CN116386791A

CN116386791A - Data management method and device for medical clinical test and electronic equipment

Info

Publication number: CN116386791A
Application number: CN202211635164.2A
Authority: CN
Inventors: 张思琦; 武惠韬; 吴家林; 代小亚; 黄海峰
Original assignee: Beijing Baidu Netcom Science and Technology Co Ltd
Current assignee: Beijing Baidu Netcom Science and Technology Co Ltd
Priority date: 2022-12-19
Filing date: 2022-12-19
Publication date: 2023-07-04

Abstract

The disclosure provides a data management method, a device, electronic equipment and a medium for medical clinical test, relates to the field of data processing, and particularly relates to the field of medical data management. The data management method may include: obtaining a first form from a first user, wherein the first user has a first identity type; determining whether the first form meets a first requirement; in response to determining that the first requirement is satisfied, displaying a first form at a terminal of a second user, wherein the second user has a second identity type that is different from the first identity type; in response to the challenge content from the second user: displaying the questioning content at the terminal of the first user for the first user to respond to the questioning content; receiving response content from the first user; and displaying the response content at the terminal of the second user; and in response to receiving a confirmation of the first form from the second user, storing the first form confirmed by the second user.

Description

Data management method and device for medical clinical test and electronic equipment

Technical Field

The present disclosure relates to the field of data processing technology, and in particular, to medical data management, and more particularly, to a data management method, apparatus, electronic device, computer readable storage medium, and computer program product for medical clinical trials.

Background

The clinical scientific research data acquisition has the characteristics of long time, large data quantity of subjects, complex acquisition management flow, numerous participation roles and the like. At present, a method and a system for uniformly managing clinical scientific research test data are lacking.

The approaches described in this section are not necessarily approaches that have been previously conceived or pursued. Unless otherwise indicated, it should not be assumed that any of the approaches described in this section qualify as prior art merely by virtue of their inclusion in this section. Similarly, the problems mentioned in this section should not be considered as having been recognized in any prior art unless otherwise indicated.

Disclosure of Invention

The present disclosure provides a data management method, apparatus, electronic device, computer-readable storage medium, and computer program product for medical clinical trials.

According to an aspect of the present disclosure, there is provided a data management method for a medical clinical trial, comprising: obtaining a first form from a first user, the first form comprising a corresponding at least one field value for at least one field for a first subject, wherein the first user has a first identity type; determining whether the first form meets a first requirement; in response to determining that the first requirement is met, displaying the first form at a terminal of a second user for the second user to question field values in the first form or to confirm the first form, wherein the second user has a second identity type different from the first identity type; in response to receiving from the second user a challenge content of a first field value of a first field in the first form: displaying the questioning content at a terminal of the first user for the first user to respond to the questioning content; receiving response content from the first user; displaying the response content at the terminal of the second user so that the second user can carry out a question operation or a confirmation operation again based on the response content; and in response to receiving a confirmation of the first form from the second user, storing the first form confirmed by the second user

According to another aspect of the present disclosure, there is provided a data management apparatus for medical clinical trials, comprising: a form obtaining unit for obtaining a first form from a first user, the first form comprising a corresponding at least one field value for at least one field with respect to a first subject, wherein the first user has a first identity type; a logic verification unit, configured to determine whether the first form meets a first requirement; a form verification unit configured to display, in response to determining that the first requirement is satisfied, the first form at a terminal of a second user for the second user to question a field value in the first form or to confirm the first form, wherein the second user has a second identity type different from the first identity type; a form response unit, configured to respond to receiving, from the second user, a challenge content of a first field value of a first field in the first form: displaying the questioning content at a terminal of the first user for the first user to respond to the questioning content; receiving response content from the first user; displaying the response content at the terminal of the second user so that the second user can carry out a question operation or a confirmation operation again based on the response content; and a form storage unit configured to store the first form confirmed by the second user in response to receiving a confirmation of the first form from the second user.

According to another aspect of the present disclosure, there is provided an electronic device including: at least one processor; and a memory communicatively coupled to the at least one processor; wherein the memory stores instructions executable by the at least one processor to enable the at least one processor to perform a data management method for medical clinical trials in accordance with one or more embodiments of the present disclosure.

According to another aspect of the present disclosure, there is provided a non-transitory computer-readable storage medium storing computer instructions for causing the computer to perform a data management method for medical clinical trials according to one or more embodiments of the present disclosure.

According to another aspect of the present disclosure, a computer program product is provided, comprising a computer program, wherein the computer program, when executed by a processor, implements a data management method for medical clinical trials according to one or more embodiments of the present disclosure.

According to one or more embodiments of the present disclosure, a reasonable data processor hierarchy and smooth data transfer may be provided, enabling more efficient scientific data management.

It should be understood that the description in this section is not intended to identify key or critical features of the embodiments of the disclosure, nor is it intended to be used to limit the scope of the disclosure. Other features of the present disclosure will become apparent from the following specification.

Drawings

The accompanying drawings illustrate exemplary embodiments and, together with the description, serve to explain exemplary implementations of the embodiments. The illustrated embodiments are for exemplary purposes only and do not limit the scope of the claims. Throughout the drawings, identical reference numerals designate similar, but not necessarily identical, elements.

FIG. 1 illustrates a schematic diagram of an exemplary system in which various methods described herein may be implemented, in accordance with an embodiment of the present disclosure;

FIG. 2 illustrates a flow chart of a data management method for a medical clinical trial according to an embodiment of the present disclosure;

FIG. 3 illustrates an example flow chart of subject data collection management according to an embodiment of the disclosure;

FIG. 4 illustrates an example flow diagram of subject data management and data challenge in accordance with an embodiment of the present disclosure;

FIG. 5 illustrates an example of an interactive interface for system challenge logic verification settings, according to an embodiment of the present disclosure;

FIG. 6 illustrates an example of an interactive interface of a manual challenge flow interface in accordance with an embodiment of the present disclosure;

FIG. 7 shows a block diagram of a data management device for medical clinical trials according to an embodiment of the present disclosure;

fig. 8 illustrates a block diagram of an exemplary electronic device that can be used to implement embodiments of the present disclosure.

Detailed Description

Exemplary embodiments of the present disclosure are described below in conjunction with the accompanying drawings, which include various details of the embodiments of the present disclosure to facilitate understanding, and should be considered as merely exemplary. Accordingly, one of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope of the present disclosure. Also, descriptions of well-known functions and constructions are omitted in the following description for clarity and conciseness.

In the present disclosure, the use of the terms "first," "second," and the like to describe various elements is not intended to limit the positional relationship, timing relationship, or importance relationship of the elements, unless otherwise indicated, and such terms are merely used to distinguish one element from another. In some examples, a first element and a second element may refer to the same instance of the element, and in some cases, they may also refer to different instances based on the description of the context.

