CN114155924A

CN114155924A - Clinical test data processing method and device, computer equipment and storage medium

Info

Publication number: CN114155924A
Application number: CN202111527523.8A
Authority: CN
Inventors: 邹兵; 刘涛; 李海为
Original assignee: Zhejiang Taimei Medical Technology Co Ltd
Current assignee: Zhejiang Taimei Medical Technology Co Ltd
Priority date: 2021-12-14
Filing date: 2021-12-14
Publication date: 2022-03-08

Abstract

The embodiment of the specification provides a clinical test data processing method, a clinical test data processing device, a computer device, a storage medium and a computer program product. The method comprises the steps of receiving a data writing request of a first client, writing target clinical trial data attached to the data writing request into a target database which stores shared data of the first client and a second client; the target clinical trial data read from the target database is provided to the user interface of the second client upon receiving the first data read request by the second client for the target clinical trial data. After the user operates the clinical test data at the first client, the user can directly read the data from the target database when using the second client, and the previous labor does not need to be repeated again, so that the processing efficiency of the clinical test data is improved, and the workload of workers is reduced.

Description

Clinical test data processing method and device, computer equipment and storage medium

Technical Field

The embodiment of the specification relates to the technical field of clinical test data processing, in particular to a clinical test data processing method, a clinical test data processing device, a computer device, a storage medium and a computer program product.

Background

In recent years, with the development of clinical trial industry, the disadvantages of the offline inspection mode become more prominent, and more clinical trial software products are beginning to be used, such as clinical trial project management systems, electronic data acquisition systems, randomization and supply systems, patient electronic reporting systems, and the like. As clinical research projects advance, at least two clinical trial software products are required to be used simultaneously.

In the conventional technology, for the situation that a certain clinical trial project needs to use two clinical trial software products at the same time, a user needs to input some clinical trial data in each clinical trial software product respectively.

However, the clinical trial data respectively entered in the clinical trial software products may be the same, and there is some repetitive labor in the operation of the clinical trial data in the conventional technology, which increases the workload of the worker.

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 processing clinical trial data, so as to solve the technical problem of low efficiency of processing clinical trial data in the conventional technology.

An embodiment of the present specification provides a clinical trial data processing method, including: receiving a data writing request of a first client; wherein the data write request is accompanied by target clinical trial data; the target clinical test data is common data of the first client and the second client; wherein the first client is different from the second client; writing the target clinical trial data to a target database; the target database is used for storing common data of the first client and the second client; providing the target clinical trial data read from the target database to a user interface of the second client upon receiving a first data read request by the second client for the target clinical trial data.

The embodiment of the specification provides a clinical test data processing method, which is applied to a second client; the method comprises the following steps: sending a first data reading request to a server; receiving target clinical test data which is returned by the server and read from a target database; the target clinical test data is attached to a data writing request of the first client and written into a target database by the server; the target database stores shared data of the second client and the first client; wherein the first client is different from the second client.

An embodiment of the present specification provides a clinical trial data processing apparatus, the apparatus including: the write-in request receiving module is used for receiving a data write-in request of a first client; wherein the data write request is accompanied by target clinical trial data; the target clinical test data is common data of the first client and the second client; wherein the first client is different from the second client; a target data writing module for writing the target clinical trial data into a target database; the target database is used for storing common data of the first client and the second client; a target data providing module, configured to provide the target clinical test data read from the target database to a user interface of the second client when a first data read request for the target clinical test data by the second client is received.

The embodiment of the specification provides a clinical test data processing device which is applied to a second client; the device comprises: the reading request sending module is used for sending a first data reading request to the server; the target data receiving module is used for receiving target clinical test data which is returned by the server and read from a target database; the target clinical test data is attached to a data writing request of the first client and written into a target database by the server; the target database stores shared data of the second client and the first client; wherein the first client is different from the second client.

The present specification provides a computing device, comprising a memory and a processor, wherein the memory stores a computer program, and the processor implements the method steps of 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 the embodiment of the specification, target clinical trial data attached to a data write request is written into a target database in which data shared by a first client and a second client is stored by receiving the data write request from the first client; the target clinical trial data read from the target database is provided to the user interface of the second client upon receiving the first data read request by the second client for the target clinical trial data. After the user operates the clinical test data at the first client, the user can directly read the data from the target database when using the second client, and the previous labor does not need to be repeated again, so that the processing efficiency of the clinical test data is improved, and the workload of workers is reduced.

Drawings

FIG. 1a is an interactive diagram illustrating a method for processing clinical trial data in an exemplary scenario provided in an embodiment;

FIG. 1b is an interactive diagram illustrating a method for processing clinical trial data in an exemplary scenario provided in an embodiment;

FIG. 1c is a diagram illustrating an application environment of a method for processing clinical trial data according to an embodiment;

FIG. 2a is a schematic flow chart of a method for processing clinical trial data according to an embodiment;

FIG. 2b is a diagram illustrating a field sharing configuration page according to an embodiment;

FIG. 3 is a flow chart illustrating a method for processing clinical trial data according to one embodiment;

FIG. 4 is a block diagram of a clinical trial data processing apparatus according to an embodiment;

FIG. 5 is a block diagram of a clinical trial data processing apparatus according to an embodiment;

fig. 6 is an internal structural diagram of a computer device according to an embodiment.

