Clinical trial data logic verification method, device, equipment, and storage medium

Abstract

The present application provides a method and apparatus, device, and storage medium for logical verification of clinical trial data, which solves the problem that the manual verification method in the prior art is time-consuming and labor-intensive, and the accuracy cannot be guaranteed. The method includes: obtaining at least one test case entered by the user, the test case includes at least one data point and at least one expected result corresponding to the data point; generating a first subject file based on the data point of at least one test case according to the target protocol standard; running the preset verification logic based on the first subject file to generate a first test report, the first test report includes the output result and expected result corresponding to each of the at least one test case.

Description

Technical Field

[0001] The present application relates to the technical field of electronic collection systems for clinical trial data, and in particular to a method and apparatus for logical verification of clinical trial data, computer equipment, and storage media. Background Art

[0002] The Electric Data Capture (EDC) system is applicable to the core information system of drug clinical trials, medical randomized controlled trials and medical cohort studies. Its core purpose is to record the information of subjects and form electronic follow-up forms. For clinical trials, data accuracy is the basis of most analytical studies. Therefore, after the clinical trial data is entered into the EDC system, special staff are usually required to perform logical verification of the entered clinical trial data to ensure the accuracy of the entered data. This manual verification method has the following problems: First, it is time-consuming and labor-intensive; second, human errors cannot be avoided. Summary of the invention

[0003] In view of this, the embodiments of the present application provide a method and apparatus for logical verification of clinical trial data, a computer device, and a storage medium to solve the problem that the manual verification method in the prior art is time-consuming and labor-intensive and the accuracy cannot be guaranteed.

[0004] The first aspect of the present application provides a method for logical verification of clinical trial data, comprising: obtaining at least one test case entered by a user, the test case comprising at least one data point and at least one expected result corresponding to the data point; generating a first subject file based on the data points of the at least one test case according to a target protocol standard; running a preset verification logic based on the first subject file to generate a first test report, the first test report comprising the output results and expected results corresponding to each of the at least one test case.

[0005] In one embodiment, the data point includes clinical trial data and a storage structure of the clinical trial data in a database; the target protocol standard includes a template file corresponding to the storage structure. Generating a first subject file based on the data point of at least one test case according to the target protocol standard includes: determining a template file that matches the storage structure; and filling the template file with the clinical trial data to obtain the first subject file.

[0006] In one embodiment, before generating the first subject file based on the data points of at least one test case according to the target protocol standard, the method further includes: determining at least one target test case in the at least one test case based on a user's selection. Generating the first subject file based on the data points of at least one test case according to the target protocol standard includes: generating the first subject file based on the data points of at least one target test case according to the target protocol standard.

[0007] In one embodiment, it also includes: obtaining at least one update case, at least one test case including a first type of test case whose output result is inconsistent with the expected result, and a second type of test case whose output result is consistent with the expected result, and the update case is obtained by adjusting the first type of test case; generating a second subject file based on the data points of at least one update case and the second type of test case according to the target protocol standard; running a preset verification logic based on the second subject file to generate a second test report, the second test report including the output result and the expected result corresponding to each of the at least one update case and the second type of test case.

[0008] In one embodiment, it also includes: obtaining at least one update case, at least one test case includes a first type of test case whose output result is inconsistent with the expected result, and the update case is obtained by adjusting the first type of test case; generating a third subject file based on the data points of at least one update case according to the target protocol standard; running a preset verification logic based on the third subject file to generate a third test report, and the third test report includes the output result and expected result corresponding to each of the at least one update case.

[0009] In one embodiment, the target protocol standard includes any one of a Clinical Data Exchange Standards Council standard, a Clinical Data Collection Integration Model, and a Research Data Listing Model.

[0010] In one embodiment, the method further includes: when the output result does not match the expected result, highlighting the output result and / or the expected result in the test report.

[0011] The second aspect of the present application provides a clinical trial data logic verification device, including: an acquisition module, used to obtain at least one test case entered by a user, the test case including at least one data point and at least one expected result corresponding to the data point; a first generation module, used to generate a first subject file based on the data points of at least one test case according to a target protocol standard; a second generation module, used to run a preset verification logic based on the first subject file to generate a first test report, the first test report including the output results and expected results corresponding to each of the at least one test case.

