CN114116800A - Data logic checking method and system - Google Patents

Abstract

The disclosure relates to a data logic checking method and system. The method comprises the following steps: acquiring a form ID to be checked; acquiring a corresponding checking standard according to the ID of the form to be checked; and performing logic check on the form to be checked identified by the form ID to be checked according to the check specification. Through the data logic checking method and the data logic checking system, online cooperative office of DM personnel and DBD personnel can be realized, the data checking efficiency is improved, and the period of clinical test data management is shortened.

Description

Data logic checking method and system

Technical Field

The present disclosure relates generally to the field of clinical data processing. More particularly, the present disclosure relates to a data logic checking method and system.

Background

The quality of medical clinical test data is concerned with the success of the test, and the main purpose of data verification is to ensure the validity and correctness of the data.

In the prior art, data verification usually requires alternating operations of DBD personnel (Database Designer) and dm (data management) personnel, and can be realized by repeating and matching for many times. Specifically, a DBD person creates a database in an EDC System (Electronic Data Capture System) and then generates an ALS file; DM personnel adopt an Excel file mode to record a data check standard required to be determined during data check according to the ALS file, and generate a DVS file; DBD personnel create a data check code in an EDC system according to the DVS file; the DM personnel checks whether the code test data is correct through the data and delivers the test result to the DBD personnel; and the DBD personnel adjusts the codes according to the test result until the DM personnel generates a data checking report after determining that the data is correct, and the data checking is finished.

If the database in the EDC system is updated, the DBD personnel need to regenerate ALS files, the DM personnel rewrite DVS files according to the updated ALS files and deliver the DBD personnel again, and the steps are repeated until all the data needing to be checked are checked.

Therefore, in the prior art, the data checking process is complicated, DM personnel and DBD personnel cannot work cooperatively, and only after the current personnel finish the work, the subsequent personnel can perform the next operation, so that the time consumption is large, and the operation mode is too traditional; when the database in the EDC system is updated, the files are regenerated, the work related to personnel is repeated, and the time and the labor cost are greatly increased. In addition, the whole process of data checking adopts an offline Excel file mode for recording and transmission, so that the risk of data loss exists, the data checking specifications of past clinical tests cannot be unified and summarized and referenced, and the analysis and filing of the subsequent test data specifications cannot be carried out.

Therefore, how to obtain a more efficient and intelligent data logic checking method is a problem to be solved in the prior art.

Disclosure of Invention

In order to at least partially solve the technical problems mentioned in the background, the present disclosure provides a data logic checking method and system.

According to a first aspect of the present disclosure, the present disclosure provides a data logic checking method, wherein the method includes: acquiring a form ID to be checked; acquiring a corresponding checking standard according to the ID of the form to be checked; and performing logic check on the form to be checked identified by the form ID to be checked according to the check specification.

Optionally, the obtaining the corresponding verification specification according to the form ID to be verified includes: acquiring a corresponding form name according to the ID of the form to be checked; and acquiring the corresponding checking specification according to the form name.

Optionally, the obtaining a corresponding form name according to the form ID to be checked includes: and searching in a data logic checking database according to the ID of the form to be checked to obtain the corresponding form name.

Optionally, the data logical check database includes: an interview sub-library, a form sub-library, a variable sub-library, a data dictionary sub-library, a form and interview relation sub-library, a form and variable relation sub-library, and a variable and data dictionary relation sub-library.

Optionally, the logically checking, according to the checking specification, the to-be-checked form identified by the to-be-checked form ID includes: searching in the form and variable relation sub-library according to the ID of the form to be checked to obtain a variable ID corresponding to the ID of the form to be checked; searching in the variable and data dictionary relation sub-library according to the variable ID to obtain a data dictionary ID corresponding to the variable ID; searching in the variable sub-library and the data dictionary sub-library respectively according to the variable ID and the data dictionary ID, and respectively obtaining a variable name corresponding to the variable ID and data dictionary content corresponding to the data dictionary ID, wherein the variable name and the data dictionary content have a corresponding relation; and performing logic check on the data dictionary content according to the check specification.

Optionally, the verification specification comprises: form information, variable information, and audit logic information.

Optionally, the method further comprises: acquiring a corresponding variable name according to the ID of the form to be checked; and comparing the variable name with the variable name of the corresponding form of the previous version, and marking the difference between the variable name and the variable name.

