CN115687356A - Method and system for realizing data verification in automatic test clinical trial - Google Patents

Method and system for realizing data verification in automatic test clinical trial Download PDF

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CN115687356A
CN115687356A CN202211393647.6A CN202211393647A CN115687356A CN 115687356 A CN115687356 A CN 115687356A CN 202211393647 A CN202211393647 A CN 202211393647A CN 115687356 A CN115687356 A CN 115687356A
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data
task
test case
execution
test
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武翔宇
朱博贡
杨思源
黄祖柳
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Shanghai Yaocheng Health Technology Co ltd
Qisheng Yaokang Information Technology Shanghai Co ltd
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Shanghai Yaocheng Health Technology Co ltd
Qisheng Yaokang Information Technology Shanghai Co ltd
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Abstract

The invention discloses a method and a system for realizing data verification in an automatic test clinical test, which can reduce the test time and the labor cost. The technical scheme is as follows: analyzing the test case file by using a table column head to obtain a plurality of rows of structured data; clustering the structured data according to the test cases and the identifiers for logic check, and forming a plurality of test case data sets in sequence; converting the test case data set into an executable task, and putting the executable task into an execution queue based on experimental environment isolation; taking out each task from the execution queue in sequence through an independent process to execute; and automatically executing the operation in the EDC in sequence according to the operation described in the task, observing data and a questioning condition of a target position on the EDC after the automatic data entry is finished, automatically confirming whether the target result is equal to a test case target result in the task, marking an execution final result of the task according to an EDC feedback result, writing the execution final result into a database, and finally generating an automatically executed test case report.

Description

Method and system for realizing data verification in automatic test clinical trial
Technical Field
The invention relates to the field of data quality guarantee of clinical medical software, in particular to a method and a system for realizing data verification in an automatic test clinical test.
Background
In a clinical experiment, on an electronic data acquisition system EDC, a database developer DBD needs to implement a rule of data verification according to a data verification plan DVP file given by a data quality manager DM. After the database developer DBD completes the data check, the QA team responsible for testing will test the work of the database developer DBD. The test content is that a test script is written according to a data check plan DVP file of a data quality manager DM, then corresponding operation is carried out on an EDC of the electronic data acquisition system according to the test script, and whether a feedback result of the EDC system accords with expectation after data is input is observed.
The whole process is usually done manually. This manual testing by the QA team adds time and labor costs to the overall test.
Disclosure of Invention
The following presents a simplified summary of one or more aspects in order to provide a basic understanding of such aspects. This summary is not an extensive overview of all contemplated aspects, and is intended to neither identify key or critical elements of all aspects nor delineate the scope of any or all aspects. Its sole purpose is to present some concepts of one or more aspects in a simplified form as a prelude to the more detailed description that is presented later.
The present invention is directed to solving the above problems and providing a method and system for data verification in an automated testing clinical trial, so that the QA team may not execute a test script manually, thereby reducing the time and labor cost of the whole test.
The technical scheme of the invention is as follows: the invention discloses a method for realizing data check in an automatic test clinical test, which comprises the following steps:
step 1: analyzing the test case file by using a column header of a predefined table to obtain a plurality of rows of structured data;
step 2: clustering multiple lines of structured data according to the test cases and the identifiers for logic check, and forming a plurality of test case data sets in sequence;
and step 3: converting the combined test case data set into an executable task, and putting the converted executable task into an execution queue based on experimental environment isolation;
and 4, step 4: taking out each task from the execution queue in sequence through an independent process to execute;
and 5: and automatically executing the operation in the electronic data acquisition system according to the operation described in the task in sequence, observing data and question conditions of a target position on the electronic data acquisition system after the automatic data entry is finished, automatically determining whether the result is equal to a test case target result in the task, marking an execution final result of the task according to a feedback result of the electronic data acquisition system, writing the execution final result into a database, and finally generating an automatically executed test case report.
According to an embodiment of the method for realizing data verification in the automated testing clinical trial, in step 1, a column header of a table, i.e., a system, defines a description format of a test case file, including an identifier of a test case, an identifier of corresponding logic verification, an input path, input data, an input data unit, a target position, and a target result.
According to an embodiment of the method for implementing data verification in an automated testing clinical trial, in step 2, clustering is performed by grouping the description rows with the same key value into a group, wherein the group is a test case, and the key value is defined as a test case ID and a logical verification ID.