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 only a part of the embodiments of the present disclosure, and not all of the embodiments. All other embodiments obtained by a person of ordinary skill in the art without any inventive work based on the embodiments in the present specification belong to the protection scope of the present specification.

In the following, some terms referred to in the present specification are explained, and the clinical trial of a drug refers to a systematic study of drugs in humans to determine the efficacy and safety of the drug. 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.

Different subjects need to be involved in the clinical trial process, such as pharmaceutical companies, Contract Research Organization (CRO), etc. Clinical CRO is mainly based on clinical research services, including phase I to IV clinical trial technical services, clinical trial data management and statistical analysis, registration declaration, post-marketing drug safety monitoring and marketing services, and the like. Pharmaceutical enterprises may choose different CRO companies based on different drug development needs, thereby expanding data resources and saving time and cost. During the clinical test, different clients, such as EDC software, IWRS software, CTMS software, PLM software, Epro software and the like, are needed by different staff. These clients may be implemented in the form of an application program (a computer program that performs one or more specific tasks), an applet (an application that can be used without downloading and installing), or a series of front-end technologies such as HTML5, CSS3, JavaScript, etc. These clients may also be implemented using a SaaS platform (Software-as-a-Service), and access a specific website through a browser, which displays a user interface of each client provided by the server. And responding to user operation through the user interface of each client to realize a preset function so as to assist the progress of clinical trial research work.

Among them, EDC (Electronic Data Capture System) is a platform software suitable for functions such as clinical trial Data acquisition and transmission. IWRS (Interactive Web Response System, clinical trial random group entry and drug delivery System) clinical random and flexible drug delivery is suitable for platform software with the functions of trial random, clinical random drug delivery, drug management, emergency blindness uncovering and the like. CTMS (Clinical research Management System) is a platform software for managing and controlling personnel, communication, budget, progress, cost, documents, declaration, etc. involved in the entire Clinical Trial. CTMS may be a clinical research project management tool provided by pharmaceutical drug research and development departments, independent new drug research units with clinical research functions, and Contract Research Organizations (CROs). The PLM (Product Lifecycle Management) may be an application solution applied to creation, Management, distribution, and application of information supporting a full Lifecycle of a Product between enterprises having a collaborative relationship in the Product research and development field, within an enterprise at a single location, dispersed within enterprises at multiple locations, and the like. PLM systems can be used to manage drawings and documents. ePro (Electronic Patient-reported Outcome, Patient-reported clinical Outcome) can be a report directly from the Patient on his own health, functional status, and treatment experience, without including interpretation by paramedics and anyone else. The ePro can provide more powerful reference for the diagnosis and treatment of doctors and has very important significance for clinical treatment practice.

The Case Report Form (CRF) may be an electronic file designed to the protocol requirements of the test, which is reported to the sponsor, and is used to record all information about each subject during the test. The case report form is the vehicle for collecting, recording and storing clinical trial data. Case Report forms (Case Report Form, CRF) include demographic attributes forms, adverse event forms, merge/past medication forms, PK sample collection forms, past medical history data forms, blood donation history forms, allergy history forms, medication records forms, coagulation function forms, urine routine forms, blood routine forms, and the like.

Please refer to fig. 1 a. In one specific scenario example, the EDC software and the IWRS software, and the access service generic components, have been pre-deployed on the platform server prior to the initiation of the clinical trial. The access service general-purpose component provides access interfaces for EDC software and IWRS software. The visit service generic component may be provided with a CRF data construction service and a generic data mount service. The general component of the visit service corresponds to a target database. Common data of the EDC software and the IWRS software are stored in the target database. The first terminal of the first user has access to the EDC software. The second terminal of the second user has access rights of the IWRS software. The first user constructs the CRF and collects clinical trial data via EDC software.

In particular, in some embodiments, it is desirable to configure study event data during the construction of CRFs in a clinical trial study program. The first terminal accesses a research event configuration page provided by EDC software, target research event data input by a first user is received through the research event configuration page, and a data write-in request of the research event data is sent to the platform server by the first terminal, wherein the data write-in request carries the target research event data. The platform server writes the target research event data to the target database. During the development of the clinical trial study, IWRS software needs to be introduced, which also needs to use the study event data. Since the research event data is already constructed by the first user in the process of constructing the CRF through the EDC software and is stored in the target database, when the second user uses the IWRS software in the same clinical trial research project, the research event data does not need to be configured in the IWRS software again, and a reading request of the research event data can be directly sent to the platform server. Specifically, the second terminal accesses a research event configuration page provided by the IWRS software, and sends a reading request of research event data to the platform server through the research event configuration page. And the platform server reads the target research event data from the target database according to the read request of the research event data. And the platform server returns the target research event data to the second terminal.

