution is that it lacks an automated process, which limits work efficiency. In addition, its review process is simplified, ignoring the necessary links of participation by quality control (QC) specialists, and failing to implement comprehensive quality control before the blind files are officially uploaded, increasing the possibility of data errors and security risks. The patent with publication number CN105262582A focuses on the strategy of protecting the security of blind information in the case of emergency unblinding of blind files. Although it has certain value for information confidentiality in specific emergency situations, its application scenario does not overlap with the core process of the present invention, namely the automatic generation and blind maintenance of blind files, and the responsibility tracing mechanism of the system. This technical document does not cover the responsibility definition and tracing mechanism from the initial stage of blind file generation to the subsequent possible leakage events, which is a significant gap in ensuring the rigor and compliance of clinical trials.

[0005] In summary, the existing technologies in the blind management of drug clinical trials are either limited by the inefficiency of manual operations and potential safety hazards, or focus on specific emergency treatments rather than a systematic responsibility management framework. Therefore, it is necessary to provide a method and system for automatically generating blind documents and maintaining blind status in blind trials of drug clinical trials to solve the above problems. Summary of the invention

[0006] In view of the problems existing in the prior art, the present invention provides a method for automatically generating a blind bottom file and maintaining a blind state for a blind clinical trial of a drug, comprising the following steps:

[0007] S10: Select a specific random algorithm, configure custom parameters, and generate logical conditions containing the SAS algorithm code structure;

[0008] S20: Assembling according to the logic conditions, automatically generating SAS code, and generating an executable SAS random algorithm file by calling the SAS algorithm macro file;

[0009] S30: transmitting the SAS random algorithm file to the random algorithm server, calling SAS software to execute the SAS random algorithm file to generate a blind background file;

[0010] S40: the random algorithm server pushes the information generated by the blind background file to the WEB system server, the WEB system server receives the blind background file, and verifies the blind background file on the WEB system server;

[0011] S50: After the blind base file is reviewed and approved, an encryption key is added to the blind base file. The encryption key cannot be stored in the database in the WEB system server to achieve blind maintenance.

[0012] Furthermore, the random algorithm includes at least one of stratified block randomization, block randomization and dynamic randomization.

[0013] Furthermore, the custom parameters include a first custom parameter, the first custom parameter includes a subject ID alias and a subject random ID alias, the configuration custom parameters are to set the subject ID alias and the subject random ID alias, and the subject ID alias can correspond to multiple subject random ID aliases.

[0014] Furthermore, the custom parameters also include a second custom parameter, the second custom parameter maps a corresponding SAS algorithm code, the second custom parameter includes at least one of queue randomization, secondary randomization and drug sampling, the configuration of the custom parameter is to select at least one of queue randomization, secondary randomization and drug sampling, and the logical condition for generating a SAS algorithm code structure is to automatically select the corresponding SAS algorithm code and map the variables in the corresponding SAS algorithm code to at least one of the first custom parameters.

[0015] Furthermore, the custom parameters also include a third custom parameter, the third custom parameter includes at least one of a random list name, a random ID digit number, a block size setting, a random seed number, and a center number, and the configuration custom parameter is to configure the third custom parameter to generate a random list, and the blind background file includes the random list.

[0016] Furthermore, the step S20 specifically includes: assembling according to the logical conditions, replacing the variables in the SAS algorithm code, assembling to generate a complete SAS code, calling the SAS algorithm macro file in the random algorithm server, and generating an executable SAS random algorithm file.

[0017] Furthermore, the SAS algorithm macro file is written after encapsulating the algorithm model, and the SAS algorithm macro file is stored in a fixed directory of the random algorithm server for calling only.

[0018] Furthermore, step S41 is also included between step S40 and step S50: calling the audit logic condition table to identify and judge the blind file, and generating an audit record, wherein the audit record includes auditor information, audit date, operation record and audit opinion.

[0019] Another object of the present invention is to provide a system for automatically generating and maintaining a blind document for a blind clinical trial of a drug, the system comprising a memory, a processor, and a program for automatically generating and maintaining a blind document for a blind clinical trial of a drug, the program being stored in the memory and executable on the processor, the program for automatically generating and maintaining a blind document for a blind clinical trial of a drug being configured to implement the steps of a method for automatically generating and maintaining a blind document for a blind clinical trial of a drug as described in any one of claims 1 to 8.