The terminology used in the description of the various illustrated examples in this disclosure is for the purpose of describing particular examples only and is not intended to be limiting. Unless the context clearly indicates otherwise, the elements may be one or more if the number of the elements is not specifically limited. Furthermore, the term "and/or" as used in this disclosure encompasses any and all possible combinations of the listed items.

Embodiments of the present disclosure will be described in detail below with reference to the accompanying drawings.

Fig. 1 illustrates a schematic diagram of an exemplary system 100 in which various methods and apparatus described herein may be implemented, in accordance with an embodiment of the present disclosure. Referring to fig. 1, the system 100 includes one or

more client devices

101, 102, 103, 104, 105, and 106, a server 120, and one or more communication networks 110 coupling the one or more client devices to the server 120.

Client devices

101, 102, 103, 104, 105, and 106 may be configured to execute one or more applications.

In an embodiment of the present disclosure, the server 120 may run one or more services or software applications that enable execution of the data management method for medical clinical trials according to the present disclosure.

In some embodiments, server 120 may also provide other services or software applications, which may include non-virtual environments and virtual environments. In some embodiments, these services may be provided as web-based services or cloud services, for example, provided to users of

client devices

101, 102, 103, 104, 105, and/or 106 under a software as a service (SaaS) model.

In the configuration shown in fig. 1, server 120 may include one or more components that implement the functions performed by server 120. These components may include software components, hardware components, or a combination thereof that are executable by one or more processors. A user

operating client devices

101, 102, 103, 104, 105, and/or 106 may in turn utilize one or more client applications to interact with server 120 to utilize the services provided by these components. It should be appreciated that a variety of different system configurations are possible, which may differ from system 100. Accordingly, FIG. 1 is one example of a system for implementing the various methods described herein and is not intended to be limiting.

The user may use

client devices

101, 102, 103, 104, 105, and/or 106 to manage medical clinical trial data, etc. The client device may provide an interface that enables a user of the client device to interact with the client device. The client device may also output information to the user via the interface. Although fig. 1 depicts only six client devices, those skilled in the art will appreciate that the present disclosure may support any number of client devices.

Client devices

101, 102, 103, 104, 105, and/or 106 may include various types of computer devices, such as portable handheld devices, general purpose computers (such as personal computers and laptop computers), workstation computers, wearable devices, smart screen devices, self-service terminal devices, service robots, gaming systems, thin clients, various messaging devices, sensors or other sensing devices, and the like. These computer devices may run various types and versions of software applications and operating systems, such as MICROSOFT Windows, APPLE iOS, UNIX-like operating systems, linux, or Linux-like operating systems (e.g., GOOGLE Chrome OS); or include various mobile operating systems such as MICROSOFT Windows Mobile OS, iOS, windows Phone, android. Portable handheld devices may include cellular telephones, smart phones, tablet computers, personal Digital Assistants (PDAs), and the like. Wearable devices may include head mounted displays (such as smart glasses) and other devices. The gaming system may include various handheld gaming devices, internet-enabled gaming devices, and the like. The client device is capable of executing a variety of different applications, such as various Internet-related applications, communication applications (e.g., email applications), short Message Service (SMS) applications, and may use a variety of communication protocols.

Network 110 may be any type of network known to those skilled in the art that may support data communications using any of a number of available protocols, including but not limited to TCP/IP, SNA, IPX, etc. For example only, the one or more networks 110 may be a Local Area Network (LAN), an ethernet-based network, a token ring, a Wide Area Network (WAN), the internet, a virtual network, a Virtual Private Network (VPN), an intranet, an extranet, a blockchain network, a Public Switched Telephone Network (PSTN), an infrared network, a wireless network (e.g., bluetooth, WIFI), and/or any combination of these and/or other networks.

The server 120 may include one or more general purpose computers, special purpose server computers (e.g., PC (personal computer) servers, UNIX servers, mid-end servers), blade servers, mainframe computers, server clusters, or any other suitable arrangement and/or combination. The server 120 may include one or more virtual machines running a virtual operating system, or other computing architecture that involves virtualization (e.g., one or more flexible pools of logical storage devices that may be virtualized to maintain virtual storage devices of the server). In various embodiments, server 120 may run one or more services or software applications that provide the functionality described below.

The computing units in server 120 may run one or more operating systems including any of the operating systems described above as well as any commercially available server operating systems. Server 120 may also run any of a variety of additional server applications and/or middle tier applications, including HTTP servers, FTP servers, CGI servers, JAVA servers, database servers, etc.

In some implementations, server 120 may include one or more applications to analyze and consolidate data feeds and/or event updates received from users of

client devices

101, 102, 103, 104, 105, and 106. Server 120 may also include one or more applications to display data feeds and/or real-time events via one or more display devices of

client devices

101, 102, 103, 104, 105, and 106.

In some implementations, the server 120 may be a server of a distributed system or a server that incorporates a blockchain. The server 120 may also be a cloud server, or an intelligent cloud computing server or intelligent cloud host with artificial intelligence technology. The cloud server is a host product in a cloud computing service system, so as to solve the defects of large management difficulty and weak service expansibility in the traditional physical host and virtual private server (VPS, virtual Private Server) service.

The system 100 may also include one or more databases 130. In some embodiments, these databases may be used to store data and other information. For example, one or more of databases 130 may be used to store information such as audio files and video files. Database 130 may reside in various locations. For example, the database used by the server 120 may be local to the server 120, or may be remote from the server 120 and may communicate with the server 120 via a network-based or dedicated connection. Database 130 may be of different types. In some embodiments, the database used by server 120 may be, for example, a relational database. One or more of these databases may store, update, and retrieve the databases and data from the databases in response to the commands.

In some embodiments, one or more of databases 130 may also be used by applications to store application data. The databases used by the application may be different types of databases, such as key value stores, object stores, or conventional stores supported by the file system.

The system 100 of fig. 1 may be configured and operated in various ways to enable application of the various methods and apparatus described in accordance with the present disclosure.

A data management method 200 for medical clinical trials according to an exemplary embodiment of the present disclosure is described below with reference to fig. 2.

At step S201, a first form is obtained from a first user, the first form comprising a corresponding at least one field value for at least one field with respect to a first subject, wherein the first user has a first identity type.

At step S202, it is determined whether the first form meets a first requirement.

At step S203, in response to determining that the first requirement is satisfied, displaying the first form at a terminal of a second user for the second user to question field values in the first form or to confirm the first form, wherein the second user has a second identity type different from the first identity type.

At step S204, in response to receiving the challenge content from the second user for the first field value of the first field in the first form: displaying the questioning content at the terminal of the first user for the first user to respond to the questioning content; receiving response content from the first user; and displaying the response content at the terminal of the second user for the second user to perform the question operation or the confirmation operation again based on the response content.

At step S205, in response to receiving a confirmation of the first form from the second user, the first form confirmed by the second user is stored.

