CN114005498B - Clinical trial data logic verification method, device, equipment, and storage medium - Google Patents
Clinical trial data logic verification method, device, equipment, and storage medium Download PDFInfo
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- CN114005498B CN114005498B CN202111266128.9A CN202111266128A CN114005498B CN 114005498 B CN114005498 B CN 114005498B CN 202111266128 A CN202111266128 A CN 202111266128A CN 114005498 B CN114005498 B CN 114005498B
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Abstract
本申请提供了一种临床试验数据逻辑核查方法和装置、设备、存储介质，解决了现有技术中人工核查方法耗时费力、准确度得不到保障的问题。其中，方法包括：获取用户录入的至少一条测试案例，测试案例包括至少一个数据点和至少一个数据点对应的期望结果；根据目标协议标准基于至少一条测试案例的数据点生成第一受试者文件；基于第一受试者文件运行预置核查逻辑，以生成第一测试报告，第一测试报告包括至少一条测试案例各自对应的输出结果和期望结果。
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
The application relates to the technical field of clinical test data electronic acquisition systems, in particular to a clinical test data logic checking method and device, computer equipment and a storage medium.
Background
The clinical trial data electronic acquisition (ELECTRIC DATA Capture, EDC) system is suitable for a core informatization system for clinical trials of medicines, medical randomized controlled trials and medical queue studies, and has the core purpose of recording information of a subject to form an electronic follow-up form. For clinical trials, data accuracy is the basis of most analytical studies. Therefore, after the clinical trial data is entered into the EDC system, a special staff is typically required to perform a logical check on the entered clinical trial data to ensure the accuracy of the entered data. The manual checking mode has the following problems of time consuming, labor consuming and unavoidable human error.
Disclosure of Invention
In view of the above, the embodiment of the application provides a clinical test data logic checking method and device, computer equipment and storage medium, so as to solve the problems that the manual checking method in the prior art is time-consuming and labor-consuming and the accuracy cannot be guaranteed.
The first aspect of the application provides a clinical test data logic checking method, which comprises the steps of obtaining at least one test case recorded by a user, wherein the test case comprises at least one data point and an expected result corresponding to the at least one data point, generating a first subject file based on the data point of the at least one test case according to a target protocol standard, and running preset checking logic based on the first subject file to generate a first test report, wherein the first test report comprises an output result and an expected result corresponding to each of the at least one test case.
In one embodiment, the data points comprise clinical trial data and a storage structure of the clinical trial data in a database, and the target protocol criteria comprise a template file corresponding to the storage structure. Generating a first subject file based on data points of at least one test case according to the target protocol criteria includes determining a template file matching the stored structure and populating the template file with clinical trial data to obtain the first subject file.
In one embodiment, prior to generating the first subject file based on the data points of the at least one test case according to the target protocol criteria, further comprising determining at least one of the at least one test case based on the user's selections. Generating the first subject file based on the data points of the at least one test case according to the target protocol criteria includes generating the first subject file based on the data points of the at least one target test case according to the target protocol criteria.
In one embodiment, the method further comprises the steps of obtaining at least one updating case, wherein the at least one testing case comprises a first type of testing case with inconsistent output results and expected results, and a second type of testing case with consistent output results and expected results, the updating case is obtained by adjusting the first type of testing case, generating a second subject file based on data points of the at least one updating case and the second type of testing case according to target protocol standards, and running preset checking logic based on the second subject file to generate a second testing report, and the second testing report comprises output results and expected results corresponding to the at least one updating case and the second type of testing case respectively.
In one embodiment, the method further comprises the steps of obtaining at least one updating case, wherein the at least one testing case comprises a first type of testing case with inconsistent output results and expected results, the updating case is obtained by adjusting the first type of testing case, generating a third subject file based on data points of the at least one updating case according to target protocol standards, and running preset checking logic based on the third subject file to generate a third testing report, and the third testing report comprises the output results and the expected results corresponding to the at least one updating case respectively.
In one embodiment, the target protocol standard comprises any one of a clinical data exchange standards association standard, a clinical data acquisition integration model, a research data listing model.