According to an embodiment of the method for realizing data check in the automated test clinical trial, in step 3, the process of converting into executable tasks comprises the following steps: each line of structured data is sequentially converted into operational data executable by the electronic data acquisition system, and data including creation time and execution state for initializing the task.
According to an embodiment of the method for realizing data check in the automated test clinical trial, in step 4, the rest interval between adjacent tasks is settable.
The invention discloses a system for realizing data verification in an automatic test clinical test, which comprises:
the analysis module is used for analyzing the test case file by using a column head of a predefined table to obtain a plurality of rows of structured data;
the clustering module is used for clustering the multiple lines of structured data according to the test cases and the identifiers for logic check and forming a plurality of test case data sets in sequence;
the task conversion module is used for converting the combined test case data set into an executable task and putting the converted executable task into an execution queue based on experimental environment isolation;
the task execution module is used for taking out each task from the execution queue in sequence through an independent process to execute;
and the report generation module is used for automatically executing the operation in the electronic data acquisition system according to the operation described in the task in sequence, observing the data and the questioning condition of the target position on the electronic data acquisition system after the automatic data entry is finished, automatically confirming whether the result is equal to the target result of the test case in the task, marking the final execution result of the task according to the feedback result of the electronic data acquisition system, writing the final execution result into a database and finally generating an automatically executed test case report.
According to an embodiment of the system for performing data check in an automated test clinical trial, the parsing module is further configured to: the column head of the table, namely the system, defines the description format of the test case file, and comprises an identifier of the test case, an identifier corresponding to logic check, an input path, input data, an input data unit, a target position and a target result.
According to an embodiment of the system for performing data verification in an automated test clinical trial of the present invention, the clustering module is further configured to: the clustering process is to group the description rows with the same key value into a group, wherein the group is a test case, and the key value is defined as a test case ID and a logic check ID.
According to an embodiment of the system for performing data check in an automated test clinical trial, the task transformation module is further configured to: the process of converting into executable tasks includes: and converting each line of structured data into operation data which can be executed by an electronic data acquisition system according to the sequence, and initializing the data of the task, including creation time and execution state.
According to an embodiment of the system for performing data verification in an automated test clinical trial, the task execution module is further configured to: the rest interval between adjacent tasks is settable.
The present invention also discloses a computer readable storage medium storing program instructions executable by a processor to implement the steps of the method for data verification in an automated test clinical trial as described above.
Also disclosed is a computer apparatus comprising a memory, a processor, and program instructions stored in the memory for execution by the processor, wherein the processor executes the program instructions to implement the steps of the method for automated testing of data review in a clinical trial as described above.
Compared with the prior art, the invention has the following beneficial effects: in general, the invention can make QA team execute test script without hand, thereby reducing time and labor cost of whole test. In detail, the invention mainly realizes the beneficial effect by the following technical means:
A. the invention designs a test case description format of forms and texts, so that a system can accurately understand the test case files of a user, thereby realizing the automatic execution of the test cases.
B. Converting each test case in the test cases into a task which can be completely executed by the EDC, storing the task by using an execution queue isolated by an experimental environment, and executing the task by using an independent flow. The innovation point can realize the automatic execution process of the test case, and the whole execution process is more controllable, such as the speed and the concurrency number of the automatic execution test task are controlled, and the overload to the system is avoided.
C. The EDC executable task is designed, test cases can be obtained through conversion, and the system can automatically fill data and analyze results in the EDC according to operation requirements and expected results in the task, and finally write the results into a database to generate a test report. The innovation point realizes the main process of automatically executing the test case.
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The above features and advantages of the present disclosure will be better understood upon reading the detailed description of embodiments of the disclosure in conjunction with the following drawings. In the drawings, components are not necessarily drawn to scale, and components having similar relative characteristics or features may have the same or similar reference numerals.
FIG. 1 illustrates a flow diagram of one embodiment of a method of implementing data verification in an automated test clinical trial of the present invention.
FIG. 2 illustrates a schematic diagram of one implementation of a system implementing data checking in an automated test clinical trial of the present invention.
Detailed Description
The invention is described in detail below with reference to the figures and specific embodiments. It is noted that the aspects described below in connection with the figures and the specific embodiments are only exemplary and should not be construed as imposing any limitation on the scope of the present invention.
FIG. 1 illustrates a flow chart of one embodiment of the present invention implementing a method for automated data review in a clinical trial. Referring to fig. 1, the steps of the method of the present embodiment are detailed as follows.
