CN114913943A - Clinical research data collection method and device, electronic device and storage medium - Google Patents

Abstract

The present application discloses a clinical research data collection method and device, electronic device and storage medium. The method includes: receiving a database construction configuration of a first database to configure a second database, wherein the configuration content of the second database includes visits, Form, field group, field, dictionary, unit; establish a docking relationship between the configured second database and the first database, and send the database construction configuration of the second database to the first database; A field mapping relationship between a database and a second database; based on the field mapping relationship, the clinical research data acquired by the second database is sent to the first database. The clinical research data acquisition method can realize the automatic acquisition of clinical research data by the EDC system, and reduce the data entry cost while improving the data acquisition efficiency.

Description

Clinical research data collection method and device, electronic device and storage medium

technical field

The present application belongs to the technical field of databases, and specifically relates to a clinical research data collection method and device, electronic equipment and storage medium.

Background technique

The Electric Data Capture (EDC) system for clinical trial data is a core information system suitable for drug clinical trials, medical randomized controlled trials and medical cohort studies. Realize data storage, management, delivery and other functions. There are many types of EDC systems currently on the market. Usually, clinical research coordinators (CRC) need to manually enter clinical research data in the EDC system, which is inefficient, cannot be real-time, and is prone to errors. It is inconvenient for customers to monitor. .

The information disclosed in this Background section is only for enhancement of understanding of the general background of the application and should not be taken as an acknowledgement or any form of suggestion that this information forms the prior art already known to a person of ordinary skill in the art.

SUMMARY OF THE INVENTION

The purpose of the present application is to provide a clinical research data collection method, which is used to solve the problems of low efficiency and error-prone data entry of clinical research data in the EDC system.

To achieve the above purpose, the present application provides a method for collecting clinical research data, the method comprising:

receiving the database construction configuration of the first database to configure the second database, wherein the configuration content of the second database includes visits, forms, field groups, fields, dictionaries, and units;

establishing a docking relationship between the configured second database and the first database, and sending the database building configuration of the second database to the first database;

establishing a field mapping relationship between the first database and the second database based on the visit sequence number and the form sequence number;

Based on the field mapping relationship, the clinical research data acquired by the second database is sent to the first database.

In one or more embodiments of the present application, establishing a docking relationship between the configured second database and the first database specifically includes:

Send the docking instruction of the second database to the transit platform for the transit platform to generate a docking identifier and a secret key, wherein the first database establishes a docking relationship with the second database based on the docking identifier and the secret key .

In one or more embodiments of the present application, establishing a docking relationship between the configured second database and the first database specifically includes:

generating a docking identifier and a secret key according to the docking instruction of the second database;

Sending the docking identifier and the secret key to the first database, so that the first database can establish a docking relationship with the second database.

In one or more embodiments of the present application, establishing a field mapping relationship between the first database and the second database based on the visit sequence number and the form sequence number, specifically includes:

Determine the field mapping order between the first database and the second database based on the visit sequence number and the form sequence number;

Using the object identifier of the field as the mapping identifier, and based on the field mapping sequence, the field mapping relationship between the first database and the second database is established.

In one or more embodiments of the present application, receiving the database construction configuration of the first database to configure the second database specifically includes:

General configuration and specific configuration of the second database based on the library configuration of the first database, wherein the general configuration includes creation of test categories and visit groups, dictionary storage, form definition storage, and field groups Incremental saving of fields, full update of visit tasks, and full update or addition of visit procedures.

In one or more embodiments of the present application, based on the field mapping relationship, sending the clinical research data acquired by the second database to the first database specifically includes:

The clinical research data obtained by preprocessing the second database is in a standard format, wherein the standard format is a data format approved by the first database;

Based on the field mapping relationship, the preprocessed clinical research data is sent to a transfer platform, wherein the first database receives the preprocessed clinical research data from the transfer platform.

In one or more embodiments of the present application, the database construction configuration of the first database is an ODM file format.

