Multifunctional data acquisition management method and system for clinical medicine scientific research

Abstract

The invention discloses a multifunctional data acquisition management method and system for clinical medicine scientific research, and belongs to the technical field of data acquisition management. The method comprises the following steps: firstly, acquiring a JSON configuration file, and generating a test case report form interface; secondly, defining variable attributes to form variable metadata, and generating standardized variables; an invitation mechanism is adopted, invitations are sent to all clinical test participants, role permissions are matched, and a multi-party cooperation management permission mechanism is established; then, collecting input fields of all clinical test participants in real time, and generating a user test case report form; and finally, acquiring a data analysis request or a data export request sent by the user, calling a corresponding user test case report form, and generating a clinical medicine scientific research file. Through the method and the system provided by the invention, the use convenience of the data acquisition management system is improved, and the flexibility of multi-center and multi-project management is greatly improved through the establishment of a multi-party cooperation management authority mechanism.

Description

Technical Field

[0001] The present invention belongs to the technical field of clinical medical research and data acquisition management, and in particular relates to a multifunctional data acquisition management method and system for clinical medical research. Background Art

[0002] Driven by today's digitalization, computer network-based electronic data collection technology has become a key support for clinical research, especially clinical trials. Due to its significant advantages, this technology has been widely used in clinical research, bringing positive changes to improve data quality and research efficiency.

[0003] Traditional manual recording methods have many drawbacks. Not only are recording errors prone to occur, but data omissions are also common. Electronic data collection methods effectively eliminate these problems. Through standardized data entry interfaces and automatic verification mechanisms, they ensure the accuracy and completeness of data. In clinical research, data accuracy is the basis for drawing reliable conclusions. The electronic collection system reduces errors caused by human factors at the source, greatly improving the reliability of research data. At the same time, it also saves a lot of manpower costs. In the past, researchers needed to spend a lot of time on organizing, checking, and entering paper records. Now, electronic systems can automatically complete some data processing work, allowing researchers to devote more energy to core links such as research design and data analysis.

[0004] However, despite the numerous advantages offered by electronic data collection systems, existing systems still suffer from several deficiencies in practical application that hinder the needs of clinical researchers. First, the cumbersome and complex system usage has become a prominent issue. For each new project, researchers must build everything from scratch, including designing data collection forms, setting data fields, and defining data validation rules. This process increases researchers' workload and reduces efficiency.

[0005] Secondly, the existing system lacks flexibility in supporting multi-center, multi-project management. In multi-center clinical trials, different research centers may need to share some data while ensuring the independence and security of their respective data. However, the current system often requires separate configuration for each project, making it impossible to achieve unified management and flexible deployment of multi-center data. This makes data exchange between research centers difficult and increases the difficulty of data integration and analysis. In addition, as the number of research projects increases, the system struggles to efficiently manage the progress, data quality, and personnel permissions of multiple projects, significantly impacting the research process.

[0006] As mentioned above, how to provide a multifunctional data collection and management method and system for clinical medical research that can improve ease of use and increase flexibility in multi-center and multi-project management has become an urgent problem to be solved. Summary of the Invention

[0007] The purpose of the present invention is to provide a multifunctional data acquisition and management method for clinical medical research to solve the above-mentioned problems existing in the prior art.

[0008] In order to achieve the above object, the present invention adopts the following technical solutions:

[0009] In a first aspect, the present invention provides a multifunctional data collection and management method for clinical medical research, comprising:

[0010] Obtaining a JSON configuration file, and defining a test case report table structure according to the JSON configuration file, so as to generate a test case report table interface based on the test case report table structure;

[0011] For each variable in the test case report form interface, variable attributes are defined to form variable metadata, and standardized variables are generated based on the variable metadata;

[0012] Adopt an invitation mechanism to send invitations to each clinical trial participant and assign corresponding role permissions to each clinical trial participant to establish a multi-party collaborative management authority mechanism;

[0013] Based on the multi-party collaborative management authority mechanism, interact with the clinical trial participants through the trial case report form interface, collect input fields of each clinical trial participant in real time, and standardize the input fields of the clinical trial participants through the standardized variables to generate a user trial case report form;

[0014] Obtain a data analysis request or a data export request sent by a user, retrieve a corresponding user trial case report form according to the data analysis request or the data export request, and generate a clinical medical research file according to the user trial case report form.

