CN114005498A - Clinical test data logic checking method and device, equipment and storage medium - Google Patents
Clinical test data logic checking method and device, equipment and storage medium Download PDFInfo
- Publication number
- CN114005498A CN114005498A CN202111266128.9A CN202111266128A CN114005498A CN 114005498 A CN114005498 A CN 114005498A CN 202111266128 A CN202111266128 A CN 202111266128A CN 114005498 A CN114005498 A CN 114005498A
- Authority
- CN
- China
- Prior art keywords
- case
- test
- data
- test case
- clinical trial
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Images
Classifications
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
- G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
- G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H15/00—ICT specially adapted for medical reports, e.g. generation or transmission thereof
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- General Health & Medical Sciences (AREA)
- Medical Informatics (AREA)
- Primary Health Care (AREA)
- Public Health (AREA)
- Automatic Analysis And Handling Materials Therefor (AREA)
Abstract
The application provides a method, a device, equipment and a storage medium for logical checking of clinical test data, and solves the problems that in the prior art, a manual checking method is time-consuming and labor-consuming, and accuracy cannot be guaranteed. The method comprises the following steps: 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; generating a first subject file based on data points of 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.
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
An Electronic Data Capture (EDC) system for clinical trial Data is suitable for a core information system for drug clinical trial, medical random contrast trial and medical cohort study, and is mainly used for recording the information of a subject and forming an electronic follow-up form. For clinical trials, data accuracy is the basis for most analytical studies. Therefore, after entering clinical trial data into the EDC system, a logical check of the entered clinical trial data is usually required by a dedicated staff member to ensure the accuracy of the entered data. The following problems exist in this manual checking method: firstly, time and labor are consumed; secondly, human errors cannot be avoided.
Disclosure of Invention
In view of this, embodiments of the present application provide a method and an apparatus for checking clinical trial data logic, a computer device, and a storage medium, so as to solve the problems in the prior art that a manual checking method is time-consuming and labor-consuming, and accuracy cannot be guaranteed.
In a first aspect, the present application provides a method for logically checking clinical trial data, including: 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; generating a first subject file based on data points of 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 include clinical trial data and a storage structure of the clinical trial data in a database; the target protocol standard comprises a template file corresponding to the storage structure. 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 a template file matched with the storage structure; and filling the template file by using the clinical test data to obtain a first subject file.
In one embodiment, before generating the first subject file based on the data points of the at least one test case according to the target protocol standard, further comprising: at least one target test case of the at least one test case is determined 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: a first subject file is generated based on the data points of the at least one target test case according to the target protocol standard.
In one embodiment, further comprising: 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, and the updating case is obtained by adjusting the first type of testing case; generating 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; and running preset checking logic based on the second subject file to generate a second test report, wherein the second test report comprises the output result and the expected result corresponding to each of the at least one updating case and the second type of test case.
In one embodiment, further comprising: 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 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 the target protocol criteria; and running preset checking logic based on the third subject file to generate a third test report, wherein the third test report comprises an output result and an expected result corresponding to each of the at least one updating case.
In one embodiment, the target protocol standard comprises any one of a clinical data exchange standards association standard, a clinical data collection integration model, a research data listing model.
In one embodiment, further comprising: when the output result and the expected result do not match, the output result and/or the expected result are highlighted in the test report.
A second aspect of the present application provides a clinical trial data logical check apparatus, including: the system comprises an acquisition module, a processing module and a display module, wherein the acquisition module is used for acquiring at least one test case input by a user, and the test case comprises at least one data point and an expected result corresponding to the at least one data point; a first generation module for generating a first subject file based on data points of at least one test case according to a target protocol standard; and the second generation module is used for running preset check logic based on the first subject file to generate a first test report, and the first test report comprises an output result and an expected result corresponding to each of the at least one test case.
A third aspect of the present application provides a computer device, comprising a memory, a processor and a computer program stored in the memory and executed by the processor, wherein the processor executes the computer program to implement the steps of the method for logically checking clinical trial data provided in any of the above embodiments.
A fourth aspect of the present application provides a computer-readable storage medium, on which a computer program is stored, wherein the computer program, when executed by a processor, implements the steps of the method for logically checking clinical trial data provided in any of the above embodiments.
According to the clinical test data logic checking method and device, the computer equipment and the storage medium, the test subject file is automatically generated based on the obtained test case for testing according to the target protocol standard, so that the test case maintenance and manual test time are saved, and the data accuracy is guaranteed.
Drawings
FIG. 1 is a flow chart illustrating a method for logically checking clinical trial data according to an embodiment of the present disclosure.
