CN113793657B

CN113793657B - Clinical trial data mapping method, device, computer equipment and storage medium

Info

Publication number: CN113793657B
Application number: CN202111364103.2A
Authority: CN
Inventors: 袁首; 王团团; 李东煊
Original assignee: Zhejiang Taimei Medical Technology Co Ltd
Current assignee: Zhejiang Taimei Medical Technology Co Ltd
Priority date: 2021-11-17
Filing date: 2021-11-17
Publication date: 2022-03-25
Anticipated expiration: 2041-11-17
Also published as: CN113793657A

Abstract

The embodiment of the specification provides a mapping method, a mapping device, a computer device, a storage medium and a computer program product for clinical trial data, wherein a domain configuration page is displayed, a mapping identifier of a submitted data template is displayed in the domain configuration page, and when the mapping identifier indicates that at least part of data items in the submitted data template are not mapped to the clinical trial data, a terminal sends a configuration instruction for the clinical trial data to a server, so that the server establishes a first mapping relationship between the clinical trial data and the data items which are not mapped to the clinical trial data. The mapping relation between the clinical test data and the submitted data template is established in a simple and direct human-computer interaction mode, a program manager is not needed to compile a data conversion script of the clinical test industry, and therefore labor cost and time cost spent in compiling the data conversion script in the traditional technology are reduced.

Description

Clinical trial data mapping method, device, computer equipment and storage medium

Technical Field

The present disclosure relates to the field of clinical trial data processing technologies, and in particular, to a method and an apparatus for mapping clinical trial data, a computer device, a storage medium, and a computer program product.

Background

The normalization and standardization of clinical trial data can promote and improve the efficiency and reliability of actual work. Therefore, several biotechnology and drug development companies have constructed CDISCs (The Clinical Data Interchange Standards Consortium). The CDISC proposes a clinical trial Data submission standard SDTM (Study Data distribution Mode, research Data table format). The regulatory pharmaceutical authorities require that clinical trial data be submitted in the SDTM format to assist them in reviewing and approving safety and efficacy data.

With respect to clinical trials of new products in medicine, the true integrity of clinical trial data is the basis for scientific and fair evaluation of the efficacy and safety of experimental drugs. Therefore, any operation on the clinical trial data is required to be traced, a workflow at each position needs to be executed by a corresponding role, and the logical relationship judgment corresponding to each data point and a series of working scenes need to be subjected to medical coding, so that software applied to the clinical trial industry contains sufficient business knowledge in the clinical medical industry.

When the clinical trial data is converted by using the industrial software of the conventional technology, firstly, a professional program manager spends a great deal of time writing a data conversion script, and secondly, the clinical trial data is converted into data satisfying the SDTM format by the data conversion script.

Disclosure of Invention

In view of the above, embodiments of the present disclosure are directed to providing a method, an apparatus, a computer device, a storage medium, and a computer program product for mapping clinical trial data, so as to solve the problem of huge labor cost and time cost for writing a data conversion script in the conventional technology.

The present specification embodiments provide a method of mapping clinical trial data, the method comprising: displaying a domain configuration page, wherein the domain configuration page is provided with a mapping identifier of a submitted data template, and the mapping identifier is used for representing the mapping condition between clinical trial data and the submitted data template; and sending configuration instructions for the clinical test data to a server under the condition that at least part of data items in the submitted data template are not mapped to the clinical test data, wherein the configuration instructions are used for instructing the server to establish a first mapping relation between the clinical test data and the data items which are not mapped to the clinical test data.

An embodiment of the present specification provides a method for mapping clinical trial data, the method comprising: under the condition that the mapping identification represents that at least part of data items in the submitted data template are not mapped to the clinical test data, receiving a configuration instruction of the clinical test data sent by a client; the mapping identifier is positioned in a domain configuration page displayed by the client, and is used for representing the mapping condition between the clinical trial data and the submitted data template; a first mapping relationship is established between the clinical trial data and data items not mapped to the clinical trial data according to the configuration instructions.

An embodiment of the present specification provides a clinical trial data mapping apparatus, the apparatus comprising: the domain configuration page display module is used for displaying a domain configuration page, wherein the domain configuration page is provided with a mapping identifier of a submitted data template, and the mapping identifier is used for representing the mapping condition between clinical trial data and the submitted data template; and the configuration instruction sending module is used for sending a configuration instruction of the clinical test data to a server under the condition that at least part of data items in the submitted data template are not mapped to the clinical test data, and the configuration instruction is used for instructing the server to establish a first mapping relation between the clinical test data and the data items which are not mapped to the clinical test data.

An embodiment of the present specification provides a clinical trial data mapping apparatus, the apparatus comprising: the system comprises a configuration instruction receiving module, a configuration instruction receiving module and a configuration instruction processing module, wherein the configuration instruction receiving module is used for receiving a configuration instruction of clinical test data sent by a client under the condition that a mapping identifier represents that at least part of data items in a submitted data template are not mapped to the clinical test data, the mapping identifier is positioned in a domain configuration page displayed by the client, and the mapping identifier is used for representing the mapping condition between the clinical test data and the submitted data template; and the mapping relation establishing module is used for establishing a first mapping relation between the clinical test data and the data item which is not mapped to the clinical test data according to the configuration instruction.

The present specification provides a computer device, which includes a memory and a processor, wherein the memory stores a computer program, and the processor implements the method steps in the above embodiments when executing the computer program.

The present specification provides a computer readable storage medium, on which a computer program is stored, which when executed by a processor implements the method steps in the above embodiments.

The present specification embodiments provide a computer program product, which includes instructions that, when executed by a processor of a computer device, enable the computer device to perform the method steps in the above embodiments.

In an embodiment of the present specification, a domain configuration page is displayed, and a mapping identifier of a submitted data template is displayed in the domain configuration page, and when the mapping identifier indicates that at least a part of data items in the submitted data template are not mapped to the clinical trial data, a terminal sends a configuration instruction for the clinical trial data to a server, so that the server establishes a first mapping relationship between the clinical trial data and the data items that are not mapped to the clinical trial data. The method and the device realize the establishment of the mapping relation between the clinical test data and the submitted data template in a simple and direct human-computer interaction mode, provide a reference basis for mapping the clinical test data to the submitted data, and no program manager is needed to compile a data conversion script in the clinical test industry, so that the labor cost and the time cost for compiling the data conversion script in the traditional technology are reduced.

Drawings

FIG. 1a is an interactive diagram illustrating a method for mapping clinical trial data in an example scenario provided by an embodiment.

Fig. 1b is a schematic diagram illustrating a source data upload page according to an embodiment.

FIG. 1c is a diagram illustrating a domain configuration page according to an embodiment.

FIG. 1d is a diagram illustrating a domain configuration page according to an embodiment.

FIG. 1e is a diagram illustrating a domain configuration page according to an embodiment.

FIG. 1f is a diagram illustrating a domain configuration page according to an embodiment.

FIG. 1g is a diagram illustrating a domain configuration page according to an embodiment.

Fig. 1h is a schematic diagram illustrating a variable mapping configuration page according to an embodiment.

Fig. 1i is a diagram illustrating an application environment of the method for mapping clinical trial data according to an embodiment.

Fig. 2 is a flowchart illustrating a method for mapping clinical trial data according to an embodiment.

Fig. 3 is a schematic diagram illustrating a domain configuration page according to an embodiment.

Fig. 4 is a flowchart illustrating a method for mapping clinical trial data according to an embodiment.

Fig. 5 is a schematic flowchart for determining a domain name of a custom domain according to an embodiment.