[0015] In one possible design, a JSON configuration file is obtained, and a trial case report table structure is defined according to the JSON configuration file, including:

[0016] Obtain historical trial case report form records, and train a JSON configuration file update model using the historical trial case report form records as input and a JSON configuration file as output;

[0017] Update the JSON configuration file through the JSON configuration file update model to obtain a JSON configuration file, wherein the JSON configuration file includes a form title, field name, field type, required attributes, and validation rules;

[0018] Defining the test case report table structure through the JSON configuration file;

[0019] Accordingly, based on the trial case report form structure, an interactive trial case report form interface is generated, which includes:

[0020] Based on the test case report table structure, the JSON configuration file is read and a form configuration instruction is generated, so as to match the corresponding component configuration according to the form configuration instruction and generate a form component;

[0021] The form component is parsed, and based on the parsed form component, each variable in the test case report table structure is cyclically rendered to generate a test case report table interface for user interaction.

[0022] In one possible design, variable attributes are defined for each variable in the trial case report form interface to form variable metadata. Based on the variable metadata, standardized variables are generated, including:

[0023] For each variable in the test case report form interface, variable attributes are defined respectively, wherein the variable attributes include variable name, variable label, value range, mandatory, variable description and variable example value;

[0024] Extracting variable attributes from each variable and using the variable attributes of each variable as variable metadata;

[0025] Creating a standardized data dictionary file based on the variable metadata to specify the variable standard of each variable, wherein the variable standard includes a standard name, data type, value range, precision, and description;

[0026] Bind each variable in the test case report form interface to the standardized data dictionary to form standardized variables.

[0027] In one possible design, an invitation mechanism is used to send invitations to each clinical trial participant and assign corresponding role permissions to each clinical trial participant to establish a multi-party collaborative management authority mechanism, including:

[0028] Obtain clinical trial project information, and establish a clinical trial participant role table and a trial invitation table based on the clinical trial project information;

[0029] Based on the trial invitation form, an invitation mechanism is used to send an invitation link to each clinical trial participant, wherein the invitation link includes an introduction to the clinical trial project, the name of the trial participant role, and the expiration date of the invitation;

[0030] Based on the clinical trial participant role table, corresponding role permissions are matched for each clinical trial participant who accepts the invitation link, wherein the role permissions include researcher permissions, coordinator permissions, and subject permissions;

[0031] A multi-party collaborative management authority mechanism is established based on the role permissions of each clinical trial participant.

[0032] In one possible design, a data analysis request or a data export request sent by a user is obtained, and a corresponding user trial case report form is retrieved according to the data analysis request or the data export request, and a clinical medical research file is generated according to the user trial case report form, including:

[0033] Collecting data analysis parameters or data export parameters input by the clinical trial participants, and storing the data analysis parameters or the data export parameters;

[0034] Retrieve the corresponding user trial case report form based on the acquired data analysis request or data export request;

[0035] Extracting the stored data analysis parameters or the data export parameters, generating a user test case data report according to the data analysis parameters, or constructing an exported user test case data structure according to the data export parameters;

[0036] Obtaining a data analysis result based on the user test case data report, or obtaining a data export file based on the user test case data structure;

[0037] The data analysis results or the data export file are sent to a visualization interface to form a visualization presentation file, and the visualization presentation file is used as a clinical medical research file.

[0038] In a possible design, before interacting with the clinical trial participants through the trial case report form interface based on the multi-party collaborative management authority mechanism, the following is further included:

[0039] Construct an open data interface to support external data access to the trial case report form interface;

[0040] Defining the data structure, data type and constraints of the open data interface, and verifying the legitimacy of external data based on the data structure, data type and constraints of the open data interface;

[0041] Based on the open authorization and authentication mechanism, external identity and role permission verification is performed on requests for external data access.

[0042] In a possible design, after generating the user trial case report form, it also includes:

[0043] Encrypting the user trial case report form using a symmetric encryption algorithm, and storing the encrypted user trial case report form;

[0044] Accordingly, according to the data analysis request or the data export request, the corresponding user trial case report form is retrieved, and a clinical medical research file is generated according to the user trial case report form, which includes:

[0045] A symmetric encryption algorithm is used to decrypt the encrypted user trial case report form, and a clinical medical research file is generated based on the decrypted user trial case report form.

