Clinical test data migration method and device

Abstract

The invention provides a clinical test data migration method and device, in the application, an independent verification environment is constructed, configuration adjustment and data verification are completed before formal data migration, it is ensured that migrated data conforms to business logic and does not affect the formal environment, all test operations are completed in the verification environment, and the verification efficiency is improved. The formal environment has no test trace, the logic correctness of data after migration is ensured through multiple times of verification, the system maintenance time is shortened, the clinical test continuity is ensured, and the change rationality before migration can be fully verified.

Description

Technical Field

[0001] This application relates to the field of computer technology, and more specifically, to a method and apparatus for migrating clinical trial data. Background Technology

[0002] In clinical trials, electronic data capture systems collect clinical information from subjects using case report forms. As the trial protocol changes, the CRF (Case Report Form) structure needs corresponding modifications, such as adding or deleting data fields and adjusting required fields. Existing technologies for directly migrating data to the production environment have the following drawbacks: Logical error risk: There are complex logical relationships between CRF projects, which can easily lead to data misalignment or logical conflicts after migration; Data integrity compromise: Testing in a production environment can leave audit trails, compromising the authenticity and integrity of the data. Project delay risk: Migration errors may require repeated corrections, affecting the progress of clinical trials; The lack of an effective mechanism to fully verify the rationality of configuration changes before migration makes the above problems difficult to avoid. Summary of the Invention

[0003] In view of this, embodiments of this application provide a method and apparatus for migrating clinical trial data to solve the problems of poor data migration security and insufficient verification in the prior art.

[0004] In a first aspect, embodiments of this application provide a method for migrating clinical trial data, the method comprising: Based on the first configuration of the case report form in the formal environment, construct a validation environment with the first configuration; In the formal environment, the first formal data conforming to the first configuration in the case report form is copied to the verification environment to form the first verification data; In the verification environment, the first configuration is modified to the second configuration; The first verification data is migrated in the verification environment to form second verification data that conforms to the second configuration; Verify the correctness of the second verification data; When the second verification data is correct, the first configuration in the production environment is modified to the second configuration; The first formal data is migrated in the formal environment to form second formal data that conforms to the second configuration in the formal environment.

[0005] Secondly, embodiments of this application provide a data migration device for clinical trials, the data migration device comprising: A building unit is used to build a validation environment with the first configuration based on the first configuration of the case report form in the production environment; The verification unit is configured to: copy first official data conforming to a first configuration from the case report form to the verification environment in the official environment to form first verification data; modify the first configuration to a second configuration in the verification environment; migrate the first verification data in the verification environment to form second verification data conforming to the second configuration; and verify the correctness of the second verification data. The migration unit is configured to modify the first configuration in the production environment to the second configuration when the second verification data is correct; and to migrate the first production data in the production environment to form second production data that conforms to the second configuration in the production environment.

[0006] The technical solution provided in this application includes, but is not limited to, the following beneficial effects: In this application, by constructing an independent verification environment, configuration adjustments and data verification are completed before the formal data migration, ensuring that the migrated data conforms to the business logic and does not affect the formal environment. All test operations are completed in the verification environment, leaving no test traces in the formal environment. Through multiple verifications, the logical correctness of the migrated data is ensured, system maintenance time is shortened, and the continuity of clinical trials is guaranteed. This application can fully verify the rationality of the changes before migration.

[0007] To make the above-mentioned objectives, features and advantages of this application more apparent and understandable, preferred embodiments are described below in detail with reference to the accompanying drawings. Attached Figure Description

[0008] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0009] Figure 1 A flowchart illustrating a method for migrating clinical trial data provided in this application embodiment; Figure 2 This is a schematic diagram of a clinical trial data migration device provided in an embodiment of this application. Detailed Implementation

[0010] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely represents selected embodiments of this application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0011] It should be noted in advance that the case report form in this application is an electronic form template used for standardized collection of subject information in clinical research. Its core features include: structural framework: defining the data organization format, field types, and layout rules; configuration carrier: containing the business rules and logical relationships for data collection; static template: serving as an empty container for data entry, not containing specific data content itself. For example, a CRF for a clinical trial may define the basic information to be collected from the subject, such as name, gender, and age, as well as the input specifications and verification rules for various test indicators.