According to the method disclosed by the embodiment of the invention, the collection, inquiry and storage of clinical scientific research data can be managed, reasonable data processor level and smooth data transmission are provided, and more effective scientific research data management is realized.

The clinical scientific research data acquisition has the advantages of long time, large data quantity of subjects, complex acquisition management flow and numerous participation roles. At present, unified management of the same project is lacking, an independent inquiry platform is often configured, and a plurality of roles in clinical scientific research projects are difficult to distinguish and manage.

According to the embodiment of the disclosure, a complete and smooth inquiry flow can be provided, and subject data can be effectively managed, so that the subject data can be clearly, accurately and completely presented to a declaration; the complex data acquisition flow is flexibly and hierarchically and clearly managed to present and transmit the data of the subject, so that the accuracy and rationality of data input are ensured; different authorities and operation entrances are supported to be provided according to a plurality of different roles, and the user operation is facilitated.

The first identity type may correspond to a data logger and the second identity type corresponds to a data verifier that is different from the data logger, and the above names are merely examples, and the disclosure is not limited thereto.

The similar expression "displaying the first form at the terminal of the second user" or throughout may refer to associating the first form with the second user such that the first form can be displayed at the terminal of the second user, may cover sending or pushing the information to (the terminal of) the user, associating the information with a user account such that the user can see the information in a "pending" taskbar in the account after logging in (while the information is not present in a pending taskbar of other types of users, for example), and so on.

According to some embodiments, determining whether the first form meets a first requirement may include: in response to determining that a field in the first form has an association with a second field in a second form that has been stored for the first subject, determining whether a field value of the field in the first form meets at least one logical requirement with a field value of the second field.

According to such embodiments, a logical check across forms may be included. For example, the subject's medical history in the current form is "20 years" and the last form subject is "18 years" in age, so that there is a logical error. Because such data is entered separately across forms, manual approaches tend to be difficult to discover.

According to some embodiments, the method 200 may further include, in response to determining that there are field values in the first form that do not meet the first requirement: outputting a prompt to the first user regarding the field value not meeting the first requirement; receiving an updated value from the first user for the field value that does not meet the first requirement; and in response to determining that the updated value can meet the first requirement, updating the first form using the updated value.

When the form is submitted or saved, the logger is prompted to modify if the logical check is not passed.

According to some embodiments, displaying the first form at the terminal of the second user may include: the first form, at least one question control for question the at least one field value, and a confirmation control for confirming the first form are displayed at a terminal of a second user.

According to such embodiments, an intelligent interactive interface may be provided so that fields may be questioned, or forms may be validated.

According to some embodiments, the method 200 may further comprise: in response to receiving a challenge content from the second user for a first field value of a first field in the first form, storing the first field value and the challenge content in association with the first field as a first challenge entry for the first field, and wherein displaying the challenge content at a terminal of the first user comprises: and displaying the first questioning item and a response control for responding to the questioning item at the terminal of the first user.

The data structure stored by taking the field as a unit enables the original information and the questioning information of the field to be completely reserved, and is convenient for checking the questioning and modifying the record in the future.

According to some embodiments, the response controls may include a clarification control and a modification control.

According to such embodiments, clarification may be performed or modifications may be made to the manually presented questions. Examples of responses, clarifies, and modifications, and exemplary interaction interfaces, are described further below.

According to some embodiments, the method 200 may further include, after receiving the response content to the first challenge entry from the first user, storing the response content in association with the first field as a first response entry for the first field.

The response record stored in the unit of field can completely store the modified record of the field, which is convenient for review and for example, for future playback.

According to some embodiments, displaying the response content at the terminal of the second user may include: updating the first form using the first response entry; and causing the updated first form, the at least one question control, and the confirmation control to be displayed at a terminal of a second user.

The updated first form is displayed at the second user for verification. Only updated fields and clarified content (if any) may be displayed.

According to some embodiments, displaying the updated first form may include displaying fields and corresponding field values in different colors with different states based on the fields, wherein the different states include at least two of: no challenge, waiting for response, responded, confirmed.

According to such embodiments, different fields in the same form may be displayed using different colors, facilitating the verification of the data by the verifier.

Specific examples of displaying different fields in different colors will be described in detail below.

According to some embodiments, the method 200 may further comprise, after storing the first form confirmed by the second user: displaying the first form confirmed by a second user at a terminal of a third user for the third user to carry out a question operation or a confirmation operation, wherein the third user has a third identity type which is different from both the first identity type and the second identity type. In response to receiving the challenge content from the third user: displaying the questioning content at a terminal of the first user for the first user to respond to the questioning content; receiving second response content from the first user; displaying the second response content at the terminal of the second user for the second user to perform a question operation or a confirmation operation based on the second response content; and in response to receiving a confirmation from the second user based on the second response content, displaying the second response content at a terminal of the third user for the third user to perform a question operation or a confirmation operation based on the second response content. In response to receiving a confirmation of the first form from the third user, the first form confirmed by the third user is stored.

According to such embodiments, a third identity type may also be introduced as a data reviewer to enable secondary manual review of the data. If the data review does not pass, the form is returned to the data logger and then goes through the process of verifying the review again.

According to some embodiments, the first form may be associated with a first topic, and the method may further comprise, after storing the first form confirmed by a third user: in response to determining that all forms related to the first topic are confirmed to be complete, displaying the first form confirmed by a third user at a terminal of a fourth user for the fourth user to sign, wherein the fourth user has a fourth identity type different from the first identity type, the second identity type, and the third identity type.

After the completion of the whole job, all forms are pushed to the fourth user (responsible person) so that the responsible person can sign all forms in the job.

According to some embodiments, the method 200 may further comprise: in response to determining that all forms associated with the first topic are signed, checking signature validity; and displaying all forms related to the first topic at the terminal of the fourth user for the fourth user to perform a lock library operation in response to the signature validity check being completed.

After all forms are signed, checking the validity of the signature, and if the signature has no problem, locking the library by a responsible person. Thus, the data management of the whole flow can be realized.

According to some embodiments, storing the first form validated by a third user may include associating the first form validated by a third user with the third user and the fourth user for at least one of the third user and the fourth user to at least one of: form freeze operation, form cancel freeze operation.

According to such an embodiment, the form confirmed to be completed may be frozen by the rechecker or responsible person. Freezing may refer to entering a state that is temporarily unable to be modified. On one hand, the integrity and stability of data can be ensured, and on the other hand, a flexible and complete data management strategy for the color separation processing is provided.