The application also provides a clinical research data acquisition device, the clinical research data acquisition device includes:

a configuration module, configured to receive the database construction configuration of the first database to configure the second database, wherein the configuration content of the second database includes visits, forms, field groups, fields, dictionaries, and units;

a docking module, configured to establish a docking relationship between the configured second database and the first database, and send the database building configuration of the second database to the first database;

a mapping relationship establishing module for establishing a field mapping relationship between the first database and the second database based on the visit sequence number and the form sequence number;

A data sending module, configured to send the clinical research data obtained from the second database to the first database based on the field mapping relationship.

The application also provides an electronic device, comprising:

at least one processor; and

A memory that stores instructions that, when executed by the at least one processor, cause the at least one processor to perform the clinical study data acquisition method as described above.

The present application also provides a machine-readable storage medium storing executable instructions that, when executed, cause the machine to perform the clinical research data acquisition method as described above.

Compared with the prior art, according to the clinical research data collection method of the present application, the configuration of visits, forms, field groups, fields, dictionaries, and units is performed on the second database through the database construction configuration based on the first database, and the configuration of the first database is established. The docking relationship between the first database and the second database, the first database and the second database can further establish a field mapping relationship based on the visit serial number and the form serial number, so that the clinical research data obtained by the second database can be sent to the first database to realize EDC system collection of clinical research data.

On the other hand, the second database can be connected with data such as in-hospital and out-of-hospital follow-up and research medical records, and transfer these data to the first database in real time based on the field mapping relationship, improving the timeliness of the EDC system for clinical research data collection. Improve data collection efficiency while reducing data entry costs.

Description of drawings

1 is a schematic diagram of an application scenario of a method and apparatus for collecting clinical research data according to an embodiment of the present application;

2 is a flowchart of a clinical research data collection method according to an embodiment of the present application;

3 is an interaction diagram of a clinical research data collection method according to an embodiment of the present application;

4 is a sequence diagram of field mapping of a first database and a second database in a clinical research data collection method according to an embodiment of the present application;

5 is a block diagram of a clinical research data acquisition device according to an embodiment of the present application;

FIG. 6 is a hardware structure diagram of an electronic device according to an embodiment of the present application.

Detailed ways

The present application will be described in detail below with reference to the various embodiments shown in the accompanying drawings. However, these embodiments do not limit the present application, and structural, method, or functional transformations made by those of ordinary skill in the art based on these embodiments are all included in the protection scope of the present application.

The terms "first", "second", "third", "fourth", etc. (if any) in the description and claims of this application and the above-mentioned drawings are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It is to be understood that the data so used may be interchanged under appropriate circumstances such that the embodiments of the application described herein can, for example, be practiced in sequences other than those illustrated or described herein. Furthermore, the terms "comprising" and "corresponding to", and any variations thereof, are intended to cover non-exclusive inclusion, eg, a process, method, system, product or device comprising a series of steps or units not necessarily limited to those expressly listed but may include other steps or units not expressly listed or inherent to these processes, methods, products or devices.

A clinical trial of a drug refers to the systematic study of a drug in humans to determine the efficacy and safety of the drug. Drug clinical trials are divided into Phase I, Phase II, Phase III clinical trials, and Phase IV clinical trials. Phase I mainly involves preliminary clinical pharmacology and human safety evaluation trials. Phase II can be understood as the preliminary evaluation of the therapeutic effect, which mainly involves the preliminary evaluation of the therapeutic effect and safety of the drug on the patients with the target indication, and also includes the provision of the basis for the design of the Phase III clinical trial and the determination of the dosing schedule. Phase III can be understood as the confirmation stage of the therapeutic effect, which mainly further verifies the therapeutic effect and safety of the drug on the patients with the target indication, evaluates the relationship between benefits and risks, and finally provides a sufficient basis for the review of the drug registration application. Phase IV is mainly a clinical trial after the drug is marketed. After the drug is launched, the efficacy and adverse reactions of the drug under widely used conditions can continue to be tracked to evaluate the relationship between benefits and risks in general or special populations and improve drug delivery. dose, etc.