According to a second aspect of the present disclosure, there is provided a data logic checking system, wherein the system comprises: the system comprises an acquisition module, a verification module and a verification module, wherein the acquisition module is configured to be used for acquiring a form ID to be verified and acquiring a corresponding verification standard according to the form ID to be verified; and the checking module is configured to perform logic checking on the form to be checked identified by the form ID to be checked according to the checking specification.

Optionally, the obtaining module is configured to obtain the verification specification by: acquiring a corresponding form name according to the ID of the form to be checked; and acquiring the corresponding checking specification according to the form name.

Optionally, the obtaining module is configured to obtain the form name by: and searching in a data logic checking database according to the ID of the form to be checked to obtain the corresponding form name.

Optionally, the system further includes a storage module, where the storage module is configured to store all to-be-checked forms involved in the logic check and related information thereof.

Optionally, the storage module includes the data logic check database, and the data logic check database includes: an interview sub-library, a form sub-library, a variable sub-library, a data dictionary sub-library, a form and interview relation sub-library, a form and variable relation sub-library, and a variable and data dictionary relation sub-library.

Optionally, the check module is configured to perform logic check in the following manner: searching in the form and variable relation sub-library according to the ID of the form to be checked to obtain a variable ID corresponding to the ID of the form to be checked; searching in the variable and data dictionary relation sub-library according to the variable ID to obtain a data dictionary ID corresponding to the variable ID; searching in the variable sub-library and the data dictionary sub-library respectively according to the variable ID and the data dictionary ID, and respectively obtaining a variable name corresponding to the variable ID and data dictionary content corresponding to the data dictionary ID, wherein the variable name and the data dictionary content have a corresponding relation; and performing logic check on the data dictionary content according to the check specification.

Optionally, the storage module is further configured to store the verification specification, where the verification specification includes: form information, variable information, and audit logic information.

Optionally, the system further includes a comparison module, and the obtaining module is further configured to obtain a corresponding variable name according to the form ID to be checked; the comparison module is used for comparing the variable name with the variable name of the corresponding form of the previous version and marking the difference between the variable name and the variable name.

According to a third aspect of the present disclosure, there is provided an electronic apparatus, wherein the electronic apparatus includes a memory and a processor, the memory stores a computer program, and the processor executes the computer program to implement the method of the first aspect of the present disclosure.

According to a fourth aspect of the present disclosure, there is provided a computer readable storage medium, wherein the storage medium stores a computer program which, when executed, implements the method of the first aspect of the present disclosure described above.

Through the data logic checking method and the data logic checking system, online cooperative office of DM personnel and DBD personnel can be realized, the data checking efficiency is improved, and the period of clinical test data management is shortened. In addition, the data logic check database is adopted to realize the associated management of the clinical test data and the unified management of the data logic check specification, so that the accuracy and the integrity of the clinical test data are ensured, a unified technical standard can be provided for the integration of the clinical test data logic check specification, and the data logic check database has reference and guidance significance for the data acquisition, check and analysis of subsequent similar clinical tests.

Drawings

The above and other objects, features and advantages of exemplary embodiments of the present disclosure will become readily apparent from the following detailed description read in conjunction with the accompanying drawings. In the drawings, several embodiments of the disclosure are illustrated by way of example and not by way of limitation, and like or corresponding reference numerals indicate like or corresponding parts and in which:

FIG. 1 is a flow diagram illustrating a method of data logic checking according to one embodiment of the present disclosure;

FIG. 2 is a schematic block diagram illustrating a data logic check system according to one embodiment of the present disclosure.

Detailed Description

The technical solutions in the embodiments of the present disclosure will be clearly and completely described below with reference to the drawings in the embodiments of the present disclosure, and it is obvious that the described embodiments are some, but not all embodiments of the present disclosure. All other embodiments, which can be derived by a person skilled in the art from the embodiments disclosed herein without making any creative effort, shall fall within the protection scope of the present disclosure.

Specific embodiments of the present disclosure are described in detail below with reference to the accompanying drawings.

The present disclosure provides a data logic checking method. Referring to fig. 1, fig. 1 is a flowchart illustrating a data logic checking method according to an embodiment of the present disclosure. As shown in fig. 1, the method comprises the following steps S101-S103. Step S101: and acquiring the ID of the form to be checked. Step S102: and acquiring a corresponding checking specification according to the ID of the form to be checked. Step S103: and performing logic check on the form to be checked identified by the form ID to be checked according to the check specification.