In some embodiments, a browser is run on each of the first terminal and the second terminal. Please refer to fig. 1 b. In a clinical trial research project, in the process of acquiring clinical trial data, a browser of a first terminal accesses a subject data entry page provided by EDC software, target subject data input by a first user is received through the subject data entry page, and the first terminal sends a data write-in request of the subject data to a platform server, wherein the data write-in request carries the target subject data. The platform server writes the target subject data to the target database. During the development of this clinical trial study, IWRS software was introduced, which also required the use of subject data. Because the first user collects the subject data through the EDC software and stores the subject data in the target database, when the second user uses the IWRS software in the same clinical trial research project, the second user can directly send a reading request of the subject data to the platform server without collecting the subject data in the IWRS software again. Specifically, a browser of the second terminal accesses a subject data entry page provided by the IWRS software, and a reading request of the subject data is sent to the platform server through the subject data entry page. And the platform server reads the target subject data from the target database according to the reading request of the subject data. The platform server returns the target subject data to the second terminal.

It should be noted that this embodiment exemplarily illustrates that the subject data and the study event data are written into the target database through the page provided by the EDC software, and then read from the target database through the page provided by the IWRS software. Likewise, in some embodiments, the subject data and the study event data may be written into the target database through a page provided by the IWRS software, and then read from the target database through a page provided by the EDC software, which will not be described herein. In addition, the present embodiment exemplarily illustrates target clinical trial data using the subject data and the study event data, and the target clinical trial data may be other data that can be easily conceived by those skilled in the art. The present embodiment uses EDC software and IWRS software to exemplarily describe software that can access a target database, and may also be other software used in clinical trial industries such as CTMS software, PLM software, and Epro software.

Referring to fig. 1c, the present specification provides a clinical trial data processing system, and the clinical trial data processing method provided by the present specification is applied to the clinical trial data processing system. The clinical trial data processing system may include a hardware environment formed by a first terminal 110, a server 120, and a second terminal 130. The first terminal 110 and the second terminal 130 communicate with the server 120 through a network, respectively. A first client and a second client are deployed in the server 120. The first terminal 110 transmits a data write request of the first client to the server 120. The server 120 receives a data write request of a first client; wherein the data write request is accompanied by target clinical trial data; the server 120 writes the target clinical trial data to the target database; the target database stores shared data of a first client and a second client; wherein the first client is different from the second client. The second terminal 130 sends a first data read request of the second client for the target clinical trial data to the server 120. The server 120 receives a first data reading request of the second client for the target clinical test data, the server 120 reads the target clinical test data from the target database, and the server 120 provides the read target clinical test data to a user interface of the second client.

The first client and the second client can be realized in any form of an application program or an applet, and can also be realized by a series of front-end technologies such as HTML5, CSS3, JavaScript, and the like. Software-as-a-Service (Software as a Service) can also be implemented by using the SaaS platform. The first client and the second client may be software deployed by the SaaS platform and implementing different functions, and the user may access the first client and the second client through a software program having a browser function and running on the first terminal or the second terminal. The first terminal 110 and the second terminal 130 may be, but are not limited to, various personal computers, notebook computers, smart phones, tablet computers, and portable wearable devices. In some embodiments, the first terminal 110 and the second terminal 130 may be independent terminals, and access the server through different terminals. In some embodiments, the first terminal 110 and the second terminal 130 may be one terminal, and the user right of a certain user may access at least two types of software of EDC software, IWRS software, CTMS software, PLM software, and Epro software deployed on the server 120. The user can log in the first client to perform data writing operation on the terminal, and the user can also switch to the second client to perform data reading operation on the terminal. The server 120 may be implemented as a stand-alone 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.

Referring to fig. 2a, the present specification provides a method for processing clinical trial data. The clinical trial data processing method includes the following steps.

S210, receiving a data writing request of a first client.

Wherein the data write request is accompanied by target clinical trial data. The target clinical trial data may be common clinical trial data commonly required by software in a plurality of clinical trial industries, such as common clinical trial data commonly used by at least two of EDC software, IWRS software, CTMS software, PLM software, and Epro software. The common clinical trial data may be subject basic information data (such as subject name, height, weight, ethnicity, etc.). The common clinical trial data may be subject status data. The subject status data is used to characterize the status of the subject during the course of a clinical trial, such as screening, screening failure, randomized, cohort entered, on-going, discontinuing withdrawal, missed visit, completed trial, follow-up visit, etc. The common clinical trial data may also be study event status data. The study event status data is used to characterize the status of the study event, such as the status of each study event being in audit, locked, frozen, etc. The common clinical trial data may also be study event configuration data. The study event configuration data may be a time plan for an visit, the study event configuration data may include visit window data, and the visit window data may be a time period within a date range of each visit specified by the clinical study protocol.

The research event may be an interview event, an adverse event, or the like. The visit event is an extremely important link in the clinical trial process and directly relates to the compliance of the subjects to the trial scheme and the completeness of the trial. Subject compliance, in turn, directly affects the outcome of the trial, so researchers and research assistants need to pay sufficient time and effort in the interview segment. In the clinical research industry, the meeting between a researcher and a subject for a clinical trial may be referred to as an interview. Visit is usually an inspection or each time a subject should visit a hospital or research institution for a researcher to see a doctor.