[0020] Another object of the present invention is to provide a storage medium, on which is stored a program for automatically generating and maintaining a blinded file for a blinded clinical trial of a drug, wherein the program for automatically generating and maintaining a blinded file for a blinded clinical trial of a drug is configured to implement the steps of a method for automatically generating and maintaining a blinded file for a blinded clinical trial of a drug as described in any one of claims 1 to 8.

[0021] Compared with the prior art, the method, system and storage medium for automatically generating and maintaining blind documents for blind clinical trials of drugs provided by the present invention have the following advantages: First, in view of the gaps in the prior art in terms of blind information security maintenance and responsibility definition, the present invention constructs a full-chain responsibility tracing system from blind document generation to possible leakage events, strengthens systematic responsibility management, ensures that each step of the clinical trial operation can be traced, enhances transparency and compliance, and maintains the fairness and scientificity of the trial; secondly, in view of the cumbersome process and inefficiency caused by manual uploading of blind documents in the prior art, the present invention completely eliminates the need for manual intervention by introducing advanced automated blind document generation methods and systems, significantly improves the efficiency and accuracy of blind document creation, reduces human errors, and reduces operating costs; thirdly, the present invention has a strict review mechanism to ensure that each blind document is strictly reviewed before formal use, effectively prevents data errors and security loopholes, enhances the reliability and data integrity of clinical trials, and makes up for the defect of the prior art in the lack of strict quality control process before blind document generation. Finally, considering the increased demand for remote work and efficient management during special periods such as the epidemic, the present invention improves adaptability and flexibility to ensure efficient and safe blind management under any circumstances, thereby promoting the smooth progress of drug clinical trials. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the embodiments of the present application. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0023] Figure 1 It is a schematic diagram of the method steps of the present invention;

[0024] Figure 2 It is a schematic diagram of a custom parameter configuration of the present invention;

[0025] Figure 3 is a schematic diagram of another custom parameter configuration of the present invention;

[0026] Figure 4 It is a schematic diagram of another custom parameter configuration of the present invention;

[0027] Figure 5 is a schematic diagram of the execution flow of step S20 of the present invention;

[0028] Figure 6 is a schematic diagram of the execution flow of step S30 of the present invention;

[0029] Figure 7 is a schematic diagram of the audit process of step S40 of the present invention;

[0030] Figure 8 It is a schematic diagram of the audit record of step S41 of the present invention. DETAILED DESCRIPTION

[0031] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0032] The present invention provides a method for automatically generating a blind bottom file and maintaining a blind state for a blind clinical trial of a drug, the steps of which include:

[0033] S10: Select a specific random algorithm, configure custom parameters, and generate logical conditions containing the SAS algorithm code structure;

[0034] Specifically, a random method in the current clinical trial industry is selected. In some embodiments, the random method includes stratified block randomization, block randomization, and dynamic randomization. Generally, a clinical trial project is only configured with one random method, so each random method is independent. It should be understood that stratified block randomization and block randomization are different random methods, and their random results are different. If a new random method needs to be added, it is only necessary to transfer the content of the module related to the random method to the server to add the new random method.

[0035] After selecting the random method, configure the custom parameters. The configuration here can be to select parameters. Specifically, the custom parameters are a kind of advanced setting options, which include three sub-options of queue random, secondary random and drug sample retention. At least one of these three sub-options can be selected, and multiple sub-options can also be selected at the same time, and different sub-options can be selected or combined. The corresponding SAS code structure that can be automatically generated in the random algorithm server. For example, select the queue random, the SAS code of the structure automatically generated later is A, select the secondary random, the SAS code of the structure automatically generated later is B, and select the queue random and secondary random at the same time, then the SAS code of the structure automatically produced later is D. Because the random method of the present invention is realized by SAS algorithm code, SAS algorithm codes are stored one by one in the WEB system server, which can be regarded as template code. After selecting the algorithm, the parameters are configured, the variables in the template code are replaced and assembled, and then the entire SAS algorithm code is sent to the random algorithm server, and then the SAS algorithm code is executed to generate the corresponding blind bottom file. Therefore, the custom parameter is actually the SAS algorithm code corresponding to the mapping, and the configuration of the custom parameter is to select the corresponding SAS algorithm code template. Here, the queue random, secondary random and drug sample retention are defined as the second custom parameter.