In one embodiment, further comprising highlighting the output result and/or the desired result in the test report when the output result and the desired result do not match.
The application provides a clinical test data logic checking device, which comprises an acquisition module, a first generation module and a second generation module, wherein the acquisition module is used for acquiring at least one test case recorded by a user, the test case comprises at least one data point and an expected result corresponding to the at least one data point, the first generation module is used for generating a first subject file based on the data point of the at least one test case according to a target protocol standard, the second generation module is used for running preset checking logic based on the first subject file so as to generate a first test report, and the first test report comprises an output result and an expected result corresponding to the at least one test case respectively.
A third aspect of the present application provides a computer device comprising a memory, a processor and a computer program stored on the memory for execution by the processor, wherein the processor, when executing the computer program, implements the steps of the clinical trial data logic verification method provided by any of the embodiments described above.
A fourth aspect of the present application provides a computer readable storage medium having stored thereon a computer program, characterized in that the computer program when executed by a processor implements the steps of the clinical trial data logic checking method provided by any of the embodiments described above.
According to the clinical test data logic checking method and device, the computer equipment and the storage medium, which are provided by the application, the test case is automatically generated based on the acquired test case to test according to the target protocol standard, so that the maintenance test case and the manual test time are avoided, and the data accuracy is ensured.
Drawings
Fig. 1 is a flow chart of a method for logically checking clinical trial data according to an embodiment of the present application.
Fig. 2 is a flow chart of a logic checking method for clinical test data according to two embodiments of the present application.
Fig. 3 is a flow chart of a method for logically checking clinical trial data according to a third embodiment of the present application.
Fig. 4 is a flow chart of a logic checking method for clinical trial data according to a fourth embodiment of the present application.
Fig. 5 is a block diagram of a clinical trial data logic checking device according to an embodiment of the present application.
Fig. 6 is a block diagram of an electronic device according to an exemplary embodiment of the present application.
Detailed Description
The following description of the embodiments of the present application will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.
Summary of the application
As described in the background art, the manual logic checking mode has the following problems of time consuming, labor consuming and unavoidable human errors. In view of the above, the application provides a clinical test data logic checking method and device, a computer device and a storage medium, which automatically generate a subject file for testing based on an acquired test case according to a target protocol standard, so that the maintenance test case and manual test time are avoided, and the accuracy of data is ensured.
Exemplary method
Fig. 1 is a flow chart of a method for logically checking clinical trial data according to an embodiment of the present application. The present embodiment can be applied to EDC, as shown in fig. 1, the logic checking method 100 includes the following steps:
Step S110, at least one test case recorded by a user is obtained, wherein the test case comprises at least one data point and an expected result corresponding to the at least one data point.
The data points include input values in custom audit logic and the storage structure of the input values in a database. The expected result is a result obtained after the input value passes through the mapping relation in the custom checking logic.
For example, a user enters a test case in a resource editor for logic checking test, wherein the test case 1 comprises a data point 1, a visit, a screening period, a form, demographic information, a field, an age, a value of 15, a data point 2, a visit, a screening period, a form, an access standard, a field, a first item of the access standard, a value of "Yes", an expected result is that a question is generated on the data point 2, the content of the question is that the age is not within a range of 18-75, and the user requests confirmation. "challenge classification, system to center.
The custom audit logic is written based on a data audit plan formulated by the user according to clinical trial business rules. The custom checking logic comprises an input value, an output value and a mapping relation between the input value and the output value. The input value is selected from clinical trial data of the subject, which may refer to data recorded during the clinical trial or an electronic health record (Electronic Health Records, EHR). The electronic health record may refer to an electronic history record with a preservation and backup value, which is directly formed by a subject in a health related activity, and may include information about vital signs, medical history, diagnosis, physical examination, laboratory examination, medication and the like generated by an electronic information system of a hospital.