[0012] The third aspect of the present application provides a computer device, including a memory, a processor, and a computer program stored in the memory and executed by the processor, characterized in that when the processor executes the computer program, the steps of the clinical trial data logic verification method provided in any of the above embodiments are implemented.

[0013] A fourth aspect of the present application provides a computer-readable storage medium having a computer program stored thereon, characterized in that when the computer program is executed by a processor, the steps of the clinical trial data logic verification method provided in any of the above embodiments are implemented.

[0014] According to the clinical trial data logic verification method and apparatus, computer equipment, and storage medium provided in this application, subject files are automatically generated for testing based on the acquired test cases according to the target protocol standard, eliminating the maintenance of test cases and manual testing time, and providing a guarantee for the accuracy of the data. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 It is a flowchart of a method for logical verification of clinical trial data provided in one embodiment of the present application.

[0016] Figure 2 It is a flowchart of the clinical trial data logic verification method provided in the second embodiment of the present application.

[0017] Figure 3 It is a flowchart of the clinical trial data logic verification method provided in the third embodiment of the present application.

[0018] Figure 4 It is a flowchart of the clinical trial data logic verification method provided in the fourth embodiment of the present application.

[0019] Figure 5 A structural block diagram of a clinical trial data logic verification device provided in one embodiment of the present application.

[0020] Figure 6 It is a structural block diagram of an electronic device provided by an exemplary embodiment of the present application. DETAILED DESCRIPTION

[0021] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0022] Application Overview

[0023] As described in the background technology, the manual logic verification method has the following problems: 1. It is time-consuming and labor-intensive; 2. It is impossible to avoid human errors. In view of this, the present application provides a method and device for logic verification of clinical trial data, a computer device, and a storage medium, which automatically generates subject files for testing based on the acquired test cases according to the target protocol standard, eliminating the maintenance of test cases and manual testing time, and providing a guarantee for the accuracy of the data.

[0024] Exemplary Methods

[0025] Figure 1 1 is a flow chart of a method for logically checking clinical trial data provided by an embodiment of the present application. This embodiment can be applied to EDC, such as Figure 1 As shown, the logic checking method 100 includes the following steps:

[0026] Step S110, obtaining at least one test case entered by the user, where the test case includes at least one data point and an expected result corresponding to the at least one data point.

[0027] Data points include the input value in the custom check logic and the storage structure of the input value in the database. The expected result refers to the result obtained after the input value passes through the mapping relationship in the custom check logic.

[0028] For example, a user enters a test case in the resource editor of the logic verification test as follows: Test case 1: Data point 1: Visit: Screening period, Form: Demographic information, Field: Age, Value: 15; Data point 2: Visit: Screening period, Form: Inclusion criteria, Field: First inclusion criterion, Value: "Yes"; Expected result: A query is generated on data point 2, and the query content is: "Age is not within the range of 18-75, please confirm." Query classification: System to center.

[0029] The custom verification logic is written based on the data verification plan formulated by the user according to the clinical trial business rules. The custom verification logic includes input values, output values, and the mapping relationship between input values ​​and output values. The input values ​​are selected from the clinical trial data of the subjects. The clinical trial data can refer to the data recorded during the clinical trial process or the Electronic Health Records (EHR). The Electronic Health Records can refer to the electronic historical records directly formed by the subjects in health-related activities with preservation value for future reference, and can include information on vital signs, medical history, diagnosis, physical examination, laboratory tests, drug treatment, etc. generated by the hospital's electronic information system.

[0030] Clinical trial data is stored in the database using electronic case report forms (eCRFs) as carriers. The electronic case report form is equivalent to the template file corresponding to the storage structure of clinical trial data. The data structure of the electronic case report form conforms to the target protocol standard, which refers to the protocol standard for submitting, collecting, exchanging and archiving clinical data formulated in the field of clinical trials. For example, the target protocol standard can be the Clinical Data Interchange Standards Consortium (CDISC) standard. CDISC is an open, non-profit organization that includes various disciplines. The association is committed to developing industry standards and providing electronic means for the acquisition, exchange, submission and archiving of clinical trial data and metadata for the development of medical and biopharmaceutical products. For another example, the target protocol standard can be the Clinical Data Acquisition Standards Harmonization (CDASH), which describes the integration of variables, implementation guidelines and best practices in the basic data acquisition domain and the text description of the CRF standard problem, and provides standard specifications. For another example, the target protocol standard can be the Study Data Tabulation Model (SDTM).