The data logic checking method is used for the data logic checking system to perform logic checking on the relevant form data of the clinical test. Through the data logic checking method disclosed by the invention, online cooperative office of DM personnel and DBD personnel can be realized, the data checking efficiency is improved, and the period of clinical test data management is shortened.

In step S101, a form ID to be checked may be acquired.

According to the embodiment of the present disclosure, the form ID (unique code) to be checked may be obtained in various manners, for example, the form ID may be manually input or selected by a DM person, or obtained through the related information of the clinical trial/item, or obtained through the related information of the form to be checked, and so on.

In this embodiment, the DM staff obtains the corresponding clinical trial through the clinical trial ID or the clinical trial related information (including, but not limited to, the clinical trial name, the keyword, etc.), and then selects the form to be checked, so that the data logic checking system obtains the ID of the form to be checked. The form ID to be checked may be a unique code for identifying the form to be checked, which is obtained according to the form name to be checked, the form remark to be checked, and other information.

Preferably, in the embodiment of the present disclosure, in order to facilitate management of each clinical trial, in the data logic check system, each clinical trial is identified by a clinical trial ID, an ALS file (referred to as a file with ALS as an extension) related to the clinical trial obtained from the EDC system is identified by an ALSID, and various examination reports or other forms contained in the ALS file are identified by a form ID. Wherein, the clinical trial ID can be obtained according to the clinical trial/project name or related information; the ALSID can be obtained according to ALS file name, clinical trial ID and ALS file version; the ID of the form to be checked can be obtained according to the name of the form to be checked, the remark of the form to be checked and the ALSID; each ID may be generated according to a preset algorithm and/or rule, for example, the ALSID may be formed by combining a code generated by hashing the related information with a version number, so that the ALSIDs of different versions of ALS files have a certain relevance.

In step S102, a corresponding verification specification may be obtained according to the form ID to be verified.

According to the embodiment of the disclosure, the corresponding checking specification can be obtained through the ID of the form to be checked, so that the logic checking can be performed on the related data of the form to be checked subsequently.

Preferably, the obtaining the corresponding checking specification according to the form ID to be checked includes: acquiring a corresponding form name according to the ID of the form to be checked; and acquiring the corresponding checking specification according to the form name.

Specifically, the form ID to be checked is used as the unique identifier of the form to be checked, and the form name of the form to be checked can be obtained according to the form ID to be checked, so that the corresponding checking specification can be obtained according to the form name. It is understood that the form name may be used to indicate the same type of inspection report or form, there may be one or more inspection specifications for the same type of inspection report or form, and one or more or all of the inspection specifications may be selected according to actual needs to perform logical inspection on the form to be inspected.

As an alternative embodiment, for a new form, there is no checking specification for the form in the data logic checking system, and then the checking specification may be created for the form, for example, the following steps may be included: acquiring a corresponding form to be checked according to the form ID to be checked; and acquiring a checking specification aiming at each key variable in the form to be checked, and storing the checking specification in association with the form name of the form to be checked. Specifically, the corresponding form to be checked is obtained according to the form ID to be checked, and the DM staff may set a checking specification for each key variable in the form to be checked, for example: the verification specification of "variable value positive" is set for the key variable "Hemoglobin (HGB)" in the blood routine table and submitted for storage.

Preferably, the obtaining the corresponding form name according to the form ID to be checked includes: and searching in a data logic checking database according to the ID of the form to be checked to obtain the corresponding form name.

Specifically, the embodiment of the present disclosure stores the relevant information, data, and the verification specification by using a data logic verification database. The data logic check database can be a large-scale database containing all relevant information, data and check specifications, and can also be composed of a plurality of sub-libraries, wherein the sub-libraries can be constructed according to actual needs.