[0036] In some embodiments, the custom parameters also include a first custom parameter, and the first custom parameter includes parameters such as subject ID alias setting, subject random ID alias setting, random function design, and subject ID setting. The subject ID alias setting is configured, and the alias is to allow users to use the system more conveniently and efficiently. When the same parameter "subject ID" of the project is inconsistent with the name designed for different projects, the alias configuration can be used to support the association and identification of the same parameters of all projects. The subject ID alias setting includes subjects, subject numbers, screening numbers, random numbers, drug numbers and other settings, and any one of them is selected to achieve association and identification of the same parameters of all projects. The configuration of the random function design is to control the screening period stage, re-screening function, skip visit function, early termination function, and replacement subject function of the subject in the system. The above functions can be selected to trigger at the same time, that is, when multiple function designs are selected, the subject can use the function or trigger the stage. Configure the subject ID settings. The subject ID is a unique code shared by the subjects. The subject code format requirements for different projects may also be different. The subject ID settings can support the length format, input rules, whether special characters are required, special character settings, and whether the center number prefix setting is required for the subject unique code of the defined project to meet the differences in the design of different projects, so that it can be used in the personalized configuration of the system. It should be noted here that the "subject ID alias" refers to a unique identifier assigned to the subject. The subject ID alias is the same in different projects and is the unique identifier of the subject. The "subject random ID alias" is the ID alias assigned to the subject during the randomization process. The subject random ID alias can also be called "random number", "subject random number", etc. in different projects, which can be different, thus maintaining randomness. The "subject ID alias" and "subject random ID alias" have a mapping relationship, and the same "subject ID alias" can have different "subject random ID aliases". By setting an alias, when the same subject participates in different clinical projects and different projects have different names for the random numbers of the same identifier, the alias can be used to customize the display in the project; when user information needs to be migrated from one system to another, the alias can be used as a universal identifier across systems, improving the accuracy of the file.

[0037] After selecting the randomization algorithm and configuring the above-mentioned advanced settings such as cohort randomization, secondary randomization and drug retention sampling, the system will generate logical conditions containing the SAS algorithm code structure. Different configurations can map different logical conditions of the SAS algorithm code structure.

[0038] S20: Assembling according to the logic conditions, automatically generating SAS code, and generating an executable SAS random algorithm file by calling the SAS algorithm macro file;

[0039] Specifically, after the project is configured with custom parameters in step S10, specifically after selecting a specific random algorithm, according to the needs, one of the three of queue randomization, secondary randomization and drug retention is selected, and the Java code program automatically selects the corresponding SAS algorithm code, and replaces the variables in the custom syntax in the SAS algorithm code, and assembles and generates a complete SAS code. At the same time, the SAS algorithm macro file that has been written before in the random algorithm server is called to generate a final executable SAS random algorithm file. It should be understood that the variables here are at least one of the aforementioned subject ID alias, subject random ID alias, random function, subject ID, and the random list name, random ID digits, block size, random seed number, center number and other parameters described later.

[0040] It needs to be further explained here that the SAS algorithm macro file is written after the algorithm model is encapsulated. In this application, the SAS algorithm macro file is fixed and can be called by the assembled SAS random algorithm file. The SAS random algorithm file is stored in the WEB system server, and the SAS algorithm macro file is stored in the fixed directory of the random algorithm server for the SAS random algorithm file to call. The SAS random algorithm file is equivalent to a template file. In this template file, the corresponding template syntax is customized using the #(xxxxxx? ?) method, including for loops, block, if else, etc., which can realize the role of flexible assembly of the corresponding SAS algorithm code, thereby generating a complete SAS code, and the corresponding SAS algorithm code calls the corresponding SAS algorithm macro file, and the final executable SAS random algorithm file is generated by the complete SAS code and the SAS algorithm macro file. It needs to be explained here that the aforementioned #(xxxxxx? ?) method is a customized method to avoid conflicts with other keywords, and xxxxxx is a variable name.