FIG. 6 is a flowchart illustrating a method for mapping clinical trial data according to an embodiment.

FIG. 7 is a flowchart illustrating a method for mapping clinical trial data according to an embodiment.

FIG. 8 is a flowchart illustrating a method for mapping clinical trial data according to an embodiment.

Fig. 9 is a block diagram showing a configuration of a clinical trial data mapping apparatus according to an embodiment.

Fig. 10 is a block diagram showing a configuration of a clinical trial data mapping apparatus according to an embodiment.

Fig. 11 is an internal configuration diagram of a computer device according to an embodiment.

Detailed Description

The technical solutions in some embodiments of the present specification will be clearly and completely described below with reference to the drawings in some embodiments of the present specification, and it is obvious that the described embodiments are only some embodiments of the present specification, but not all embodiments. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments in the present specification without any creative effort belong to the scope of the present specification.

In the following, some terms referred to in this specification are explained, and the source data (or data source) may be clinical trial data generated during a clinical trial. The source Data may be case form Data (such as demographic attribute Data, adverse event form, merged/past medication form, PK sample collection form, past medical history Data, blood donation history, allergy history, medication record form, coagulation function form, urine routine, blood routine, etc.) from an EDC (Electronic Data Capture System); medical data from an ECG (electrocardiogram information management system); but also medical data from other data systems. The regulatory body may be National Drug Administration (NMPA) in china, or Food and Drug Administration (FDA) in the united states.

The SDTM format specifies a Standard Domain (DOMAIN) required to deliver data, a Standard Variable (Variable Name or Variable Label) included in the Standard Domain. Accordingly, the data source form in the source data is sometimes also referred to as a source data field. The data source form may be a file configured according to a clinical trial protocol for recording clinical trial data for each subject during the trial. The data source Form may be a Case Report Form (CRF). The data source form may also be other forms generated during a clinical trial.

Clinical trials of drugs refer to systematic study of drugs in humans to determine the efficacy and safety of drugs. The clinical test stages of the medicine are divided into phase I, phase II, phase III clinical tests and phase IV clinical tests. Phase I is mainly related to preliminary clinical pharmacology and human safety evaluation tests. Phase II is understood to be the initial stage of treatment, which is primarily related to the initial assessment of the therapeutic effect and safety of the drug on the patient with the target indication, and also provides the basis for the design of phase III clinical trial studies and the determination of the dosage regimen for administration. Stage III can be understood as a treatment effect confirmation stage, which is mainly used for further verifying the treatment effect and safety of the drug on a target indication patient, evaluating the relationship between benefit and risk and finally providing a sufficient basis for the examination of a drug registration application. The stage IV is mainly a clinical test after the medicine is on the market, and after the medicine is on the market, the curative effect and adverse reaction of the medicine under the condition of wide use can be continuously tracked so as to evaluate the benefit and risk relationship in the use of ordinary or special people, improve the administration dosage and the like.

Since the format of the source data (e.g., case report form in clinical trial) does not meet the requirements of the regulatory administration of medicine (e.g., the SDTM format), a method of mapping clinical trial data is provided. The clinical trial data mapping method may be used in the process of converting the collected source data into a data format required by the medical regulatory body. For example, data submitted to the drug administration needs to meet the SDTM format, and according to the requirements of the SDTM, the submitted data needs to include a plurality of standard domains, and each standard domain includes a plurality of standard variables.

Please refer to fig. 1 a. In one particular example scenario, a user may access a web page provided by a platform server through a terminal. An operation interface of the terminal is provided with a source data uploading button, a user clicks the source data uploading button, after the terminal monitors that the source data uploading button is triggered, the terminal displays a source data uploading page 102 (as shown in fig. 1 b), the source data uploading page 102 is provided with a data importing control 104, the source data can be uploaded to a platform server through the data importing control 104 by adopting a mode of designating a source data storage path or dragging the source data, and the platform server obtains the source data. The source data includes a number of data source forms, with corresponding clinical trial data (e.g., demographic attribute data, adverse event data, merged/past medication data, past medical history data, blood donation history, allergy history, medication record, urine routine, blood routine, etc.) in different types of data source forms.

After the source data is uploaded to the platform server, the terminal exposes a domain configuration page 106 (as shown in fig. 1 c), and the domain configuration page 106 has a mapping identifier 108 for submitting the data template.

In some embodiments, the clinical trial data is appended in a data source form. Referring to FIG. 1d, the submitted data template includes standard fields (e.g., CO, DM, SE, etc.) that include standard variables (e.g., STUDYID, DOMAIN, USUBJID, SUBJID, etc.). The mapping identifier comprises a domain mapping identifier and a variable mapping identifier. In the event that at least a portion of the standard domains in the submitted data template are not mapped to clinical trial data, the domain-mapped identifications 110 for the portion of the standard domains are presented in a domain configuration page. In the event that at least some of the standard variables in the submitted data template are not mapped to clinical trial data, there is a variable mapping identifier 112 for that portion of the standard variables in the domain configuration page.

The mapping identifier is used for informing the user of the mapping between the clinical trial data and the submitted data template. In the event that data items (e.g., standard fields, standard variables) in the submitted data template do not fully successfully map to clinical trial data, the mapping identifier may alert the user to data items that do not map to clinical trial data. In the event that the mapping identity gives a reminder, the user may configure through the domain configuration page 106 for data items that do not map to clinical trial data. The terminal responds to the configuration operation of the clinical test data, the terminal sends a configuration instruction of the clinical test data to the platform server, the platform server receives the configuration instruction, and the platform server establishes a first mapping relation between the clinical test data and a data item which is not mapped to the clinical test data according to the configuration instruction.

In some embodiments, referring to fig. 1e, the domain configuration page 106 has a source data editing control 114, the user can click the source data editing control 114, the terminal monitors that the source data editing control 114 is triggered, displays a domain mapping configuration page 116 (see fig. 1 f), responds to the domain mapping configuration instruction of the user on the clinical trial data through the domain mapping configuration page 116, sends the domain mapping configuration instruction to the platform server, and the platform server receives the domain mapping configuration instruction and establishes a domain mapping relationship between the standard domain and the data source form according to the domain mapping configuration instruction.

In some embodiments, the data source form includes several fields. Referring to fig. 1g, the domain configuration page 106 has a field editing control 118, the user can click on the field editing control 118, the terminal monitors that the field editing control 118 is triggered, displays a variable mapping configuration page 120 (see fig. 1 h), and sends a variable mapping configuration instruction to the platform server through the variable mapping configuration page 120 in response to the variable mapping configuration instruction of the user on the clinical trial data. And the platform server receives the variable mapping configuration instruction and establishes a variable mapping relation between the standard variable and the field of the data source form according to the variable mapping configuration instruction.

Referring to fig. 1i, the present specification provides a clinical trial data mapping system. The clinical trial data mapping system may operate in a hardware environment formed by a terminal 122 and a server 124, with the terminal 122 communicating with the server 124 over a network. Specifically, the terminal 122 may present a domain configuration page. The domain configuration page is provided with a mapping identifier of the submitted data template, and the mapping identifier is used for representing the mapping condition between the clinical trial data and the submitted data template. Under the condition that at least part of data items in the submitted data template are not mapped to the clinical test data, the terminal 122 sends a configuration instruction of the clinical test data to the server 124, the server 124 receives the configuration instruction, and a first mapping relation is established between the clinical test data and the data items which are not mapped to the clinical test data according to the configuration instruction. The terminal 122 may be, but not limited to, various personal computers, notebook computers, smart phones, tablet computers, and portable wearable devices, and the server 124 may be implemented by an independent server or a server cluster composed of a plurality of servers. With the development of scientific technology, new computing devices, such as quantum computing servers, may be developed, and may also be applied to the embodiments of the present specification.