Fig. 2 is a schematic flow chart of a method for logically checking clinical trial data according to the second embodiment of the present application.
Fig. 3 is a schematic flow chart of a method for logically checking clinical trial data according to three embodiments of the present application.
FIG. 4 is a schematic flow chart of a method for logically checking clinical trial data according to the fourth embodiment of the present application.
Fig. 5 is a block diagram illustrating a structure of a clinical trial data logical check apparatus 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 technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.
Summary of the application
As described in the background art, the manual logic check method has the following problems: firstly, time and labor are consumed; secondly, human errors cannot be avoided. In view of this, the present application provides a method and an apparatus for logical verification of clinical test data, a computer device, and a storage medium, and a test subject file is automatically generated based on an acquired test case for testing according to a target protocol standard, so that maintenance of a test case and manual test time are avoided, and a guarantee is provided for data accuracy.
Exemplary method
FIG. 1 is a flow chart illustrating a method for logically checking clinical trial data according to an embodiment of the present disclosure. The present embodiment can be applied to EDC, and as shown in FIG. 1, the logic check method 100 includes the following steps:
step S110, at least one test case entered by the user is obtained, where the test case includes at least one data point and an expected result corresponding to the at least one data point.
The data points include input values in the custom check logic and a storage structure for the input values in the database. The expected result is a result obtained after the input value passes through the mapping relation in the custom check logic.
For example, a user enters a test case into a resource editor for a logic verification test, as follows: test case 1: data point 1: visiting: screening phase, table: demographic data, field: age, value: 15; data point 2: visiting: screening phase, table: inclusion criteria, field: inclusion criteria first, value: "yes"; the expected result is: challenge was generated on data point 2, challenge content: "age is not in the interval 18-75, please confirm. ", question classification: system to center.
The custom check logic is compiled based on a data check plan formulated by the user according to the clinical trial business rules. The custom check logic includes input values, output values, and a mapping between input values to output values. The input value is selected from clinical trial data of the subject, which may refer to data recorded during the course of a clinical trial or an Electronic Health Record (EHR). The electronic health record can be an electronic history record which is directly formed by the subject in health-related activities and has a value of being stored for future reference, and can comprise information such as related vital signs, medical history, diagnosis, physical examination, laboratory examination, drug treatment and the like generated by an electronic information system of a hospital.
Clinical trial data is stored in a database by taking an electronic Case Report Form (eCRF) as a carrier, and the electronic Case Report Form is equivalent to a template file corresponding to a storage structure of the 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 established in the field of clinical trials. For example, the target protocol standard may be a Clinical Data exchange Standards association (CDISC) standard. The CDISC is an open, non-profit organization that includes various disciplines, and the association is working on developing industry standards that provide an electronic means of acquisition, 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 (CDASH), which describes a fusion of variables, implementation guidelines, and optimal operating protocols described by the underlying Data Acquisition domain and CRF standard problem texts, providing specification Standards. As another example, the target protocol standard may be a research Data listing Model (SDTM).
A first subject file is generated based on the data points of the at least one test case according to the target protocol criteria, step 120.
As described above, the data points include input values in the custom check logic and a storage structure for the input values in the database, wherein the input values are selected from clinical trial data. The target protocol standard comprises a template file corresponding to the storage structure. In this case, after the user enters at least one test case, a template file matched with the storage structure of each test case may be determined, for example, by using a text matching algorithm; the template file is then populated with clinical trial data to obtain a first subject file.
And 130, 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, after step S130, the logic checking method 100 further includes: when the output result and the expected result do not match, the output result and/or the expected result are highlighted in the test report. For example, when the output result and the expected result are inconsistent, the output result and/or the expected result are highlighted in the test report. When the output result is not matched with the expected result, it means that the test case needs to be adjusted, or the corresponding checking logic of the test case needs to be adjusted. In this case, the highlighted manner facilitates the user to quickly find the test case or the verification logic that needs to be adjusted.
In one embodiment, logic verification method 100 further comprises: at least one test case is derived. In this way, retention may be facilitated.
According to the clinical test data logic checking method provided by the embodiment, the test subject file is automatically generated based on the obtained test case for testing according to the target protocol standard, so that the test case maintenance and manual test time are saved, and the data accuracy is guaranteed.
Fig. 2 is a schematic flow chart of a method for logically checking clinical trial data according to the second embodiment of the present application. The logic check method 200 shown in fig. 2 is different from the logic check method 100 shown in fig. 1 in that before step S120, the method further includes:
step S210, determining at least one target test case in the at least one test case based on the selection of the user.
The user can select the at least one input test case in the resource editor to select a part of the at least one test case as a target test case.