In the course of clinical trials, a large amount of clinical research data will be generated, including in-hospital and out-of-hospital follow-up and research medical records. Taking in-hospital data as an example, it can include Laboratory Information Management System (LIS), Hospital Information System (HIS), Picture archiving and communication systems (PACS), radiology information Management system (Radioiogy information system, RIS) and other system data.

Referring to Figure 1, in an application scenario of the present application, a unified data management system can be provided for these clinical research data, the data management system can be connected with different EDC systems, and the clinical research data can be automatically sent to the EDC. In the system, to realize the collection of these clinical research data by the EDC system. The clinical research data may be captured by the data management software in real time or according to a specified period, or the clinical research data may be transferred and stored to the storage space configured by the data management system as required.

Referring to FIG. 2, an embodiment of the clinical research data collection method of the present application is introduced. In this embodiment, the method includes:

S11. Receive the database construction configuration of the first database to configure the second database.

With reference to FIG. 3 , the first database may correspond to the EDC system, and after the EDC system completes the database building of the first database, the database building configuration may be exported in a set format.

In an embodiment, the database building configuration of the first database exported here is in an Operational Data Model (Operational Data Model, ODM) file format. ODM is one of the standards published by CDISC (The Clinical Data Interchange Standards Consortium). The normalization and standardization of clinical trial data drives and improves the efficiency and reliability of practical work, and as a result, several biotechnology and drug development companies have formed CDISC. ODM is an XML-based, content and format standard for capturing, exchanging, reporting or submitting, and filing Case Report Form (CRF)-based clinical research data.

The second database may correspond to a data management system, and the data management system may import the database construction configuration of the first database to configure the second database. For clinical research data, the configuration contents of the first database and the second database may include visits, forms, field groups, fields, dictionaries, units, and the like.

Taking a clinical trial project (Study) as an example, it will involve multiple subjects (Subject), each subject will have multiple visit periods (Event), and multiple forms will be generated under each visit period ( Form) data, each form may have one or more field groups (ItemGroup), and each field group corresponds to a specific field (Item); for each field, it can have corresponding description information , the description information can include the name displayed on the EDC system interface, the data type, the meaning of the field, the business rule corresponding to the field, and the presentation method of the field in the export table. Fields and corresponding interpretation information are extracted from standard operating procedure (Standard Operating Procedure, SOP) documents and other materials, and such information is called a dictionary. The above content can be combined into a complete clinical research data (Clinical Data).

It can be seen that through the configuration of visits, forms, field groups, fields, dictionaries, units, etc., the database can build the basis for carrying clinical research data.

In a specific configuration process, a general configuration and a dedicated configuration may be performed on the second database based on the database building configuration of the first database.

Common configuration includes creation of test categories and visit groups, dictionary saving, form definition saving and field group field incremental saving, full update of visit tasks, and full update or addition of visit procedures. Among them, the same configuration fields may exist for different configuration contents, so when configuring the field group fields, full updates are not performed, but only incremental saving is performed in the corresponding configuration contents.

For example, in the creation of trial categories and visit groups, the import of units in the library configuration of the first database may be included. The corresponding relationship of the elements imported by the specific unit is shown in Table I.

Table I

first database second database OID Unit OID Name company name TranslatedText value of unit item = sign of unit item

The corresponding relationship between the elements imported by the dictionary in the dictionary storage is shown in Table II.

Table II

first database second database OID Dictionary OID Name dictionary name DataType do not handle SASFormatName do not handle CodedValue dictionary item value OrderNumber dictionary item ordering TranslatedText dictionary item name

Form definition saving and field group field incremental saving include form definition import, field group keyword import, field group definition import, field keyword import, field definition import, and data type import.

Table III: Form Definition Imported Element Correspondence.