Specifically, the first client may be any piece of software of clinical trial industry software such as EDC, IWRS, CTMS, PLM, Epro, and the like. The first terminal has the authority of accessing the first client, the first terminal sends a data writing request of the first client to the server, and the server receives the data writing request. In some implementations, the data write request may be a request to write target clinical trial data to a server. For example, the data write request may be a write request to store the subject data collected by the EDC to the server. The data write request may also be a write request to store the visit time plan data to the server.

And S220, writing the target clinical test data into a target database.

And S230, under the condition that a first data reading request of the second client for the target clinical test data is received, providing the target clinical test data read from the target database to a user interface of the second client.

The target database stores shared data of the first client and the second client. The first client can be any software of clinical trial industry software such as EDC, IWRS, CTMS, PLM, Epro and the like. The second client can be any piece of software of clinical trial industry software such as EDC, IWRS, CTMS, PLM, Epro and the like, and the first client is different from the second client. Specifically, the first terminal sends a data writing request of the first client to the server, and the server receives the data writing request. The data writing request carries target clinical test data, and the server writes the target clinical test data into a target database. The second terminal has the right of accessing the second client, the second terminal sends a first data reading request of the second client for the target clinical test data to the server, and the server receives the first data reading request. And the server reads the target clinical test data from the target database, returns the read target clinical test data to the second terminal, and displays the target clinical test data on a user interface of the second client.

In some embodiments, the first data read request may be a request to read clinical trial data from a target database. For example, the data write request may be a write request to store the subject data collected by the EDC to the target database. Accordingly, the first data read request may be a request for other software than the EDC to read the subject data from the target database. In some embodiments, the data write request may also be a write request to store the access time plan data to the target database through the EDC. Accordingly, the first data read request may be a request for other software than the EDC to read the access time plan data from the target database.

According to the clinical test data processing method, the data writing request of the first client is received, and the target clinical test data attached to the data writing request is written into the target database in which the common data of the first client and the second client are stored; the target clinical trial data read from the target database is provided to the user interface of the second client upon receiving the first data read request by the second client for the target clinical trial data. After the user operates the clinical test data at the first client, the user can directly read the data from the target database when using the second client, and the previous labor does not need to be repeated again, so that the processing efficiency of the clinical test data is improved, and the workload of workers is reduced.

In some embodiments, when the data write request is accompanied by clinical trial data used by the first client alone, the clinical trial data used by the first client alone is written into an independent database of the first client.

The target database is used for storing shared data between the first client and the second client, and the server can be deployed in an independent database of the first client or the second client. In a relatively sense, the target database may be understood as a common database for the first client or the second client. Specifically, the server may write the clinical test data attached to the data write request into the independent database of the first client when receiving the data write request from the first client and detecting that the clinical test data is used by the first client alone. Similarly, the server may write the clinical test data attached to the data write request into the independent database of the second client when receiving the data write request from the second client and detecting that the clinical test data is used by the second client alone.

In some embodiments, the clinical trial data processing method may further include: under the condition that a second data reading request of a second client is received, processing target clinical test data in a target database according to a data type attached to the second data reading request; and providing the formatted target clinical trial data to a user interface of the second client.

In which clinical trial data is shared among several clients, as described above, target clinical trial data related to a first client may be written directly into the target database, and a second client may read target clinical trial data directly from the target database. However, in some embodiments, the second client may have different data type requirements, such as data range, data format, data length, etc., for the clinical trial data than the first client. Therefore, the second client cannot directly use the target clinical trial data in the target database, and needs to process the target clinical trial data. Specifically, the second terminal sends a second data reading request of the second client to the server, where the second data reading request carries the data type. And reading the target clinical test data from the target database, and processing the read target clinical test data according to the data type carried by the second data reading request. The server returns the processed target clinical test data to the second terminal, and the second terminal can display a user interface of the second client and display the processed target clinical test data in the user interface of the second client.

Illustratively, the data type may be a date-event format, the date-time format adopted by the first client may be { yyy } - { MM } - { dd } { HH }: MM }: ss } format, which represents year, month, day, time, minute, and second, respectively, and the date-time format adopted by the second client may be { dd } - { MMM } - { yyyy } format, and thus { yyyy } - { MM } - { HH }: MM }: ss } format may be processed in accordance with { dd } - { MMM } - { yyyy } format.

For example, if the target clinical trial data stored in the target database by the first client is 300 characters and the data length required by the second client is 100 characters, the target clinical trial data may be processed by keyword extraction or truncation according to the requirement of the second client, so as to obtain 100 fields, and the fields are provided to the user interface of the second client.

In the embodiment, the target clinical test data in the target database is processed according to the data type attached to the second data reading request, the processed target clinical test data is provided to the user interface of the second client, the clinical test data meeting the second client is obtained by directly processing based on the shared data in the target database, and no additional operation is required to be performed by a worker at the second client, so that the user operation cost is reduced, the workload of the worker is reduced, and the processing efficiency of the clinical test data is improved.

In some embodiments, the data write request is accompanied by a first field identification of the first client. Writing target clinical trial data to the target database may include the following steps.