The method for mapping clinical trial data provided by the embodiments of the present specification can be applied to the application environment shown in fig. 1 i. Wherein the terminal 122 communicates with the server 124 through a network. The terminal 122 displays a source data uploading page, uploads clinical test data to the server 124 through the source data uploading page, and the server 124 performs matching mapping between the uploaded clinical test data and the submitted data template and returns the mapping between the clinical test data and the submitted data template to the terminal. The terminal displays a domain configuration page and has a mapping identifier for submitting the data template in the domain configuration page. When the mapping identifier indicates that the submitted data template is not mapped to the clinical trial data, the mapping relationship between the clinical trial data and the submitted data template needs to be manually established. Therefore, at this time, in response to the configuration operation on the clinical test data, the terminal sends a configuration instruction on the clinical test data to the server, and the server establishes a first mapping relation between the clinical test data and the submitted data template according to the configuration instruction. When the mapping identifier indicates that the submitted data template successfully maps to the clinical trial data, a second mapping relationship (which may also be referred to as an automatic mapping relationship) is automatically established between the clinical trial data and the submitted data template.

In some embodiments, the terminal may provide a source data editing page, and a data conversion control is provided in the source data editing page, and the data conversion control corresponds to the conversion function. Under the condition that the data conversion control is triggered, the corresponding conversion function is not executed temporarily, a first mapping relation between the clinical test data and the submitted data template is established through a provided configuration page, the execution control of the clinical test data is detected, under the condition that the execution control of the clinical test data is triggered, the clinical test data is mapped to the submitted data template through the established first mapping relation and the conversion function, the clinical test data is mapped to the submitted data template through the established second mapping relation, and the final submitted data meeting the submitting requirement can be obtained. Under the condition that the data conversion control is triggered, a conversion function can be called to carry out conversion processing on clinical test data in time, then a mapping relation between a conversion processing result and a submitted data template is established, and under the condition that the execution control of the clinical test data is triggered, the conversion processing result is mapped to the submitted data template according to the mapping relation between the conversion processing result and the submitted data template, so that final submitted data meeting the submitting requirements are obtained.

Please refer to fig. 2. One embodiment of the present specification provides a method of mapping clinical trial data. In some embodiments, the clinical trial data mapping method may be performed by a client. The client can run on the terminal electronic device. In particular, the client may run on the terminal in fig. 1i, for example. The clinical trial data mapping method may include the following steps.

And S210, displaying a domain configuration page.

Wherein the domain configuration page may be an entry page that provides configuration of clinical trial data. Specifically, the domain configuration page may be a web interface provided by platform software having a clinical trial data mapping function, or may be a user interface corresponding to the clinical trial data mapping function in clinical trial industry software. The submitted data template may be a data template for storing the submitted data. The mapping identifier may use different types of identifiers to inform the user of the mapping between the clinical trial data and the submitted data template. The mapping identifier can adopt a literal reminding identifier. The mapping identifier can also adopt a shape type reminding identifier. The mapping identification can also adopt a reminding identification symbol of a punctuation mark class.

Specifically, the submitted data template includes data items of different levels. And at the server side, each data item in the submitted data template can be mapped with the clinical test data, and the server obtains the mapping condition between the clinical test data and the submitted data template and returns the mapping condition to the terminal. The terminal may present the domain configuration page through the display. And the domain configuration page is provided with a mapping identifier for submitting the data template. Of course, in some embodiments, the domain configuration page may also be displayed on the terminal by using a naked-eye 3D technology or the like.

And S220, sending a configuration instruction of the clinical test data to a server under the condition that at least part of data items in the submitted data template are not mapped to the clinical test data.

Wherein the configuration instructions may be for instructing the server to establish a first mapping relationship between the clinical trial data and data items that are not mapped to the clinical trial data. The configuration instruction may be an instruction generated by configuring the corresponding relationship between the clinical trial data and the data items in the submitted data template through an operation interface provided by the terminal by the user. Data items in the submitted data template may be used to represent data units at different levels in the submitted data. In some embodiments, the data item may be an indivisible minimum unit of data in the rendered data, the data item may be a divisible intermediate unit of data in the rendered data, and the intermediate unit of data may directly or indirectly include the minimum unit of data. At least part of the data items in the submitted data template may be part of the data items in the submitted data template, or may be all of the data items in the submitted data template.

In particular, the mapping identifier may be used to represent a mapping between the clinical trial data and the submitted data template. When the mapping identifier indicates that at least a part of the data items in the submitted data template are not mapped to the clinical trial data, the clinical trial data needs to be configured to establish a corresponding relationship between the clinical trial data and the submitted data template. The terminal responds to the configuration operation of the clinical test data and sends a configuration instruction to the server. The configuration instruction may carry clinical trial data and a submitted data template for which a corresponding relationship needs to be established, and therefore, the server establishes a first mapping relationship between the clinical trial data and data items which are not mapped to the clinical trial data according to the configuration instruction.

In the method for mapping clinical test data, a domain configuration page is displayed, and a mapping identifier of a submitted data template is displayed in the domain configuration page, and when the mapping identifier indicates that at least part of data items in the submitted data template are not mapped to the clinical test data, a terminal sends a configuration instruction of the clinical test data to a server, so that the server establishes a first mapping relationship between the clinical test data and the data items which are not mapped to the clinical test data. The method and the device realize the establishment of the mapping relation between the clinical test data and the submitted data template in a simple and direct human-computer interaction mode, provide a reference basis for mapping the clinical test data to the submitted data, and no program manager is needed to compile a data conversion script in the clinical test industry, so that the labor cost and the time cost for compiling the data conversion script in the traditional technology are reduced.

In some embodiments, the mapping identity may be presented in at least one of the following ways: data item mapping failure indications are presented at corresponding positions of data items that are not mapped to clinical trial data. And displaying the data item mapping success identification at the corresponding position of the data item successfully mapped to the clinical test data. And under the condition that all data items in the submitted data template are successfully mapped to the clinical test data, displaying a template mapping success identifier at a corresponding position of the submitted data template. In the event that at least some of the data items in the submitted data template are not mapped to clinical trial data, a template mapping failure indication is presented at a corresponding location of the submitted data template.

In some implementations, the mapping identification may include a data item mapping failure identification. And displaying the data items which are not mapped to the clinical test data in the domain configuration page, and displaying data item mapping failure identifiers at corresponding positions of the data items which are not mapped to the clinical test data.

In some implementations, the mapping identification may include a data item mapping success identification. And displaying the data item successfully mapped to the clinical test data in the domain configuration page, and displaying a data item mapping success identifier at the corresponding position of the data item successfully mapped to the clinical test data. It should be noted that, different identifier symbols may be used for the data item mapping failure identifier and the data item mapping success identifier.

In some embodiments, the mapping identity may comprise a template mapping success identity. And under the condition that all data items in the submitted data template are successfully mapped to the clinical test data, displaying a template mapping success identifier at a position corresponding to the submitted data template in the domain configuration page.

In some implementations, the mapping identification may include a template mapping failure flag. And under the condition that at least part of data items in the submitted data template are not mapped to the clinical test data, displaying a template mapping failure identifier at a position corresponding to the submitted data template in the domain configuration page. It should be noted that, different identifier symbols may be used for the template mapping failure identifier and the template mapping success identifier.