In recent years, along with rapid accumulation of clinical data in modern hospitals, clinical test data are increasingly widely electronized, and manual writing of medical record records cannot meet scientific research requirements. Clinical data acquisition modes are various but lack of unified standards, and data collection quality is uneven. Different data acquisition modes are needed for different clinical study design types, and particularly, prospective study relates to recording of visit data and inquiry and check of related data, the test period is long, the number of subjects is large, and the scientific study output can be influenced. At present, a plurality of hospital scientific research stands, a plurality of platforms are required to be switched for completing data acquisition, and meanwhile, a plurality of roles in clinical scientific research projects are required to be distinguished and managed. For example, if a researcher wants to perform a prospective clinical test of a cardiac research and performs multi-platform operation manually, the researchers need to group the subjects according to specific conditions, manually fill in data or fill in an eCRF form designed by an electronic entry system, and perform data checking and tracing after switching to a query platform. Based on reasonable and standard setting, the smooth and simple subject data acquisition and management method can provide subject inclusion and data input which are simple and easy to understand for scientific researchers, and system checking, manual inquiry and corresponding clarification reply completion.

Based on the above requirements, the method is suitable for the technical field of clinical medicine, and the method is suitable for collecting and managing subject data in prospective medical scientific research analysis, and aims to support a research process by centering on clinical research; the method provides simple and easy-to-understand data input for scientific researchers, system checking and manual inquiry processes, provides corresponding clear reply and data modification, ensures traceability tools of research information, serves for discipline construction, establishes a clinical scientific research work platform, and better meets clinical test requirements and serves the public.

In the related technical field, the existing clinical test data acquisition and management method relates to the problems of numerous platforms, lack of unified management of the same project, configuration of an independent inquiry platform, incomplete coverage of a data structure and the like, and cannot meet the basic requirements of scientific researchers on prospective clinical test data input management, project management, complete inquiry and data tracing. Meanwhile, the clinical scientific research projects have a plurality of roles and are also required to be managed in a distinguishing mode. For example, if a researcher wants to collect data of a prospective medical scientific research clinical test once, if a manual operation is performed on multiple platforms, the researcher needs to group the subjects according to specific conditions, enter a system to fill in a designed eCRF form, and enter a query platform to perform data checking and tracing. Generally, clinical scientific research data acquisition has long time, large data quantity of subjects, complex acquisition management flow and numerous participation roles. Therefore, based on the reasonable and standard setting, the smooth and simple subject data acquisition and management method can provide simple and understandable data input for scientific researchers, system checking, manual inquiry, corresponding clear reply and data modification completion and complete record data modification record, ensure traceability of research information, better meet clinical test requirements, support research process and utilize medical big data resources to serve the public. According to the embodiment of the disclosure, the method for collecting and managing the subject data in the prospective medical scientific research analysis can be provided, and the collection and management of the subject inclusion group and the subject data are intuitively and effectively displayed. The complete and smooth inquiry flow is provided, and the subject data is effectively managed, so that the subject data can be clearly, accurately and completely presented to a declaration; the complex data acquisition flow is flexibly and hierarchically and clearly managed, subject data is presented and transmitted electronically according to the set eCRF form, and the accuracy and rationality of data input are ensured; the method supports providing different authorities and operation entrances according to a plurality of different roles, is simple and easy to understand, facilitates user operation, reduces the computer skill requirements on medical workers, improves the scientific research work efficiency of the medical workers, and saves time cost.

Because of the long test period and the large number of subjects in clinical studies, data needs to be entered at different stages, cross-form data exists, and data logic is complex, however, a well-established solution in the related technology is not available. For example, the entry and challenge in the related art is not a platform; there is no shaped challenge scheme in the related art, especially no system challenge across the logical level of the form; in the related art, no scheme for presenting the data to be processed according to roles/rights is available, and interaction is not friendly.

Embodiments of the present disclosure provide a subject data collection and management method suitable for clinical research projects to enable more accurate and complete presentation of subject data. The method aims at supporting the research data acquisition management process by centering on clinical research and serving for discipline construction; therefore, the management process of clinical research data acquisition is standardized, and the traceability of research information is ensured.

In one aspect, the present disclosure provides a subject inclusion, as well as management and operational procedures for a subject level. Upon receiving an inclusion instruction for subject data, comprising: recording basic information of the subjects, carrying out randomized or non-randomized group entry on the included subjects, and checking the subjects through group screening; if the study is a multicenter clinical study, screening review can be performed by the participating centers; the subject data can be imported or exported in batches according to different authorities; inputting subject data based on the case report form, and submitting the form; and (5) checking and rechecking the form, and signing a series of processes. Performing a related operation at a subject level, comprising: confirming the falling of a subject and recording the falling reason; care-of subjects to other study centers; deleting the subject from the list; checking the medical record details of the subject; subjects were frozen and unfrozen. Viewing a subject visit progress, comprising: the progress of input, the progress of audit, the progress of review and the progress of signature can be convenient for researchers to timely master the situation of the subjects in the process of clinical trial research, and the subjects can be clearly and effectively brought into management.

In a second aspect, the present disclosure provides a complete challenge procedure for eCRF form fields in a subject data entry management process. The eCRF form is designed completely before the clinical trial begins, including the design of field types in the form, logic verification, and explicit and implicit settings. The challenge procedure includes a manual challenge and a system challenge, and the present disclosure provides a logical verification module for a researcher to support the system challenge. Supporting the researcher to check the configuration information in the logic checking module comprises the following steps: presetting a field to be questioned on a point location; and/or conditions for verifying the rationality of the subject data. The relative and absolute configuration conditions are provided so as to more conveniently set the system inquiry logic, thereby reducing the burden of a checker and facilitating the management of subject data. The manual inquiry is mainly used for finishing the input and submitting of the data input personnel according to the pre-configured eCRF form, and then finishing the checking and rechecking of the data by the data checker and rechecker, wherein in the process, the manual inquiry is put forward to the unreasonable field, the input personnel can reply the inquiry, and the input personnel can optionally make modification and reply the clarification reason. The field questioning state can be seen in real time, so that the data of the subject can be regulated, and the clinical trial research process is smoother and more convenient.

In a third aspect, the present disclosure provides differentiated management for a multitude of colors in clinical research projects. In the process of subject data acquisition management, four important roles can be divided, a data entry person is responsible for entering subject data and form submission according to an eCRF form, and can also carry out modification and supplementary recording, and a manual inquiry presented by a data checker and a rechecker for part of fields and a system inquiry generated when entering the submitted form are replied; the data checker performs manual check on the form submitted by the inputter, initiates inquiry aiming at unreasonable fields, and can select to close the inquiry or reinitiate the field of the clarity of the inputter; the data manager rechecks the table list for the checked person, and can initiate inquiry for unreasonable fields and can select to close the inquiry or reinitiate the field with clear thickness for the input person; the study responsible person freezes and signs the form after rechecking.

Method steps and interaction examples according to some example embodiments of the present disclosure are described below in connection with fig. 3-6.

Fig. 3 illustrates a schematic diagram of a subject data collection management procedure, according to some example embodiments of the present disclosure.

At step S301, subject-level related operations such as subject inclusion and grouping are performed.