And S310, writing the target clinical test data into the target database under the common field corresponding to the first field identification.

Accordingly, providing the target clinical trial data read from the target database to the user interface of the second client upon receiving the first data read request for the target clinical trial data by the second client may include the following steps.

And S320, under the condition that the first data reading request is received, reading the target clinical test data from the target database according to the first field identification.

And S330, providing the target clinical test data to a user interface of the second client.

The shared field is a field which is respectively possessed by the first client and the second client. Illustratively, the first client has a field a and a field B, and the second client includes a field B and a field C, then the field B is a common field of the first client and the second client. The field B may be generated in the target database. When any one of the addition, modification and deletion of the field data of the field B is performed through the user interface of the first client, the user interface of the second client may display the field data of the field B after the processing operation. Similarly, when any one of the addition, modification and deletion of the field data of the field B is performed through the user interface of the second client, the user interface of the first client may display the field data of the field B after the processing operation.

Specifically, the first terminal sends a data writing request of the first client to the server, and the server receives the data writing request. The data writing request carries target clinical test data and a first field identification of the first client, wherein the first field identification corresponds to the target clinical test data. The server writes the target clinical trial data into the target database under the common field corresponding to the first field identification. The second terminal has the right of accessing the second client, the second terminal sends a first data reading request of the second client for the target clinical test data to the server, and the server receives the first data reading request. In some embodiments, the first data read request may carry a first field identification, and the server reads the target clinical trial data from the target database according to the first field identification. The second terminal sends a first data reading request of the second client for the target clinical test data to the server, and the server receives the first data reading request. And the server reads the target clinical test data from the target database according to the first field identification, returns the read target clinical test data to the second terminal, and displays the target clinical test data on a user interface of the second client.

In this embodiment, after the first client performs the operation on the clinical test data, when the user uses the second client, the user can directly read the data from the target database according to the first field identifier of the first client attached to the data write request, and the previous labor does not need to be repeated again, so that the processing efficiency of the clinical test data is improved, and the workload of the staff is reduced.

In some embodiments, the first data read request carries a second field identification of the second client. In the case that the first data reading request is received, before reading the target clinical trial data from the target database according to the first field identification, the clinical trial data processing method may further include: and under the condition of receiving a first data reading request, inquiring in the field mapping relation set according to the second field identification, and determining the first field identification corresponding to the second field identification.

The server stores a field mapping relation set in advance. The field mapping relation set stores the corresponding relation between the first field identification and the second field identification. Specifically, the second terminal sends a first data reading request to the server. The first data reading request carries a second field identification of the second client. And the server queries the field mapping relation set by using the second field identification of the second client to obtain the first field identification corresponding to the second field identification. The server reads the target clinical trial data from the target database according to the first field identification. The server provides the target clinical trial data to a user interface of the second client.

In this embodiment, after the first client performs the operation on the clinical test data, when the user uses the second client, the user may determine the first field identifier corresponding to the target clinical test data according to the second field identifier of the second client carried in the first data reading request, and read the data from the target database according to the first field identifier, which does not need to repeat the previous work again, thereby improving the processing efficiency of the clinical test data and reducing the workload of the staff.

In some embodiments, the first client has a first field. The second client has a second field. The clinical trial data processing method may further include: receiving a field sharing configuration request; the field sharing configuration request carries a second field and a first field; a field mapping relationship is established between the second field and the first field to generate a set of field mapping relationships.

Specifically, in some embodiments, the first client has already completed deployment at the server, and the user has stored the shared data in the shared database through the first client. In the event that the second client needs to use or enter the shared data, the user interface of the second client may provide a field sharing configuration page. And the field sharing configuration page is provided with a field sharing configuration control. And sending a field sharing configuration request to the server under the condition that the field sharing configuration control is triggered, wherein the field sharing configuration request carries a second field and a first field. The server receives a field sharing configuration request. The server establishes a field mapping relationship between the second field and the first field to generate a field mapping relationship set.

In some embodiments, if the user accesses the server through the second terminal, the second terminal may present the field sharing configuration page. And the second terminal monitors the field sharing configuration control, and sends a field sharing configuration request to the server under the condition that the field sharing configuration control is triggered. The field sharing configuration request carries a first field of the first client and a second field of the second client. The server receives a field sharing configuration request, so that the server establishes a field mapping relationship between the second field and the first field to generate a field mapping relationship set.

In some embodiments, referring to fig. 2b, the field sharing configuration page has a first field selection control and a second field selection control. The first field selection control is used to select a first list of fields (field a, field B, field C) for the first client. And receiving field selection operation of a user in the first field list, and determining a first field in the first client, which needs to establish a mapping relation, in the first field list of the first client. The second field selection control is used for selecting a second field list (field X, field Y and field Z) of the second client, receiving field selection operation of a user in the second field list, and determining a second field which needs to establish a mapping relation in the second client in the second field list of the second client.