[0031] Step 120 , generating a first subject file based on at least one test case data point according to the target protocol standard.

[0032] As described above, the data point includes an input value in the custom verification logic and a storage structure of the input value in the database, wherein the input value is selected from clinical trial data. The target protocol standard includes a template file corresponding to the storage structure. In this case, after the user enters at least one test case, a template file matching the storage structure of each test case can be determined first, for example, by using a text matching algorithm; then, the template file is filled with the clinical trial data to obtain a first subject file.

[0033] Step 130 , running a preset verification logic based on the first subject file to generate a first test report, the first test report including an output result and an expected result corresponding to each of at least one test case.

[0034] In one embodiment, the logic verification method 100 further includes, after step S130, highlighting the output result and / or the expected result in the test report when the output result does not match the expected result. For example, when the output result is inconsistent with the expected result, the output result and / or the expected result is highlighted in the test report. When the output result does not match the expected result, it means that the test case needs to be adjusted, or the verification logic corresponding to the test case needs to be adjusted. In this case, by highlighting, it is convenient for the user to quickly find the test case or verification logic that needs to be adjusted.

[0035] In one embodiment, the logic checking method 100 further includes: exporting at least one test case, so as to facilitate archiving.

[0036] According to the clinical trial data logic verification method provided in this embodiment, according to the target protocol standard, the subject file is automatically generated based on the acquired test cases for testing, eliminating the maintenance of test cases and manual testing time, and providing a guarantee for the accuracy of the data.

[0037] Figure 2 2 is a flow chart of a method for logically checking clinical trial data provided by the second embodiment of the present application. Figure 2 The logic verification method 200 and Figure 1 The difference of the logic checking method 100 shown is that before step S120, it also includes:

[0038] Step S210: determining at least one target test case in at least one test case based on the user's selection.

[0039] The user may select at least one entered test case in the resource editor to select a portion of test cases from the at least one test case as target test cases.

[0040] In this case, step S120 is specifically performed as follows:

[0041] Step S220 , generating a first subject file based on data points of at least one target test case according to the target protocol standard.

[0042] Subsequently, step S130 is performed, that is, running the preset verification logic based on the first subject file to generate a first test report. In this case, the first test report includes the output result and the expected result corresponding to each of at least one target test case.

[0043] According to the clinical trial data logic verification method provided in this embodiment, a first subject file is generated based on the target test case selected by the user, and then a first test report is obtained, thereby achieving the effect of selectively executing the entered test case and having greater flexibility.

[0044] Figure 3 Schematic diagram of the process of the clinical trial data logic verification method provided by the third embodiment of the present application. Figure 3 The logic verification method 300 and Figure 1 The difference of the logic checking method 100 shown is that after step S130, it also includes:

[0045] Step S310, obtaining at least one updated case. The at least one test case includes a first type of test case whose output result is inconsistent with the expected result and a second type of test case whose output result is consistent with the expected result. The updated case is obtained by adjusting the first type of test case.

[0046] When the output result in the first test report is inconsistent with the expected result, the user can adjust the test case, for example, by rewriting the inconsistent test case in the resource editor to obtain an updated case.

[0047] Step S320 , generating a second subject file based on the data points of at least one update case and a second type of test case according to the target protocol standard.

[0048] When the user rewrites the unmatched test cases in the resource editor, the cases displayed in the resource editor include two categories, one is the update cases, and the other is the second category of test cases whose output results in the first test report match the expected results. The second subject file is generated based on these two categories of cases.

[0049] Step S330, running the preset verification logic based on the second subject file to generate a second test report, the second test report including the output result and expected result corresponding to at least one update case and the second type of test case.

[0050] According to the clinical trial data logic verification method provided in this embodiment, a second subject file is generated based on data points of at least one update case and a second type of test case, and then a second test report is obtained, thereby achieving debugging of the test case.

[0051] Figure 4 Schematic diagram of the process of the clinical trial data logic verification method provided by the fourth embodiment of the present application. Figure 4 The logic verification method 400 and Figure 1 The difference of the logic checking method 100 shown is that after step S130, it also includes:

[0052] Step S410, obtaining at least one update case, where the update case is obtained by adjusting the test case whose output result is inconsistent with the expected result.

[0053] When the output result in the first test report does not match the expected result, the user can adjust the test case, for example, by rewriting the mismatched test case in the resource editor to obtain an updated case.