For example, a researcher can click on "newly added subjects", display a newly added subject window, input basic information, click on storage, and realize inclusion in subjects. The method can delete or batch delete the subjects, supports the batch import of the subjects through the downloading template, supports the export of subject data according to the form, data auditing records and data inquiry records. In the art, "incorporating" may refer to the first time subject data is newly added, and in the case of having multi-level user rights in accordance with embodiments of the present disclosure, may be newly added by an inputter user as well as by other rights users.

After the subjects are included, a subject list is formed to display basic information of the current project scientific research queue, such as subject ID (automatic generation, generation principle is center unique code+intra-project patient unique code), an inputter, a belonging center, subject name abbreviation, group entering date and operation, and a visit progress overview comprises an input progress, an audit progress, a review progress, a signature progress and the like. Visit may refer to entry of a new form during the course of the study (e.g., every few months) and may be completed by a first identity user (e.g., an "entry clerk"). Illustratively, the operations directed to the subject include, for example, one or more of: entry, drop, freeze, care of, delete, group entry, medical record details, and operational records.

Researchers can enter pre-set eCRF forms by "entering". The subject is subjected to shedding treatment by "shedding" due to reasons including, but not limited to, loss of connectivity, inability to connect, failure to meet inclusion criteria, and the like. The "freeze" freezes all eCRF form data for the patient, and the patient data cannot be frozen until the freeze is removed. The "group entry" may be accomplished at the same time as the subject entry is entered according to clinical trial design requirements, and may include a randomized group, a non-randomized group, wherein the randomized group supports a simple randomized, a group-stratified-group randomized, a center-stratified-group-randomized, a dynamic randomized approach.

The non-random access group may include a manual access group and a conditional access group.

Illustratively, "medical record details" may be used by a researcher to check whether patient information is authentic, and may view 360 views of patient case-by-case visit information corresponding to the subject. The content in the "medical record details" may not be a previously entered form, but a database of the hospital. For example, each subject has a patient ID within the hospital system in addition to the subject ID, and through the patient ID, data in the hospital background database can be queried.

The "operation record" may include new addition, group entry, freezing, freeze withdrawal, drop withdrawal, roll-out, roll-in, and the like. For example, if the subject is handed over, two pieces of content can be added to the operation record, the position of the transferring-out recorder displays the transferring-out, the transferred-in recorder displays the transferring-in, the existing information row of the patient in the center of the transferring-in recorder is deleted, and the new row is started at the position of the transferred-in recorder, and the operation record remains all along with the patient handing-over track, so that the study is convenient for a researcher to check at any time.

Table 1 shows different hierarchy operation summary examples. It is to be understood that the following are examples and that systems according to embodiments of the present disclosure may include more or fewer types of operations. For example, the "case details" operation may not be included, only the check may be included without the review operation, or a third level check operation may be included, and so on.

Table 1 different level operation summary table

Hierarchy level	Operation of
		A subject	Entry, drop, freeze, care of, delete, group entry, medical record details, and operational records
Multiple forms	Freezing and signing
		Single sheet form	Submitting, checking, rechecking, freezing, signing
Single field	Entry, modification, challenge

According to one or more embodiments of the present disclosure, differentiated management may be performed, configuring different rights for different people. For example, the inspector may only see the form to be inspected, the reply challenge, the challenge to be closed, and so on.

At step S302, operations of subject data entry and submission may be performed, including subject data entry and eCRF form, field level operations. After the test is carried out on the subject, the data entry staff enters subject data in a specified time according to a preset eCRF form and can submit the form after completing the entry of one form. The form undergoes steps in the complete experimental study flow as shown in table 2, and has different operation rights in different states, and each data modification will leave a data audit record after the form is submitted by the user. For a multi-record form, when the page is first entered, the record of all fields in the form is added once through newly adding the record, and after the record is recorded, the record is clicked to be submitted and the record is completed, so that the record can be added for a plurality of times, and a row of records is newly added on the initial page of the multi-record form. The commit check is used to complete the commit after the multiple recordings. Submitting and checking the multi-record form after finishing multiple newly added records, wherein the record cannot be newly added; the user can enter the data viewing state of the single record through the enter button, for example, a challenge is generated in the following flow, a challenge mark appears behind a challenge field to indicate that modification is entered, and after clicking the enter button, the page of the single record is indistinguishable from the modification logic and the common form.

Table 2 form status and operation rights summary

Form status	Entry/save	Modification/update	Challenge (System/human)
				Uncommitted with	Has the following components	——	——
Submitted to	——	Has the following components	Has the following components
				Checking	——	Has the following components	Has the following components
Rechecking	——	Has the following components	Has the following components
				Freezing	——	——	Has the following components
Signing	——	——	——

At step S303, a check and review (if any) operation of the data may be performed. For example, the verification may be performed by a data verifier and subsequently reviewed by a data administrator, e.g., may include subject data verification, review, accompanied by a complete challenge procedure. As the form states in table 2 demonstrate, the eCRF form may have, for example, 5 states during subject data management, including: submitted, checked, rechecked, frozen, signed. For the challenge procedure, the status of the field may be as shown in table 4 below, including for example no challenge, to be clarified, close challenge, and this will be further described below. After the data is entered by the entry clerk and the forms are submitted, three functions of editing, data auditing records and data inquiry information can be provided for each field of all the forms. The form whose state is submitted will enter the data check and data review flow.

Fig. 4 illustrates a data flow 400 according to an exemplary embodiment of the present disclosure. As shown in fig. 4, a complete data challenge may be accompanied in this process, and may include both a system challenge and a manual challenge.

At 401, subject data entry is performed.

At 402, subject data submission is performed.

At 403, possible self-checking error correction is performed, and modifications, updates, etc. are made.

At 404, data modification is performed, resulting in a modified record, and/or a reply challenge, e.g., a system challenge, a manual challenge.

At 405, data freezing occurs.

At 405, a data signature is performed.

Also shown in FIG. 4 is a data auditor portion 410 and a data administrator portion 420. Specifically, at 411, the data verifier initiates a challenge. At 412, the clerk clarifies the challenge. At 413, the data inspector closes/re-opens the challenge. At 414, a challenge record is generated. Similarly, at 421, the data administrator initiates a challenge. At 422, the officer clarifies the challenge. At 423, the data administrator turns the challenge off/on again. At 424, a challenge record is generated.

For a system challenge: when an inputter submits the click of the data input system, the system can automatically check the data in real time, such as the range of data values, the logic relationship and the like, and can remind a researcher that the data has a systematic challenge, and the system mainly depends on the setting of logic checking rules. The researcher can set logic rules in specific conditions of different clinical trials of the logic checking module, and put forward a questioning field to fill out questioning information.