Preferably, the data logic check database may include: an interview sub-library, a form sub-library, a variable sub-library, a data dictionary sub-library, a form and interview relation sub-library, a form and variable relation sub-library, and a variable and data dictionary relation sub-library. The visiting sub-library is used for storing and managing identification and information related to visiting; the form sub-library is used for storing and managing the identification and the information related to the form; the variable sub-library is used for storing and managing identification and information related to the variable; the data dictionary sub-library is used for storing and managing identification and information related to the variable value; the form and visit relation sub-library is used for storing and managing the corresponding relation between the visit and the form; the form and variable relation sub-library is used for storing and managing the corresponding relation between the form and the variable; and the variable and data dictionary relation sublibrary is used for storing and managing the corresponding relation between the variable and the variable value.

As a preferred embodiment, the method for establishing the data logic check database may include: obtaining clinical trial data, which may be derived from an electronic data capture system; extracting key information in the clinical test data and carrying out format conversion; carrying out duplicate removal on the data after format conversion, and generating a corresponding unique identifier for each piece of information after duplicate removal; and storing the information after the duplication removal and the unique identification thereof, and constructing the data logic check database. Wherein the electronic data capture system is preferably an EDC system.

Specifically, the ALS files obtained from the EDC system include: the views-oriented system comprises a flood sheet, a form sheet, a Fields sheet, a data dictionary sheet, and an interview flow chart sheet, wherein the flood sheet records interview-related information and comprises: visit name, visit remark, etc.; the Forms sheet records various form related information, including: form names, form remarks, and the like; fields sheet records information about various variables contained in various forms, including: form name, variable name, data dictionary name, variable remark, whether to repeat or not, whether to fill in, and the like; the datadictionary entries sheet records the relevant data values and relevant information of each variable, and comprises the following steps: data dictionary names, data dictionary content, data dictionary comments, and the like; the visit flow chart sheet records the corresponding relation between visits and forms, and comprises the following steps: visit name, form name, etc. In the visit flow chart sheet, if a certain visit does not include a certain form, the corresponding position in the table is null, for example, in the visit flow chart sheet, the behavior visit name a and the column a are form names, if visit 1 includes form 2 and form 3, and does not include form 1, the cell (B2B2) where visit 1 intersects with form 1 may be set to be null, and the cell (C3B2/C4B2) where visit 1 intersects with form 2/3 may be set to be a preset value (for example, a preset certain number or letter).

When each sub-library of the data logic checking database is established, firstly, key information in each Table in the acquired ALS file needs to be extracted, format conversion is carried out, the ALS file is converted into a Table or JSON data format, corresponding sub-libraries are constructed after duplication is removed, corresponding unique identifiers are generated according to each piece of key information, and the unique identifiers are associated with versions of the ALS file to which each Table belongs and clinical trials to which the ALS file belongs.

Specifically, when the access sub-library is established, information such as an access name, an access remark and the like can be extracted from the flood sheet, format conversion and de-duplication are performed, and then the information is stored together with the ALSID, and an access ID of each piece of access data is generated according to the access name, the access remark and the ALSID of each piece of access data and is stored in the access sub-library corresponding to each piece of access data. It is understood that, for the same version of an ALS file, its ALSID is consistent; for different visit names and/or different visit remarks, the visit IDs are different, namely the visit ID is the unique identifier of each visit data. Similarly, when the form sub-library is established, information such as form names and form remarks can be extracted from the Forms sheet, the form name, the form remarks and the like are subjected to format conversion and de-duplication and then are stored together with the ALSID, the form ID of each piece of form data is generated according to the form name, the form remark and the ALSID of each piece of form data, and the form ID and each piece of form data are correspondingly stored in the form sub-library; when the variable sub-library is established, information such as variable names, variable remarks, repeatability and filling necessity can be extracted from the Fields sheet, format conversion and de-duplication are carried out, then the information is stored together with the ALSID, the variable ID of each piece of variable data is generated according to the information of each piece of variable data and the ALSID, and the variable ID and each piece of variable data are stored in the variable sub-library correspondingly; when the data dictionary sub-library is established, information such as data dictionary names, data dictionary contents, data dictionary comments and the like can be extracted from the datadictionary entries, format conversion and de-duplication are performed, and then the extracted information and the ALSID are stored together, and respective variable IDs of each data dictionary are generated according to the information and the ALSID of each data dictionary and are stored in the data dictionary sub-library corresponding to each data dictionary. It can be understood that the form ID, the variable ID and the data dictionary ID are unique identifiers of each form data, variable data and data dictionary respectively; the data dictionary sub-library is used as a database for storing and managing variable values and related information thereof, wherein the content of the data dictionary refers to specific measured values and/or theoretical values (called "variable values" for short) of the variables.