[0054] Step S420 , generating a third subject file based on at least one data point of the updated case according to the target protocol standard.

[0055] When the user rewrites the unmatched test case in the resource editor, the cases displayed in the resource editor include two categories, one is the updated case, and the other is the test case whose output result in the first test report matches the expected result. The system generates the third subject file only for the updated case, that is, the user selects the updated case while entering the updated case. In other embodiments, the selection of the updated case can also be realized based on the user's selection operation. For example, before step S320, it also includes: obtaining the user's selection information for at least one updated case.

[0056] Step S430, running the preset verification logic based on the third subject file to generate a third test report, the third test report including the output result and the expected result corresponding to each of the at least one update case.

[0057] According to the clinical trial data logic verification method provided in this embodiment, a third subject file is generated based on the data points of at least one update case, and then a third test report is obtained, thereby improving the test efficiency.

[0058] Exemplary Devices

[0059] Figure 5 This is a structural block diagram of a clinical trial data logic verification device provided by an embodiment of the present application. Figure 5 As shown, the logic verification device 50 includes: an acquisition module 51, a first generation module 52 and a second generation module 53. The acquisition module 51 is used to obtain at least one test case entered by a user, and the test case includes at least one data point and an expected result corresponding to at least one data point. The first generation module 52 is used to generate a first subject file based on the data points of at least one test case according to the target protocol standard. The second generation module 53 is used to run the preset verification logic based on the first subject file to generate a first test report, and the first test report includes the output result and the expected result corresponding to each of the at least one test case.

[0060] In one embodiment, the first generating module 52 is specifically used to determine a template file that matches the storage structure; fill the template file with clinical trial data to obtain a first subject file.

[0061] In one embodiment, the logic checking device 50 further includes a determination module for determining at least one target test case in the at least one test case based on the user's selection. In this case, the first generation module 52 is specifically configured to generate a first subject file based on the data points of the at least one target test case according to the target protocol standard.

[0062] In one embodiment, the acquisition module 51 is also used to acquire at least one update case, the at least one test case includes a first type of test case whose output result is inconsistent with the expected result, and a second type of test case whose output result is consistent with the expected result, and the update case is obtained by adjusting the first type of test case. In this case, the first generation module 52 is also used to generate a second subject file based on the data points of the at least one update case and the second type of test case according to the target protocol standard. The second generation module 53 is also used to run the preset verification logic based on the second subject file to generate a second test report, and the second test report includes the output results and expected results corresponding to the at least one update case and the second type of test case.

[0063] In one embodiment, the acquisition module 51 is further used to acquire at least one update case, the at least one test case includes a first type of test case whose output result is inconsistent with the expected result, and the update case is obtained by adjusting the first type of test case. The first generation module 52 is also used to generate a third subject file based on the data points of the at least one update case according to the target protocol standard. The second generation module 53 is also used to run the preset verification logic based on the third subject file to generate a third test report, and the third test report includes the output result and the expected result corresponding to each of the at least one update case.

[0064] The clinical trial data logic verification device provided in this embodiment belongs to the same application concept as the clinical trial data logic verification method provided in the embodiment of this application, and can execute the clinical trial data logic verification method provided in any embodiment of this application, and has the corresponding functional modules and beneficial effects of executing the clinical trial data logic verification method. For technical details not fully described in this embodiment, please refer to the clinical trial data logic verification method provided in the embodiment of this application, and will not be repeated here.

[0065] Exemplary Electronic Devices

[0066] Figure 6 is a structural block diagram of an electronic device provided by an exemplary embodiment of the present application. Figure 6 As shown, the electronic device 60 includes one or more processors 61 and a memory 62 .

[0067] The processor 61 may be a central processing unit (CPU) or other forms of processing units having data processing capabilities and / or instruction execution capabilities, and may control other components in the electronic device 60 to perform desired functions.

[0068] The memory 62 may include one or more computer program products, which may include various forms of computer-readable storage media, such as volatile memory and / or non-volatile memory. Volatile memory may include, for example, random access memory (RAM) and / or cache memory (cache), etc. Non-volatile memory may include, for example, read-only memory (ROM), hard disk, flash memory, etc. One or more computer program instructions may be stored on a computer-readable storage medium, and the processor 11 may run the program instructions to implement the clinical trial data logic verification method of each embodiment of the present application described above and / or other desired functions. Various contents such as target protocol standards may also be stored in the computer-readable storage medium.