Step 1: and analyzing the test case file by using a column header of a predefined table to obtain a plurality of rows of structured data.
In this step, the column header of the table, i.e. the system defines the description format of the test case file, including the identifier of the test case, the identifier of the corresponding logical check (implemented by the check rule of data quality assurance in EDC), the input path, the input data unit, the target location, the target result, and so on. The test case file is uploaded to the system and read by the system, the reading process is equivalent to a simple excel reading, each row of data in the test case file is sequentially analyzed, and the obtained structured data structure which accords with the test case, namely the identifier of the test case at the head of the table column, the identifier of the corresponding logic check, the input path, the input data unit, the target position and the format of the target result are obtained.
Step 2: and clustering the multiple lines of structured data according to the test cases and the identifiers for logic check, and sequentially forming a plurality of test case data sets.
In the clustering process in this step, description rows of the same key value (key) are grouped into one group, the group is a test case, and the definition of the key value is, for example, test case ID + logic check ID. The multiple groups are multiple test cases, and a test case data set is formed by the multiple groups.
And step 3: and converting the combined test case data set into an executable task, and putting the converted executable task into an execution queue based on experiment environment isolation.
In this step, the process of converting into an executable task includes: and converting each line of structured data into operation data which can be executed by the EDC in sequence, and initializing the data of the task such as the creation time, the execution state and the like. Wherein, an executable task can be described by data, specifically as: all inputs in the test case, the input sequence, the expected result in the test case, the creation time of the task itself, and the execution state of the task itself: non-execution, in execution, successful execution, failed execution, and the like. The conversion process is to convert a test case into a task described in data, and the execution state of the task is initialized to be 'not executed'.
And 4, step 4: and taking each task from the execution queue in sequence through an independent process to execute.
Wherein a rest interval between adjacent tasks may be set.
And 5: the operations described in the task are automatically performed in the EDC in the order in which the data is automatically entered. And after the data is automatically input, observing the data and the questioning condition of the target position on the EDC, and automatically determining whether the result is equal to the target result of the test case in the task. And marking the final execution result of the task according to the EDC feedback result, writing the final execution result into a database, and generating an automatically executed test case report.
That is, for each task, data is sequentially filled in the EDC by spec of the task (referring to the description of the data input and data result in the task), feedback from the EDC is observed, and the execution result is recorded.
Figure 2 illustrates the principles of one implementation of the system of the present invention that enables data review in an automated test clinical trial. Referring to fig. 2, the system of the present embodiment includes: the system comprises an analysis module, a clustering module, a task conversion module, a task execution module and a report generation module.
The analysis module outputs the data to the clustering module, the clustering module outputs the data to the task conversion module, the task conversion module outputs the data to the task execution module, and the task execution module outputs the data to the report generation module.
The analysis module is used for analyzing the test case file by using a column head of a predefined table to obtain a plurality of rows of structured data.
The parsing module is further configured to: the column header of the table, i.e. the system, defines the description format of the test case file, including the identifier of the test case, the identifier of the corresponding logic check, the input path, the input data unit, the target position, and the target result.
The test case file is uploaded to the system and read by the system, the reading process is equivalent to a simple excel reading, each row of data in the test case file is sequentially analyzed, and the obtained structured data structure which accords with the test case, namely the identifier of the test case at the head of the table column, the identifier of the corresponding logic check, the input path, the input data unit, the target position and the format of the target result are obtained.
The clustering module is used for clustering the multiple lines of structured data according to the test cases and the identifiers for logic check, and forming a plurality of test case data sets in sequence.
The clustering module is further configured to: the clustering process is to group the description rows with the same key value into a group, wherein the group is a test case, and the key value is defined as a test case ID and a logic check ID. The multiple groups are multiple test cases, and a test case data set is formed by the multiple groups.
And the task conversion module is used for converting the combined test case data set into an executable task and putting the converted executable task into an execution queue based on experimental environment isolation.
The task conversion module is further configured to: the process of converting into an executable task includes: each line of structured data is sequentially converted into operational data executable by the electronic data acquisition system, and data including creation time and execution state for initializing the task.
Wherein, an executable task can be described by data, specifically as: all inputs in the test case, the input sequence, the expected result in the test case, the creation time of the task itself, and the execution state of the task itself: not executed, in execution, successful execution, failed execution, etc. The conversion process is to convert a test case into a task described in data, and the execution state of the task is initialized to be 'not executed'.