Table IV: Element correspondences imported by field group keywords.

Table V: Element correspondences imported by field keywords.

Table VI: Element correspondences imported by field keywords.

Table VII: Field Definition Imported Element Correspondence.

Table VIII: Element correspondence for data type import.

Table IX: Element correspondences imported by the visit task.

It can be seen that the above general configuration may be a part of the database construction configuration based on the first database. After the general configuration of the second database is performed, a dedicated configuration of the second database may also be performed based on the remaining part of the database building configuration of the first database.

S12. Establish a docking relationship between the configured second database and the first database, and send the database building configuration of the second database to the first database.

In one embodiment, the second database may establish a docking relationship with the first database through a transfer platform.

Specifically, a docking instruction of the second database may be sent to the transit platform, and the transit platform may generate a docking identifier and a secret key according to the received docking instruction. The docking identifier is used for the first database to "identify" the object docked with it, and the secret key can ensure that only the permitted database establishes a docking relationship with the second database. After the transit platform sends the docking identifier and the secret key to the first database, the first database establishes a docking relationship with the second database based on the docking identifier and the secret key.

In such an embodiment, a transfer platform is used as a docking medium between the two system databases, and the transfer platform can be adapted to the docking between a variety of different systems, so that the development of software products is modularized and adaptable to different scenarios .

In one embodiment, the second database may also directly establish a docking relationship with the first database without going through a transfer platform.

In such an embodiment, it is equivalent to integrating the functions of the transfer platform in the previous embodiment into a system corresponding to the second database (for example, a data management system). That is, the docking identifier and the secret key can be directly generated according to the docking instruction of the second database, and the docking identifier and the secret key can be sent to the first database for establishing a docking relationship between the first database and the second database.

When establishing the docking relationship, the database building configuration of the second database is also sent to the first database. The database construction configuration of the second database is formed based on the above-mentioned database construction contents such as visits, forms, field groups, fields, dictionaries, and units. In the application scenario of the present application, the acquisition of clinical research data is performed based on the data management system corresponding to the second database, and these clinical research data will first be processed into a storage structure that can be carried by the second database. The configuration is transmitted back to the first database, so that the first database can obtain the ability to identify the clinical research data transmitted by the second database.

S13. Based on the visit serial number and the form serial number, establish a field mapping relationship between the first database and the second database.

In a clinical trial, a clinical trial protocol (Protocol) will be designed to describe the purpose, design, methodology, statistics and organizational implementation of the trial. A clinical trial protocol describes in detail how a clinical trial should be conducted, such as which type of patients should be enrolled (enrollment/exclusion criteria), the design and purpose of the trial, how the investigational drug should be administered, how the data should be analyzed, and how it should be handled adverse reactions, etc. Table X below illustrates a common study flow diagram in a clinical trial protocol.

Table X.

Table X includes baseline, visit dates (1 week, 2 weeks, 4 weeks, 8 weeks), and final steps and other periodic visit information. There will be corresponding visit tasks under each visit, such as demographics/ Medical history, concomitant therapy, blood count, skin lesion count, overall improvement, adverse events, and quality of life. For the visit tasks under each visit, there will be a corresponding form to record the relevant specific inspection items, etc.

Exemplarily, the visit sequence number can be determined according to the information of the periodic visit here, for example, in the order of baseline-1 week-2 weeks-4 weeks-8 weeks-final steps, the sequence number corresponding to each visit is determined. Correspondingly, the form number can be determined according to the visit task under each visit, for example, according to the order of demographics/medical history-concomitant treatment-blood routine-skin lesion count-overall improvement-adverse events-quality of life , and determine the serial number of the form corresponding to each visit task.

Of course, in the embodiment of the present application, the determination of the visit sequence number and the form sequence number may not be determined based on the information of the above exemplary research flow chart. That is, the visit serial number and the form serial number can be determined according to their respective preset rules, and there is no need to have the step of "re-determining the corresponding serial number according to the information in the research flow chart".