For the form and the access relation sub-base, all data can be extracted from the access flow chart sheet, each line of data is traversed after format conversion, access names and form names corresponding to each non-null cell in the access flow chart sheet are obtained, the access names and the form names are respectively searched in the corresponding access sub-base and the corresponding form sub-base, the access IDs and the form IDs corresponding to the access names and the form IDs are obtained, the obtained access IDs and the form IDs are stored according to the corresponding relation, and the form and the access relation sub-base are constructed and obtained. For the form and variable relation sub-library, information such as a form name and a variable name can be extracted from the Fields sheet, duplication is removed after format conversion, the information is respectively searched in the corresponding form sub-library and variable sub-library to obtain a form ID and a variable ID which respectively correspond to the form name and the variable name, the obtained form ID and variable ID are stored according to the corresponding relation, and the form and variable relation sub-library is constructed and obtained. For the sub-library of the relationship between the variable and the data dictionary, information such as the name of the variable and the name of the data dictionary can be extracted from the Fields sheet, the duplication is removed after the format conversion, the information is respectively searched in the corresponding sub-library of the variable and the data dictionary to obtain the corresponding ID of the variable and the ID of the data dictionary, the obtained ID of the variable and the ID of the data dictionary are stored according to the corresponding relationship, and the sub-library of the relationship between the variable and the data dictionary is constructed.

Preferably, each sub-library is associated with the version of the ALS file to which the corresponding table belongs and the clinical trial to which the corresponding table belongs at the time of establishing, and for example, the corresponding ALSID and/or clinical trial ID can be stored in each sub-library to better manage the related data.

It is understood that each sub-library may be separately established for each clinical trial (i.e., established and managed in units of clinical trials), may be established in units of the same version of ALS file, or may be a unified management of all relevant data. Regardless of the form of management, the sub-library supports retrieval of relevant data/information using basic information such as clinical trial name, clinical trial ID, ALSID, clinical trial administrator/responsible person name/ID, etc. as an entry; meanwhile, the sub-libraries support searching by taking the ID and/or name information contained in the sub-libraries as entries.

In the embodiment of the disclosure, the key information of each table in the ALS file is processed and stored in each sub-library in the form of a transaction, and has the characteristics of Atomicity (Atomicity), Consistency (Consistency), Isolation (Isolation) and Durability (Durability), when an error occurs in data storage in any step, the system will give up all storage associated with the ALSID that has been completed before, and prompt the relevant personnel to check the ALS file identified by the ALSID, thereby avoiding data confusion.

Optionally, the check specification may be stored in one of the sub-libraries according to the corresponding relationship between the check specification and the form name, or the sub-library of the check specification may be separately established. The present embodiment preferably stores and manages the verification specification in the form of a verification specification sub-library.

As a preferred embodiment, checking the specification may include: form information, variable information, and check logic information, wherein the form information may be a form name and/or related information corresponding to the form name (e.g., form name abbreviation/code); the variable information may be a variable name and/or related information corresponding to the variable name (e.g., variable name abbreviation/code); the check logic information may be a logic check rule for each variable, and its presentation form may be set according to actual needs, for example: visit name, form name, variable name (operator) data dictionary content. The checking specifications can be stored in a checking specification sub-library one by one and can be retrieved through form names and/or variable names.

Preferably, the checking the specification may further include: the information of the state of the checking specification and the information of the creation process of the checking specification can be used for recording the current state of the piece of checking specification, and the information of the creation process of the checking specification can be used for recording all the information related to the creation of the piece of checking specification.

Specifically, checking the canonical status information may include, for example: audit (Rve), freeze (Frzn), and Lock (Lock), wherein "audit" indicates that the piece of check specification has been audited and confirmed by the relevant personnel, "freeze" indicates that the piece of check specification has been created within the EDC system to complete the corresponding check code, and "Lock" indicates that the corresponding check code of the piece of check specification has been tested within the EDC system. And checking the creation process of the specification by sequentially carrying out Rve, Frzn and Lock, and if any one of the processes is cancelled, cancelling the subsequent processes. Necessary information such as audit staff information of each node, reasons for canceling the process and the like in the creation process of the verification specification can be stored as verification specification creation process information so as to comprehensively manage the verification specification creation process.