[0069] In one example, the electronic device 60 may further include: an input device 63 and an output device 64, and these components are interconnected via a bus system and / or other forms of connection mechanisms (not shown).

[0070] For example, the input device 63 may be a microphone or a microphone array for capturing input signals from a sound source. When the electronic device is a stand-alone device, the input device 63 may be a communication network connector for receiving input signals. In addition, the input device 63 may also include, for example, a keyboard, a mouse, and the like.

[0071] The output device 64 can output various information to the outside, including the determined distance information, direction information, etc. The output device 64 can include, for example, a display, a speaker, a printer, a communication network and a remote output device connected thereto, and the like.

[0072] Of course, to simplify, Figure 6 Only some of the components related to the present application in the electronic device 60 are shown, and components such as a bus, an input / output interface, etc. are omitted. In addition, according to specific application situations, the electronic device 60 may also include any other appropriate components.

[0073] Exemplary computer program products and computer-readable storage media

[0074] In addition to the above-mentioned methods and devices, an embodiment of the present application may also be a computer program product, which includes computer program instructions, which, when executed by a processor, enable the processor to execute the steps in the target protocol standard according to various embodiments of the present application described in the above-mentioned "Exemplary Method" section of this specification.

[0075] The computer program product may be written in any combination of one or more programming languages ​​to write program codes for performing the operations of the embodiments of the present application, including object-oriented programming languages ​​such as Java, C++, etc., and conventional procedural programming languages ​​such as "C" language or similar programming languages. The program code may be executed entirely on the user computing device, partially on the user device, as a separate software package, partially on the user computing device and partially on a remote computing device, or entirely on a remote computing device or server.

[0076] In addition, an embodiment of the present application may also be a computer-readable storage medium on which computer program instructions are stored. When the computer program instructions are executed by the processor, the processor 11 executes the steps in the target protocol standard according to various embodiments of the present application described in the above "Exemplary Method" section of this specification.

[0077] The computer readable storage medium can adopt any combination of one or more readable media. The readable medium can be a readable signal medium or a readable storage medium. The readable storage medium can include, for example, but is not limited to, a system, device or device of electricity, magnetism, light, electromagnetic, infrared, or semiconductor, or any combination of the above. More specific examples (non-exhaustive list) of readable storage media include: an electrical connection with one or more wires, a portable disk, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disk read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the above.

[0078] The basic principles of the present application are described above in conjunction with specific embodiments. However, it should be noted that the advantages, strengths, effects, etc. mentioned in the present application are only examples and not limitations, and it cannot be considered that these advantages, strengths, effects, etc. are required by each embodiment of the present application. In addition, the specific details disclosed above are only for the purpose of illustration and ease of understanding, not for limitation, and the above details do not limit the present application to being implemented by adopting the above specific details.

[0079] The block diagrams of the devices, apparatuses, equipment, and systems involved in this application are only illustrative examples and are not intended to require or imply that they must be connected, arranged, and configured in the manner shown in the block diagram. As will be appreciated by those skilled in the art, these devices, apparatuses, equipment, and systems can be connected, arranged, and configured in any manner. Words such as "including", "comprising", "having", etc. are open words, referring to "including but not limited to", and can be used interchangeably with them. The words "or" and "and" used here refer to the words "and / or" and can be used interchangeably with them, unless the context clearly indicates otherwise. The words "such as" used here refer to the phrase "such as but not limited to", and can be used interchangeably with them.

[0080] It should also be noted that in the apparatus, device and method of the present application, each component or each step can be decomposed and / or recombined. Such decomposition and / or recombination should be regarded as equivalent solutions of the present application.

[0081] The above description of the disclosed aspects is provided to enable any person skilled in the art to make or use the present application. Various modifications to these aspects will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other aspects without departing from the scope of the present application. Therefore, the present application is not intended to be limited to the aspects shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

[0082] It should be understood that the qualifiers "first", "second", "third", "fourth", "fifth" and "sixth" used in the description of the embodiments of the present application are only used to more clearly explain the technical solutions and cannot be used to limit the scope of protection of the present application.