The clinical test data are stored in the database with an electronic case report table (electronic Case Report Form, eCRF) as a carrier, and the electronic case report table is equivalent to a template file corresponding to a storage structure of the clinical test data. The data structure of the electronic case report table accords with the target protocol standard, and the target protocol standard refers to the protocol standard for submitting, collecting, exchanging and archiving clinical data, which is formulated in the clinical test field. For example, the target protocol standard may be a clinical data exchange standards association (CLINICAL DATA INTERCHANGE STANDARDS Consortium, CDISC) standard. CDISC is an open, non-profitable institution that includes various disciplines, and the society is dedicated to developing industry standards that provide electronic means for the retrieval, exchange, submission, and archiving of clinical trial data and metadata for the development of medical and biopharmaceutical products. As another example, the target protocol standard may be a clinical data acquisition integration model (CLINICAL DATA Acquisition Standards Harmonization, CDASH) that describes the fusion of variables, implementation guidelines, and optimal operating schemes of the underlying data acquisition domain and CRF standard problem text description, providing a canonical standard. For another example, the target protocol standard may be a research data list model (Study Data Tabulation Model, sd).
Step 120 generates a first subject file based on data points of at least one test case according to a target protocol standard.
As described above, the data points include input values in custom audit logic and a stored structure of the input values in a database, wherein the input values are 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 may be determined, for example, using a text matching algorithm, and then the template file is populated with clinical trial data to obtain a first subject file.
Step 130, running preset audit logic based on the first subject file to generate a first test report including output results and expected results for each of the at least one test case.
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 and the expected result do not match. For example, when the output result and the desired result are inconsistent, the output result and/or the desired result is highlighted in the test report. When the output result and the expected result do not match, this means that the test case needs to be adjusted, or that the verification logic corresponding to the test case needs to be adjusted. In this case, by highlighting, the user can be facilitated to quickly find the test case or audit logic that needs to be adjusted.
In one embodiment, the logic verification method 100 further includes deriving at least one test case. In this way, a shift can be facilitated.
According to the clinical test data logic checking method provided by the embodiment, according to the target protocol standard, the test case is automatically generated based on the acquired test case to test, so that the maintenance test case and the manual test time are avoided, and the data accuracy is ensured.
Fig. 2 is a flow chart of a logic checking method for clinical test data according to two embodiments of the present application. The logic verification method 200 shown in fig. 2 is different from the logic verification method 100 shown in fig. 1 in that it further includes, before step S120:
step S210, determining at least one target test case of the at least one test case based on the user selection.
The user may select at least one of the entered test cases in the resource editor to select a portion of the test cases from the at least one test case as the target test case.
In this case, step S120 is specifically performed as:
step S220, generating a first subject file based on the data points of the at least one target test case according to the target protocol standard.
Subsequently, step S130 is performed, in which preset checking logic is executed based on the first subject file to generate a first test report. In this case, the first test report includes the output results and the expected results of each of the at least one target test case.
According to the clinical test data logic checking method provided by the embodiment, the first subject file is generated based on the target test case selected by the user, so that the first test report is obtained, the effect of selectively executing the recorded test case is realized, and the flexibility is higher.
Fig. 3 is a flow chart of a method for logically checking clinical trial data according to a third embodiment of the present application. The logic verification method 300 shown in fig. 3 is different from the logic verification method 100 shown in fig. 1 in that it further includes, after step S130:
Step S310, at least one updated case is obtained. The at least one test case comprises a first type of test case with inconsistent output results and expected results, and a second type of test case with consistent output results and expected results, and the update case is obtained by adjusting the first type of test case.
When the output result is inconsistent with the expected result in the first test report, the user can adjust the test case. For example, inconsistent test cases are rewritten in the resource editor to obtain updated cases.
Step S320 generates 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 criteria.
When the user rewrites the unmatched test cases in the resource editor, the cases displayed in the resource editor include two types, one type is an update case, the other type is a second type of test case with the output result in the first test report matched with the expected result, and a second subject file is generated according to the two types of cases.
Step S330, running preset checking logic based on the second subject file to generate a second test report, where the second test report includes at least one output result and an expected result corresponding to each of the update case and the second type of test case.
According to the clinical test data logic checking method provided by the embodiment, the second test subject file is generated based on at least one data point of the update case and the second type test case, so that a second test report is obtained, and the test case is debugged.