Further exemplary, the present disclosure provides a logic verification module for a researcher to add a logic verification rule interface as shown in fig. 5, where the first step defines configuration composition content of a single condition, the second step selects a field to be questioned, and the third step fills out questioning information. A researcher may configure multiple conditions in one logical rule, supporting logical relationships between constraint conditions, i.e., satisfying "all" or "any" conditions. Configuration composition content defining a single condition includes, but is not limited to, a condition type element, a field element, a condition logical symbol element, and a condition description element. The condition types are divided into absolute conditions for describing rule definition of the condition for 1 field and relative conditions for rule definition of the relationship between 2 numerical fields. The field element is used to describe the information that the condition acts on the detailed field in the eCRF form, the field of absolute conditions is a range of selectable types: single-choice enumeration, multi-choice enumeration and numerical value; the fields of the relative conditions may select a value. The condition logic element is used for describing logic control description of the located field element, and when the field is multi-choice enumeration, the condition logic element comprises: equal to, unequal to, including any one, including all, not including any one; when the field is a radio enumeration, the logic Fu Xiala block includes: equal to, unequal to, including any one; when the field is a value, the logic Fu Xiala block includes: equal to, not equal to, > equal to, <, and within the range. The condition description element may be used to describe the condition of the located field element in detail. After the conditions are configured, confirming a field to be questioned, filling in questioning information, and displaying the questioning information to remind researchers that a piece of data is systematically questioned if the logic checking rule is violated when the data of the field is recorded.

Table 3 logical check rule configuration examples

For manual challenge: the manual challenge may occur after form submission, with the data auditor, the data administrator and research principal initiating a manual challenge generated on the data submitted by the inputter. When checking, the checker puts forward a question for a certain field and fills in the reason of the question. The inputter needs to reply and data modification to the content generating the inquiry.

After the system inquiry proposed by the entry person for a certain field is modified and updated, the entry person is provided with the following steps: replying to person role, username, time, clarification challenge (reply challenge action): clear content, modify record (if any): the field name, field original value, field modification value (if the multi-field table content is compared twice and the difference is displayed for the difference field, detailed in the audit record) system performs verification on the inquiry content, if the verification is correct, the content is automatically replied: the system challenge checks without errors. After the manual inquiry is presented by the inputter aiming at a certain field, the inquiry information button of the field at the inputter is set red, and the inputter can see the specific contents comprising: challenger role, username, time, propose challenge (reply challenge action): challenge content. After the inputter clarifies the inquiry, the inquiry information button turns yellow, and the inquiry information configuration comprises: replying to person role, username, time, clarification challenge (reply challenge action): clear content, modify record (if any): after the checker feeds back the content of the clear inquiry (closes/proposes the inquiry again) if the other party closes the inquiry, the specific content of the inquiry information button is configured as follows: challenger role, username, time, close challenge (reply challenge action): the inquiry content is marked after the round of inquiry is finished, namely the round of inquiry is finished; if the other party is not closed, the configuration content is continuously inquired until the configuration content is finished. An exemplary interface presentation may be as shown in fig. 6.

Table 4 field challenge status list example

Further illustratively, the specific content of the field audit information may be each modified record of the field since the first submission. Auditing the track modification cause types may include, for example: 1. first submission 2, self-checking and correcting 3, modifying 4 according to manual inquiry and modifying according to system inquiry. The field audit record table list includes: modification time, modifier, modification field (if applicable), pre-modification value, post-modification value, modification reason, challenge information (if applicable). Modification of complex fields: after clicking and editing, the user can modify each sub-field in the complex field, so that the content recorded in the audit trail is compared by two results, and the names of the sub-fields subjected to modification are recorded in the audit record of the complex field.

According to one or more embodiments of the present disclosure, data may be in the unit of research topic. For example, a study topic is created, form fields are designed, and system challenge logic conditions are configured. The conditions may be, for example, conditions specific to the subject, such as age requirements, whether or not a certain operation has been performed. The condition may be a logical judgment for preventing an input error. For example, the course of the disease is not older than the age. A portion of the logic conditions may also be automatically generated or determined based on configurations in other topics previously described (e.g., the latter).

The system challenge may include checking for logical errors across forms, and the like. For example, a system challenge is triggered when a new form is submitted, and the newly added field may be logically judged with other fields in the current form/associated fields in the previous form according to set and/or automatically generated logic. If there is a problem, a notification is pushed to the entry clerk.

After submitting the challenge, the person (check/recheck) of the subsequent flow can see the form, initiate a challenge, and return the data to the inputter for clarification and/or modification. This process may be repeated a number of times and may be recorded.

At step S304, subject data freezing and signing may be performed, such as signing by a study responsible person. The research responsible person can sign the single or batch form or cancel the signature under the condition that no field exists in the challenged state. The study responsible person confirms that the eCRF data is complete and accurate and signed upon challenge. The signed form data cannot be modified and if it is necessary to alter certain data on the signed eCRF, the researcher modifies the data after the signature is revoked and re-signs. In addition, the freeze button may occur at any point during the study, and the patient may not be modified after clicking and may be re-modified after thawing. All the operations on the form are recorded to be viewed.

At step S305, subject data locking, archiving may be performed. Database locking is an important milestone in clinical trials. All tasks required in the database lock list have been completed before, while the study's responsible person's electronic signature is ultimately verified. And after finishing data quality evaluation and approving database locking and notifying test related personnel, formally locking the whole database, and canceling editing rights of all users to the data. The locked data may be entered into a subsequent statistical analysis. After the database is finally locked, the user can file the eCRF form and the corresponding data collected by the subject and the data audit records of all the data.

Further exemplary, the process of data entry in a clinical trial subject involves multiple roles, each taking on a different role task, and also requiring differentiated management. The present disclosure provides users with four role management that take on the main tasks in the test flow, including data entry clerks, data auditors, data administrators, study takers (if multi-center study, there are branch center study takers). Different subject-level operating rights are provided for each role (as shown in table 5), and the greatest possible convenience is provided for the different roles at the field level to complete the task of the task per se, so that the test flow is quickened, and the extra stress of participating researchers is relieved. Three shortcut entries are provided for the data entry clerk: all, all data can be viewed; directly starting to input related data of the subject after inputting, completing form submission, and performing self-checking and error correction; to reply, looking at the questioned field to make a clear reply or modification. Three shortcut entries are provided for the data inspector: all, all data can be viewed; to be checked, rapidly checking the submitted form of the entry person to perform data checking; to close, a field check that the inputter has clarified the reply confirms whether closing it will again issue a question. Three shortcut entries are provided for a data manager: all, all data can be viewed; quickly checking the form which is checked to perform data rechecking; to close, a field looking at the reply that the inputter has clarified confirms whether to close it or send a challenge again. Three shortcut entries are provided for the study responsible person: all, all data can be viewed; after signing, rapidly checking the form subjected to review to carry out form signing; to close, a field to see if the inputter has clarified the reply confirms whether to close it will issue a challenge again.