[0012] Formal data refers to specific data records that are actually stored and used in a formal environment. Its core characteristics include: content entities: actual values ​​and information filled in the CRF; business value: having real clinical research value and business significance; dynamic updates: continuously accumulating and updating as clinical trials progress; examples: real records such as the age of a specific subject "Zhang San" as "45 years old" and the test indicator "blood glucose level 5.6 mmol / L".

[0013] The relationship between case report forms and formal data is as follows: CRF is the form, defining how data is recorded, while formal data is the content, reflecting what kind of data is recorded. During the data entry phase, clinicians use the CRF template → enter subject information → generate formal data. The data storage structure is: CRF configuration (structure definition) + formal data (specific content) = complete data record.

[0014] CRF-related configuration details: First configuration item: CRF form item settings (such as the number and type of fields); Second configuration item: Logical verification rules (such as verification of required fields); Third configuration option: Automatic calculation rules (such as the BMI (Body Mass Index) calculation formula); And user permission settings.

[0015] Content characteristics of formal data: Specific numerical information of the subjects; The actual measured value of the test result; Metadata such as timestamps and operation records.

[0016] Roles during the migration process: When the CRF structure needs to be changed (e.g., adding new inspection items): CRF level: Modify the first configuration item and adjust the form structure; At the formal data level: the existing data is remapped to the new structure; Validation requirement: Ensure the correctness of the data under the new CRF framework.

[0017] The connection and dependence between the two: Dependency creation: The generation of formal data depends on the structure definition of the CRF; Quality correlation: The design quality of a CRF directly affects the standardization of the final data; Change linkage: Adjustments to the CRF structure will inevitably trigger the need to migrate formal data; Value symbiosis: Only when the two are combined can the full value of clinical research be realized.

[0018] The following is a detailed description of this application.

[0019] Figure 1 A flowchart illustrating a method for migrating clinical trial data provided in this application embodiment is shown below. Figure 1 As shown, the migration method includes the following steps: Step 101: Based on the first configuration of the case report form in the formal environment, construct a validation environment with the first configuration.

[0020] Step 102: In the formal environment, copy the first formal data that conforms to the first configuration in the case report form to the verification environment to form the first verification data.

[0021] Step 103: In the verification environment, modify the first configuration to the second configuration.

[0022] Step 104: Migrate the first verification data in the verification environment to form second verification data that conforms to the second configuration.

[0023] Step 105: Verify the correctness of the second verification data.

[0024] Step 106: When the second verification data is correct, modify the first configuration in the production environment to the second configuration.

[0025] Step 107: Migrate the first formal data in the formal environment to form second formal data that conforms to the second configuration in the formal environment.

[0026] Specifically, in step S110, the validation environment and the formal environment refer to the operating environment of the electronic data acquisition system for clinical research. The validation environment is independent of the formal environment. When a clinical trial project needs to add a new test item, the validation environment is constructed by selecting the same software and hardware environment as the formal environment. This ensures that the validation environment is independent of the formal environment, and the operations performed in the validation environment will not affect the settings and data in the formal environment. Through environmental isolation, it is ensured that the testing process will not affect the formal business data.

[0027] In step S120, the first official data includes data filled in the case report form, which includes a first configuration item for determining the specific items to be filled in the case report form. A copy operation is performed using the data migration function of the clinical research electronic data acquisition system to ensure that the first validation data and the first official data are completely identical. This step enables complete data copying, providing accurate basic data for subsequent validation.

[0028] Taking the addition of "serum protein detection" to the CRF form of a clinical trial project as an example, firstly, a validation environment that is exactly the same as the production environment is constructed, existing data is copied, the addition of the new project is simulated and data migration is verified in the validation environment, and after confirming that there are no errors, the actual migration is performed in the production environment.