In some embodiments, the terminal may monitor the mapping identifier, and when the terminal monitors that the mapping identifier is triggered, the terminal may remind the user of the mapping between the clinical trial data and the submitted data template in a text form or a voice form, for example, remind the user of a reason why the clinical trial data is not mapped to the clinical trial data, and further, for example, remind the user how to configure the clinical trial data, so as to establish a mapping relationship between the clinical trial data and the submitted data template.

In the embodiment, the mapping identifier is displayed on the domain configuration page in different modes, and the mapping condition between the clinical trial data and the submitted data template can be intuitively and quickly informed to the user in various different modes.

In some embodiments, the clinical trial data is appended to a data source form, and the submitted data template includes a standard field. The clinical trial data mapping method may further include: and displaying the domain mapping identification of the standard domain in a domain configuration page.

The domain mapping identification is used for representing the mapping condition between the standard domain and the data source form. The standard field may be a data structure required by the SDTM for recording clinical trial data generated by the subject's participation in the clinical trial process. Illustratively, the standard field may be AE (inverse Events). The standard domain may be CE (Clinical Events). The standard domain may be DM (Demographics ), etc. The submitted data template includes a standard field. The clinical trial data is appended to the data source form. A domain mapping relationship needs to be established between the data source form and the standard domain. In this way, when the submitted data meeting the submission requirement is obtained, the clinical trial data in the data source form can be mapped to the submitted data template according to the domain mapping relation.

Specifically, at the server side, each standard domain in the submitted data template can be mapped with clinical trial data, and the server obtains the mapping condition between the standard domain and the data source form and returns the mapping condition to the terminal. And the terminal displays a domain configuration page, wherein the domain configuration page is provided with a domain mapping identifier of the standard domain. In some embodiments, the gamut mapping identification of any standard gamut may be used to indicate that the standard gamut is not mapped to a data source form. In some embodiments, the domain-mapping identification of any standard domain may be used to indicate that the standard domain maps successfully to the data source form.

In some embodiments, when the domain mapping identifier indicates that at least a portion of the standard domains in the submitted data template are not mapped to the data source form, the data source form needs to be configured to establish a domain mapping relationship between the data source form and the standard domains. And the terminal responds to the configuration operation of the data source form and sends a configuration instruction to the server. The configuration instruction may carry a data source form and a standard domain that need to establish a corresponding relationship, and therefore the server establishes a domain mapping relationship between the data source form and the standard domain according to the configuration instruction.

In the embodiment, by displaying the domain mapping identifier on the domain configuration page, the mapping condition of the mapping condition between the user data source form and the standard domain can be intuitively and quickly informed in various different ways.

In some embodiments, the standard domain includes standard variables. The clinical trial data mapping method may further include: and a variable mapping identifier of the standard variable is arranged in the domain configuration page.

Wherein the variable mapping identifier represents a mapping condition between the standard variable and a field included in the data source form. Different standard domains correspond to respective standard variables. Illustratively, the standard field AE corresponds to a standard variable STUDYID (Study Identifier), USUBJID (Unique Subject Identifier), aesr (Sequence Number), and the like. Standard variables cesipid (Sponsor-Defined Identifier) corresponding to the standard field CE, CETERM (Reported Term for the clinical event, name of report of clinical event), CEDECOD (standardized-Defined Term), etc. The standard field includes standard variables. The data source form includes fields. A variable mapping relationship needs to be established between the field and the standard variable. In this way, when the submitted data meeting the submission requirement is obtained, the clinical trial data in the data source form can be mapped to the submitted data template according to the variable mapping relation.

Specifically, at the server side, each standard variable in the submitted data template can be mapped with clinical trial data, and the server obtains the mapping condition between the standard variable and the field included in the data source form and returns the mapping condition to the terminal. And the terminal displays a domain configuration page, and the domain configuration page is provided with a variable mapping identifier of a standard variable. In some embodiments, the variable mapping identification of any standard variable may be used to indicate that the standard variable does not map to a field contained in the data source form. In some embodiments, the variable mapping identification of any standard variable may be used to indicate that the standard variable successfully maps to the fields contained in the data source form.

In some embodiments, when the variable mapping identifier indicates that at least a part of standard variables in the submitted data template are not mapped to fields contained in the data source form, the fields contained in the data source form need to be configured to establish a variable mapping relationship between the fields contained in the data source form and the standard variables. And the terminal responds to the configuration operation of the fields contained in the data source form and sends a configuration instruction to the server. The configuration instruction may carry fields and standard variables included in the data source form for which the corresponding relationship needs to be established, and therefore, the server establishes a variable mapping relationship between the fields and the standard variables included in the data source form according to the configuration instruction.

Please refer to fig. 3. In some embodiments, the domain configuration page may also have an execution control 302 therein. The clinical trial data mapping method may further include: and when the standard domain is successfully mapped to the data source form and the standard variable is successfully mapped to the field contained in the data source form, sending an execution instruction to the server under the condition that the execution control is triggered.

The execution instruction is used for instructing the server to perform conversion processing on the data source form to obtain conversion data corresponding to the data source form. The execution control may be a button provided in the domain configuration page, and the user triggers the execution control to execute the button of the data conversion function by a simple operation (such as clicking).

Specifically, at the server side, the standard domain is mapped with the data source form, the standard variable is mapped with the field included in the data source form, the server returns the mapping condition between the standard domain and the data source form and the mapping condition between the standard variable and the field included in the data source form to the terminal, and the terminal displays the domain mapping identifier and the variable mapping identifier. When the standard domain is successfully mapped to the data source form and the standard variable is successfully mapped to the field contained in the data source form, the mapping can be represented by the domain mapping identifier and the variable mapping identifier.

In some embodiments, the domain mapping identifier and the variable mapping identifier both use identifier symbols representing successful mapping. When the domain mapping identifier indicates that the standard domain is successfully mapped to the data source form and the variable mapping identifier indicates that the standard variable is successfully mapped to the field contained in the data source form, the terminal monitors that the execution control is triggered, the terminal sends an execution instruction to the server, the server receives the execution instruction, and the server performs conversion processing on the data source form according to the execution instruction to obtain conversion data corresponding to the data source form.

In some embodiments, the domain mapping identifier and the variable mapping identifier may both use identifier symbols representing failed mappings. When the standard domain is successfully mapped to the data source form and the standard variable is successfully mapped to the field contained in the data source form, the domain mapping identifier and the variable mapping identifier may not be displayed in the domain configuration page. The user sees that the domain mapping identifier and the variable mapping identifier are not present in the domain configuration page (as shown in fig. 3), and can know that the standard domain is successfully mapped to the data source form and the standard variable is successfully mapped to the field contained in the data source form. At this time, the user may trigger the execution control 302, the terminal monitors that the execution control is triggered, the terminal sends an execution instruction to the server, the server receives the execution instruction, and the server performs conversion processing on the data source form according to the execution instruction to obtain conversion data corresponding to the data source form.

It is noted that, in some embodiments, the conversion data may be delivery data that satisfies a delivery format. In some embodiments, the converted data may also be understood as intermediate format data, and the intermediate format data needs some simple processing to obtain the delivery data in the delivery format.

In this embodiment, when the standard domain is successfully mapped to the data source form and the standard variable is successfully mapped to the field included in the data source form, an execution instruction is sent to the server, so that the server performs conversion processing on the data source form. The user sends interactive operation to the execution control, so that the data conversion work of the clinical trial industry can be completed, the requirement of the data conversion work on the programming capability of workers is lowered, and the personnel cost of enterprises is lowered.