Fig. 4 is a flow chart of a logic checking method for clinical trial data according to a fourth embodiment of the present application. The logic verification method 400 shown in fig. 4 is different from the logic verification method 100 shown in fig. 1 in that it further includes, after step S130:
In step S410, at least one update case is obtained by adjusting a test case in which the output result is inconsistent with the expected result.
When a mismatch between the output result and the expected result occurs in the first test report, the user may adjust the test case. For example, the unmatched test cases are rewritten in the resource editor to obtain updated cases.
Step S420, generating a third subject file based on the data points of the at least one updated case according to the target protocol criteria.
When the user rewrites the unmatched test cases in the resource editor, the cases displayed in the resource editor comprise two types, one type is an update case, the other type is a test case with the output result matched with the expected result in the first test report, and the system only generates a third subject file aiming at the update case, namely, the user inputs the update case and simultaneously realizes the operation of selecting the update case. In other embodiments, the selection of the update case may also be accomplished based on a user selection operation. For example, prior to step S320, further comprising obtaining user selected information for at least one update case.
Step S430, running preset checking logic based on the third subject file to generate a third test report, wherein the third test report comprises output results and expected results corresponding to at least one updating case respectively.
According to the clinical trial data logic checking method provided by the embodiment, the third subject file is generated based on the data points of at least one updated case, so that a third test report is obtained, and the test efficiency is improved.
Exemplary apparatus
Fig. 5 is a block diagram of a clinical trial data logic checking device according to an embodiment of the present application. As shown in fig. 5, the logic checking device 50 includes an acquisition module 51, a first generation module 52, and a second generation module 53. The acquiring module 51 is configured to acquire at least one test case recorded by a user, where the test case includes at least one data point and a desired result corresponding to the at least one data point. The first generation module 52 is configured to generate a first subject file based on the data points of the at least one test case according to the target protocol criteria. The second generating module 53 is configured to run preset checking logic based on the first subject file to generate a first test report, where the first test report includes output results and expected results corresponding to at least one test case.
In one embodiment, the first generation module 52 is specifically configured to determine a template file matching the stored structure, and populate the template file with clinical trial data to obtain a first subject file.
In one embodiment, the logic verification device 50 further includes a determination module for determining at least one target test case of the at least one test case based on a user selection. In this case, the first generation module 52 is specifically configured to generate the first subject file based on the data points of the at least one target test case according to the target protocol standard.
In one embodiment, the obtaining module 51 is further configured to obtain at least one update case, where 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 a second type of test case in which the 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 further configured 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 criteria. The second generating module 53 is further configured to run preset checking logic based on the second subject file to generate a second test report, where the second test report includes output results and expected results corresponding to at least one update case and the second type of test case, respectively.
In one embodiment, the obtaining module 51 is further configured to obtain at least one update case, where the at least one test case includes a first type of test case where the 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 further configured to generate a third subject file based on the data points of the at least one updated case according to the target protocol criteria. The second generating module 53 is further configured to run preset checking logic based on the third subject file to generate a third test report, where the third test report includes the output result and the expected result corresponding to each of the at least one update case.
The clinical test data logic checking device provided by the embodiment of the application belongs to the same application conception as the clinical test data logic checking method provided by the embodiment of the application, and can execute the clinical test data logic checking method provided by any embodiment of the application, and has the corresponding functional modules and beneficial effects of executing the clinical test data logic checking method. Technical details not described in detail in this embodiment may be referred to the clinical trial data logic checking method provided in the embodiment of the present application, and will not be described herein.
Exemplary electronic device
Fig. 6 is a block diagram of an electronic device according to an exemplary embodiment of the present application. As shown in fig. 6, the electronic device 60 includes one or more processors 61 and memory 62.
The processor 61 may be a Central Processing Unit (CPU) or other form of processing unit having data processing and/or instruction execution capabilities and may control other components in the electronic device 60 to perform the desired functions.