[0029] In this application, by constructing an independent verification environment, configuration adjustments and data verification are completed before the formal data migration, ensuring that the migrated data conforms to the business logic and does not affect the formal environment. All test operations are completed in the verification environment, leaving no test traces in the formal environment. Through multiple verifications, the logical correctness of the migrated data is ensured, system maintenance time is shortened, and the continuity of clinical trials is guaranteed. This application can fully verify the rationality of the changes before migration.

[0030] It should be noted that the second configuration is the configuration corresponding to the modified case report form.

[0031] In one feasible implementation, when the second verification data is incorrect, the second configuration is modified in the verification environment; the first verification data is migrated again in the verification environment to form new second verification data that conforms to the modified second configuration; then the correctness of the new second verification data is re-verified, and the above steps are repeated until the new second verification data is correct.

[0032] Specifically, when a data location error is found after the initial migration, the migration verification is re-executed by adjusting the data mapping rules and iterating multiple times until all data is correctly mapped. In this application, an iterative verification mechanism is used to achieve the expected results.

[0033] In one feasible implementation, the first configuration includes at least one of the following: The first configuration item used to determine the specific items to be filled in the case report form; The second configuration item corresponding to the logical check of the case report form; The third configuration item corresponds to the automatically calculated content of the case report form; User permission settings.

[0034] Specifically, the first configuration item includes the test item settings in the CRF table; the second configuration item includes the verification rules for required fields; the third configuration item includes the automatic calculation formula; and the user permission settings differentiate the access permissions for data administrators, experimenters, and subjects.

[0035] The automatic calculation formula is a pre-defined mathematical operation rule in the case report form. It can automatically calculate and generate the value of the result field based on the value of the input field. In the clinical trial data management system, the automatic calculation formula is a core technical component for the intelligent data processing of the case report form (CRF). It represents the automation capability of the clinical research electronic data acquisition system, and its core features include: Predefined rules: predefined computational logic and mathematical expressions; Automatic triggering: Calculations are automatically executed based on changes in input data; Real-time updates: The calculation results are updated in real time as the input data changes; Business relevance: Closely related to the specific business needs of clinical research.

[0036] Configuration elements: Input data definition: The source data fields on which the calculation depends; Mathematical expression: the specific calculation formula and operational logic; Output specifications: data type, precision, and units of the result fields; Verification rules: Conditions for checking the reasonableness of the calculation results.

[0037] Event-driven: Data entry events: User inputs or modifies source data fields; Calculation triggers detection: The system detects changes in the values ​​of relevant fields; Formula execution: Automatically calls preset calculation formulas for calculation; Result update: Fill the calculation result into the target field; Verification and checking: Verify the reasonableness of the calculation results.

[0038] In one feasible implementation, in order for the system to automatically check environmental compatibility, generate migration contingency plans and rollback schemes, and ensure compliance with regulatory requirements for clinical trial software, a configuration modification operation is performed in the production environment before the first configuration is changed to the second configuration in the validation environment to determine whether the configuration modification is allowed.

[0039] In a feasible implementation, in order to facilitate the management of the verification environment and the production environment, the verification environment with the first configuration needs to be set as the first version; when the first configuration in the verification environment is modified to the second configuration, the version of the verification environment is upgraded to the second version; when the second verification data is correct, the version of the production environment is directly upgraded from the first version to the second version, that is: the verification environment and the production environment are managed by version number.

[0040] For example, the initial version is V1.0. After secondary configuration and adjustment in the verification environment, it reaches version V3.0. After verification, the production environment is directly upgraded from V1.0 to V3.0, skipping intermediate versions.

[0041] In the above-described cyclical verification process, each configuration modification corresponds to an independent verification environment version, and the version number is consistent with the configuration version.

[0042] In one feasible implementation, the data migration method is applicable to a clinical research electronic data acquisition system, wherein both the formal data and the validation data are clinical trial data filled in the case report form.