In this case, step S120 is specifically executed as:
step S220, a first subject file is generated 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 an output result and an expected result corresponding to each of the at least one target test case.
According to the clinical test data logical 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 input test case is realized, and the flexibility is stronger.
Fig. 3 is a schematic flow chart of a method for logically checking clinical trial data according to three embodiments of the present application. The difference between logic check method 300 shown in fig. 3 and logic check method 100 shown in fig. 1 is that after step S130, the method further includes:
step S310, at least one update 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 updating 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 get updated cases.
Step S320, generating a second subject file based on the data points of the at least one updated case and the second type of test case according to the target protocol standard.
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 updating case, the other type is a second type of test case with matched output results and expected results in the first test report, and a second subject file is generated according to the two types of cases.
Step S330, running a preset checking logic based on the second subject file to generate a second test report, where the second test report includes an output result and an expected result corresponding to each of the at least one updated case and the second type of test case.
According to the clinical trial data logic checking method provided by the embodiment, the second subject file is generated based on the data points of the at least one updating case and the second type of test case, so that the second test report is obtained, and the test case is debugged.
FIG. 4 is a schematic flow chart of a method for logically checking clinical trial data according to the fourth embodiment of the present application. The difference between logic check method 400 shown in fig. 4 and logic check method 100 shown in fig. 1 is that after step S130, the method further includes:
step S410, at least one updating case is obtained, and the updating case is obtained by adjusting the test case with inconsistent output result and expected result.
When the output result and the expected result are not matched in the first test report, the user can adjust the test case. For example, the unmatched test cases are overwritten in the resource editor to get updated cases.
Step S420, a third subject file is generated 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 the updating case, the other type is the test case with the output result matched with the expected result in the first test report, the system only generates a third subject file aiming at the updating case, namely, the user realizes the selection operation of the updating case while inputting the updating case. In other embodiments, the selection of the update case can also be realized based on the selection operation of the user. For example, before step S320, the method further includes: and acquiring the selected information of the user on at least one updating case.
Step S430, running a preset checking logic based on the third subject file to generate a third test report, where the third test report includes an output result and an expected result corresponding to each of the at least one update case.
According to the clinical trial data logical check method provided by the embodiment, the third subject file is generated based on the data point of the at least one update case, so that the third test report is obtained, and the test efficiency is improved.
Exemplary devices
Fig. 5 is a block diagram illustrating a structure of a clinical trial data logical check apparatus according to an embodiment of the present application. As shown in fig. 5, logic check device 50 includes: an acquisition module 51, a first generation module 52 and a second generation module 53. The obtaining module 51 is configured to obtain at least one test case entered by a user, where the test case includes at least one data point and an expected result corresponding to the at least one data point. The first generation module 52 is for generating a first subject file based on the data points of the at least one test case according to the target protocol standard. The second generating module 53 is configured to run a preset checking logic based on the first subject file to generate a first test report, where the first test report includes an output result and an expected result corresponding to each of the at least one test case.
In one embodiment, the first generation module 52 is specifically configured to determine a template file matching the storage structure; and filling the template file by using the clinical test data to obtain a first subject file.
In one embodiment, logic checker 50 further includes a determination module for determining at least one target test case from the at least one test case based on a selection of a user. 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 an embodiment, the obtaining module 51 is further configured to obtain at least one updating case, where the at least one testing case includes a first type of testing case where the output result is inconsistent with the expected result, and a second type of testing case where the output result is consistent with the expected result, and the updating case is obtained by adjusting the first type of testing 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 updated case and the second type of test case according to the target protocol standard. The second generating module 53 is further configured to run a preset checking logic based on the second subject file to generate a second test report, where the second test report includes an output result and an expected result corresponding to each of the at least one updated case and the second type of test case.
In one embodiment, the obtaining module 51 is further configured to obtain at least one updating case, where the at least one testing case includes a first type of testing case where the output result is inconsistent with the expected result, and the updating case is obtained by adjusting the first type of testing 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 standard. The second generating module 53 is further configured to run a preset checking logic based on the third subject file to generate a third test report, where the third test report includes an output result and an expected result corresponding to each of the at least one updated case.
The clinical trial data logic checking device provided by the embodiment of the present application belongs to the same application concept as the clinical trial data logic checking method provided by the embodiment of the present application, can execute the clinical trial data logic checking method provided by any embodiment of the present application, and has functional modules and beneficial effects corresponding to the execution of the clinical trial data logic checking method. The technical details that are not described in detail in this embodiment can be referred to the method for checking the clinical trial data logic provided in the embodiments of the present application, and are not described herein again.