Memory 62 may include one or more computer program products that may include various forms of computer-readable storage media, such as volatile memory and/or non-volatile memory. Volatile memory can include, for example, random Access Memory (RAM) and/or cache memory (cache) and the like. The non-volatile memory may include, for example, read Only Memory (ROM), hard disk, flash memory, and the like. One or more computer program instructions may be stored on a computer readable storage medium that can be executed by the processor 11 to implement the clinical trial data logic checking method and/or other desired functions of the various embodiments of the application described above. Various content, such as target protocol standards, may also be stored in the computer-readable storage medium.
In one example, electronic device 60 may also include input device 63 and output device 64, which may be interconnected by a bus system and/or other form of connection mechanism (not shown).
For example, the input device 63 may be a microphone or a microphone array for capturing an input signal of a sound source. When the electronic device is a stand-alone device, the input means 63 may be a communication network connector for receiving an input signal. In addition, the input device 63 may also include, for example, a keyboard, a mouse, and the like.
The output device 64 may output various information to the outside, including the determined distance information, direction information, and the like. Output devices 64 may include, for example, a display, speakers, a printer, and a communication network and remote output devices connected thereto, etc.
Of course, only some of the components of the electronic device 60 that are relevant to the present application are shown in fig. 6 for simplicity, components such as buses, input/output interfaces, etc. are omitted. In addition, the electronic device 60 may include any other suitable components depending on the particular application.
Exemplary computer program product and computer readable storage Medium
In addition to the methods and apparatus described above, embodiments of the application may also be a computer program product comprising computer program instructions which, when executed by a processor, cause the processor to perform steps in a target protocol standard according to various embodiments of the application described in the "exemplary methods" section of this specification.
The computer program product may be written in any combination of one or more programming languages, including an object oriented programming language such as Java, C++ or the like and conventional procedural programming languages, such as the "C" programming language or similar programming languages. The program code may execute entirely on the user's computing device, partly on the user's device, as a stand-alone software package, partly on the user's computing device, partly on a remote computing device, or entirely on the remote computing device or server.
Furthermore, embodiments of the present application may also be a computer-readable storage medium, having stored thereon computer program instructions that, when executed by a processor, cause the processor 11 to perform the steps in the target protocol standard according to the various embodiments of the present application described in the "exemplary methods" section of the present specification.
The computer readable storage medium may employ any combination of one or more readable media. The readable medium may be a readable signal medium or a readable storage medium. The readable storage medium may include, for example, but is not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or a combination of any of the foregoing. More specific examples (a non-exhaustive list) of a readable storage medium include an electrical connection having 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 disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing.
The basic principles of the present application have been described above in connection with specific embodiments, but it should be noted that the advantages, benefits, effects, etc. mentioned in the present application are merely examples and not intended to be limiting, and these advantages, benefits, effects, etc. are not to be construed as necessarily possessed by the various embodiments of the application. Furthermore, the specific details disclosed herein are for purposes of illustration and understanding only, and are not intended to be limiting, as the application is not necessarily limited to practice with the above described specific details.
The block diagrams of the devices, apparatuses, devices, systems referred to in the present application are only illustrative examples and are not intended to require or imply that the connections, arrangements, configurations must be made in the manner shown in the block diagrams. As will be appreciated by one of skill in the art, the devices, apparatuses, devices, systems may be connected, arranged, configured in any manner. Words such as "including," "comprising," "having," and the like are words of openness and mean "including but not limited to," and are used interchangeably therewith. The terms "or" and "as used herein refer to and are used interchangeably with the term" and/or "unless the context clearly indicates otherwise. The term "such as" as used herein refers to, and is used interchangeably with, the phrase "such as, but not limited to.
It is also noted that in the apparatus, devices and methods of the present application, the components or steps may be disassembled and/or assembled. Such decomposition and/or recombination should be considered as equivalent aspects of the present application.
The previous 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 generic principles defined herein may be applied to other aspects without departing from the scope of the application. Thus, the present application is not intended to be limited to the aspects shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
It should be understood that the terms "first", "second", "third", "fourth", "fifth" and "sixth" used in the description of the embodiments of the present application are used for more clearly describing the technical solutions, and are not intended to limit the scope of the present application.