Please refer to fig. 4. In some embodiments, the clinical trial data mapping method may further include the following steps.

And S410, providing a new control of the custom domain.

The custom field newly-added control can be a control for adding the custom field. The custom domain add-on control can be provided in at least one of the following ways. One is that the domain configuration page has a custom domain addition control. And the other method is that the operation interface of the terminal can display the target interface through multiple interface jumps, and the target interface is provided with a newly added control of a custom domain.

And S420, displaying the custom domain configuration page of the custom domain under the condition that the custom domain newly-added control is triggered.

The user-defined domain is an expansion part of the standard domain. The custom domain can be understood as an expansion domain corresponding to a part of standard domains required by the drug administration regulatory department, and is used for storing mapping residual data in a data source form having a mapping relation with the standard domains. The mapping surplus data may be understood as field data other than the field data mapped to the standard domain in the data source table having a mapping relationship with the standard domain. The data in the source data form may be more than is needed for the standard domain. Illustratively, a field in the data source form includes 500 characters, and the format requirement of the standard variable in the standard field is 200 characters, the top 200 characters in the order need to be obtained from the 500 characters of the field, in which case a corresponding custom field needs to be added, and the custom field is used for storing data corresponding to 300 characters except the top 200 characters in the order.

Specifically, the terminal monitors the newly added control of the custom domain, and when the newly added control of the custom domain is triggered, the configuration page of the custom domain is displayed in response to the triggering operation of the newly added control of the custom domain.

S430, according to the configuration instruction of the user-defined domain, displaying the domain name of the user-defined domain and the form name of the data source form to be mapped on a user-defined domain configuration page.

The data source form to be mapped is a form which has a mapping relation with the user-defined domain in the data source form.

Specifically, the configuration instruction for the custom domain may be a series of operation instructions. In some embodiments, a data source form pull-down control and a standard domain pull-down control can be provided in the custom domain mapping configuration page. And responding to the triggering operation of the data source form pull-down control, displaying the data source form list, selecting the data source form through the data source form list, and taking the selected data source form as the data source form to be mapped. And displaying the domain name of the custom domain on a custom domain configuration page. It is understood that the number of the data source forms to be mapped may be one or more. And the number of custom fields is one. And if the number of the data source forms to be mapped is multiple, respectively establishing mapping relations between the user-defined domain and the multiple data source forms to be mapped.

In some embodiments, in response to a trigger operation on the standard domain pull-down control, a standard domain list is displayed, a standard domain is selected through the standard domain list, and the selected standard domain is used as a standard domain to be expanded. And displaying the domain name of the custom domain on a custom domain configuration page based on the domain name of the standard domain to be expanded.

In the embodiment, by providing the new custom domain control and the custom domain configuration page, and displaying the domain name of the custom domain and the form name of the data source form to be mapped on the custom domain configuration page according to the configuration instruction of the custom domain, the mapping of clinical test data into the custom domain is implemented in a simple and direct human-computer interaction manner, and accurate and complete data can be submitted to the medical administration supervision department.

Please refer to fig. 5. In some embodiments, the following steps may be taken to determine the domain name of the custom domain.

And S510, displaying a standard domain list on a custom domain configuration page.

And S520, under the condition that any standard domain in the standard domain list is selected, taking the selected standard domain as a standard domain to be expanded.

S530, adding an expansion identification field for the domain name of the standard domain to be expanded to obtain the domain name of the user-defined domain.

Specifically, the custom domain configuration page is provided with a standard domain control, the terminal monitors the standard domain control, and when the standard domain control is triggered, the terminal responds to the triggering operation of the standard domain control and displays a standard domain list on the custom domain configuration page. There are several standard domains shown in the standard domain list. And under the condition that any standard domain in the standard domain list is selected, taking the selected any standard domain as a standard domain to be expanded. And adding an expansion identification field for the domain name of the standard domain to be expanded according to a preset rule to obtain the domain name of the user-defined domain. In some embodiments, a preset field is added to the domain name of the standard domain to be expanded to obtain the domain name of the custom domain. The preset field may employ SUPP.

In the embodiment, the domain name of the user-defined domain is obtained by adding the expansion identification field to the domain name of the standard domain to be expanded, so that the domain name of the user-defined domain is automatically generated, and the efficiency of mapping the clinical test data to the user-defined domain is improved.

Please refer to fig. 6. In some embodiments, the method of clinical trial data mapping further comprises the following steps.

S610, displaying a detection variable list in a custom domain configuration page.

S620, under the condition that any field name in the detection variable list is selected, a variable configuration instruction of the custom domain is sent to the server.

The fields in the detection variable list comprise other fields except the mapping fields in the data source form to be mapped, and the mapping fields are fields to which the standard variables of the standard domain to be expanded are successfully mapped in the data source form to be mapped. And the variable configuration instruction is used for indicating the server to establish a mapping relation between the selected field name and a preset standard variable of the user-defined domain.

Specifically, a variable detection control is arranged in the custom domain configuration page. And monitoring the variable detection control by the terminal. And when the variable detection control is monitored to be triggered, responding to the triggered operation of the variable detection control, and displaying a detection variable list in a custom domain configuration page. The list of detection variables includes a series of field names. Since the standard variables of the standard domain to be expanded have been successfully mapped to the partial fields in the data source form to be mapped, these successfully mapped partial fields may be referred to as mapping fields. The field data under the mapping field does not need to be mapped into the custom field, so that the mapping field is not displayed on the detected variable list, namely, the field in the detected variable list comprises other fields except the mapping field in the data source form to be mapped.

And under the condition that any field name in the detection variable list is selected, responding to the selection operation of any field name, and sending a variable configuration instruction of the custom domain to the server by the terminal. And the server establishes a mapping relation between the selected any field name and a preset standard variable of the user-defined domain according to the variable configuration instruction.

In the embodiment, by displaying the fields except the mapping field in the data source form to be mapped in the detection variable list, the operation error of the user can be avoided, and the operation difficulty and the operation cost of the user are reduced.

In some embodiments, the clinical trial data mapping method may further include: and displaying the preset standard variables of the custom domain in a domain configuration page.

Specifically, the preset standard variable may be a standard variable preset to belong to a custom domain. The number of the preset standard variables may be predetermined, for example, 10. The preset standard variables may include at least one of STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM, QLABEL, QVAL, and the like. The preset standard variables of the custom domain can be shown in a list form or a table form in the domain configuration page.

In the embodiment, the preset standard variable of the user-defined domain is displayed in the domain configuration page, so that the preset standard variable of the user-defined domain is visually displayed for the user, the user can configure the user-defined domain conveniently, and the user experience is improved.

In some embodiments, the preset standard variables include default variables, and the built-in functions of the default variables are in an invisible state.

Specifically, the number of default variables may be one or more. The default variable is provided with a corresponding built-in function, an entrance for editing the built-in function is not provided, the built-in function of the default variable can be set to be in an invisible state, and the built-in function of the default variable is in an uneditable state. Illustratively, the number of default variables is three, for example, the default variables may be QNAM, QLABEL, QVAL. The number of default variables is two, for example, the default variables may be QNAM, QVAL, or the default variables may be QLABEL, QVAL. In some embodiments, the name of the default variable of the custom domain is shown in the domain configuration page, and the built-in function of the default variable is not displayed.

In the embodiment, the built-in function for setting the default variable is in an invisible state, so that unnecessary operation of the built-in function for setting the default variable by a user is avoided.