And the task execution module is used for taking out each task from the execution queue in sequence through an independent process to execute.
The task execution module is further configured to: the rest interval between adjacent tasks is settable.
And the report generation module is used for automatically executing the operation in the electronic data acquisition system according to the operation described in the task in sequence, observing the data and the questioning condition of the target position on the electronic data acquisition system after the automatic data entry is finished, automatically confirming whether the result is equal to the target result of the test case in the task, marking the final execution result of the task according to the feedback result of the electronic data acquisition system, writing the final execution result into a database and finally generating an automatically executed test case report.
That is, for each task, data is sequentially filled in the EDC in spec (meaning the description of the data input and data result in the task) of the task, the feedback of the EDC is observed, and the execution result is recorded.
The present invention also discloses a computer readable storage medium storing program instructions executable by a processor to implement the steps of the method for performing data verification in an automated test clinical trial as shown in fig. 1. For the specific steps, please refer to the above embodiments, which are not described herein again.
Furthermore, a computer device is disclosed, comprising a memory, a processor and program instructions stored in the memory for execution by the processor, wherein the processor executes the program instructions to implement the steps of the method for performing data verification in an automated test clinical trial as shown in fig. 1. For the specific steps, please refer to the above embodiments, which are not described herein again.
While, for purposes of simplicity of explanation, the methodologies are shown and described as a series of acts, it is to be understood and appreciated that the methodologies are not limited by the order of acts, as some acts may, in accordance with one or more embodiments, occur in different orders and/or concurrently with other acts from that shown and described herein or not shown and described herein, as would be understood by one skilled in the art.
Those of skill would further appreciate that the various illustrative logical blocks, modules, circuits, and algorithm steps described in connection with the embodiments disclosed herein may be implemented as electronic hardware, computer software, or combinations of both. To clearly illustrate this interchangeability of hardware and software, various illustrative components, blocks, modules, circuits, and steps have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system. Skilled artisans may implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the present invention.
The various illustrative logical blocks, modules, and circuits described in connection with the embodiments disclosed herein may be implemented or performed with a general purpose processor, a Digital Signal Processor (DSP), an Application Specific Integrated Circuit (ASIC), a Field Programmable Gate Array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general-purpose processor may be a microprocessor, but in the alternative, the processor may be any conventional processor, controller, microcontroller, or state machine. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.
The steps of a method or algorithm described in connection with the embodiments disclosed herein may be embodied directly in hardware, in a software module executed by a processor, or in a combination of the two. A software module may reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, a CD-ROM, or any other form of storage medium known in the art. An exemplary storage medium is coupled to the processor such the processor can read information from, and write information to, the storage medium. In the alternative, the storage medium may be integral to the processor. The processor and the storage medium may reside in an ASIC. The ASIC may reside in a user terminal. In the alternative, the processor and the storage medium may reside as discrete components in a user terminal.
In one or more exemplary embodiments, the functions described may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software as a computer program product, the functions may be stored on or transmitted over as one or more instructions or code on a computer-readable medium. Computer-readable media includes both computer storage media and communication media including any medium that facilitates transfer of a computer program from one place to another. A storage media may be any available media that can be accessed by a computer. By way of example, and not limitation, such computer-readable media can comprise RAM, ROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to carry or store desired program code in the form of instructions or data structures and that can be accessed by a computer. Any connection is properly termed a computer-readable medium. For example, if the software is transmitted from a web site, server, or other remote source using a coaxial cable, fiber optic cable, twisted pair, digital Subscriber Line (DSL), or wireless technologies such as infrared, radio, and microwave, then the coaxial cable, fiber optic cable, twisted pair, DSL, or wireless technologies such as infrared, radio, and microwave are included in the definition of medium. Disk (disk) and disc (disc), as used herein, includes Compact Disc (CD), laser disc, optical disc, digital Versatile Disc (DVD), floppy disk and blu-ray disc where disks (disks) usually reproduce data magnetically, while discs (discs) reproduce data optically with lasers. Combinations of the above should also be included within the scope of computer-readable media.