Based on the visit sequence number and the form sequence number, the field mapping order between the first database and the second data can be determined. For example, for the field corresponding to the blood routine, it may appear in multiple forms (different time points), and the form may appear under multiple visits. Fields corresponding to multiple blood routines can be sorted, and by analogy, the mapping order of all fields between the first database and the second data can be determined.

In conjunction with FIG. 4 , visits 1 to m, and forms 1 to n are determined, for example, in accordance with the above-described demonstration. Then visit 1-form 1 determines the first mapped blood routine field: field mapping 1, visit 1-form 2 determines the second mapped blood routine field: field mapping 2, and so on, until the m*nth A mapped blood routine field: field mapping m*n.

In an embodiment, in the establishment of the mapping relationship between the first database and the second database, an object identifier (OID) of a field may be selected as a mapping identifier, and established based on a determined field mapping sequence.

S14. Based on the field mapping relationship, send the clinical research data obtained from the second database to the first database.

For the data management system, the clinical research data obtained by the second database may come from various sources such as in-hospital, out-of-hospital follow-up and research medical records, and the format of these data may not be recognized by the first database of the collecting party (such as the EDC system). . Taking time information as an example, the original time data obtained by the data management system may be "Date: December 25, 2020, Time: 17:52", while corresponding to the EDC system, the time information is in the form of timestamps. save. Therefore, the data management system will first preprocess the clinical research data obtained from the second database to convert it into a data format recognized by the first database of the data collector, that is, a standard format.

In one embodiment, the preprocessed clinical research data can be sent to the transfer platform based on the field mapping relationship, and the transfer platform can perform operations such as previewing the data, and then indirectly send the clinical research data to the first database through the transfer platform.

Of course, in an alternative embodiment, the data management system may also directly send the clinical research data obtained from the second database to the first database after preprocessing, without being forwarded by the transfer platform.

Referring to FIG. 5, an embodiment of the clinical research data acquisition device of the present application is introduced. In this embodiment, the clinical research data collection device includes a configuration module 21 , a docking module 22 , a mapping relationship establishing module 23 and a data sending module 24 .

The configuration module 21 is used to receive the database construction configuration of the first database to configure the second database, wherein the configuration content of the second database includes visits, forms, field groups, fields, dictionaries, and units; the docking module 22 is used to configure the completed configuration. The second database establishes a docking relationship with the first database, and sends the database building configuration of the second database to the first database; the mapping relationship establishing module 23 is used to establish a relationship between the first database and the second database based on the visit sequence number and the form sequence number. The data sending module 24 is configured to send the clinical research data obtained from the second database to the first database based on the field mapping relationship.

In one embodiment, the docking module 22 is specifically configured to send a docking instruction of the second database to the transit platform, so that the transit platform can generate a docking identifier and a secret key, wherein the first database establishes docking with the second database based on the docking identifier and the secret key relation.

In one embodiment, the docking module 22 is specifically configured to generate a docking identifier and a secret key according to the docking instruction of the second database; and send the docking identifier and the secret key to the first database, so that the first database and the second database can establish a docking relationship .

In one embodiment, the mapping relationship establishing module 23 is specifically configured to determine the field mapping order between the first database and the second database based on the visit sequence number and the form sequence number; and use the object identifier of the field as the mapping identifier, and based on the field The mapping sequence is used to establish the field mapping relationship between the first database and the second database.

In one embodiment, the configuration module 21 is specifically configured to perform general configuration and special configuration on the second database based on the database construction configuration of the first database, wherein the general configuration includes creation of test categories and visit groups, dictionary storage, forms Definition saving and incremental saving of field group fields, full update of visit tasks, and full update or addition of visit procedures.

In one embodiment, the data sending module 24 is specifically configured to preprocess the clinical research data acquired by the second database into a standard format, wherein the standard format is a data format approved by the first database; and based on the field mapping relationship, the preprocessed The clinical research data is sent to the transfer platform, wherein the first database receives the preprocessed clinical research data from the transfer platform.