[0083] The above description has been given for the purpose of illustration and description. In addition, this description is not intended to limit the embodiments of the present application to the forms disclosed herein. Although multiple example aspects and embodiments have been discussed above, those skilled in the art will recognize certain variations, modifications, changes, additions and sub-combinations thereof.

Claims

1. A method for logical verification of clinical trial data, characterized in that: include: Obtain at least one test case entered by a user, wherein the test case includes at least one data point and an expected result corresponding to the at least one data point, wherein the data point includes an input value in a custom verification logic and a storage structure of the input value in a database, wherein the expected result is a result obtained after the input value passes through a mapping relationship in the custom verification logic, and wherein the custom verification logic is written based on a data verification plan formulated by the user according to clinical trial business rules; generating a first subject file based on the data points of the at least one test case according to a target protocol standard, the target protocol standard including a template file corresponding to the storage structure; Running a preset verification logic based on the first subject file to generate a first test report, wherein the first test report includes an output result corresponding to each of the at least one test case and the expected result; When the output result does not match the expected result, the output result and / or the expected result are highlighted in the first test report so that the user can find the test case or verification logic that needs to be adjusted.

2. The clinical trial data logic verification method according to claim 1, characterized in that: The data points include clinical trial data and a storage structure of the clinical trial data in a database; generating a first subject file based on the data points of the at least one test case according to the target protocol standard includes: Determining the template file matching the storage structure; The template file is filled with the clinical trial data to obtain the first subject file.

3. The clinical trial data logic verification method according to claim 1 or 2, characterized in that: Before generating a first subject file based on the data points of the at least one test case according to the target protocol standard, the method further includes: Determine at least one target test case among the at least one test case based on the user's selection; Generating a first subject file based on the data points of the at least one test case according to the target protocol standard includes: The first subject file is generated based on the data points of the at least one target test case according to a target protocol standard.

4. The clinical trial data logic verification method according to claim 1 or 2, characterized in that: Also includes: Obtain at least one updated case, the at least one test case comprising a first type of test case in which the output result is inconsistent with the expected result, and a second type of test case in which the output result is consistent with the expected result, the updated case being obtained by adjusting the first type of test case; generating a second subject file based on the at least one update case and the data points of the second type of test cases according to the target protocol standard; A preset verification logic is run based on the second subject file to generate a second test report, wherein the second test report includes the output results and the expected results corresponding to the at least one update case and the second type of test case.

5. The clinical trial data logic verification method according to claim 1 or 2, characterized in that: Also includes: Obtaining at least one updated case, wherein the at least one test case includes a first type of test case in which the output result is inconsistent with the expected result, and the updated case is obtained by adjusting the first type of test case; generating a third subject file based on the data points of the at least one updated case according to target protocol standards; A preset verification logic is run based on the third subject file to generate a third test report, wherein the third test report includes the output result corresponding to each of the at least one update case and the expected result.

6. The clinical trial data logic verification method according to claim 1 or 2, characterized in that: The target protocol standard includes any one of the Clinical Data Exchange Standards Association standard, the Clinical Data Collection Integration Model, and the Research Data List Model.

7. A clinical trial data logic verification device, characterized in that: include: An acquisition module, used to acquire at least one test case entered by a user, wherein the test case includes at least one data point and an expected result corresponding to the at least one data point, wherein the data point includes an input value in a custom verification logic and a storage structure of the input value in a database, wherein the expected result is a result obtained after the input value passes through a mapping relationship in the custom verification logic, and wherein the custom verification logic is written based on a data verification plan formulated by the user according to clinical trial business rules; a first generating module, configured to generate a first subject file based on the data points of the at least one test case according to a target protocol standard, wherein the target protocol standard includes a template file corresponding to the storage structure; A second generating module, configured to run a preset verification logic based on the first subject file to generate a first test report, wherein the first test report includes an output result and the expected result corresponding to each of the at least one test case; When the output result does not match the expected result, the output result and / or the expected result are highlighted in the first test report so that the user can find the test case or verification logic that needs to be adjusted.

8. A computer device comprising a memory, a processor, and a computer program stored in the memory and executed by the processor, characterized in that: When the processor executes the computer program, the steps of the clinical trial data logic verification method according to any one of claims 1 to 6 are implemented.

9. A computer-readable storage medium having a computer program stored thereon, characterized in that: When the computer program is executed by a processor, the steps of the clinical trial data logic verification method according to any one of claims 1 to 6 are implemented.

Images