In some embodiments, the clinical trial data mapping method further comprises at least one of the following steps: mapping the field name of any selected field to a default variable; mapping field data of any selected field to a default variable.

Specifically, in some embodiments, two default variables are provided, and the default variables are QNAM and QVAL, respectively, and any selected field is described by taking ATC as an example, and the field data corresponding to the field ATC is NERVOUS SYSTEM. The field name ATC is mapped to QNAM, and the field data as NERVOUS SYSTEM is mapped to QVAL.

In some embodiments, the default variables are QNAM, QLABEL, and QVAL, and any selected field is described as ATC, and the field data corresponding to the field ATC is NERVOUS SYSTEM. Mapping the field name ATC to QNAM, mapping the field name ATC to QLABEL, and mapping the field data as NERVOUS SYSTEM to QVAL.

In some embodiments, the clinical trial data mapping method may further include: and uploading the clinical test data to a server.

Wherein the clinical trial data is used for instructing the server to establish a second mapping relation between the clinical trial data and the data items successfully mapped to the clinical trial data under the condition that at least part of the data items in the submitted data template are successfully mapped to the clinical trial data.

Specifically, the clinical test data are added to the source data uploading page through the source data uploading page in the modes of source data file dragging, source data file selection and the like, and the source data are uploaded to a server in communication connection with the terminal through triggering a source data import control. The uploaded source data can comprise a plurality of data source forms, and each data source form can be displayed in a source data editing page. Clinical test data are attached to the data source form, the server obtains the clinical test data, and the submitted data template is mapped with the clinical test data. In the event that at least some of the data items in the submitted data template are successfully mapped to clinical trial data, the server establishes a second mapping between the clinical trial data and the data items successfully mapped to the clinical trial data.

In the embodiment, when the source data is uploaded to the server, the server can be triggered to map the submitted data template with the clinical test data, and a second mapping relation is automatically established between the clinical test data and the data item successfully mapped to the clinical test data, so that the difficulty of the conversion work of the clinical test data is greatly reduced, and the conversion efficiency of the clinical test data is improved.

In some embodiments, a method of mapping clinical trial data may be provided. The clinical trial data may be appended in a data source form that includes several fields. The submitted data template may include standard fields. The standard field may include a standard variable. The clinical trial data mapping method may include the following steps.

And S702, uploading the clinical test data to a server.

And S704, displaying a domain configuration page.

In some embodiments, the domain configuration page has a mapping identifier of the submitted data template, and the mapping identifier is used for representing the mapping condition between the clinical trial data and the submitted data template. Further, the mapping identifier is displayed in at least one of the following ways: presenting data item mapping failure identifiers at corresponding locations of data items that are not mapped to clinical trial data; displaying a data item mapping success identifier at a corresponding position of a data item successfully mapped to the clinical trial data; displaying a template mapping success identifier at a corresponding position of the submitted data template under the condition that each data item in the submitted data template is successfully mapped to the clinical test data; in the event that at least some of the data items in the submitted data template are not mapped to clinical trial data, a template mapping failure indication is presented at a corresponding location of the submitted data template.

In some embodiments, the domain configuration page has a domain mapping identification of a standard domain and/or a variable mapping identification of a standard variable. The domain mapping identifier is used for representing the mapping condition between the standard domain and the data source form. The variable map identifies a mapping between the representative standard variable and the fields included in the data source form.

In some embodiments, the domain configuration page has an execution control and a custom domain addition control.

And S706, sending a configuration instruction of the clinical test data to a server under the condition that at least part of data items in the submitted data template are not mapped to the clinical test data.

Wherein the configuration instructions are to instruct the server to establish a first mapping between the clinical trial data and data items that are not mapped to the clinical trial data.

And S708, when the standard domain is successfully mapped to the data source form and the standard variable is successfully mapped to the field contained in the data source form, sending an execution instruction to the server under the condition that the execution control is triggered.

The execution instruction is used for instructing the server to perform conversion processing on the data source form to obtain conversion data corresponding to the data source form.

And S710, displaying a custom domain configuration page of the custom domain under the condition that the custom domain newly-added control is triggered.

The user-defined domain is an expansion part of the standard domain.

And S712, according to the configuration instruction of the user-defined domain, displaying the domain name of the user-defined domain and the form name of the data source form to be mapped on the user-defined domain configuration page.

In some embodiments, the domain name of the custom domain is determined in the following manner: under the condition that the standard domain control is triggered, displaying a standard domain list on a custom domain configuration page; under the condition that any standard domain in the standard domain list is selected, taking the selected any standard domain as a standard domain to be expanded; and adding an expansion identification field for the domain name of the standard domain to be expanded to obtain the domain name of the user-defined domain.

And S714, under the condition that the variable detection control is triggered, displaying a detection variable list in a custom domain configuration page.

The fields in the detection variable list comprise other fields except the mapping fields in the data source form to be mapped, and the mapping fields are fields to which the standard variables of the standard domain to be expanded are successfully mapped in the data source form to be mapped.

S716, under the condition that any field name in the detection variable list is selected, sending a variable configuration instruction of the custom domain to the server.

The variable configuration instruction is used for indicating the server to establish a mapping relation between the selected field name and a preset standard variable of the user-defined domain.

S718, displaying the preset standard variable of the user-defined domain in the domain configuration page.

And S720, mapping the field name of any selected field to a default variable.

And S722, mapping field data of any selected field to a default variable.

Referring to fig. 7, in some embodiments, a method of mapping clinical trial data may be provided. The clinical trial data mapping method may be applied to the server in fig. 1 i. The method may include the following steps.

And S810, receiving a configuration instruction of the clinical test data sent by the client under the condition that the mapping identification indicates that at least part of data items in the submitted data template are not mapped to the clinical test data.

The mapping identifier is positioned in a domain configuration page displayed by the client, and is used for representing the mapping condition between the clinical trial data and the submitted data template;

and S820, establishing a first mapping relation between the clinical test data and the data items which are not mapped to the clinical test data according to the configuration instructions.

Referring to fig. 8, in some embodiments, the method for mapping clinical trial data may further include the following steps.

S910, receiving clinical test data uploaded by the client to the server.

S920, under the condition that at least part of data items in the submitted data template are successfully mapped to the clinical test data, establishing a second mapping relation between the clinical test data and the data items successfully mapped to the clinical test data.

For specific limitations of the clinical trial data mapping method applied to the server, reference may be made to the above limitations of the clinical trial data mapping method, which will not be described herein again.

It should be understood that, although the steps in the above-described flowcharts of fig. 2, 4, 5, 6, 7, and 8 are shown in order as indicated by arrows, the steps are not necessarily performed in order as indicated by the arrows. The steps are not performed in the exact order shown and described, and may be performed in other orders, unless explicitly stated otherwise. Moreover, at least some of the steps in the above-mentioned flowcharts 2, 4, 5, 6, 7 and 8 may include multiple steps or multiple stages, which are not necessarily performed at the same time, but may be performed at different times, and the order of performing the steps or stages is not necessarily sequential, but may be performed alternately or alternatively with other steps or at least some of the other steps.

In some embodiments, a clinical trial data mapping apparatus may be provided, and referring to fig. 9, the clinical trial data mapping apparatus 900 may include: a domain configuration page display module 902 and a configuration instruction sending module 904.