Preferably, the verification specification may further include a Test Case (Test Case) for managing the Test Case used by the Test verification code. Each verification specification can have one or more test cases, and only when all the test cases pass the test, the test of the verification code corresponding to the verification specification is calculated to pass, and the state of the verification specification is changed into Lock. The test cases can be set according to actual needs, wherein the first test case can be automatically established according to the checking logic information. The fields contained by different test cases may differ, and the fields of a test case may include, for example, a number, a variable, a value, an Expected output (Expected output), a status, and the like.

The embodiment of the disclosure effectively improves the reusability and the normalization of the checking standard by creating the checking standard and uniformly managing the checking standard, so that the logic checking of the clinical test data is more efficient and convenient, and the checking process is more standardized and normalized. In addition, each role personnel can simultaneously operate on line, the data split is minimized, the single file integral processing of the clinical test in the prior art is changed into the online parallel processing of a plurality of ECs (logical check), the working efficiency of the clinical test data personnel is effectively improved, the data check accuracy is improved, and the method is favorable for obtaining high-quality clinical data.

In step S103, the to-be-checked form identified by the to-be-checked form ID may be logically checked according to the check specification.

According to the embodiment of the disclosure, logic Check (EC) can be performed on the relevant variables in the to-be-checked form according to the Check specification, so as to quickly find out the logic error of the relevant data through the logic Check.

Preferably, the logically checking the to-be-checked form identified by the to-be-checked form ID according to the checking specification includes: searching in the form and variable relation sub-library according to the ID of the form to be checked to obtain a variable ID corresponding to the ID of the form to be checked; searching in the variable and data dictionary relation sub-library according to the variable ID to obtain a data dictionary ID corresponding to the variable ID; searching in the variable sub-library and the data dictionary sub-library respectively according to the variable ID and the data dictionary ID, and respectively obtaining a variable name corresponding to the variable ID and data dictionary content corresponding to the data dictionary ID, wherein the variable name and the data dictionary content have a corresponding relation; and performing logic check on the data dictionary content according to the check specification.

The method and the device for locating the variable of the variable access device take the form name as an entry to obtain the corresponding check specification, and adopt the check specification to carry out logic check on the variable value of the relevant variable so as to quickly find out the variable which does not accord with the check specification, and locate the variable by obtaining the relevant information of the variable. Specifically, when a variable is found to be not in accordance with the check specification, the variable ID and the data dictionary ID of the variable can be obtained according to the variable name and the data dictionary content of the variable, and then the corresponding form ID and the visit ID can be obtained through database retrieval, so that the variable which is not in accordance with the check specification can be located to belong to a certain form for a certain visit, and convenience is provided for subsequent data adjustment.

As a preferred embodiment, the data logic checking method further includes: acquiring a corresponding variable name according to the ID of the form to be checked; and comparing the variable name with the variable name of the corresponding form of the previous version, and marking the difference between the variable name and the variable name.

In the preferred embodiment, if the ALS file is updated, the ALS file may be compared with the related data of the previous version, and the difference is marked, so that only the changed related data may be logically checked, and the efficiency of data checking is effectively improved.

Specifically, after the updated ALS file is uploaded to a data logic checking system, the ALS file name and the corresponding data such as the clinical trial ID to which the ALS file belongs are stored in an associated manner, and a unique identifier (new ALSID) of the updated ALS file is generated; then, by extracting and de-duplicating the key information, associating the key information with the new ALSID, and correspondingly storing the key information to each sub-library of the data logic check database (or establishing a new sub-library). And acquiring a corresponding variable name according to the ID of the form to be checked, comparing the variable name with the related data of the previous version, searching for the difference with the previous version, and marking the difference on the page. For the newly added variable, a new verification specification can be created for the newly added variable according to actual needs, or the existing verification specification is applicable. Therefore, the efficiency of data checking can be effectively improved, the applicability of checking specifications can be improved, repeated labor is avoided, and labor and time cost are saved.

The present disclosure also provides a data logic checking system. The system is configured to perform the steps in the embodiment of the data logic check method described above in connection with fig. 1.