[0046] In a second aspect, the present invention provides a multifunctional data acquisition and management system for clinical medical research, comprising:

[0047] An interface configuration unit, configured to obtain a JSON configuration file, and define a test case report table structure according to the JSON configuration file, so as to generate a test case report table interface based on the test case report table structure;

[0048] A variable standardization unit is used to define variable attributes for each variable in the test case report form interface to form variable metadata, and generate standardized variables based on the variable metadata;

[0049] The authority allocation unit is used to use the invitation mechanism to send invitations to each clinical trial participant and assign corresponding role permissions to each clinical trial participant to establish a multi-party collaborative management authority mechanism;

[0050] a report form generating unit, configured to interact with the clinical trial participants through the trial case report form interface based on the multi-party collaborative management authority mechanism, collect input fields of each clinical trial participant in real time, and standardize the input fields of the clinical trial participants through the standardized variables to generate a user trial case report form;

[0051] The scientific research file generation unit is used to obtain the data analysis request or data export request sent by the user, to retrieve the corresponding user trial case report form according to the data analysis request or the data export request, and to generate a clinical medical research file according to the user trial case report form.

[0052] In a third aspect, the present invention provides an electronic device comprising a memory, a processor and a transceiver communicatively connected in sequence, wherein the memory is used to store computer programs, the transceiver is used to send and receive messages, and the processor is used to read the computer program and execute the multifunctional data acquisition and management method for clinical medical research as described in the first aspect or any possible design of the first aspect.

[0053] In a fourth aspect, the present invention provides a computer-readable storage medium having instructions stored thereon. When the instructions are executed on a computer, the multifunctional data acquisition and management method for clinical medical research described in the first aspect or any possible design of the first aspect is executed.

[0054] In a fifth aspect, the present invention provides a computer program product comprising instructions, which, when executed on a computer, causes the computer to execute the multifunctional data acquisition and management method for clinical medical research as described in the first aspect or any possible design of the first aspect.

[0055] Beneficial effects: The present invention provides a multifunctional data acquisition management method and system for clinical medical research, which includes: obtaining a JSON configuration file, and defining a test case report form structure according to the JSON configuration file, so as to generate a test case report form interface based on the test case report form structure; defining variable attributes for each variable in the test case report form interface to form variable metadata, and generating standardized variables based on the variable metadata; using an invitation mechanism to send invitations to each clinical trial participant, and respectively providing corresponding matching role permissions for each clinical trial participant to establish a multi-party collaborative management authority mechanism; based on the multi-party collaborative management authority mechanism, interacting with the clinical trial participant through the test case report form interface, collecting the input fields of each clinical trial participant in real time, and standardizing the input fields of the clinical trial participant through the standardized variables to generate a user test case report form; obtaining a data analysis request or a data export request sent by the user, so as to retrieve the corresponding user test case report form according to the data analysis request or the data export request, and generating a clinical medical research file based on the user test case report form. The multifunctional data acquisition management method and system provided by the present invention provide comprehensive trial management functions, simplify the tedious and complicated process of clinical medical trials, improve the convenience of trial participants in using the data acquisition management system, and through the establishment of a multi-party collaborative management authority mechanism, greatly improve the flexibility of multi-center and multi-project management during interaction. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] Figure 1A flowchart of a multifunctional data acquisition and management method for clinical medical research provided by an embodiment of the present invention;

[0057] Figure 2 A schematic diagram of the functional structure of a multifunctional data acquisition and management system for clinical medical research provided by an embodiment of the present invention;

[0058] Figure 3 A schematic structural diagram of an electronic device provided by an embodiment of the present invention. DETAILED DESCRIPTION

[0059] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the present invention will be briefly introduced below in conjunction with the drawings and the description of the embodiments or the prior art. Obviously, the following description of the structure of the drawings is only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative work. It should be noted that the description of these embodiments is used to help understand the present invention, but does not constitute a limitation of the present invention.