In some embodiments, the server stores a correspondence between the first field and the second field in advance. The first client already completes deployment at the server, and the user already stores shared data in the shared database through the first client. And under the condition that the second client is accessed to the server, acquiring the preset corresponding relation between the first field and the second field from the server. The user interface of the second client may provide a field sharing configuration page, and the correspondence between the first field and the second field is shown in the field sharing configuration page. The displayed corresponding relation between the first field and the second field can be used as a recommendation for the user, and the user establishes a field mapping relation between the second field and the first field based on the corresponding relation when determining the recommended corresponding relation. In some embodiments, the user may also modify the recommended correspondence, and establish a field mapping relationship based on the modified correspondence.

In the embodiment, the field mapping relationship is established between the first field of the first client and the second field of the second client to generate the field mapping relationship set, so that a data basis is provided for a subsequent user to complete data operation and automatic synchronization to the second client at the first client, the operation of the user on the second client is reduced, the workload of the user is reduced, and the processing efficiency of clinical test data is improved.

In some embodiments, the target database stores subject data for use by the first client in conjunction with the second client, the target data including target subject data. Providing the target clinical trial data read from the target database to the user interface of the second client upon receiving the first data read request by the second client for the target clinical trial data may include: and in the case of receiving a reading request of the second client for the target subject data, providing the target subject data read from the target database to a user interface of the second client.

The subject data may be basic information data of the subject (such as name, height, weight, ethnicity, etc.). The subject data may be subject status data. The subject status data is used to characterize the status of the subject during the course of a clinical trial, such as screening, screening failure, randomized, cohort entered, on-going, discontinuing withdrawal, missed visit, completed trial, follow-up visit, etc.

Specifically, the first terminal sends a data writing request of the first client to the server, and the server receives the data writing request. The data writing request carries target subject data, and the server writes the target subject data into a target database. The second terminal has the right of accessing the second client, sends a reading request of the second client for the target subject data to the server, and receives the reading request for the target subject data. The server reads the target subject data from the target database, returns the read target subject data to the second terminal, and displays the target subject data on a user interface of the second client.

In some embodiments, any terminal accesses a first client deployed on a server, the terminal presenting a subject data collection page of the first client. Target subject data input by a user is received through the subject data acquisition page, and in response to the input operation of the subject data, the terminal sends an input request carrying the target subject data to the server so as to be stored in the target database. When the terminal is switched to a second client, and the data acquisition of the subjects is carried out aiming at the same clinical test item, reminding information is given on a user interface to inform a user that the data of the target subjects is input through the first client, the data of the target subjects is read from the target database, and the read data of the target subjects is provided to the user interface of the second client.

In the embodiment, the common subject data of the first client and the second client is written into the target database, and when the second client uses the subject data, the target subject data in the target database can be provided without repeatedly executing the entry of the subject data again, so that the entry efficiency of the subject data is improved, and the workload of workers is reduced.

In some embodiments, the target database stores study event data for use by the first client in conjunction with the second client, the target clinical trial data including target study event data. Providing the target clinical trial data read from the target database to the user interface of the second client upon receiving the first data read request by the second client for the target clinical trial data may include: and in the case of receiving a reading request of the second client for the target research event data, providing the target research event data read from the target database to a user interface of the second client.

Wherein the research event data may be research event configuration data. The study event configuration data may be a time plan for an visit, the study event configuration data may include visit window data, and the visit window data may be a time period within a date range of each visit specified by the clinical study protocol. The research event data may also be research event status data. The study event status data is used to characterize the status of the study event, such as the status of each study event being in audit, locked, frozen, etc.

Specifically, the first terminal sends a data writing request of the first client to the server, and the server receives the data writing request. The data writing request carries target research event data, and the server writes the target research event data into a target database. The second terminal has the right of accessing the second client, sends a reading request of the second client for the target research event data to the server, and receives the reading request for the research event data. And the server reads the target research event data from the target database, returns the read target research event data to the second terminal, and displays the target research event data on a user interface of the second client.

In some embodiments, any terminal accesses a first client deployed on a server, the terminal presenting a research event data configuration page of the first client. And receiving target research event data configured by a user through a research event data configuration page, responding to configuration operation of the research event data, and sending a configuration request carrying the target research event data to a server by a terminal so as to store the target research event data in a target database. When the terminal is switched to a second client side and research event data configuration is carried out aiming at the same clinical test project, reminding information is given on a user interface to inform a user that the research event data configuration is carried out through the first client side, target research event data is read from a target database, and the read target research event data is provided to the user interface of the second client side.

In the embodiment, the common subject data of the first client and the second client is written into the target database, and when the second client uses the research event data, the target research event data in the target database can be provided therebetween, so that the configuration of the research event data does not need to be repeatedly executed again, the configuration efficiency of the research event data is improved, and the workload of workers is reduced.

The embodiment of the specification provides a clinical test data processing method, which comprises the following steps.

S402, receiving a data writing request of the first client.

Wherein the data write request is accompanied by target clinical trial data. The data write request is accompanied by a first field identification of the first client.

And S404, writing the target clinical test data into the target database under the common field corresponding to the first field identification.

The target database stores shared data of a first client and a second client; wherein the first client is different from the second client. The common field is a field that the first client and the second client have respectively. The first client has a first field; the second client has a second field.