Table 5 summary of operating rights for different role subject levels

It will be appreciated that freezing may be interspersed throughout the course of the experiment, may occur a number of times, and may be undone by temporarily freezing a form. The signature may refer to the last person signing at the last time of completion and may not be revoked. Specifically, if the data administrator closes the challenge, the data will go to the responsible party who signs it.

Furthermore, it will be appreciated that after all forms have been signed, the system can check the validity of each electronic signature in a manner known to those skilled in the art, and then push to the research responsible for the responsible person to click on the lock bank.

It is to be understood that the specific user role types, rights, operations, etc. described above are examples, and the present disclosure is not limited thereto. For example, depending on the actual needs, the system may include more user roles (e.g., add more levels for verification, a topic principal level), fewer user roles (e.g., only one level of review is needed, even by a principal), contain fewer operations (e.g., omit some of the operations above), or support more operations, etc., and the disclosure is not limited thereto.

Generally, the clinical scientific research data acquisition has the characteristics of long time, large data quantity of subjects, complex acquisition and management flow, numerous participation roles and the like. According to exemplary embodiments of the present disclosure, a clinical study-centric, supportive study procedure can be implemented; based on subject data acquisition management, perfecting acquisition flow standard and serving discipline construction; and a query process of complete clinical study is provided, and traceability of study information is ensured.

According to exemplary embodiments of the present disclosure, subject inclusion groups and subject data collection management are intuitively and effectively demonstrated. And providing a complete and smooth inquiry flow, effectively binding the inquiry dialogue with the corresponding modification, and supporting complete export. The subject data is effectively managed, so that the subject data can be clearly, accurately and completely presented to the claimant.

According to the exemplary embodiment of the disclosure, the complicated data acquisition flow is flexibly and hierarchically and clearly combed, subject data is presented and transferred electronically according to the set eCRF form, and the accuracy and rationality of data input are ensured. And a project management function is embedded, and the visit progress of the subject is recorded, so that a researcher can clearly control the experiment progress at any time.

According to the exemplary embodiment of the disclosure, different authorities and operation entrances are supported to be provided according to a plurality of different roles, the user operation is facilitated by a simple and easily understood mode, the computer skill requirements on medical workers are reduced, the scientific research work efficiency of the medical workers is improved, and the time cost is saved.

Table 6 shows an example challenge record template example of a closed loop challenge procedure (system, manual) binding with a modification record.

Table 6 challenge record template example

Wherein the number of challenge rounds may be counted for the number of challenge rounds generated for a single topic, e.g. ending with 1 round at one turn-on- >. The challenge information may be an information interface that is sent when the challenge/reply challenge/close challenge is initiated is read, and may be, for example, denoted as "-" if not operating within the challenge frame. The challenge operation may include initiating a challenge/reply challenge/close challenge. Whether or not the value range of the question data is modified for the challenge may be yes/no. For example, only the clinical coordinator/clinical trial coordinator has the possibility to modify the field, no when only reply unmodified, yes when modified and replied.

The modification field may employ the following logic: for simple fields, if modification occurs, the title is the title; for complex fields, if a modification occurs, then the field name of the modification that occurred. Only the entry clerk has the possibility to modify the field, and when modifying and replying, the corresponding row name information is generated according to the simple/complex field.

A data management device 700 for medical clinical trials according to an embodiment of the present disclosure will now be described with reference to fig. 7. The data management apparatus 700 for medical clinical trials may include a form obtaining unit 701, a logic verifying unit 702, a form verifying unit 703, a form responding unit 704, and a form storing unit 705. The form obtaining unit 701 may be configured to obtain a first form from a first user, the first form comprising a corresponding at least one field value for at least one field with respect to a first subject, wherein the first user has a first identity type. The logic verification unit 702 may be configured to determine whether the first form meets a first requirement. The form verification unit 703 may be configured to display the first form at a terminal of a second user for the second user to question field values in the first form or to confirm the first form in response to determining that the first requirement is satisfied, wherein the second user has a second identity type different from the first identity type. The form response unit 704 may be configured to, in response to receiving from the second user a challenge content of a first field value of a first field in the first form: displaying the questioning content at a terminal of the first user for the first user to respond to the questioning content; receiving response content from the first user; and displaying the response content at the terminal of the second user for the second user to perform a question operation or a confirmation operation again based on the response content. The form storage unit 705 may be configured to store the first form confirmed by the second user in response to receiving a confirmation of the first form from the second user.

According to the device disclosed by the embodiment of the invention, reasonable data processor level and smooth data transmission can be provided, and more effective scientific research data management is realized.

In the technical scheme of the disclosure, the related processes of collecting, acquiring, storing, using, processing, transmitting, providing, disclosing and the like of the personal information of the user accord with the regulations of related laws and regulations, and the public order is not violated.

According to embodiments of the present disclosure, there is also provided an electronic device, a readable storage medium and a computer program product.

Referring to fig. 8, a block diagram of an electronic device 800 that may be a server or a client of the present disclosure, which is an example of a hardware device that may be applied to aspects of the present disclosure, will now be described. Electronic devices are intended to represent various forms of digital electronic computer devices, such as laptops, desktops, workstations, personal digital assistants, servers, blade servers, mainframes, and other suitable computers. The electronic device may also represent various forms of mobile devices, such as personal digital processing, cellular telephones, smartphones, wearable devices, and other similar computing devices. The components shown herein, their connections and relationships, and their functions, are meant to be exemplary only, and are not meant to limit implementations of the disclosure described and/or claimed herein.

As shown in fig. 8, the electronic device 800 includes a computing unit 801 that can perform various appropriate actions and processes according to a computer program stored in a Read Only Memory (ROM) 802 or a computer program loaded from a storage unit 808 into a Random Access Memory (RAM) 803. In the RAM803, various programs and data required for the operation of the electronic device 800 can also be stored. The computing unit 801, the ROM 802, and the RAM803 are connected to each other by a bus 804. An input/output (I/O) interface 805 is also connected to the bus 804.

Various components in electronic device 800 are connected to I/O interface 805, including: an input unit 806, an output unit 807, a storage unit 808, and a communication unit 809. The input unit 806 may be any type of device capable of inputting information to the electronic device 800, the input unit 806 may receive input numeric or character information and generate key signal inputs related to user settings and/or function control of the electronic device, and may include, but is not limited to, a mouse, a keyboard, a touch screen, a trackpad, a trackball, a joystick, a microphone, and/or a remote control. The output unit 807 may be any type of device capable of presenting information and may include, but is not limited to, a display, speakers, video/audio output terminals, vibrators, and/or printers. The storage unit 808 may include, but is not limited to, magnetic disks, optical disks. The communication unit 809 allows the electronic device 800 to exchange information/data with other devices over computer networks, such as the internet, and/or various telecommunications networks, and may include, but is not limited to, modems, network cards, infrared communication devices, wireless communication transceivers and/or chipsets, such as bluetooth (TM) devices, 802.11 devices, wiFi devices, wiMax devices, cellular communication devices, and/or the like.