[0060] It should be understood that although the terms "first," "second," etc. may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. For example, a first element can be referred to as a second element, and similarly, a second element can be referred to as a first element without departing from the scope of the exemplary embodiments of the present invention.

[0061] It should be understood that the term "and / or" that may appear in this document is merely a description of the association relationship between associated objects, indicating that three relationships may exist. For example, A and / or B may indicate three situations: A exists alone, B exists alone, and A and B exist at the same time. The term " / and" that may appear in this document describes another type of association object relationship, indicating that two relationships may exist. For example, A / and B may indicate two situations: A exists alone, and A and B exist alone. In addition, the character " / " that may appear in this document generally indicates that the previous and subsequent associated objects are in an "or" relationship.

[0062] Example:

[0063] like Figure 1 As shown, this embodiment provides a multifunctional data acquisition and management method for clinical medical research, which may include but is not limited to the following steps:

[0064] S1. Obtain a JSON configuration file, and define a test case report table structure according to the JSON configuration file, so as to generate a test case report table interface based on the test case report table structure;

[0065] In a possible implementation, in step S1, a JSON configuration file is obtained, and a test case report table structure is defined according to the JSON configuration file, which may be decomposed into, but not limited to, the following steps S11-S15, including:

[0066] S11. Obtain historical test case report form records, and use the historical test case report form records as input and the JSON configuration file as output to train a JSON configuration file update model;

[0067] S12. Update the JSON configuration file model by updating the JSON configuration file to obtain a JSON configuration file, wherein the JSON configuration file includes a form title, field name, field type, required attributes, and validation rules;

[0068] S13. Define the test case report table structure through the JSON configuration file;

[0069] Accordingly, based on the trial case report form structure, an interactive trial case report form interface is generated, which can be decomposed into, but not limited to, the following steps S14-S15, including:

[0070] S14. Based on the test case report table structure, read the JSON configuration file and generate a form configuration instruction, so as to match the corresponding component configuration according to the form configuration instruction and generate a form component;

[0071] S15. Parse the form component, and based on the parsed form component, loop-render each variable in the trial case report table structure to generate a trial case report table interface for user interaction.

[0072] It should be noted that when the structure of the trial case report form (CRF form) is dynamically defined through a JSON configuration file, a JavaScript parser can be optionally used to read the JSON configuration file. According to the form configuration instructions, the corresponding component configuration can be matched. Then, according to the variable type, the component configuration of the corresponding front-end component library (ElementPlus) can be matched to generate a renderable form component; and the dynamic rendering of the parsed form component can be based on the Vue.js framework, and all variables can be rendered in a loop through the v-for instruction to finally generate a trial case report form interface for user interaction; and, during the interaction, the trial case report form data submitted by the user can also be stored in the database in JSON format, and an association relationship between the form record and the clinical trial project can be established to ensure information management of the trial participants.

[0073] S2. For each variable in the test case report form interface, define the variable attributes to form variable metadata, and generate standardized variables based on the variable metadata;

[0074] In one possible implementation, in step S2, variable attributes are defined for each variable in the trial case report form interface to form variable metadata. Based on the variable metadata, standardized variables are generated, which can be decomposed into, but not limited to, the following steps S21-S24, including:

[0075] S21. For each variable in the trial case report form interface, define the variable attributes, wherein the variable attributes include variable name, variable label, value range, required field, variable description and variable example value;

[0076] S22 extracts variable attributes from the various variables, and uses the variable attributes of each variable as variable metadata;

[0077] S23. Create a standardized data dictionary file based on the variable metadata to specify the variable standards for each variable, wherein the variable standards include a standard name, data type, value range, precision, and description;

[0078] S24. Bind each variable in the trial case report form interface to the standardized data dictionary to form standardized variables.

[0079] It should be noted that in the process of constructing the trial case report form, the fields (variables) entered by the user are bound to the variables in the standardized data dictionary file. Through the back-end system, the field type and value range can be verified in real time to ensure data standardization.