S406, under the condition that a first data reading request of a second client for target clinical test data is received, inquiring in the field mapping relation set according to the second field identification, and determining the first field identification corresponding to the second field identification.

And the field mapping relation set stores the corresponding relation between the first field identification and the second field identification. And the first data reading request carries a second field identification of the second client.

And S408, reading the target clinical test data from the target database according to the first field identification.

And S410, providing the target clinical test data to a user interface of the second client.

In some embodiments, the target database stores subject data for use by the first client in conjunction with the second client, the target data including target subject data. Specifically, the target subject data read from the target database is provided to the user interface of the second client upon receiving a read request for the target subject data by the second client.

In some embodiments, the target database stores study event data for use by the first client in conjunction with the second client, the target clinical trial data including target study event data; and in the case of receiving a reading request of the second client for the target research event data, providing the target research event data read from the target database to a user interface of the second client.

And S412, when a second data reading request of the second client is received, processing the target clinical test data in the target database according to the data type attached to the second data reading request.

And S414, providing the processed target clinical test data to a user interface of the second client.

S416, receiving a field sharing configuration request; the field sharing configuration request carries a second field and a first field.

And S418, establishing a field mapping relationship between the second field and the first field to generate a field mapping relationship set.

Referring to fig. 3, an embodiment of the present disclosure provides a method for processing clinical trial data. The clinical trial data processing method includes the following steps.

S510, sending a first data reading request to a server.

And S520, receiving the target clinical test data which is returned by the server and read from the target database.

The target clinical test data is attached to the data writing request of the first client side and written into the target database by the server; the target database stores shared data of the second client and the first client; wherein the first client is different from the second client.

In some embodiments, the method for processing clinical trial data may further include the steps of: providing a field sharing configuration page; under the condition that the field sharing configuration control is triggered, sending a field sharing configuration request to a server; the field sharing configuration page is provided with a field sharing configuration control; the field sharing configuration request carries a first field of a first client and a second field of a second client; the field sharing configuration request is used for instructing the server to establish a field mapping relationship between the second field and the first field so as to generate a field mapping relationship set.

In some embodiments, the field sharing configuration page has a first field selection control and a second field selection control therein. The clinical trial data processing method may further include: determining a first field needing to establish a mapping relation under the condition that a first field selection control is triggered; and determining a second field needing to establish the mapping relation under the condition that the second field selecting control is triggered.

In some embodiments, the clinical trial data processing method may further include: acquiring a corresponding relation between a first field and a second field which are configured in advance; and determining a second field and a first field which need to establish a field mapping relation based on the corresponding relation.

For specific limitations of the clinical trial data processing method applied to the second application program, reference may be made to the above limitations of the clinical trial data processing method applied to the server side, and details thereof are not repeated here.

It should be understood that, although the steps in the above-described flowcharts are shown in order as indicated by the 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 a part of the steps in the above-mentioned flowcharts may include a plurality of steps or a plurality of 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 the stages is not necessarily performed in sequence, but may be performed alternately or alternately with other steps or at least a part of the steps or the stages in other steps.

Referring to fig. 4, an embodiment of the present disclosure provides a clinical trial data processing apparatus 400. The clinical trial data processing apparatus 400 may include a write request receiving module 410, a target data writing module 420, and a target data providing module 430.

A write request receiving module 410, configured to receive a data write request of a first client; wherein the data write request is accompanied by target clinical trial data; the target clinical test data is common data of the first client and the second client; wherein the first client is different from the second client.

A target data writing module 420 for writing the target clinical trial data to a target database; the target database is used for storing common data of the first client and the second client.

A target data providing module 430, configured to provide the target clinical trial data read from the target database to a user interface of the second client if a first data reading request for the target clinical trial data by the second client is received.

Referring to fig. 5, an embodiment of the present disclosure provides a clinical trial data processing apparatus 500. The clinical trial data processing apparatus 500 may include a read request transmitting module 510, a target data receiving module 520.

A read request sending module 510, configured to send a first data read request to a server.

A target data receiving module 520, configured to receive target clinical test data read from the target database and returned by the server; the target clinical test data is attached to the data writing request of the first client side and written into the target database by the server; the target database stores shared data of the second client and the first client; wherein the first client is different from the second client

For specific limitations of the clinical trial data processing apparatus, reference may be made to the above limitations of the clinical trial data processing method, which are not described herein again. The various modules in the clinical trial data processing apparatus described above 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 is provided, which may be a terminal, and its internal structure diagram may be as shown in fig. 6. 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 processing. 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. 6 is merely a block diagram of some of the structures associated with the disclosed aspects and is not intended to limit the computing device to which the disclosed aspects apply, and that a computing device may in particular include more or less components than those shown, or combine certain components, or have a different arrangement of components.

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

In some embodiments, a computer-readable storage medium is 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 is also provided, which comprises instructions that are executable by a processor of a computer device to implement the method steps in 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 for the purpose of illustrating the preferred embodiments of the present disclosure and is not to be construed as limiting the present disclosure, and any modifications, equivalents and the like that are within the spirit and principle of the present disclosure are intended to be included within the scope of the present disclosure.