The previous description of the disclosure is provided to enable any person skilled in the art to make or use the disclosure. Various modifications to the disclosure will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other variations without departing from the spirit or scope of the disclosure. Thus, the disclosure is not intended to be limited to the examples and designs described herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (12)

1. A method for performing data verification in an automated testing clinical trial, the method comprising:
step 1: analyzing the test case file by using a column header of a predefined table to obtain a plurality of rows of structured data;
step 2: clustering multiple lines of structured data according to the test cases and the identifiers for logic check, and forming a plurality of test case data sets in sequence;
and step 3: converting the combined test case data set into an executable task, and putting the converted executable task into an execution queue based on experiment environment isolation;
and 4, step 4: taking out each task from the execution queue in sequence through an independent process to execute;
and 5: and automatically executing the operation in the electronic data acquisition system according to the operation described in the task in sequence, observing data and questioning conditions of a target position on the electronic data acquisition system after the data is automatically input, automatically confirming whether the data and the questioning conditions are equivalent to a test case target result in the task, marking an execution final result of the task according to a feedback result of the electronic data acquisition system, writing the execution final result into a database, and finally generating an automatically executed test case report.
2. The method for implementing data verification in automated testing clinical trial as claimed in claim 1, wherein in step 1, the system-defined header of the table defines the description format of the test case file, including the identifier of the test case, the identifier of the corresponding logic verification, the input path, the input data unit, the target location, and the target result.
3. The method of claim 1, wherein in step 2, the clustering process is to group the description rows with the same key value into a group, the group is a test case, wherein the key value is defined as a test case ID and a logical check ID.
4. The method for realizing data check in the automated testing clinical trial as set forth in claim 1, wherein the process of converting into executable tasks in step 3 comprises: and converting each line of structured data into operation data which can be executed by an electronic data acquisition system according to the sequence, and initializing the data of the task, including creation time and execution state.
5. The method for performing data verification in an automated testing clinical trial of claim 1, wherein in step 4, the rest interval between adjacent tasks is settable.
6. A system for enabling data verification in an automated test clinical trial, the system comprising:
the analysis module is used for analyzing the test case file by using a column header of a predefined table to obtain a plurality of rows of structured data;
the clustering module is used for clustering the multiple lines of structured data according to the test cases and the identifiers for logic check and forming a plurality of test case data sets in sequence;
the task conversion module is used for converting the combined test case data set into an executable task and putting the converted executable task into an execution queue based on experimental environment isolation;
the task execution module is used for taking out each task from the execution queue in sequence through an independent process to execute;
and the report generation module is used for automatically executing the operation in the electronic data acquisition system according to the operation described in the task in sequence, observing the data and the questioning condition of the target position on the electronic data acquisition system after the automatic data entry is finished, automatically confirming whether the result is equal to the target result of the test case in the task, marking the final execution result of the task according to the feedback result of the electronic data acquisition system, writing the final execution result into a database and finally generating an automatically executed test case report.
7. The system for enabling data review in an automated test clinical trial of claim 6, wherein the parsing module is further configured to: the column head of the table, namely the system, defines the description format of the test case file, and comprises an identifier of the test case, an identifier corresponding to logic check, an input path, input data, an input data unit, a target position and a target result.
8. The system for enabling data review in an automated testing clinical trial of claim 6, wherein the clustering module is further configured to: the clustering process is to group the description rows with the same key value into a group, wherein the group is a test case, and the key value is defined as a test case ID and a logic check ID.
9. The system for enabling data review in an automated testing clinical trial of claim 6, wherein the task transformation module is further configured to: the process of converting into an executable task includes: each line of structured data is sequentially converted into operational data executable by the electronic data acquisition system, and data including creation time and execution state for initializing the task.
10. The system for enabling data review in an automated testing clinical trial of claim 6, wherein the task performance module is further configured to: the rest interval between adjacent tasks is settable.
11. A computer readable storage medium storing program instructions executable by a processor to perform the steps of a method of performing data review in an automated test clinical trial according to any one of claims 1 to 5.
12. A computer device comprising a memory, a processor and program instructions stored in the memory for execution by the processor, wherein the program instructions are executed by the processor to implement the steps of a method of performing data review in an automated testing clinical trial according to any of claims 1 to 5.
CN202211393647.6A 2022-11-08 2022-11-08 Method and system for realizing data verification in automatic test clinical trial Pending CN115687356A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117473128A (en) * 2023-10-24 2024-01-30 北京方胜远临医药科技有限公司 Clinical trial data checking method based on logic checking

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117473128A (en) * 2023-10-24 2024-01-30 北京方胜远临医药科技有限公司 Clinical trial data checking method based on logic checking

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