The foregoing description has been presented for purposes of illustration and description. Furthermore, this description is not intended to limit embodiments of the application to the form disclosed herein. Although a number of example aspects and embodiments have been discussed above, a person of ordinary skill in the art will recognize certain variations, modifications, alterations, additions, and subcombinations thereof.
Claims (9)
1. A method for logically verifying clinical trial data, comprising:
Acquiring at least one test case input by a user, wherein the test case comprises at least one data point and an expected result corresponding to the at least one data point, the data point comprises an input value in a custom checking logic and a storage structure of the input value in a database, the expected result is obtained after the input value passes through a mapping relation in the custom checking logic, and the custom checking logic is written based on a data checking plan formulated by the user according to clinical test 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, wherein the target protocol standard comprises a template file corresponding to the storage structure;
running preset checking logic based on the first subject file to generate a first test report, wherein the first test report comprises output results and expected results corresponding to the at least one test case respectively;
when the output result and the expected result do not match, the output result and/or the expected result is highlighted in the first test report so that the user finds a test case or audit logic that needs to be adjusted.
2. The method of claim 1, wherein the data points comprise clinical trial data and a stored structure of the clinical trial data in a database, wherein the generating a first subject file based on the data points of the at least one test case according to a target protocol standard comprises:
determining the template file matched with the storage structure;
and filling the template file by using the clinical test data to obtain the first subject file.
3. The method of claim 1 or 2, further comprising, prior to the generating a first subject file based on the data points of the at least one test case according to a target protocol standard:
determining at least one target test case of the at least one test case based on the user selection;
the generating a first subject file based on the data points of the at least one test case according to a target protocol standard includes:
the first subject file is generated based on the data points of the at least one labeled test case according to a target protocol standard.
4. The clinical trial data logic verification method of claim 1 or 2, further comprising:
Acquiring at least one updating case, wherein the at least one testing case comprises a first testing case with inconsistent output results and expected results and a second testing case with consistent output results and expected results, and the updating case is obtained by adjusting the first testing case;
Generating a second subject file based on the at least one update case and the data points of the second type of test case according to a target protocol standard;
And running preset checking logic based on the second subject file to generate a second test report, wherein the second test report comprises output results and expected results corresponding to the at least one updating case and the second type of test cases respectively.
5. The clinical trial data logic verification method of claim 1 or 2, further comprising:
Acquiring at least one updating case, wherein the at least one testing case comprises a first type of testing case with inconsistent output results and expected results, and the updating case is obtained by adjusting the first type of testing case;
generating a third subject file based on the data points of the at least one update case according to a target protocol standard;
and running preset checking logic based on the third subject file to generate a third test report, wherein the third test report comprises output results and expected results corresponding to the at least one updating case respectively.
6. The method of claim 1 or 2, wherein the target protocol standard comprises any one of clinical data exchange standard association standard, clinical data collection integration model, research data list model.
7. A clinical trial data logic verification device, comprising:
The system comprises an acquisition module, a verification module and a verification module, wherein the acquisition module is used for acquiring at least one test case recorded by a user, the test case comprises at least one data point and an expected result corresponding to the at least one data point, the data point comprises an input value in a custom verification logic and a storage structure of the input value in a database, the expected result is obtained after the input value passes through a mapping relation in the custom verification logic, and the custom verification logic is written based on a data verification plan formulated by the user according to clinical test business rules;
a first generation 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, where the target protocol standard includes a template file corresponding to the storage structure;
The second generation module is used for running preset checking logic based on the first subject file to generate a first test report, and the first test report comprises output results and expected results corresponding to the at least one test case respectively; when the output result and the expected result do not match, the output result and/or the expected result is highlighted in the first test report so that the user finds a test case or audit logic that needs to be adjusted.
8. A computer device comprising a memory, a processor and a computer program stored on the memory for execution by the processor, wherein the processor, when executing the computer program, implements the steps of the clinical trial data logic verification method of any one of claims 1 to 6.
9. A computer readable storage medium having stored thereon a computer program, wherein the computer program when executed by a processor implements the steps of the clinical trial data logic verification method of any one of claims 1 to 6.
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