[0080] S3. Use an invitation mechanism to send invitations to each clinical trial participant and assign corresponding role permissions to each clinical trial participant to establish a multi-party collaborative management authority mechanism;

[0081] In one possible implementation, in step S3, an invitation mechanism is used to send invitations to each clinical trial participant, and corresponding role permissions are assigned to each clinical trial participant to establish a multi-party collaborative management authority mechanism. This mechanism may be decomposed into, but is not limited to, the following steps S31-S34, including:

[0082] S31. Obtain clinical trial project information and establish a clinical trial participant role table and trial invitation table based on the clinical trial project information;

[0083] S32. Based on the trial invitation form, an invitation mechanism is used to send an invitation link to each clinical trial participant, wherein the invitation link includes a description of the clinical trial project, the name of the trial participant role, and the expiration date of the invitation;

[0084] S33. Based on the clinical trial participant role table, matching corresponding role permissions for each clinical trial participant who accepts the invitation link, wherein the role permissions include researcher permissions, coordinator permissions, and subject permissions;

[0085] S34. Establish a multi-party collaborative management authority mechanism based on the role permissions of each clinical trial participant.

[0086] It should be noted that a clinical trial role table and an invitation table are established, and the tables can be linked through foreign key constraints. An invitation mechanism is used to manage clinical trial participants. Users send an invitation link containing the project ID, role ID, and expiration time, and can record the invitation status (pending, accepted, rejected) and response time. According to the specific role permissions, their operating permissions in the system (researcher permissions, coordinator permissions, and subject permissions) are dynamically allocated. Taking subject permissions as an example, subject permissions can include but are not limited to form editing permissions, data viewing permissions, and data export permissions.

[0087] S4. Based on the multi-party collaborative management authority mechanism, interact with the clinical trial participants through the trial case report form interface, collect input fields from each clinical trial participant in real time, and standardize the input fields of the clinical trial participants using the standardized variables to generate a user trial case report form;

[0088] S5. Obtain a data analysis request or a data export request sent by the user, retrieve a corresponding user trial case report form according to the data analysis request or the data export request, and generate a clinical medical research file according to the user trial case report form.

[0089] In one possible implementation, in step S5, a data analysis request or a data export request sent by a user is obtained, a corresponding user trial case report form is retrieved according to the data analysis request or the data export request, and a clinical medical research file is generated according to the user trial case report form. This may be decomposed into, but not limited to, the following steps S51-S55, including:

[0090] S51. Collecting data analysis parameters or data export parameters input by the clinical trial participants, and storing the data analysis parameters or the data export parameters;

[0091] S52. Based on the acquired data analysis request or data export request, retrieve the corresponding user trial case report form;

[0092] S53. Extract the stored data analysis parameters or the data export parameters, generate a user test case data report based on the data analysis parameters, or construct an export user test case data structure based on the data export parameters;

[0093] S54. Obtaining data analysis results based on the user test case data report, or obtaining a data export file based on the user test case data structure;

[0094] S55. Send the data analysis result or the data export file to a visualization interface to form a visualization display file, and use the visualization display file as a clinical medical research file.

[0095] It should be noted that in the operation permissions corresponding to certain roles, users can set data analysis parameters or data export parameters in the user trial case report form (CRF form) and store the parameters in the database; after obtaining the data analysis request or data export request issued by the trial participants, the corresponding user trial case report form record is extracted from the database (and where possible, variable metadata can also be obtained to update the trial case report form); data reports are dynamically generated according to the analysis parameters, or the export data structure is constructed according to the export parameters, and finally an export file in CSV or Excel format is generated; the analysis results or export files are displayed through a visual interface, and a download function is provided.

[0096] In a possible implementation, before interacting with the clinical trial participants through the trial case report form interface based on the multi-party collaborative management authority mechanism, the method further includes:

[0097] Construct an open data interface to support external data access to the trial case report form interface;

[0098] Defining the data structure, data type and constraints of the open data interface, and verifying the legitimacy of external data based on the data structure, data type and constraints of the open data interface;

[0099] Based on the open authorization and authentication mechanism, external identity and role permission verification is performed on requests for external data access.

[0100] It should be noted that the data interface is built based on the RESTful API style (Representational State Transfer, a Web service architecture style based on the HTTP protocol) to support data docking with external systems (such as hospital HIS systems); the structure of the interface data uses JSON Schema to define the data structure, data type and constraints of the open data interface, and the legitimacy of the input data is ensured through Schema verification; OAuth (open authorization, an authorization framework) and Token (token, the core credential in OAuth, used to verify client identity and authority) authentication mechanisms are integrated to authenticate API requests and control permissions; in addition, a circuit breaker mechanism (using the Hystrix framework) needs to be deployed to automatically interrupt the request and return a preset error response when the interface response times out or the error rate exceeds the preset threshold.