A domain configuration page display module 902, configured to display a domain configuration page, where the domain configuration page has a mapping identifier of a submitted data template, and the mapping identifier is used to represent a mapping between clinical trial data and the submitted data template;

a configuration instruction sending module 904, configured to send a configuration instruction for the clinical trial data to a server if at least a part of the data items in the submitted data template are not mapped to the clinical trial data, where the configuration instruction is used to instruct the server to establish a first mapping relationship between the clinical trial data and the data items that are not mapped to the clinical trial data.

In some embodiments, a clinical trial data mapping apparatus may be provided, and referring to fig. 10, the clinical trial data mapping apparatus 1000 may include: a configuration instruction receiving module 1002 and a mapping relation establishing module 1004.

A configuration instruction receiving module 1002, configured to receive a configuration instruction for clinical test data sent by a client when a mapping identifier indicates that at least a part of data items in the submitted data template are not mapped to the clinical test data; the mapping identifier is positioned in a domain configuration page displayed by the client, and is used for representing the mapping condition between the clinical trial data and the submitted data template;

a mapping relationship establishing module 1004 for establishing a first mapping relationship between the clinical trial data and data items not mapped to the clinical trial data according to the configuration instructions.

For specific limitations of the clinical trial data mapping apparatus, reference may be made to the above limitations of the clinical trial data mapping method, which are not described herein again. The modules in the clinical trial data mapping apparatus may be implemented in whole or in part by software, hardware, and combinations thereof. The modules can be embedded in a hardware form or independent from a processor in the computer device, and can also be stored in a memory in the computer device in a software form, so that the processor can call and execute operations corresponding to the modules.

In some embodiments, a computer device may be provided, and the computer device may be a terminal, and its internal structure diagram may be as shown in fig. 11. The computer device includes a processor, a memory, a communication interface, a display screen, and an input device connected by a system bus. Wherein the processor of the computer device is configured to provide computing and control capabilities. The memory of the computer device comprises a nonvolatile storage medium and an internal memory. The non-volatile storage medium stores an operating system and a computer program. The internal memory provides an environment for the operation of an operating system and computer programs in the non-volatile storage medium. The communication interface of the computer device is used for carrying out wired or wireless communication with an external terminal, and the wireless communication can be realized through WIFI, an operator network, NFC (near field communication) or other technologies. The computer program is executed by a processor to implement a method of clinical trial data mapping. The display screen of the computer equipment can be a liquid crystal display screen or an electronic ink display screen, and the input device of the computer equipment can be a touch layer covered on the display screen, a key, a track ball or a touch pad arranged on the shell of the computer equipment, an external keyboard, a touch pad or a mouse and the like.

Those skilled in the art will appreciate that the architecture shown in fig. 11 is merely a block diagram of some of the structures associated with some aspects of the present description, and is not intended to limit the computing devices to which the aspects of the present application may be applied, and that a particular computing device may include more or less components than those shown in fig. 11, or may combine certain components, or have a different arrangement of components.

In some embodiments, a computer device may be provided, comprising a memory and a processor, the memory having stored therein a computer program, the processor implementing the method steps of the above embodiments when executing the computer program.

In some embodiments, a computer-readable storage medium may be provided, on which a computer program is stored, which when executed by a processor implements the method steps in the above-described embodiments.

In some embodiments, a computer program product may be provided, comprising instructions which, when executed by a processor of a computer device, implement the method steps of the above-described embodiments.

It will be understood by those skilled in the art that all or part of the processes of the methods of the embodiments described above can be implemented by hardware instructions of a computer program, which can be stored in a non-volatile computer-readable storage medium, and when executed, can include the processes of the embodiments of the methods described above. Any reference to memory, storage, database or other medium used in the various embodiments provided herein can include at least one of non-volatile and volatile memory. Non-volatile Memory may include Read-Only Memory (ROM), magnetic tape, floppy disk, flash Memory, optical storage, or the like. Volatile Memory can include Random Access Memory (RAM) or external cache Memory. By way of illustration and not limitation, RAM can take many forms, such as Static Random Access Memory (SRAM) or Dynamic Random Access Memory (DRAM), among others.

The features of the above embodiments may be arbitrarily combined, and for the sake of brevity, all possible combinations of the features in the above embodiments are not described, but should be construed as being within the scope of the present specification as long as there is no contradiction between the combinations of the features.

The above description is only a few embodiments of the present disclosure, and should not be taken as limiting the present disclosure, and any modifications, equivalents and the like that are within the spirit and principle of the present disclosure should be included in the disclosure of the present disclosure.

Claims

1. A method of mapping clinical trial data, the method comprising:

uploading the clinical trial data to a server; wherein the clinical trial data is for instructing the server to map between data items of a submitted data template and clinical trial data; wherein, in the event that at least some of the data items in the submitted data template are successfully mapped to the clinical trial data, there is a second mapping between the clinical trial data and the data items successfully mapped to the clinical trial data; wherein, the submitted data template is a data template with a submitted format required by a drug administration supervision department;

displaying a domain configuration page, wherein the domain configuration page has a mapping identifier of a submitted data template, and the mapping identifier is used for representing a mapping condition between the clinical test data and the submitted data template; wherein the clinical trial data is attached to a data source form, and the mapping identifier comprises a domain mapping identifier, wherein the domain mapping identifier is used for representing the mapping between the standard domain included in the submitted data template and the data source form;

receiving, by the domain configuration page, a configuration operation for a mapping relationship of at least some data items that are not mapped to the clinical trial data, in the event that the mapping identification indicates that at least some data items in the submitted data template are not mapped to the clinical trial data; wherein, in the case that the domain mapping identification indicates that at least part of the standard domains in the submitted data template are not mapped to the data source form, the configuration operation comprises a configuration operation on the data source form;

in response to a configuration operation for a mapping relationship that does not map to at least a portion of data items of the clinical trial data, sending configuration instructions for the clinical trial data to a server, the configuration instructions for instructing the server to establish a first mapping relationship between the clinical trial data and data items that do not map to the clinical trial data; the first mapping relation provides reference basis for mapping the clinical test data to the submitted data, and the second mapping relation is used for mapping the clinical test data to the submitted data template; the configuration instruction carries a data source form and a standard domain which need to establish a corresponding relationship, and the configuration instruction is further used for indicating the server to establish a domain mapping relationship between the data source form and the standard domain which need to establish the corresponding relationship.

2. The method of claim 1, wherein the mapping identifier is presented in at least one of the following ways:

presenting a data item mapping failure identifier at a corresponding location of a data item that is not mapped to the clinical trial data;

displaying a data item mapping success identifier at a corresponding position of a data item successfully mapped to the clinical trial data;

displaying a template mapping success identifier at a corresponding position of the submitted data template under the condition that each data item in the submitted data template is successfully mapped to the clinical trial data;

in the event that at least some of the data items in the submitted data template are not mapped to the clinical trial data, presenting a template mapping failure indication at a corresponding location of the submitted data template.

3. The method of claim 1, wherein the standard field comprises a standard variable; the method further comprises the following steps:

and a variable mapping identifier of the standard variable is arranged in the domain configuration page, and the variable mapping identifier represents the mapping condition between the standard variable and the field included in the data source form.

4. The method of claim 3, wherein the domain configuration page further has an execution control therein; the method further comprises the following steps:

when the standard domain is successfully mapped to the data source form and the standard variable is successfully mapped to the field contained in the data source form, sending an execution instruction to the server under the condition that the execution control is triggered, wherein the execution instruction is used for instructing the server to convert the data source form to obtain conversion data corresponding to the data source form.