In one embodiment, the configuration module 21 is specifically configured to receive the database building configuration in the ODM file format of the first database to configure the second database.

As above, with reference to FIGS. 1 to 4 , the clinical research data collection method according to the embodiment of the present specification is described. The details mentioned in the above description of the method embodiments are also applicable to the clinical research data acquisition device of the embodiments of the present specification. The above clinical research data acquisition device may be implemented by hardware, or may be implemented by software or a combination of hardware and software.

FIG. 6 shows a hardware structure diagram of an electronic device according to an embodiment of the present specification. As shown in FIG. 6, the electronic device 30 may include at least one processor 31, memory 32 (eg, non-volatile memory), memory 33, and communication interface 34, and at least one processor 31, memory 32, memory 33, and communication interface 34 are connected together via a bus 35 . At least one processor 31 executes at least one computer readable instruction stored or encoded in memory 32 .

It should be understood that the computer-executable instructions stored in memory 32, when executed, cause at least one processor 31 to perform various operations and functions described above in connection with FIGS. 1-4 in various embodiments of this specification.

In the embodiments of this specification, the electronic device 30 may include, but is not limited to, a personal computer, a server computer, a workstation, a desktop computer, a laptop computer, a notebook computer, a mobile electronic device, a smart phone, a tablet computer, a cellular phone, Personal Digital Assistants (PDAs), handheld devices, messaging devices, wearable electronics, consumer electronics, and the like.

According to one embodiment, a program product such as a machine-readable medium is provided. A machine-readable medium may have instructions (ie, the above-described elements implemented in software) that, when executed by a machine, cause the machine to perform the various operations and operations described above in connection with FIGS. 1-5 in various embodiments of this specification. Function. Specifically, a system or an apparatus equipped with a readable storage medium may be provided, on which software program codes for realizing the functions of any of the above-described embodiments are stored, and a computer or a computer of the system or apparatus may be provided. The processor reads and executes the instructions stored in the readable storage medium.

In this case, the program code itself read from the readable medium can realize the functions of any one of the above-described embodiments, and thus the machine-readable code and the readable storage medium storing the machine-readable code constitute the present specification a part of.

Examples of readable storage media include floppy disks, hard disks, magneto-optical disks, optical disks (eg, CD-ROM, CD-R, CD-RW, DVD-ROM, DVD-RAM, DVD-RW, DVD-RW), magnetic tape, non- Volatile memory cards and ROMs. Alternatively, the program code may be downloaded from a server computer or the cloud over a communications network.

It should be understood by those skilled in the art that various variations and modifications may be made to the various embodiments disclosed above without departing from the spirit of the invention. Accordingly, the scope of protection of this specification should be defined by the appended claims.

It should be noted that not all steps and units in the above-mentioned processes and system structure diagrams are necessary, and some steps or units may be omitted according to actual needs. The execution order of each step is not fixed and can be determined as required. The device structure described in the above embodiments may be a physical structure or a logical structure, that is, some units may be implemented by the same physical client, or some units may be implemented by multiple physical clients, or may be implemented by multiple physical clients. Some components in separate devices are implemented together.

In the above embodiments, the hardware units or modules may be implemented mechanically or electrically. For example, a hardware unit, module or processor may include permanent dedicated circuits or logic (eg, dedicated processors, FPGAs or ASICs) to perform corresponding operations. The hardware unit or processor may also include programmable logic or circuits (such as a general-purpose processor or other programmable processors), which may be temporarily set by software to complete corresponding operations. The specific implementation (mechanical, or dedicated permanent circuit, or temporarily provided circuit) can be determined based on cost and time considerations.