[0041] In addition, the inventor would like to further explain that the custom parameters also include a third custom parameter, and the third custom parameter includes at least one of the random list name, the number of random ID digits, the block size setting, the number of random seeds, and the center number. Configuring custom parameters can also include selecting or entering the contents of "random list name", "random ID digits", "block size setting", "random seed number", "center number", etc., so as to generate a random list. Further explanation, the above has explained the random method and advanced settings such as stratified block randomization, block randomization, dynamic randomization, cohort randomization, secondary randomization and drug retention samples, representing the random method and specific scheme adopted for the subjects, and the random list is used to disrupt the order of the subjects and the order of the drugs used. Neither the subjects nor the doctors know who uses what drug. The random method and specific scheme are to disrupt this order in a fair way. The blind bottom file can reveal which subject is using the test drug, which subject is using the placebo, and which subject is using the control drug.

[0042] Specifically, the "Random List Name" is the table name of the random table, that is, the name of the generated blind file. The "Random ID Digit Number" indicates the number of digits of the sequence number in the random number. For example, if the number of digits is filled in as 3, the sequence number is generated from 001, and then 002, 003, 004... and so on. In some embodiments, the custom parameters may also include a "Random ID Starting Number", that is, the starting number of the sequence number in the random number. For example, if the number is filled in as 100, the sequence number is generated from 100, and then 101, 102, 103... and so on. In some embodiments, the custom parameters may also include a "Random ID Prefix", that is, the prefix of the random number. If a prefix is ​​not required, it does not need to be filled in. The prefix of the random number can be uppercase and lowercase letters, numbers, and dashes. "Block size setting" is used to indicate the number of numbers generated in a block, so "Block size setting" includes block size and number of blocks. For example, if the block size is 4, then the numbers in a block are generated from 1 to 4, that is, 1, 2, 3, 4. Each number corresponds to a random number, so there are 4 random numbers in a block. The number of blocks is the number of blocks contained in the random table, and the number of blocks determines the number of random numbers. The more random numbers there are, the larger the number of blocks needs to be configured. For example, if the number of blocks is 4, then the number of blocks in the random table is 1 block, 2 blocks, 3 blocks, and 4 blocks. Combined with the "block size" filled in previously, each block has 4 random numbers, and there are 4 blocks in total, which adds up to 16 random numbers. "Number of random seeds" is a positive integer, preferably an 8-digit positive integer, which can avoid the situation of inferring the blind bottom of project B after unblinding project A, because a pharmaceutical factory may have multiple projects using this method, avoiding the same random seed, the same number of patients, and the same random results. Therefore, it is necessary to reduce collisions as much as possible. An 8-bit random seed can avoid duplication and eliminate this situation with a small probability. The random seed will be saved in the SQL database and SAS code of the WEB system server. In some embodiments, the custom parameters may also include a selection of "whether to scramble the random numbers". The random numbers in the random table in this application are generated in sequence by default. When "No" is selected, they are still generated in sequence, such as A01, A02, A03; when "Yes" is selected, the order will be disrupted and generated in an irregular order, such as A01, A13, A08.

[0043] S30: Transmit the SAS random algorithm file to the random algorithm server, and call SAS software to execute the SAS random algorithm file to generate a blind background file.

[0044] Specifically, when step S20 is executed and the SAS random algorithm file is generated, the WEB system server pushes the SAS random algorithm file to the random algorithm server, and the random algorithm server receives the SAS random algorithm file and saves it to the directory to be executed. In some embodiments, the random algorithm server also includes a task queue database, and the random algorithm server saves the SAS random algorithm file to the directory to be executed, and saves the SAS random algorithm file to be executed as a task to be executed in the task queue database, waiting for the execution of the task. The random algorithm server also includes a task detection program, which can detect whether there is a task to be executed in the task queue database at regular intervals. If there is a task to be executed, and the SAS software is in an idle state, the SAS software is called to execute the corresponding SAS random algorithm file. If the SAS software is in a running state, the next task is executed after the SAS software is completed. It should be understood that when the random algorithm server does not include a task queue database, the random algorithm server can perform multiple tasks simultaneously, or it can be sequentially executed according to the received SAS random algorithm file sequence, which is not limited here. After the SAS software calls the SAS random algorithm file to execute, the blind bottom file of the generated result will be output to the completed directory. And synchronously set the tasks in the task queue database to completed status.