Referring to FIG. 2, FIG. 2 is a schematic block diagram illustrating a data logic check system 100 according to one embodiment of the present disclosure. The system 100 includes an acquisition module 101 and a verification module 102. The obtaining module 101 is configured to obtain a form ID to be checked, and obtain a corresponding checking specification according to the form ID to be checked. The checking module 102 is configured to perform logic checking on the to-be-checked form identified by the to-be-checked form ID according to the checking specification.

According to an embodiment of the present disclosure, the obtaining module 101 is configured to obtain the verification specification by: acquiring a corresponding form name according to the ID of the form to be checked; and acquiring the corresponding checking specification according to the form name.

According to an embodiment of the present disclosure, the obtaining module 101 is configured to obtain the form name in the following manner: and searching in a data logic checking database according to the ID of the form to be checked to obtain the corresponding form name.

According to the embodiment of the disclosure, the system further comprises a storage module, and the storage module is used for storing all the forms to be checked related to the logic check and the related information thereof.

According to an embodiment of the present disclosure, the storage module includes the data logic check database, and the data logic check database includes: an interview sub-library, a form sub-library, a variable sub-library, a data dictionary sub-library, a form and interview relation sub-library, a form and variable relation sub-library, and a variable and data dictionary relation sub-library. Preferably, the data logic checking database further comprises a checking specification sub-library for storing the checking specification.

According to an embodiment of the present disclosure, the checking module 102 is configured to perform logic checking in the following manner: searching in the form and variable relation sub-library according to the ID of the form to be checked to obtain a variable ID corresponding to the ID of the form to be checked; searching in the variable and data dictionary relation sub-library according to the variable ID to obtain a data dictionary ID corresponding to the variable ID; searching in the variable sub-library and the data dictionary sub-library respectively according to the variable ID and the data dictionary ID, and respectively obtaining a variable name corresponding to the variable ID and data dictionary content corresponding to the data dictionary ID, wherein the variable name and the data dictionary content have a corresponding relation; and performing logic check on the data dictionary content according to the check specification.

According to an embodiment of the present disclosure, the verification specification includes: form information, variable information, and audit logic information.

According to an embodiment of the present disclosure, the verification specification further includes: checking the state information of the specification and the information of the creation process of the specification.

According to an embodiment of the present disclosure, the verification specification further includes a test case.

According to the embodiment of the disclosure, the system further comprises a comparison module, and the acquisition module is further configured to acquire a corresponding variable name according to the ID of the form to be checked; the comparison module is used for comparing the variable name with the variable name of the corresponding form of the previous version and marking the difference between the variable name and the variable name.

It is to be understood that, regarding the data logic check system in the embodiment described above with reference to fig. 2, the specific manner in which each module performs operations has been described in detail in the embodiment of the data logic check method described in conjunction with fig. 1, and will not be elaborated herein.

The data logic checking system can be matched with an EDC system to logically check clinical test data, effectively realizes the storage and management of the clinical test data and the logic checking specification, is favorable for ensuring the accuracy and the integrity of the clinical test data, can provide a uniform technical standard for the integration of the logic checking specification of the clinical test data, and has reference and guidance significance for the data acquisition, checking and analysis of subsequent similar clinical tests. In addition, the data logic checking system disclosed by the invention can enable related personnel to work cooperatively online, effectively improve the data checking efficiency and shorten the period of clinical trial data management.

An embodiment of the present disclosure further provides an electronic apparatus, where the electronic apparatus includes a memory and a processor, where the memory stores a computer program, and when the processor executes the computer program, the following steps are implemented: acquiring a form ID to be checked; acquiring a corresponding checking standard according to the ID of the form to be checked; and performing logic check on the form to be checked identified by the form ID to be checked according to the check specification.

It is understood that the steps implemented when the computer program is executed by the processor are substantially the same as the implementation of the steps in the above method, and the specific manner is described in detail in the embodiment of the data logic checking method, and will not be elaborated herein.

In another aspect, the present disclosure provides a computer-readable storage medium, wherein the storage medium stores a computer program that, when executed, implements the steps of: acquiring a form ID to be checked; acquiring a corresponding checking standard according to the ID of the form to be checked; and performing logic check on the form to be checked identified by the form ID to be checked according to the check specification.

It is understood that the steps implemented when the computer program is executed by the processor are substantially the same as the implementation of the steps in the above method, and the specific manner is described in detail in the embodiment of the data logic checking method, and will not be elaborated herein.