[0101] In a possible implementation, after generating the user trial case report form, the method further includes:

[0102] Encrypting the user trial case report form using a symmetric encryption algorithm, and storing the encrypted user trial case report form;

[0103] Accordingly, according to the data analysis request or the data export request, the corresponding user trial case report form is retrieved, and a clinical medical research file is generated according to the user trial case report form, which includes:

[0104] A symmetric encryption algorithm is used to decrypt the encrypted user trial case report form, and a clinical medical research file is generated based on the decrypted user trial case report form.

[0105] It should be noted that the DES symmetric encryption algorithm is used to encrypt the user trial case report form. In a possible implementation method, the encryption key generation and encryption / decryption operations can be implemented through the javax.crypto package (the core package for encryption operations in the Java platform), and the encrypted data can be transmitted through the HTTPS protocol to ensure the security of the data transmission process.

[0106] like Figure 2 As shown, the second aspect of this embodiment provides a hardware system for implementing the multifunctional data acquisition and management method for clinical medical research described in the first aspect of the embodiment, including:

[0107] An interface configuration unit, configured to obtain a JSON configuration file, and define a test case report table structure according to the JSON configuration file, so as to generate a test case report table interface based on the test case report table structure;

[0108] A variable standardization unit is used to define variable attributes for each variable in the test case report form interface to form variable metadata, and generate standardized variables based on the variable metadata;

[0109] The authority allocation unit is used to use the invitation mechanism to send invitations to each clinical trial participant and assign corresponding role permissions to each clinical trial participant to establish a multi-party collaborative management authority mechanism;

[0110] a report form generating unit, configured to interact with the clinical trial participants through the trial case report form interface based on the multi-party collaborative management authority mechanism, collect input fields of each clinical trial participant in real time, and standardize the input fields of the clinical trial participants through the standardized variables to generate a user trial case report form;

[0111] The scientific research file generation unit is used to obtain the data analysis request or data export request sent by the user, to retrieve the corresponding user trial case report form according to the data analysis request or the data export request, and to generate a clinical medical research file according to the user trial case report form.

[0112] The working process, working details and technical effects of the system provided in this embodiment can be found in the first aspect of the embodiment and will not be described in detail here.

[0113] like Figure 3 As shown, the third aspect of this embodiment provides an electronic device, comprising: a memory, a processor and a transceiver that are communicatively connected in sequence, wherein the memory is used to store computer programs, the transceiver is used to send and receive messages, and the processor is used to read computer programs and execute the multifunctional data acquisition and management method for clinical medical research as described in the first aspect of the embodiment.

[0114] For example, the memory may include, but is not limited to, random access memory (RAM), read-only memory (ROM), flash memory, first-in first-out memory (FIFO), and / or first-in last-out memory (FILO); specifically, the processor may include one or more processing cores, such as a quad-core processor, an octa-core processor, etc. The processor may be implemented in at least one hardware form selected from DSP (Digital Signal Processing), FPGA (Field-Programmable Gate Array), and PLA (Programmable Logic Array). Furthermore, the processor may include a main processor and a coprocessor. The main processor is a processor for processing data in an awake state, also known as a CPU (Central Processing Unit); and the coprocessor is a low-power processor for processing data in a standby state.

[0115] In some embodiments, the processor may be integrated with a GPU (Graphics Processing Unit), which is responsible for rendering and drawing the content to be displayed on the display screen. For example, the processor may be, but is not limited to, a microprocessor of the STM32F105 series, a reduced instruction set computer (RISC) microprocessor, an X86 architecture processor, or a processor with an integrated embedded neural network processing unit (NPU); the transceiver may be, but is not limited to, a wireless fidelity (WIFI) wireless transceiver, a Bluetooth wireless transceiver, a general packet radio service technology (GPRS) wireless transceiver, a ZigBee protocol (a low-power local area network protocol based on the IEEE802.15.4 standard, ZigBee) wireless transceiver, a 3G transceiver, a 4G transceiver, and / or a 5G transceiver. In addition, the device may also include, but is not limited to, a power module, a display screen, and other necessary components.