[0045] S40: The random algorithm server pushes the information generated by the blind background file to the WEB system server, and the WEB system server receives the blind background file and verifies the blind background file on the WEB system server.

[0046] Specifically, when the corresponding task in the task queue database is set to the completed state in step S30, the random algorithm server will push the message of execution completion to the interface of the WEB system server, informing the WEB system server that the blind bottom file has been generated and please receive it. After the WEB system server receives the blind bottom file, the random algorithm server will automatically delete the blind bottom file and repeat the execution cycle process of waiting for the next SAS random algorithm file.

[0047] After the blind document is pushed to the WEB system server, the project manager will review the blind document. The advantage of online review through the WEB system server is that it is controlled by unique permissions. Without authorization, only the project manager can see it. The review process can be that after the blind document is generated, the blind document in the pending review state on the WEB system server is reviewed. When the review is passed, the blind document will be officially released; when the review fails, that is, the review is rejected, it will trigger a re-review or the blind document will be invalidated. If the review is passed, the document will be released. If there is an error in the blind document, the document will be invalidated.

[0048] More specifically, the audit process includes an "Audit Logic Condition Table", which is used to record the audit conditions of each link in the audit process, including whether the randomization scheme content settings are met, whether the block and block size meet the requirements, whether the random number format meets the requirements, whether the output results meet the randomization scheme requirements, whether there is no error information in the program log, whether other reasons cause the random table to not meet the requirements, etc. Therefore, step 41 can also be included after step 40. Step 41 is that when the blind file is audited, the "Audit Logic Condition Table" will be called for the auditor to identify and judge the blind file. When there are non-conforming items, the audit will be rejected. The audit result will generate an "Audit Result Table", which records the final result of the audit process, including the following fields: audit result number, audit process number, audit result name, audit result value, etc.

[0049] The audit process also includes the "Audit Record Form" and the "Auditor Form". The Audit Record Form is used to record the specific information of each audit, including the following fields: audit record number, auditor, audit time, audit results, audit opinions, etc. The Auditor Form is used to record the information of all personnel involved in the audit, including the following fields: personnel number, personnel name, personnel role, contact information, etc.

[0050] S50: After the blind base file is reviewed and approved, an encryption key is added to the blind base file. The encryption key cannot be stored in the database in the WEB system server to achieve blind maintenance.

[0051] After the blind file passes the review, the project manager sets an encryption key for the blind file. After entering the encryption key, the system will automatically compress and encrypt the blind file. The encryption key will not be saved in the database of the WEB system server, so only the project manager who added it knows it. When project participants view the blind file, they need to be authorized by the project manager before they can view the corresponding blind file, which greatly protects the privacy of the blind file and maintains the blind state of the blind file. Because the blind file can be downloaded, and the encryption key is only known to the project manager, if the blind file is downloaded and opened by others and leaked, the only source of the leak is the project manager, so the leakage of the blind file is uniquely traceable.

[0052] The present invention also provides a system for automatically generating blind background files and maintaining a blind state for a blind clinical trial of a drug, which includes a memory and a processor. A computer program is stored on the memory. When the computer program is executed by the processor, the steps of the aforementioned method for automatically generating blind background files and maintaining a blind state for a blind clinical trial of a drug are implemented.

[0053] The present invention also provides a storage medium, in which a computer program is stored, wherein the computer program is a program for automatically generating and maintaining a blind bottom file for a blind clinical trial of a drug, and is configured to execute the steps of the method for automatically generating and maintaining a blind bottom file for a blind clinical trial of a drug when running. The storage medium may include, for example, a floppy disk, an optical disk, a DVD, a hard disk, a flash memory, a U disk, a CF card, an SD card, an MMC card, a SM card, a memory stick, an XD card, and the like.