The embodiments of the present disclosure are described in detail above, and the principles and embodiments of the present disclosure are explained herein by applying specific embodiments, and the descriptions of the embodiments are only used to help understanding the method and the core ideas of the present disclosure; meanwhile, for a person skilled in the art, based on the idea of the present disclosure, there may be variations in the specific embodiments and the application scope, and in summary, the content of the present disclosure should not be construed as a limitation to the present disclosure.

It should be understood that the terms "first" and "second," etc. in the claims, description, and drawings of the present disclosure are used for distinguishing between different objects and not for describing a particular order. The terms "comprises" and "comprising," when used in the specification and claims of this disclosure, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.

It is also to be understood that the terminology used in the description of the disclosure herein is for the purpose of describing particular embodiments only, and is not intended to be limiting of the disclosure. As used in the specification and claims of this disclosure, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should be further understood that the term "and/or" as used in the specification and claims of this disclosure refers to any and all possible combinations of one or more of the associated listed items and includes such combinations.

The embodiments of the present disclosure have been described in detail, and the principles and embodiments of the present disclosure are explained herein using specific examples, which are provided only to help understand the method and the core idea of the present disclosure. Meanwhile, a person skilled in the art should, based on the idea of the present disclosure, change or modify the specific embodiments and application scope of the present disclosure. In view of the above, the description is not intended to limit the present disclosure.

Claims (11)

1. A method for data logic verification, wherein the method comprises:

acquiring a form ID to be checked;

acquiring a corresponding checking standard according to the ID of the form to be checked;

and performing logic check on the form to be checked identified by the form ID to be checked according to the check specification.

2. The method for checking data logic according to claim 1, wherein the obtaining of the corresponding checking specification according to the form ID to be checked includes:

acquiring a corresponding form name according to the ID of the form to be checked;

and acquiring the corresponding checking specification according to the form name.

3. The method for checking data logic according to claim 2, wherein the obtaining of the corresponding form name according to the form ID to be checked includes:

and searching in a data logic checking database according to the ID of the form to be checked to obtain the corresponding form name.

4. The data logic check method of claim 3, wherein the data logic check database comprises: an interview sub-library, a form sub-library, a variable sub-library, a data dictionary sub-library, a form and interview relation sub-library, a form and variable relation sub-library, and a variable and data dictionary relation sub-library.

5. The method for logically checking data according to any one of claims 1 to 4, wherein the logically checking the form to be checked identified by the form ID to be checked according to the checking specification includes:

searching in the form and variable relation sub-library according to the ID of the form to be checked to obtain a variable ID corresponding to the ID of the form to be checked;

searching in the variable and data dictionary relation sub-library according to the variable ID to obtain a data dictionary ID corresponding to the variable ID;

searching in the variable sub-library and the data dictionary sub-library respectively according to the variable ID and the data dictionary ID, and respectively obtaining a variable name corresponding to the variable ID and data dictionary content corresponding to the data dictionary ID, wherein the variable name and the data dictionary content have a corresponding relation;

and performing logic check on the data dictionary content according to the check specification.

6. The data logic checking method according to any one of claims 1 to 5, wherein the checking specification includes: form information, variable information, and audit logic information.

7. The method of claim 1, wherein the method further comprises:

acquiring a corresponding variable name according to the ID of the form to be checked;

and comparing the variable name with the variable name of the corresponding form of the previous version, and marking the difference between the variable name and the variable name.

8. A data logic checking system, wherein the system comprises:

the system comprises an acquisition module, a verification module and a verification module, wherein the acquisition module is configured to be used for acquiring a form ID to be verified and acquiring a corresponding verification standard according to the form ID to be verified;

and the checking module is configured to perform logic checking on the form to be checked identified by the form ID to be checked according to the checking specification.

9. The data logic checking system according to claim 8, wherein the system further includes a comparison module, and the obtaining module is further configured to obtain a corresponding variable name according to the form ID to be checked; the comparison module is used for comparing the variable name with the variable name of the corresponding form of the previous version and marking the difference between the variable name and the variable name.

10. An electronic device, wherein the electronic device comprises a memory having a computer program stored therein and a processor that, when executed, implements the method of any of claims 1-7.

11. A computer-readable storage medium, wherein the storage medium stores a computer program which, when executed, implements the method of any of claims 1 to 7.

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