[0116] The working process, working details and technical effects of the electronic device provided in this embodiment can be found in the first aspect of the embodiment and will not be described in detail here.

[0117] The fourth aspect of this embodiment provides a storage medium that stores instructions for the multifunctional data acquisition and management method for clinical medical research described in the first aspect of the embodiment, that is, the storage medium stores instructions, and when the instructions are run on a computer, the multifunctional data acquisition and management method for clinical medical research described in the first aspect of the embodiment is executed.

[0118] The storage medium refers to a carrier for storing data, which may include but is not limited to a floppy disk, an optical disk, a hard disk, a flash memory, a USB flash drive and / or a memory stick, and the computer may be a general-purpose computer, a special-purpose computer, a computer network, or other programmable device.

[0119] The working process, working details and technical effects of the storage medium provided in this embodiment can be found in the first aspect of the embodiment and will not be described in detail here.

[0120] The fifth aspect of this embodiment provides a computer program product containing instructions, which, when executed on a computer, enables the computer to execute the multifunctional data acquisition and management method for clinical medical research as described in the first aspect of the embodiment, wherein the computer may be a general-purpose computer, a special-purpose computer, a computer network, or other programmable device.

[0121] Finally, it should be noted that the above description is only a preferred embodiment of the present invention and is not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention shall be included in the scope of protection of the present invention.

Claims

1. A multifunctional data acquisition and management method for clinical medical research, characterized in that: include: Obtaining a JSON configuration file, and defining a test case report table structure according to the JSON configuration file, so as to generate a test case report table interface based on the test case report table structure; For each variable in the test case report form interface, variable attributes are defined to form variable metadata, and standardized variables are generated based on the variable metadata; Adopt an invitation mechanism to send invitations to each clinical trial participant and assign corresponding role permissions to each clinical trial participant to establish a multi-party collaborative management authority mechanism; Based on the multi-party collaborative management authority mechanism, interact with the clinical trial participants through the trial case report form interface, collect input fields of each clinical trial participant in real time, and standardize the input fields of the clinical trial participants through the standardized variables to generate a user trial case report form; Obtain a data analysis request or a data export request sent by a user, retrieve a corresponding user trial case report form according to the data analysis request or the data export request, and generate a clinical medical research file according to the user trial case report form.

2. The multifunctional data acquisition and management method for clinical medical research according to claim 1, characterized in that: Obtain a JSON configuration file and define the test case report table structure according to the JSON configuration file, including: Obtain historical trial case report form records, and train a JSON configuration file update model using the historical trial case report form records as input and a JSON configuration file as output; Update the JSON configuration file through the JSON configuration file update model to obtain a JSON configuration file, wherein the JSON configuration file includes a form title, field name, field type, required attributes, and validation rules; Defining the test case report table structure through the JSON configuration file; Accordingly, based on the trial case report form structure, an interactive trial case report form interface is generated, which includes: Based on the test case report table structure, the JSON configuration file is read and a form configuration instruction is generated, so as to match the corresponding component configuration according to the form configuration instruction and generate a form component; The form component is parsed, and based on the parsed form component, each variable in the test case report table structure is cyclically rendered to generate a test case report table interface for user interaction.

3. The multifunctional data acquisition and management method for clinical medical research according to claim 1, characterized in that: For each variable in the trial case report form interface, variable attributes are defined to form variable metadata. Based on the variable metadata, standardized variables are generated, including: For each variable in the test case report form interface, variable attributes are defined respectively, wherein the variable attributes include variable name, variable label, value range, mandatory, variable description and variable example value; Extracting variable attributes from each variable and using the variable attributes of each variable as variable metadata; Creating a standardized data dictionary file based on the variable metadata to specify the variable standard of each variable, wherein the variable standard includes a standard name, data type, value range, precision, and description; Bind each variable in the test case report form interface to the standardized data dictionary to form standardized variables.