[0054] As a computer software product, the above-mentioned automatic generation of blind files and blind state maintenance program for blind clinical trials of drugs is stored in a storage medium, including a number of instructions for enabling one or more computer devices (which may be personal computer devices, servers or other network devices, etc.) to execute all or part of the steps of the method of the present invention.

[0055] The specific implementation of the present invention described above does not constitute a limitation on the protection scope of the present invention. Any other corresponding changes and modifications made based on the technical concept of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. A method for automatically generating and maintaining a blind document for a blind clinical trial of a drug, characterized in that: The steps include: S10: Select a specific random algorithm, configure custom parameters, and generate logical conditions containing the SAS algorithm code structure; S20: Assembling according to the logic conditions, automatically generating SAS code, and generating an executable SAS random algorithm file by calling the SAS algorithm macro file; S30: transmitting the SAS random algorithm file to the random algorithm server, calling SAS software to execute the SAS random algorithm file to generate a blind background file; S40: the random algorithm server pushes the information generated by the blind background file to the WEB system server, the WEB system server receives the blind background file, and verifies the blind background file on the WEB system server; S50: After the blind base file is reviewed and approved, an encryption key is added to the blind base file. The encryption key cannot be stored in the database in the WEB system server to achieve blind maintenance.

2. The method for automatically generating and maintaining blind background files according to claim 1, characterized in that: The random algorithm includes at least one of stratified block randomization, block randomization and dynamic randomization.

3. The method for automatically generating and maintaining blind background files according to claim 1, characterized in that: The custom parameters include a first custom parameter, which includes a subject ID alias and a subject random ID alias. The configuration of the custom parameters is to set the subject ID alias and the subject random ID alias. The subject ID alias can correspond to multiple subject random ID aliases.

4. The method for automatically generating and maintaining blind background files according to claim 3, characterized in that: The custom parameters also include a second custom parameter, the second custom parameter maps a corresponding SAS algorithm code, the second custom parameter includes at least one of queue randomization, secondary randomization and drug sampling, the configuration of the custom parameter is to select at least one of queue randomization, secondary randomization and drug sampling, and the logical condition for generating a structure containing a SAS algorithm code is to automatically select the corresponding SAS algorithm code and map the variables in the corresponding SAS algorithm code to at least one of the first custom parameters.

5. The method for automatically generating and maintaining blind background files according to claim 1, characterized in that: The custom parameters also include a third custom parameter, and the third custom parameter includes at least one of a random list name, a number of random ID digits, a block size setting, a random seed number, and a center number. The configuration custom parameter is to configure the third custom parameter to generate a random list, and the blind file includes the random list.

6. The method for automatically generating and maintaining blind background files according to claim 4, characterized in that: The step S20 specifically includes: assembling according to the logical conditions, replacing the variables in the SAS algorithm code, assembling to generate a complete SAS code, calling the SAS algorithm macro file in the random algorithm server, and generating an executable SAS random algorithm file.

7. The method for automatically generating and maintaining blind background files according to claim 6, characterized in that: The SAS algorithm macro file is written after encapsulating the algorithm model. The SAS algorithm macro file is stored in a fixed directory of the random algorithm server and is only used for calling.

8. The method for automatically generating and maintaining blind background files according to claim 1, characterized in that: The step S41 is also included between step S40 and step S50: calling the audit logic condition table to identify and judge the blind document, and generating an audit record, wherein the audit record includes the auditor information, audit date, operation record and audit opinion.

9. A system for automatically generating blind documents and maintaining blind status for blind clinical trials of drugs, characterized in that: The system includes a memory, a processor, and a program for automatically generating and maintaining a blinded document for a blinded clinical trial of a drug, which is stored in the memory and can be run on the processor. The program for automatically generating and maintaining a blinded document for a blinded clinical trial of a drug is configured to implement the steps of a method for automatically generating and maintaining a blinded document for a blinded clinical trial of a drug as described in any one of claims 1 to 8.

10. A storage medium, characterized in that: The storage medium stores a program for automatically generating and maintaining a blind background file for a blind clinical trial of a drug, and the program for automatically generating and maintaining a blind background file for a blind clinical trial of a drug is configured to implement the steps of a method for automatically generating and maintaining a blind background file for a blind clinical trial of a drug as described in any one of claims 1 to 8.

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