[0043] In one feasible implementation, when building a verification environment with the first configuration, first select a hardware and software environment that is isolated from the production environment; then copy all configuration parameters of the production environment; finally, establish an independent data storage space, and by using independent server hardware, install the same EDC (Electronic Data Capture System) system software, copy the database structure and business rule configuration, and establish a completely isolated operating environment.

[0044] Figure 2 This is a schematic diagram of the structure of a clinical trial data migration device provided in an embodiment of this application, as shown below. Figure 2 As shown, the migration device includes: Construction unit 21 is used to construct a validation environment with the first configuration based on the first configuration of the case report form in the formal environment; Verification unit 22 is configured to: copy first formal data conforming to a first configuration from the case report form to the verification environment in the formal environment to form first verification data; modify the first configuration to a second configuration in the verification environment; migrate the first verification data in the verification environment to form second verification data conforming to the second configuration; and verify the correctness of the second verification data. Migration unit 23 is configured to modify the first configuration in the production environment to the second configuration when the second verification data is correct; and to migrate the first production data in the production environment to form second production data that conforms to the second configuration in the production environment.

[0045] In one feasible implementation, the verification unit is further configured to: If the second verification data is incorrect, modify the second configuration in the verification environment; The first verification data is migrated again in the verification environment to form new second verification data that conforms to the modified second configuration. Verify the correctness of the new second verification data; Repeat the above steps until the new second verification data is correct.

[0046] In one feasible implementation, the first configuration includes at least one of the following: The first configuration item used to determine the specific items to be filled in the case report form; The second configuration item corresponding to the logical check of the case report form; The third configuration item corresponds to the automatically calculated content of the case report form; User permission settings.

[0047] In one feasible implementation, the verification unit is further configured to: Before changing the first configuration to the second configuration in the verification environment, a configuration modification operation is performed in the production environment to determine whether the configuration modification is allowed.

[0048] In one feasible implementation, the verification unit is further configured to: Set the verification environment with the first configuration to the first version; When the first configuration is changed to the second configuration in the verification environment, the version of the verification environment is upgraded to the second version. When the second verification data is correct, the version of the production environment is directly upgraded from the first version to the second version.

[0049] In one feasible implementation, the data migration method is applicable to a clinical research electronic data acquisition system, wherein both the formal data and the validation data are clinical trial data filled in the case report form.

[0050] In one feasible implementation, the building unit, when used to build a verification environment with the first configuration, includes: Select a hardware and software environment that is isolated from the formal environment; Copy all configuration parameters of the production environment; Establish an independent data storage space.

[0051] about Figure 2 For explanations of the principles behind the relevant content, please refer to [link / reference]. Figure 1 Detailed explanations of the relevant content will not be repeated here.

[0052] In the embodiments provided in this application, it should be understood that the disclosed apparatus and methods can be implemented in other ways. The apparatus embodiments described above are merely illustrative. For example, the division of units is only a logical functional division, and in actual implementation, there may be other division methods. Furthermore, multiple units or components may be combined or integrated into another system, or some features may be ignored or not executed. Additionally, the displayed or discussed mutual couplings, direct couplings, or communication connections may be through some communication interfaces; indirect couplings or communication connections between devices or units may be electrical, mechanical, or other forms.

[0053] The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.

[0054] In addition, the functional units in the embodiments provided in this application can be integrated into one processing unit, or each unit can exist physically separately, or two or more units can be integrated into one unit.

[0055] If the aforementioned functions are implemented as software functional units and sold or used as independent products, they can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of this application, in essence, or the part that contributes to the prior art, or a portion of the technical solution, can be embodied in the form of a software product. This computer software product is stored in a storage medium and includes several instructions to cause a computer device (which may be a personal computer, server, or network device, etc.) to execute all or part of the steps of the methods described in the various embodiments of this application. The aforementioned storage medium includes various media capable of storing program code, such as USB flash drives, portable hard drives, read-only memory (ROM), random access memory (RAM), magnetic disks, or optical disks.