4. The multifunctional data acquisition and management method for clinical medical research according to claim 1, characterized in that: Adopt an invitation mechanism to send invitations to each clinical trial participant and assign corresponding role permissions to each clinical trial participant to establish a multi-party collaborative management authority mechanism, including: Obtain clinical trial project information, and establish a clinical trial participant role table and a trial invitation table based on the clinical trial project information; Based on the trial invitation form, an invitation mechanism is used to send an invitation link to each clinical trial participant, wherein the invitation link includes an introduction to the clinical trial project, the name of the trial participant role, and the expiration date of the invitation; Based on the clinical trial participant role table, corresponding role permissions are matched for each clinical trial participant who accepts the invitation link, wherein the role permissions include researcher permissions, coordinator permissions, and subject permissions; A multi-party collaborative management authority mechanism is established based on the role permissions of each clinical trial participant.

5. The multifunctional data acquisition and management method for clinical medical research according to claim 1, characterized in that: Obtaining a data analysis request or a data export request sent by a user, retrieving a corresponding user trial case report form according to the data analysis request or the data export request, and generating a clinical medical research file according to the user trial case report form, including: Collecting data analysis parameters or data export parameters input by the clinical trial participants, and storing the data analysis parameters or the data export parameters; Retrieve the corresponding user trial case report form based on the acquired data analysis request or data export request; Extracting the stored data analysis parameters or the data export parameters, generating a user test case data report according to the data analysis parameters, or constructing an exported user test case data structure according to the data export parameters; Obtaining a data analysis result based on the user test case data report, or obtaining a data export file based on the user test case data structure; The data analysis results or the data export file are sent to a visualization interface to form a visualization presentation file, and the visualization presentation file is used as a clinical medical research file.

6. The multifunctional data acquisition and management method for clinical medical research according to claim 1, characterized in that: Before interacting with the clinical trial participants through the trial case report form interface based on the multi-party collaborative management authority mechanism, the method further includes: Constructing an open data interface to support external data access to the trial case report form interface; Defining the data structure, data type and constraints of the open data interface, and verifying the legitimacy of external data based on the data structure, data type and constraints of the open data interface; Based on the open authorization and authentication mechanism, external identity and role permission verification is performed on requests for external data access.

7. The multifunctional data acquisition and management method for clinical medical research according to claim 1, characterized in that: After generating the user trial case report form, it also includes: Encrypting the user trial case report form using a symmetric encryption algorithm, and storing the encrypted user trial case report form; Accordingly, according to the data analysis request or the data export request, the corresponding user trial case report form is retrieved, and a clinical medical research file is generated according to the user trial case report form, which includes: A symmetric encryption algorithm is used to decrypt the encrypted user trial case report form, and a clinical medical research file is generated based on the decrypted user trial case report form.

8. A multifunctional data acquisition and management system for clinical medical research, characterized in that: include: An interface configuration unit, configured to obtain a JSON configuration file, and define a test case report table structure according to the JSON configuration file, so as to generate a test case report table interface based on the test case report table structure; A variable standardization unit is used to define variable attributes for each variable in the test case report form interface to form variable metadata, and generate standardized variables based on the variable metadata; The authority allocation unit is used to use the invitation mechanism to send invitations to each clinical trial participant and assign corresponding role permissions to each clinical trial participant to establish a multi-party collaborative management authority mechanism; a report form generating unit, configured to interact with the clinical trial participants through the trial case report form interface based on the multi-party collaborative management authority mechanism, collect input fields of each clinical trial participant in real time, and standardize the input fields of the clinical trial participants through the standardized variables to generate a user trial case report form; The scientific research file generation unit is used to obtain the data analysis request or data export request sent by the user, to retrieve the corresponding user trial case report form according to the data analysis request or the data export request, and to generate a clinical medical research file according to the user trial case report form.

9. An electronic device, characterized in that: It includes a memory, a processor and a transceiver that are communicatively connected in sequence, wherein the memory is used to store computer programs, the transceiver is used to send and receive messages, and the processor is used to read the computer program and execute the multifunctional data acquisition and management method for clinical medical research as described in any one of claims 1 to 7.

10. A computer program product comprising a computer program or instructions, characterized in that When executed by a computer, the computer program or the instruction implements the multifunctional data acquisition and management method for clinical medical research according to any one of claims 1 to 7.

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