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 a memory 62.
The processor 61 may be a Central Processing Unit (CPU) or other form of processing unit having data processing capabilities and/or instruction execution capabilities, and may control other components in the electronic device 60 to perform desired functions.
The 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), cache memory (or the like). The non-volatile memory may include, for example, Read Only Memory (ROM), a hard disk, flash memory, and the like. One or more computer program instructions may be stored on a computer readable storage medium and executed by processor 11 to implement the clinical trial data logic check method of the various embodiments of the present application described above and/or other desired functionality. Various content such as target protocol standards may also be stored in the computer readable storage medium.
In one example, the electronic device 60 may further include: an input device 63 and an output device 64, which are interconnected by a bus system and/or other form of connection mechanism (not shown).
The input means 63 may be, for example, a microphone or a microphone array for capturing an input signal of a sound source. The input means 63 may be a communication network connector for receiving an input signal when the electronic device is a stand-alone device. The input device 63 may also include, for example, a keyboard, a mouse, and the like.
The output device 64 may output various information including the determined distance information, direction information, and the like to the outside. Output devices 64 may include, for example, a display, speakers, a printer, and a communication network and remote output devices connected thereto, among others.
Of course, for the sake of simplicity, only some of the components of the electronic device 60 relevant to the present application are shown in fig. 6, and components such as buses, input/output interfaces, and the like 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 above-described methods and apparatus, embodiments of the present application may also be a computer program product comprising computer program instructions that, when executed by a processor, cause the processor to perform the steps in the target protocol standard according to various embodiments of the present application described in the above-mentioned "exemplary methods" section of this specification.
The computer program product may include program code for carrying out operations for embodiments of the present application 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 and 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 various embodiments of the present application described in the "exemplary methods" section above in this specification.
The computer-readable storage medium may take any combination of one or more readable media. The readable medium may be a readable signal medium or a readable storage medium. A readable storage medium may include, for example, but 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 the 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 foregoing describes the general principles of the present application in conjunction with specific embodiments, however, it is noted that the advantages, effects, etc. mentioned in the present application are merely examples and are not limiting, and they should not be considered essential to the various embodiments of the present application. Furthermore, the foregoing disclosure of specific details is for the purpose of illustration and description and is not intended to be limiting, since the foregoing disclosure is not intended to be exhaustive or to limit the disclosure to the precise details disclosed.
The block diagrams of devices, apparatuses, systems referred to in this application are only given as illustrative examples and are not intended to require or imply that the connections, arrangements, configurations, etc. must be made in the manner shown in the block diagrams. These devices, apparatuses, devices, systems may be connected, arranged, configured in any manner, as will be appreciated by those skilled in the art. Words such as "including," "comprising," "having," and the like are open-ended words that mean "including, but not limited to," and are used interchangeably therewith. The words "or" and "as used herein mean, and are used interchangeably with, the word" and/or, "unless the context clearly dictates otherwise. The word "such as" is used herein to mean, and is used interchangeably with, the phrase "such as but not limited to".
It should also be noted that in the devices, apparatuses, and methods of the present application, the components or steps may be decomposed and/or recombined. These decompositions and/or recombinations are to be considered as equivalents 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 only used for clearly explaining the technical solutions, and are not used for limiting the protection scope of the present application.
The foregoing description has been presented for purposes of illustration and description. Furthermore, the description is not intended to limit embodiments of the application to the form disclosed herein. While a number of example aspects and embodiments have been discussed above, those of skill in the art will recognize certain variations, modifications, alterations, additions and sub-combinations thereof.
Claims (10)
1. A method for logically reviewing clinical trial data, comprising:
obtaining 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;
generating a first subject file based on the data points of the at least one test case according to a target protocol standard;
running preset checking logic based on the first subject file to generate a first test report, wherein the first test report comprises the output result and the expected result corresponding to each of the at least one test case.
2. The method for logically reviewing clinical trial data as set forth in claim 1, wherein the data points include clinical trial data and a storage structure of the clinical trial data in a database; the target protocol standard comprises a template file corresponding to the storage structure; 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 with the clinical test data to obtain the first subject file.
3. The method for logically reviewing clinical trial data as set forth in 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's 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 comprises:
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 method for logically checking clinical trial data according to claim 1 or 2, further comprising:
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, and the updating case is obtained by adjusting the first type of testing case;
generating a second subject file based on the data points of the at least one updated case and 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 the output result and the expected result corresponding to each of the at least one updating case and the second type of test case.
5. The method for logically checking clinical trial data according to claim 1 or 2, further comprising:
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 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;
running preset checking logic based on the third subject file to generate a third test report, wherein the third test report comprises the output result and the expected result corresponding to each of the at least one update case.