5. The method according to any one of claims 1 to 4, further comprising:

providing a new control of a custom domain;

under the condition that a user-defined domain new control is triggered, displaying a user-defined domain configuration page of a user-defined domain, wherein the user-defined domain is an expansion part of a standard domain;

and according to the configuration instruction of the user-defined domain, displaying the domain name of the user-defined domain and the form name of a data source form to be mapped on the user-defined domain configuration page, wherein the data source form to be mapped is a form which has a mapping relation with the user-defined domain in the data source form.

6. The method of claim 5, wherein determining the domain name of the custom domain is performed by:

displaying a standard domain list on the user-defined domain configuration page;

under the condition that any standard domain in the standard domain list is selected, taking the selected any standard domain as a standard domain to be expanded;

and adding an expansion identification field for the domain name of the standard domain to be expanded to obtain the domain name of the user-defined domain.

7. The method of claim 6, further comprising:

displaying a detection variable list in the user-defined domain configuration page; fields in the detection variable list comprise other fields except for mapping fields in the data source form to be mapped, and the mapping fields are fields to which the standard variables of the standard domain to be expanded are successfully mapped in the data source form to be mapped;

and under the condition that any field name in the detection variable list is selected, sending a variable configuration instruction of the custom domain to the server, wherein the variable configuration instruction is used for indicating the server to establish a mapping relation between the selected any field name and a preset standard variable of the custom domain.

8. The method of claim 7, further comprising:

and displaying the preset standard variable of the user-defined domain in the domain configuration page.

9. The method of claim 8, wherein the preset standard variable comprises a default variable, and wherein the built-in function of the default variable is in an invisible state.

10. The method of claim 9, further comprising at least one of:

mapping a field name of any of the selected fields to the default variable;

mapping field data of any of the selected fields to the default variable.

11. A method of mapping clinical trial data, the method comprising:

receiving the clinical test data uploaded by a client, and mapping between data items of a submitted data template and the clinical test data;

establishing a second mapping relationship between the clinical trial data and data items successfully mapped to the clinical trial data in the case that at least some data items in the submitted data template were successfully mapped to the clinical trial data; wherein, the submitted data template is a data template with a submitted format required by a drug administration supervision department;

under the condition that the mapping identification represents that at least part of data items in the submitted data template are not mapped to the clinical test data, receiving a configuration instruction of the clinical test data sent by a client; the mapping identifier is positioned in a domain configuration page displayed by the client, and is used for representing the mapping condition between the clinical trial data and the submitted data template; wherein the clinical trial data is attached to a data source form, and the mapping identifier comprises a domain mapping identifier, wherein the domain mapping identifier is used for representing the mapping between the standard domain included in the submitted data template and the data source form; the configuration instructions are generated by the client in response to a configuration operation received through the domain configuration page for a mapping that does not map to at least a portion of the data items of the clinical trial data; wherein, in the case that the domain mapping identification indicates that at least part of the standard domains in the submitted data template are not mapped to the data source form, the configuration operation comprises a configuration operation on the data source form; the configuration instruction carries a data source form and a standard domain which need to establish a corresponding relation; establishing a first mapping relationship between the clinical trial data and data items not mapped to the clinical trial data according to the configuration instructions; the first mapping relation provides reference basis for mapping the clinical test data to the submitted data, and the second mapping relation is used for mapping the clinical test data to the submitted data template; wherein the establishing a first mapping relationship between the clinical trial data and data items not mapped to the clinical trial data according to the configuration instructions comprises: and establishing a domain mapping relation between the data source form and the standard domain according to the configuration instruction, wherein the corresponding relation needs to be established.

12. A clinical trial data mapping apparatus, the apparatus comprising:

the domain configuration page display module is used for uploading the clinical test data to a server; displaying a domain configuration page, wherein the clinical trial data is used for instructing the server to map between data items of a submitted data template and the clinical trial data; wherein, in the event that at least some of the data items in the submitted data template are successfully mapped to the clinical trial data, there is a second mapping between the clinical trial data and the data items successfully mapped to the clinical trial data; wherein, the submitted data template is a data template with a submitted format required by a drug administration supervision department; the domain configuration page is provided with a mapping identifier of a submitted data template, and the mapping identifier is used for representing the mapping condition between clinical test data and the submitted data template; wherein the clinical trial data is attached to a data source form, and the mapping identifier comprises a domain mapping identifier, wherein the domain mapping identifier is used for representing the mapping between the standard domain included in the submitted data template and the data source form;

a configuration instruction sending module, configured to receive, through the domain configuration page, a configuration operation for a mapping relation of at least some data items that are not mapped to the clinical trial data, if the mapping identifier indicates that at least some data items in the submitted data template are not mapped to the clinical trial data; in response to a configuration operation for a mapping relationship that does not map to at least a portion of data items of the clinical trial data, sending configuration instructions for the clinical trial data to a server, the configuration instructions for instructing the server to establish a first mapping relationship between the clinical trial data and data items that do not map to the clinical trial data; the first mapping relation provides reference basis for mapping the clinical test data to the submitted data, and the second mapping relation is used for mapping the clinical test data to the submitted data template; wherein, in the case that the domain mapping identification indicates that at least part of the standard domains in the submitted data template are not mapped to the data source form, the configuration operation comprises a configuration operation on the data source form; the configuration instruction carries a data source form and a standard domain which need to establish a corresponding relationship, and the configuration instruction is further used for indicating the server to establish a domain mapping relationship between the data source form and the standard domain which need to establish the corresponding relationship.

13. A clinical trial data mapping apparatus, the apparatus comprising:

the configuration instruction receiving module is used for receiving the clinical test data uploaded by the client and mapping between data items of the submitted data template and the clinical test data; establishing a second mapping relationship between the clinical trial data and data items successfully mapped to the clinical trial data in the case that at least some data items in the submitted data template were successfully mapped to the clinical trial data; under the condition that the mapping identification represents that at least part of data items in the submitted data template are not mapped to the clinical test data, receiving a configuration instruction of the clinical test data sent by a client; wherein, the submitted data template is a data template with a submitted format required by a drug administration supervision department; the mapping identifier is positioned in a domain configuration page displayed by the client, and is used for representing the mapping condition between the clinical trial data and the submitted data template; wherein the clinical trial data is attached to a data source form, and the mapping identifier comprises a domain mapping identifier, wherein the domain mapping identifier is used for representing the mapping between the standard domain included in the submitted data template and the data source form; the configuration instructions are generated by the client in response to a configuration operation received through the domain configuration page for a mapping that does not map to at least a portion of the data items of the clinical trial data; wherein, in the case that the domain mapping identification indicates that at least part of the standard domains in the submitted data template are not mapped to the data source form, the configuration operation comprises a configuration operation on the data source form; the configuration instruction carries a data source form and a standard domain which need to establish a corresponding relation;

the mapping relation establishing module is used for establishing a first mapping relation between the clinical test data and a data item which is not mapped to the clinical test data according to the configuration instruction; the first mapping relation provides reference basis for mapping the clinical test data to the submitted data, and the second mapping relation is used for mapping the clinical test data to the submitted data template; the mapping relation establishing module is further used for establishing a domain mapping relation between the data source form and the standard domain according to the configuration instruction, wherein the data source form needs to establish the corresponding relation.

14. A computer device comprising a memory and a processor, the memory storing a computer program, characterized in that the processor realizes the steps of the method of any one of claims 1 to 11 when executing the computer program.

15. 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 of any one of claims 1 to 11.

16. A computer program product comprising instructions, characterized in that said instructions, when executed by a processor of a computer device, enable said computer device to perform the steps of the method according to any one of claims 1 to 11.