[0056] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures. In addition, the terms "first", "second", "third", etc. are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0057] Finally, it should be noted that the above-described embodiments are merely specific implementations of this application, used to illustrate the technical solutions of this application, and not to limit them. The protection scope of this application is not limited thereto. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that any person skilled in the art can still modify or easily conceive of changes to the technical solutions described in the foregoing embodiments, or make equivalent substitutions for some of the technical features, within the scope of the technology disclosed in this application; and these modifications, changes, or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application. All should be covered within the protection scope of this application. Therefore, the protection scope of this application should be determined by the protection scope of the claims.

Claims

1. A method for transferring clinical trial data, characterized in that, The migration method includes: Based on the first configuration of the case report form in the formal environment, construct a validation environment with the first configuration; In the formal environment, the first formal data conforming to the first configuration in the case report form is copied to the verification environment to form the first verification data; In the verification environment, the first configuration is modified to the second configuration; The first verification data is migrated in the verification environment to form second verification data that conforms to the second configuration; Verify the correctness of the second verification data; When the second verification data is correct, the first configuration in the production environment is modified to the second configuration; The first formal data is migrated in the formal environment to form second formal data that conforms to the second configuration in the formal environment.

2. The migration method as described in claim 1, characterized in that, When the second verification data is incorrect, the method further includes: Modify the second configuration in the verification environment; The first verification data is migrated again in the verification environment to form new second verification data that conforms to the modified second configuration. Verify the correctness of the new second verification data; Repeat the above steps until the new second verification data is correct.

3. The migration method as described in claim 1, characterized in that, The first configuration includes at least one of the following: The first configuration item used to determine the specific items to be filled in the case report form; The second configuration item corresponding to the logical check of the case report form; The third configuration item corresponds to the automatically calculated content of the case report form; User permission settings.

4. The migration method as described in claim 1, characterized in that, Before modifying the first configuration to the second configuration in the verification environment, the method further includes: Perform the configuration modification operation in the production environment to determine whether the configuration modification is allowed.

5. The migration method as described in claim 1, characterized in that, The method further includes: Set the verification environment with the first configuration to the first version; When the first configuration is changed to the second configuration in the verification environment, the version of the verification environment is upgraded to the second version. When the second verification data is correct, the version of the production environment is directly upgraded from the first version to the second version.

6. The migration method as described in claim 1, characterized in that, The data migration method described herein is applicable to electronic data acquisition systems for clinical research, and both the formal data and the validation data are clinical trial data filled in the case report form.

7. The migration method as described in claim 1, characterized in that, The construction of the verification environment with the first configuration includes: Select a hardware and software environment that is isolated from the formal environment; Copy all configuration parameters of the production environment; Establish an independent data storage space.

8. A device for transferring clinical trial data, characterized in that, The migration device includes: A building unit is used to build a validation environment with the first configuration based on the first configuration of the case report form in the production environment; The verification unit is configured to: copy first official data conforming to a first configuration from the case report form to the verification environment in the official environment to form first verification data; modify the first configuration to a second configuration in the verification environment; migrate the first verification data in the verification environment to form second verification data conforming to the second configuration; and verify the correctness of the second verification data. The migration unit is configured to modify the first configuration in the production environment to the second configuration when the second verification data is correct; and to migrate the first production data in the production environment to form second production data that conforms to the second configuration in the production environment.

9. The migration device as claimed in claim 8, characterized in that, The verification unit is further configured to: If the second verification data is incorrect, modify the second configuration in the verification environment; The first verification data is migrated again in the verification environment to form new second verification data that conforms to the modified second configuration. Verify the correctness of the new second verification data; Repeat the above steps until the new second verification data is correct.

10. The migration device as claimed in claim 8, characterized in that, The first configuration includes at least one of the following: The first configuration item used to determine the specific items to be filled in the case report form; The second configuration item corresponding to the logical check of the case report form; The third configuration item corresponds to the automatically calculated content of the case report form; User permission settings.

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