Claims

1. A method of processing clinical trial data, comprising:

receiving a data writing request of a first client; wherein the data write request is accompanied by target clinical trial data; the target clinical test data is common data of the first client and the second client; wherein the first client is different from the second client;

writing the target clinical trial data to a target database; the target database is used for storing common data of the first client and the second client;

providing the target clinical trial data read from the target database to a user interface of the second client upon receiving a first data read request by the second client for the target clinical trial data.

2. The method of claim 1, further comprising:

under the condition that a second data reading request of the second client is received, processing target clinical test data in the target database according to the data type attached to the second data reading request;

providing the formatted target clinical trial data to a user interface of the second client.

3. The method of claim 1, wherein the data write request is accompanied by a first field identification of the first client; the writing the target clinical trial data to the target database includes:

writing the target clinical trial data to the target database under a common field corresponding to the first field identification; wherein the common field is a field that the first client and the second client have respectively;

accordingly, the providing the target clinical trial data read from the target database to the user interface of the second client upon receiving the first data read request by the second client for the target clinical trial data comprises:

reading the target clinical trial data from the target database according to the first field identification if the first data read request is received;

providing the target clinical trial data to a user interface of the second client.

4. The method of claim 3, wherein the first data read request carries a second field identifier of a second client; prior to said reading said target clinical trial data from said target database in accordance with said first field identification in the event of said receiving said first data read request, said method further comprises:

under the condition of receiving the first data reading request, inquiring in a field mapping relation set according to the second field identification, and determining the first field identification corresponding to the second field identification; and the field mapping relation set stores the corresponding relation between the first field identification and the second field identification.

5. The method of claim 3, wherein the first client has a first field; the second client has a second field; the method further comprises the following steps:

receiving a field sharing configuration request; wherein the field sharing configuration request carries the second field and the first field;

establishing a field mapping relationship between the second field and the first field to generate the set of field mapping relationships.

6. The method of claim 1, wherein the target database stores subject data for use by the first client in conjunction with a second client, the target data including target subject data; the providing, to a user interface of the second client, the target clinical trial data read from the target database upon receiving a first data read request by the second client for the target clinical trial data, comprising:

providing the target subject data read from the target database to a user interface of the second client upon receiving a read request by the second client for the target subject data.

7. The method of claim 1, wherein the target database stores study event data for use by the first client in conjunction with a second client, the target clinical trial data including target study event data; the providing, to a user interface of the second client, the target clinical trial data read from the target database upon receiving a first data read request by the second client for the target clinical trial data, comprising:

providing the target research event data read from the target database to a user interface of the second client upon receiving a read request by the second client for the target research event data.

8. The method of claim 1, further comprising:

when the first client uses clinical test data alone in the data write request, the clinical test data used by the first client alone is written in an independent database of the first client.

9. A clinical trial data processing method is characterized by being applied to a second client; the method comprises the following steps:

sending a first data reading request to a server;

receiving target clinical test data which is returned by the server and read from a target database; the target clinical test data is attached to a data writing request of the first client and written into a target database by the server; the target database stores shared data of the second client and the first client; wherein the first client is different from the second client.

10. The method of claim 9, further comprising:

providing a field sharing configuration page; wherein the field sharing configuration page has a field sharing configuration control therein;

under the condition that the field sharing configuration control is triggered, sending a field sharing configuration request to a server; wherein the field sharing configuration request carries a first field of the first client and a second field of the second client; the field sharing configuration request is used for instructing the server to establish a field mapping relationship between the second field and the first field to generate the field mapping relationship set.

11. The method of claim 10, wherein the field sharing configuration page has a first field selection control, a second field selection control; the method further comprises the following steps:

determining a first field needing to establish the mapping relation under the condition that the first field selection control is triggered;

and under the condition that the second field selection control is triggered, determining a second field needing to establish a mapping relation.

12. The method of claim 9, wherein the method comprises:

acquiring a corresponding relation between a first field and a second field which are configured in advance;

and determining the second field and the first field needing to establish a field mapping relation based on the corresponding relation.

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

the write-in request receiving module is used for receiving a data write-in request of a first client; wherein the data write request is accompanied by target clinical trial data; the target clinical test data is common data of the first client and the second client; wherein the first client is different from the second client;

a target data writing module for writing the target clinical trial data into a target database; the target database is used for storing common data of the first client and the second client;

a target data providing module, configured to provide the target clinical test data read from the target database to a user interface of the second client when a first data read request for the target clinical test data by the second client is received.

14. The clinical test data processing device is characterized by being applied to a second client; the device comprises:

the reading request sending module is used for sending a first data reading request to the server;

the target data receiving module is used for receiving target clinical test data which is returned by the server and read from a target database; the target clinical test data is attached to a data writing request of the first client and written into a target database by the server; the target database stores shared data of the second client and the first client; wherein the first client is different from the second client.

15. A computer device comprising a memory and a processor, the memory storing a computer program, characterized in that the processor, when executing the computer program, implements the steps of the method of any of claims 1 to 12.

16. 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 12.

17. 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 12.