6. The method of claim 1 or 2, wherein the target protocol standard comprises any one of a clinical data exchange standards association standard, a clinical data collection integration model, a research data listing model.
7. The method for logically checking clinical trial data according to claim 1 or 2, further comprising:
when the output result and the expected result do not match, highlighting the output result and/or the expected result in the test report.
8. A clinical trial data logical check apparatus, comprising:
the system comprises an acquisition module, a processing module and a display module, wherein the acquisition module is used for acquiring at least one test case input by a user, and the test case comprises at least one data point and an expected result corresponding to the at least one data point;
a first generation module to generate a first subject file based on the data points of the at least one test case according to a target protocol standard;
a second generating module, configured to run preset checking logic based on the first subject file to generate a first test report, where the first test report includes the output result and the expected result corresponding to each of the at least one test case.
9. 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 performs the steps of the method for logical check of clinical trial data according to any of claims 1 to 7.
10. A computer-readable storage medium, on which a computer program is stored, which, when being executed by a processor, carries out the steps of the method for logical check of clinical trial data according to any one of claims 1 to 7.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111266128.9A CN114005498A (en) | 2021-10-28 | 2021-10-28 | Clinical test data logic checking method and device, equipment and storage medium |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111266128.9A CN114005498A (en) | 2021-10-28 | 2021-10-28 | Clinical test data logic checking method and device, equipment and storage medium |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN114005498A true CN114005498A (en) | 2022-02-01 |
Family
ID=79924789
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202111266128.9A Pending CN114005498A (en) | 2021-10-28 | 2021-10-28 | Clinical test data logic checking method and device, equipment and storage medium |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN114005498A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116795725A (en) * | 2023-08-23 | 2023-09-22 | 长沙砝码柯数据科技有限责任公司 | Automatic library checking method and system of clinical electronic data acquisition system |
-
2021
- 2021-10-28 CN CN202111266128.9A patent/CN114005498A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116795725A (en) * | 2023-08-23 | 2023-09-22 | 长沙砝码柯数据科技有限责任公司 | Automatic library checking method and system of clinical electronic data acquisition system |
| CN116795725B (en) * | 2023-08-23 | 2023-11-17 | 长沙砝码柯数据科技有限责任公司 | Automatic library checking method and system of clinical electronic data acquisition system |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN109584975B (en) | Medical data standardization processing method and device | |
| US10657612B2 (en) | Claim processing validation system | |
| CN101739390B (en) | Data transformation based on a technical design document | |
| CN107799160B (en) | Medication aid decision-making method and device, storage medium and electronic equipment | |
| CN109524120B (en) | Automatic extraction and calculation method, system, equipment and storage medium for clinical data | |
| CN109599153B (en) | Medical data tracking method and device, storage medium and electronic equipment | |
| CN109524070B (en) | Data processing method and device, electronic equipment and storage medium | |
| CN109542966B (en) | Data fusion method and device, electronic equipment and computer readable medium | |
| CN111081329A (en) | Automatic clinical data entry method and device, electronic equipment and storage medium | |
| CN111090641A (en) | Data processing method and device, electronic equipment and storage medium | |
| US20150371203A1 (en) | Medical billing using a single workflow to process medical billing codes for two or more classes of reimbursement | |
| Sooter et al. | Modeling a clinical pathway for contraception | |
| KR102563038B1 (en) | System for standardized processing clinical trial data by therapeutic area | |
| Devine et al. | Preparing electronic clinical data for quality improvement and comparative effectiveness research: the SCOAP CERTAIN automation and validation project | |
| CN114005498A (en) | Clinical test data logic checking method and device, equipment and storage medium | |
| Soto-Rey et al. | Implementation of an ODM and HL7 compliant electronic patient-reported outcome system | |
| Kaloyanova et al. | Addressing data quality in healthcare | |
| CN115293155A (en) | Diagnostic word normalizing method and device | |
| CN115759040A (en) | Electronic medical record analysis method, device, equipment and storage medium | |
| US20160321124A1 (en) | Request processing system that maps errors to corresponding data sources | |
| US20230377697A1 (en) | System and a way to automatically monitor clinical trials - virtual monitor (vm) and a way to record medical history | |
| CN112331355B (en) | Disease type evaluation table generation method and device, electronic equipment and storage medium | |
| CN109616215B (en) | Medical data extraction method, device, storage medium and electronic equipment | |
| JP5583306B1 (en) | Information system and updating method thereof | |
| CN113077857A (en) | Medical data correlation method and device |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination |