Data management method and system for clinical research projects

Abstract

The present invention provides a data management method for clinical research projects, the method comprising: in response to a node event initiated by a workflow management center, triggering a call request, the workflow management center communicating with multiple clinical research tools; in response to the call request, calling a specific research tool among the multiple clinical research tools, and collecting at least one target parameter provided by the specific research tool; creating a customized format copy of the target parameter and storing it in an underlying database. In addition, the present invention also provides corresponding computer equipment and readable media, as well as a data management system for clinical research projects. Implementation of the various embodiments of the present invention helps to improve the efficiency of team collaboration and clinical research.

Description

Technical Field

[0001] The present invention belongs to the field of computer data management and storage, and in particular, relates to a data management method, system, device and readable medium for clinical research projects. Background Art

[0002] Medical clinical research projects are relatively complex, and different tools are required for each link involved. However, these tools are often developed independently, so data cannot be quickly exchanged between tools, or data can only be exchanged to a low degree, which greatly affects the collaboration efficiency of teams involved in medical clinical research projects. For example, in randomized controlled trial studies, data from tools such as comprehensive data collection systems and clinical research randomization systems are required.

[0003] In addition, due to the wide variety of clinical research types, when conducting new types of research, it is often necessary to design new tools to connect with existing tools, which will also consume a lot of development time and seriously affect the progress of clinical research.

[0004] The existing automation system cannot support the rapid calling of different tools in the workflow nodes of clinical research projects in terms of data interoperability, and redeveloping and adapting the data interoperability of each tool requires time and development costs. Therefore, how to efficiently complete clinical research projects has always been a problem that troubles the teams involved in clinical research projects. Summary of the invention

[0005] In order to overcome the above-mentioned defects in the prior art, the present invention provides a data management method for a clinical research project, the method comprising:

[0006] In response to a node event initiated by a workflow management center, a call request is triggered, and the workflow management center communicates with a plurality of clinical research tools;

[0007] In response to the calling request, calling a specific research tool among the plurality of clinical research tools, and collecting at least one target parameter provided by the specific research tool;

[0008] A customized rendition of the target parameters is created and stored in the underlying database.

[0009] According to one aspect of the present invention, before triggering the call request, the method further includes: determining whether the node event triggers the execution of the specific research tool; if so, triggering the call request.

[0010] According to another aspect of the present invention, the step of collecting at least one target parameter provided by the specific research tool in the method includes: the caller included in the workflow management center creates / searches for a call record table corresponding to the specific research tool according to the call request; obtains a configuration information table according to the call record table; and collects the at least one target parameter according to a predetermined strategy based on the configuration information table.

[0011] According to another aspect of the present invention, after collecting the at least one target parameter according to the configuration information table in accordance with a predetermined strategy, the method further includes: updating the call record table to record that the status of the target parameter is collected.

[0012] According to another aspect of the present invention, the attribute information recorded in the call record table in the method includes: any one or more of: call description, tool name, tool code, execution status identifier, creation time, and execution time.

[0013] According to another aspect of the present invention, the step of collecting the at least one target parameter according to a predetermined strategy according to the configuration information table in the method includes: selecting the calling mode of the at least one target parameter as asynchronous calling or synchronous calling according to the configuration information table; accessing the callback address or calling address of the at least one target parameter according to the configuration information table; and obtaining the at least one target parameter from the callback address or calling address.

[0014] According to another aspect of the present invention, the attribute information recorded in the configuration table in the method includes: any one or more of: tool code, tool name, interaction mode, input parameter indication identifier, output parameter indication identifier, call address, and callback address.

[0015] According to another aspect of the present invention, the step of creating a customized format copy of the target parameters and storing it in the underlying database in the method includes: the parser included in the workflow management center obtains and parses the target parameters; creates the customized format copy based on the results of the parsing; and sends the customized format copy to the underlying database for storage.

[0016] According to another aspect of the present invention, the target parameters in the method include: key information in the clinical research project recorded using the specific research tool; the key information at least includes any one or more of the project name, drug name, disease name, time, and identity name.

[0017] According to another aspect of the present invention, the clinical research tools in the method include: a tool for recording participant data of a clinical research project, a tool for recording or analyzing medical data of a clinical research project, a tool for managing electronic documents of a clinical research project, and / or a tool for monitoring the quality of a clinical research project.

[0018] The present invention also provides a data management system for clinical research projects, the system comprising a workflow management platform, multiple clinical research tools and an underlying database, wherein:

[0019] The workflow management platform communicates with the plurality of clinical research tools;

[0020] The workflow management middle platform is used to trigger a call request in response to a node event initiated by the workflow management middle platform, and in response to the call request, call a specific research tool among the multiple clinical research tools, collect at least one target parameter provided by the specific research tool, and create a customized format copy of the target parameter;

[0021] The underlying database is used to store the customized format copy.

[0022] In addition, the present invention provides one or more computer-readable media storing computer-executable instructions, which, when used by one or more computer devices, cause the one or more computer devices to execute the data management method for a clinical research project as described above.

[0023] Accordingly, the present invention also provides a computer device, comprising a memory and a processor, wherein: the memory stores a computer program, and the processor implements the data management method for clinical research projects as described above when executing the computer program.

[0024] The data management method for clinical research projects provided by the present invention uses a workflow management platform to centrally manage the data of multiple clinical research tools, and stores the customized format copies created according to the target parameters provided by the specific research tools in the underlying database, so that the data generated by the clinical research tools involved in each node in the clinical research project can be copied and deposited in the underlying database. Usually, the data of different clinical research tools are retained in a universal and customized manner, so that the clinical research project realizes the data intercommunication of multiple clinical research tools, which helps to improve the efficiency of team collaboration and clinical research. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Other features, objects and advantages of the present invention will become more apparent from the detailed description of non-limiting embodiments made with reference to the following drawings:

[0026] Figure 1 is a flow chart of a specific embodiment of a data management method for a clinical research project according to the present invention;

[0027] Figure 2 yes Figure 1 A flowchart of an optional specific implementation of the step of collecting at least one target parameter provided by the specific research tool in step S200 is shown;

[0028] Figure 3 yes Figure 2 The flowchart of an optional specific implementation of step S230 is shown;

[0029] Figure 4 yes Figure 1 The flowchart of step S300 is shown as an optional specific implementation method;

[0030] Figure 5 is a schematic structural diagram of an optional specific implementation of a data management system for a clinical research project according to the present invention;

[0031] Figure 6 It is a schematic diagram of the structure of a typical computer device for executing a specific embodiment of the data management method for clinical research projects of the present invention.

[0032] The same or similar reference numerals in the drawings represent the same or similar components. DETAILED DESCRIPTION

[0033] In order to better understand and explain the present invention, the present invention will be further described in detail below in conjunction with the accompanying drawings. The present invention is not limited to these specific embodiments. On the contrary, modifications or equivalent substitutions made to the present invention should all be included in the scope of the claims of the present invention.

[0034] It should be noted that many specific details are given in the following specific embodiments. It should be understood by those skilled in the art that the present invention can also be implemented without these specific details. In the multiple specific embodiments given below, structures and components well known in the art are not described in detail in order to highlight the main purpose of the present invention.

[0035] The present invention provides a data management method for clinical research projects, please refer to Figure 1 , Figure 1 1 is a flow chart of a specific embodiment of a data management method for a clinical research project according to the present invention, the method comprising:

[0036] Step S100, in response to a node event initiated by a workflow management platform, triggering a call request, wherein the workflow management platform communicates with a plurality of clinical research tools;

[0037] Step S200, in response to the calling request, calling a specific research tool among the multiple clinical research tools, and collecting at least one target parameter provided by the specific research tool;

[0038] Step S300: creating a customized format copy of the target parameter and storing it in an underlying database.

[0039] The following will Figure 1 Each step is described in detail.

[0040] Specifically, a clinical research project has multiple stages, such as project launch, centralized training, data analysis, etc. The multiple stages are usually abstracted into multiple nodes, such as project launch nodes, centralized training nodes, and data analysis nodes. When a clinical research project is executed, the transactions required to be processed in each stage (i.e., each node) correspond to multiple relatively independent work items. Each work item specifies the operations required, such as filling out documents and recording data using clinical research tools. Node events refer to one or more of the work items. The multiple nodes corresponding to the clinical research project can be serial or parallel to each other. These nodes and the serial and parallel rules between the nodes together constitute the workflow of the clinical research project.

[0041] In step S100, the object processed by the workflow management center is at least one workflow of multiple clinical research projects, and the node event is the work item corresponding to the node in the workflow. Since each of the clinical research projects may need to use a variety of different types of clinical research tools, accordingly, the workflow management center is configured to communicate with multiple clinical research tools. More specifically, the workflow management center is usually implemented as a software logic running on a suitable hardware environment, such as a software program configured to communicate with the clinical research tool. The clinical research tools include one or more of the following types: tools for recording participant data of clinical research projects, such as customer relationship management tools, etc.; tools for recording or analyzing medical data of clinical research projects, such as data collection tools, data analysis tools, follow-up tools, clinical research randomization tools, etc.; tools for managing electronic documents of clinical research projects, such as electronic trial master document management tools (eTMF) for clinical trial documents; tools for monitoring the quality of clinical research projects, such as quality control tools and audit tools. Typically, the clinical research tool consists of software and hardware, and systematically integrates the required software logic and hardware interfaces. Typically, when the node event is initiated, the specific research tool required for the node event can be determined immediately, and the corresponding call request is also triggered.

[0042] Since the specific research tool to be used has been selected from the multiple clinical research tools according to the node event in step S100, it is obvious that the call request triggered thereupon is also associated with the specific research tool. Further in step S200, in response to the call request, a specific research tool among the multiple clinical research tools is called, and the purpose of calling the specific research tool is to collect at least one target parameter provided by the specific research tool. Typically, the target parameters include: key information in the clinical research project recorded using the specific research tool. Usually the key information includes at least one or more of the project name, drug name, disease name, time, and identity name. In other embodiments, the key information may also include a code for identifying an entity or abstract body involved in the clinical research project, such as a project code, a drug code, a disease code, etc.

[0043] Those skilled in the art can understand that any data provided by the specific research tool and associated with the node event belongs to the target parameter and can be collected in step S200.

[0044] Optionally, before the step of triggering the call request in step S100, Figure 1The specific implementation shown may also include the following optional steps: determining whether the node event triggers the execution of the specific research tool; if so, triggering the call request. For the workflow management center, the multiple clinical research tools that communicate with it are in a silent running state when not called. The workflow management center usually cannot know whether a specific research tool among the multiple clinical research tools will be triggered by the node event and executed. Therefore, it can first determine whether the node event triggers the execution of the specific research tool. When the result of the judgment is yes, the call request has the possibility of being responded to by the specific research tool, thereby further triggering the call request to facilitate the smooth execution of step S200.

[0045] For further explanation of step S200, please refer to Figure 2 , Figure 2 yes Figure 1 The flowchart of an optional specific implementation of the step of collecting at least one target parameter provided by the specific research tool in step S200 is shown, and the step of collecting at least one target parameter provided by the specific research tool includes:

[0046] Step S210, the caller included in the workflow management center creates / searches a call record table corresponding to the specific research tool according to the call request;

[0047] Step S220, obtaining a configuration information table according to the call record table;

[0048] Step S230: collecting the at least one target parameter according to the configuration information table in accordance with a predetermined strategy.

[0049] Specifically, the caller in step S210 can be implemented as a software program or function integrated in the workflow management platform, and its function is to create or search for a call record table corresponding to the specific research tool according to the call request. The function of the call record table is at least used to record the object, purpose, status or time of the call request and other attribute information, so as to provide a basis for subsequent traceability, verification and other operations. Based on this consideration, the attribute information recorded in the call record table typically includes: any one or more of the call description, tool name, tool code, execution status identifier, creation time, and execution time.

[0050] In step S220, the function of the configuration information table is at least to determine the data calling method that the specific research tool can support and the data calling address that can be provided, so that the workflow management center can smoothly collect the at least one target parameter. In addition, if a filter condition is added to the call request, it is also necessary to provide input parameters associated with the filter condition, and consider the subsequent reception of output parameters. At this time, the configuration information table may also be used to mark the existence status of input parameters and output parameters. Based on this consideration, typically, the attribute information recorded in the configuration table includes: any one or more of the tool code, tool name, interaction mode, input parameter indication identifier, output parameter indication identifier, call address, and callback address.

[0051] In step S230, since the configuration information table has been obtained, the at least one target parameter can be collected according to the configuration information table and the predetermined strategy. Figure 3 , Figure 3 yes Figure 2 The flowchart of an optional specific implementation of step S230 is shown, and step S230 further optionally includes:

[0052] Step S231, selecting the calling mode of the at least one target parameter as asynchronous calling or synchronous calling according to the configuration information table;

[0053] Step S232, accessing the callback address or calling address of the at least one target parameter according to the configuration information table;

[0054] Step S233: Acquire the at least one target parameter from the callback address or the calling address.

[0055] In this optional specific implementation, the purpose of executing step S231 and step S232 is to determine the predetermined strategy, and determining the predetermined strategy refers to determining the calling method (such as asynchronous calling or synchronous calling) and the acquisition address (such as obtaining the callback address or calling address) of the at least one target parameter, so that the at least one target parameter can be successfully acquired in step S233. Whether it is an asynchronous call or a synchronous call, the means of acquiring the at least one target parameter in step S233 includes but is not limited to acquiring through a communication link constructed based on the http protocol, the https protocol, the ftp protocol, the socket connection, etc.

[0056] Please continue to refer to Figure 2 , optionally, after step S230, Figure 2 The process shown may also include:

[0057] Step S240, update the call record table to record the state of the target parameter as having been collected. For example, update the execution status identifier recorded in the call record table, and change the value of the execution status identifier from the character "0" indicating unexecuted to the character "1" indicating executed. The purpose of executing step S240 is to provide verification or traceability for the result of collecting the target parameter, so as to avoid the target parameter being collected without being perceived when errors or omissions occur.

[0058] Please continue to refer to Figure 1 , after step S200 is executed, since at least one target parameter has been collected, step S300 is further executed, that is, a customized format copy of the target parameter is created and stored in the underlying database. Typically, the data structure of the customized format copy is, for example, an independent data table that can be stored and recognized by the underlying database. The reason for creating the customized format copy is to encapsulate the target parameter into a format that can be directly recognized by the workflow management center, and store it persistently in the underlying database, so that the target parameter can be directly read, modified or distributed by the workflow management center, and the above reading, modification or distribution no longer requires the participation of the specific research tool that generates the target parameter, which improves the team collaboration efficiency of clinical research projects.

[0059] Please refer to Figure 4 , Figure 4 yes Figure 1 FIG. 1 is a flow chart of an optional specific implementation of step S300. In this optional specific implementation, step S300 includes:

[0060] Step S310, the parser included in the workflow management platform obtains and parses the target parameters;

[0061] Step S320, creating the customized format copy according to the parsing result;

[0062] Step S330: sending the customized format copy to the underlying database for storage.

[0063] Specifically, the parser in step S310 can be implemented as a software program or function integrated in the workflow management platform, and its function is to parse the target parameter. The purpose of the parsing is to strip useful information from the original package of the target parameter so as to create the customized format copy in step S320.

[0064] It should be noted that although the operations of the method of the present invention are described in a specific order in the accompanying drawings, this does not require or imply that the operations must be performed in this specific order, or that all the operations shown must be performed to achieve the desired results. On the contrary, the steps depicted in the flow chart can be changed in the order of execution. Additionally or alternatively, some steps can be omitted, multiple steps can be combined into one step for execution, and / or one step can be decomposed into multiple steps for execution.

[0065] The present invention also provides a data management system for clinical research projects, please refer to Figure 5 , Figure 5 : is a schematic diagram of an optional specific implementation of a data management system for a clinical research project according to the present invention, wherein the system includes a workflow management platform 20, multiple clinical research tools and an underlying database 30, wherein:

[0066] The workflow management platform 20 communicates with the plurality of clinical research tools;

[0067] The workflow management platform 20 is used to trigger a call request in response to a node event initiated by the workflow management platform 20, and to call a specific research tool among the multiple clinical research tools in response to the call request, and to collect at least one target parameter provided by the specific research tool, and to create a customized format copy of the target parameter;

[0068] The underlying database 30 is used to store the customized format copies.

[0069] The terms and nouns appearing in this section have the same meaning as the same terms or nouns in the previous text, such as the "node events", "clinical research tools" and "target parameters". The above terms or nouns and their related working principles can refer to the descriptions and explanations in the relevant parts of the previous text. For the sake of simplicity, they will not be repeated here.

[0070] Specifically, the object processed by the workflow management platform 20 is at least one flow of work in multiple clinical research projects, such as Figure 5 The workflow 40 shown in FIG. 40; the node event is, for example, a work item belonging to the node 41 within the workflow 40, and the plurality of clinical research tools is, for example, Figure 5 Of the clinical research tools 11 , 12 , 13 and 14 shown, the particular research tool is, for example, the selected clinical research tool 11 .

[0071] In some embodiments, the workflow management platform 20 can be composed of a server device; in other embodiments, the workflow management platform 20 can also be composed of multiple server devices distributed and running on the Internet, and each functional module separated from the workflow management platform 20 runs on the above multiple servers respectively, and the functional module or the workflow management platform 20 can be implemented as a hardware part and a software part that can be interpreted and executed by the hardware part, and these hardware parts and software parts work together to realize the functions of the server. Similarly, the underlying database 30 can also be implemented as a distributed, permission-controlled database.

[0072] Please refer to Figure 6 , Figure 6 1 is a schematic diagram of a typical computer device for executing a specific embodiment of the data management method for clinical research projects of the present invention. More specifically, an automated device for executing the data management method for clinical research projects can be included as a part of the computer device. The computer device at least includes the following parts: CPU (central processing unit) 501, RAM (random access memory) 502, ROM (read-only memory) 503, system bus 500, hard disk control unit 504, hard disk 505, human-computer interaction external device control unit 506, human-computer interaction external device 507, serial interface control unit 508, serial interface external device 509, parallel interface control unit 510, parallel interface external device 511, display device control unit 512 and display device 513. Among them, CPU 501, RAM 502, ROM 503, hard disk control unit 504, human-computer interaction external device control unit 506, serial interface control unit 508, parallel interface control unit 510 and display device control unit 512 are connected to the system bus 500, and realize communication between each other through the system bus 500. In addition, the hard disk control unit 504 is connected to the hard disk 505; the human-computer interaction external device control unit 506 is connected to the human-computer interaction external device 507, which is typically a mouse, a trackball, a touch screen or a keyboard; the serial interface control unit 508 is connected to the serial interface external device 509; the parallel interface control unit 510 is connected to the parallel interface external device 511; and the display device control unit 512 is connected to the display device 513.

[0073] Figure 6 The structural block diagram merely shows the structure of a computer device that can practice various embodiments of the present invention, and is not intended to limit the practice environment of the present invention. In some cases, some devices in the computer device can be added or reduced as needed. For example, Figure 6The device shown can remove the human-computer interaction external device 507 and the display device 513, and its specific implementation form is only a server that can be accessed by external devices. Figure 6 The computer devices shown can independently implement the operating environment of the present invention, or can be interconnected through a network to provide an operating environment suitable for each specific embodiment of the present invention. For example, each module and / or step of the present invention can be implemented in a distributed manner in each interconnected computer device.

[0074] In addition, the present invention also discloses one or more computer-readable media storing computer-executable instructions, which, when used by one or more computer devices, enable one or more computer devices to execute various specific embodiments of the data management method for clinical research projects as described above, such as Figure 1 The specific implementation shown. The computer-readable medium can be any available medium that can be accessed by a computer device, and includes volatile and non-volatile media, removable and non-removable media implemented by any method and technology to store information such as computer-readable instructions, data structures, program modules or other data. Computer-readable media include, but are not limited to, RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital versatile disk (DVD) or other optical storage, cassettes, magnetic tapes, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to store the desired information and can be accessed by a computing device. Any combination of the above should also be included in the scope of computer-readable media.

[0075] Accordingly, the present invention further discloses a computer device, the computer device comprising a memory and a processor, wherein: the memory stores a computer program, and the processor implements various specific embodiments of the data management method for clinical research projects as described above when executing the computer program, for example Figure 1 The specific implementation shown.

[0076] The part involving software logic in the data management method for clinical research projects provided by the present invention can be implemented using a programmable logic device, or can be implemented as a computer program product, which enables a computer to execute the above method. The computer program product includes a computer-readable storage medium, which contains a computer program logic or code part, and is used to implement each step of the above method. The computer-readable storage medium can be a built-in medium installed in a computer or a removable medium (such as a hot-swappable storage device) that can be removed from the computer body. The built-in medium includes but is not limited to a rewritable non-volatile memory, such as RAM, ROM and hard disk. The removable medium includes but is not limited to: optical storage media (such as CD-ROM and DVD), magneto-optical storage media (such as MO), magnetic storage media (such as magnetic tape or mobile hard disk), a medium with a built-in rewritable non-volatile memory (such as a memory card) and a medium with a built-in ROM (such as a ROM box).

[0077] Those skilled in the art will appreciate that any computer system with an appropriate programming device can perform the steps of the method of the present invention contained in the computer program product. Although most of the specific embodiments described in this specification focus on software programs, alternative embodiments that implement the method provided by the present invention in hardware are also within the scope of the present invention.

[0078] It is obvious to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the present invention can be implemented in other specific forms without departing from the spirit or essential features of the present invention. Therefore, the embodiments should be regarded as exemplary and non-restrictive, and the scope of the present invention is defined by the appended claims rather than the above description, and all changes within the meaning and scope of the equivalent elements of the claims are included in the present invention. Any figure mark in the claims should not be regarded as limiting the claims involved. In addition, it is obvious that the word "comprising" does not exclude other parts, units or steps, and the singular does not exclude the plural. Multiple parts, units or devices stated in the claims may also be implemented by one part, unit or device through software or hardware.

[0079] The data management method for clinical research projects provided by the present invention uses a workflow management platform to centrally manage the data of multiple clinical research tools, and stores the customized format copies created according to the target parameters provided by the specific research tools in the underlying database, so that the data generated by the clinical research tools involved in each node in the clinical research project can be copied and deposited in the underlying database. Usually, the data of different clinical research tools are retained in a universal and customized manner, so that the clinical research project realizes the data intercommunication of multiple clinical research tools, which helps to improve the efficiency of team collaboration and clinical research.

[0080] The above disclosure is only a part of the embodiments or specific implementations of the present invention, which cannot be used to limit the scope of rights of the present invention. Equivalent changes made according to the claims of the present invention are still within the scope covered by the present invention.

Claims

1. A data management method for a clinical research project, the method comprising: In response to a node event initiated by a workflow management center, a call request is triggered, and the workflow management center communicates with a plurality of clinical research tools; In response to the calling request, calling a specific research tool among the plurality of clinical research tools, and collecting at least one target parameter provided by the specific research tool; creating a customized format copy of the target parameters and storing it in an underlying database; Wherein, the step of collecting at least one target parameter provided by the specific research tool comprises: The caller included in the workflow management center creates / searches a call record table corresponding to the specific research tool according to the call request; Acquire a configuration information table according to the call record table; Collecting the at least one target parameter according to the configuration information table and a predetermined strategy; The step of collecting the at least one target parameter according to the configuration information table in accordance with a predetermined strategy comprises: Selecting, according to the configuration information table, a calling mode of the at least one target parameter as asynchronous calling or synchronous calling; Accessing a callback address or a calling address of the at least one target parameter according to the configuration information table; The at least one target parameter is obtained from the callback address or the calling address.

2. The data management method according to claim 1, before the triggering call request, the method further comprises: Determining whether the node event triggers the execution of the specific research tool; If so, the call request is triggered.

3. The data management method according to claim 1, after collecting the at least one target parameter according to the configuration information table in accordance with a predetermined strategy, the method further comprises: The call record table is updated to record that the status of the target parameter is collected.

4. The data management method according to claim 1 or 3, wherein: The attribute information recorded in the call record table includes: Any one or more of call description, tool name, tool code, execution state identifier, creation time, and execution time.

5. The data management method according to claim 1, wherein: The attribute information recorded in the configuration table includes: Any one or more of the following: tool code, tool name, interaction mode, input parameter indicator identifier, output parameter indicator identifier, call address, and callback address.

6. The data management method according to claim 1, wherein: The step of creating a customized format copy of the target parameters and storing it in an underlying database comprises: The parser included in the workflow management center obtains and parses the target parameter; creating the customized format copy according to the result of the parsing; The customized format copy is sent to the underlying database for storage.

7. The data management method according to any one of claims 1, 3 or 6, wherein: The target parameters include: Key information from the clinical research project recorded using the specific research tool described; The key information includes at least one or more of the project name, drug name, disease name, time, and identity name.

8. The data management method according to claim 1, wherein: The clinical research tools include: Tools for recording participant data for a clinical research project, tools for recording or analyzing medical data for a clinical research project, tools for managing electronic documents for a clinical research project, and / or tools for monitoring the quality of a clinical research project.

9. A data management system for a clinical research project, the system comprising a workflow management platform, multiple clinical research tools and an underlying database, wherein: The workflow management platform communicates with the plurality of clinical research tools; The workflow management middle platform is used to trigger a call request in response to a node event initiated by the workflow management middle platform, and in response to the call request, call a specific research tool among the multiple clinical research tools, collect at least one target parameter provided by the specific research tool, and create a customized format copy of the target parameter; The underlying database is used to store the customized format copy; Wherein, the step of collecting at least one target parameter provided by the specific research tool comprises: The caller included in the workflow management center creates / searches a call record table corresponding to the specific research tool according to the call request; Acquire a configuration information table according to the call record table; Collecting the at least one target parameter according to the configuration information table and a predetermined strategy; The step of collecting the at least one target parameter according to the configuration information table in accordance with a predetermined strategy comprises: Selecting, according to the configuration information table, a calling mode of the at least one target parameter as asynchronous calling or synchronous calling; Accessing a callback address or a calling address of the at least one target parameter according to the configuration information table; The at least one target parameter is obtained from the callback address or the calling address.

10. One or more computer-readable media storing computer-executable instructions, which, when used by one or more computer devices, cause the one or more computer devices to execute the data management method for a clinical research project according to any one of claims 1 to 8.

11. A computer device comprising a memory and a processor, wherein: The memory stores a computer program, and when the processor executes the computer program, the data management method for a clinical research project according to any one of claims 1 to 8 is implemented.

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