The detailed description set forth above in connection with the accompanying drawings describes exemplary embodiments and does not represent all embodiments that may be implemented or fall within the scope of the claims. The term "exemplary" as used throughout this specification means "serving as an example, instance, or illustration" and does not mean "preferred" or "advantage" over other embodiments. The detailed description includes specific details for the purpose of providing an understanding of the described technology. However, these techniques may be practiced without these specific details. In some instances, well-known structures and devices are shown in block diagram form in order to avoid obscuring the concepts of the described embodiments.

The above description of the present disclosure is provided to enable any person of ordinary skill in the art to make or use the present disclosure. Various modifications to the present disclosure will be readily apparent to those of ordinary skill in the art, and the general principles corresponding herein may also be applied to other modifications without departing from the scope of the present disclosure. . Thus, the present disclosure is not intended to be limited to the examples and designs described herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (10)

1. a clinical research data collection method, is characterized in that, described method comprises: receiving the database construction configuration of the first database to configure the second database, wherein the configuration content of the second database includes visits, forms, field groups, fields, dictionaries, and units; establishing a docking relationship between the configured second database and the first database, and sending the database building configuration of the second database to the first database; establishing a field mapping relationship between the first database and the second database based on the visit sequence number and the form sequence number; Based on the field mapping relationship, the clinical research data acquired by the second database is sent to the first database. 2. The method for collecting clinical research data according to claim 1, characterized in that, establishing a docking relationship with the configured second database and the first database, specifically comprising: Send the docking instruction of the second database to the transit platform for the transit platform to generate a docking identifier and a secret key, wherein the first database establishes a docking relationship with the second database based on the docking identifier and the secret key . 3. The method for collecting clinical research data according to claim 1, wherein a docking relationship is established between the configured second database and the first database, specifically comprising: generating a docking identifier and a secret key according to the docking instruction of the second database; Sending the docking identifier and the secret key to the first database, so that the first database can establish a docking relationship with the second database. 4. clinical research data collection method according to claim 1, is characterized in that, based on visit serial number and form serial number, establishes the field mapping relationship between described first database and second database, specifically comprises: Determine the field mapping order between the first database and the second database based on the visit sequence number and the form sequence number; Using the object identifier of the field as the mapping identifier, and based on the field mapping sequence, the field mapping relationship between the first database and the second database is established. 5. The method for collecting clinical research data according to claim 1, wherein, based on the field mapping relationship, sending the clinical research data acquired by the second database to the first database, specifically comprising: The clinical research data obtained by preprocessing the second database is in a standard format, wherein the standard format is a data format approved by the first database; Based on the field mapping relationship, the preprocessed clinical research data is sent to a transfer platform, wherein the first database receives the preprocessed clinical research data from the transfer platform. 6. The method for collecting clinical research data according to claim 1, wherein receiving the database construction configuration of the first database to configure the second database, specifically comprising: General configuration and special configuration are performed on the second database based on the database construction configuration of the first database, wherein the general configuration includes creation of test categories and visit groups, dictionary storage, form definition storage, and field group fields Incremental saving, full update of visit tasks, and full update or addition of visit procedures. 7. The method for collecting clinical research data according to any one of claims 1 to 6, wherein the database building configuration of the first database is an ODM file format. 8. A clinical research data acquisition device, wherein the clinical research data acquisition device comprises: a configuration module, configured to receive the database construction configuration of the first database to configure the second database, wherein the configuration content of the second database includes visits, forms, field groups, fields, dictionaries, and units; a docking module, configured to establish a docking relationship between the configured second database and the first database, and send the database building configuration of the second database to the first database; a mapping relationship establishing module for establishing a field mapping relationship between the first database and the second database based on the visit sequence number and the form sequence number; A data sending module, configured to send the clinical research data obtained from the second database to the first database based on the field mapping relationship. 9. An electronic device comprising: at least one processor; and A memory that stores instructions that, when executed by the at least one processor, cause the at least one processor to perform the clinical research data acquisition method of any one of claims 1 to 7 . 10. A machine-readable storage medium storing executable instructions that, when executed, cause the machine to perform the clinical research data acquisition method of any one of claims 1 to 7.

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