The computing unit 801 may be a variety of general and/or special purpose processing components having processing and computing capabilities. Some examples of computing unit 801 include, but are not limited to, a Central Processing Unit (CPU), a Graphics Processing Unit (GPU), various specialized Artificial Intelligence (AI) computing chips, various computing units running machine learning model algorithms, a Digital Signal Processor (DSP), and any suitable processor, controller, microcontroller, etc. The computing unit 801 performs the various methods and processes described above, such as the method 200 and variations thereof, and the like. For example, in some embodiments, the method 200, variations thereof, and the like may be implemented as a computer software program tangibly embodied on a machine-readable medium, such as the storage unit 808. In some embodiments, part or all of the computer program may be loaded and/or installed onto the electronic device 800 via the ROM 802 and/or the communication unit 809. When a computer program is loaded into RAM 803 and executed by computing unit 801, one or more steps of method 200 and variations thereof, etc., described above may be performed. Alternatively, in other embodiments, the computing unit 801 may be configured to perform the method 200, variations thereof, and the like, in any other suitable manner (e.g., by means of firmware).

Various implementations of the systems and techniques described here above may be implemented in digital electronic circuitry, integrated circuit systems, field Programmable Gate Arrays (FPGAs), application Specific Integrated Circuits (ASICs), application Specific Standard Products (ASSPs), systems On Chip (SOCs), complex Programmable Logic Devices (CPLDs), computer hardware, firmware, software, and/or combinations thereof. These various embodiments may include: implemented in one or more computer programs, the one or more computer programs may be executed and/or interpreted on a programmable system including at least one programmable processor, which may be a special purpose or general-purpose programmable processor, that may receive data and instructions from, and transmit data and instructions to, a storage system, at least one input device, and at least one output device.

Program code for carrying out methods of the present disclosure may be written in any combination of one or more programming languages. These program code may be provided to a processor or controller of a general purpose computer, special purpose computer, or other programmable data processing apparatus such that the program code, when executed by the processor or controller, causes the functions/operations specified in the flowchart and/or block diagram to be implemented. The program code may execute entirely on the machine, partly on the machine, as a stand-alone software package, partly on the machine and partly on a remote machine or entirely on the remote machine or server.

In the context of this disclosure, a machine-readable medium may be a tangible medium that can contain, or store a program for use by or in connection with an instruction execution system, apparatus, or device. The machine-readable medium may be a machine-readable signal medium or a machine-readable storage medium. The machine-readable medium may include, but is not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples of a machine-readable storage medium would include an electrical connection based on one or more wires, a portable computer diskette, a hard disk, a Random Access Memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing.

To provide for interaction with a user, the systems and techniques described here can be implemented on a computer having: a display device (e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor) for displaying information to a user; and a keyboard and pointing device (e.g., a mouse or trackball) by which a user can provide input to the computer. Other kinds of devices may also be used to provide for interaction with a user; for example, feedback provided to the user may be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and input from the user may be received in any form, including acoustic input, speech input, or tactile input.

The systems and techniques described here can be implemented in a computing system that includes a background component (e.g., as a data server), or that includes a middleware component (e.g., an application server), or that includes a front-end component (e.g., a user computer having a graphical user interface or a web browser through which a user can interact with an implementation of the systems and techniques described here), or any combination of such background, middleware, or front-end components. The components of the system can be interconnected by any form or medium of digital data communication (e.g., a communication network). Examples of communication networks include: local Area Networks (LANs), wide Area Networks (WANs), and the internet.

The computer system may include a client and a server. The client and server are typically remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other. The server may be a cloud server, a server of a distributed system, or a server incorporating a blockchain.

It should be appreciated that various forms of the flows shown above may be used to reorder, add, or delete steps. For example, the steps recited in the present disclosure may be performed in parallel, sequentially or in a different order, provided that the desired results of the disclosed aspects are achieved, and are not limited herein.

Although embodiments or examples of the present disclosure have been described with reference to the accompanying drawings, it is to be understood that the foregoing methods, systems, and apparatus are merely illustrative embodiments or examples and that the scope of the present disclosure is not limited by these embodiments or examples but only by the claims following the grant and their equivalents. Various elements of the embodiments or examples may be omitted or replaced with equivalent elements thereof. Furthermore, the steps may be performed in a different order than described in the present disclosure. Further, various elements of the embodiments or examples may be combined in various ways. It is important that as technology evolves, many of the elements described herein may be replaced by equivalent elements that appear after the disclosure.

Claims

1. A data management method for a medical clinical trial, comprising:

Obtaining a first form from a first user, the first form comprising a corresponding at least one field value for at least one field for a first subject, wherein the first user has a first identity type;

determining whether the first form meets a first requirement;

in response to determining that the first requirement is met, displaying the first form at a terminal of a second user for the second user to question field values in the first form or to confirm the first form, wherein the second user has a second identity type different from the first identity type;

in response to receiving from the second user a challenge content of a first field value of a first field in the first form:

displaying the questioning content at a terminal of the first user for the first user to respond to the questioning content;

receiving response content from the first user; and

displaying the response content at the terminal of the second user for the second user to perform a question operation or a confirmation operation again based on the response content; and is also provided with

In response to receiving a confirmation of the first form from the second user, the first form confirmed by the second user is stored.

2. The method of claim 1, wherein determining whether the first form meets a first requirement comprises:

in response to determining that a field in the first form has an association with a second field in a second form that has been stored for the first subject, determining whether a field value of the field in the first form meets at least one logical requirement with a field value of the second field.

3. The method of claim 1 or 2, further comprising, in response to determining that there are field values in the first form that do not meet the first requirement:

outputting a prompt to the first user regarding the field value not meeting the first requirement;

receiving an updated value from the first user for the field value that does not meet the first requirement; and

in response to determining that the updated value can meet the first requirement, the first form is updated with the updated value.

4. A method according to any of claims 1-3, wherein displaying the first form at the terminal of the second user comprises:

the first form, at least one question control for question the at least one field value, and a confirmation control for confirming the first form are displayed at a terminal of a second user.

5. The method of any of claims 1-4, further comprising: in response to receiving a challenge content from the second user for a first field value of a first field in the first form, storing the first field value and the challenge content in association with the first field as a first challenge entry for the first field, and

wherein displaying the challenge content at the terminal of the first user comprises:

and displaying the first questioning item and a response control for responding to the questioning item at the terminal of the first user.

6. The method of claim 5, wherein the response controls include a clarification control and a modification control.

7. The method of any of claims 1-6, further comprising, after receiving the response content to the first challenge entry from the first user, storing the response content in association with the first field as a first response entry for the first field.

8. The method of claim 7, wherein displaying the response content at the terminal of the second user comprises:

updating the first form using the first response entry; and

Causing the updated first form, the at least one question control, and the confirmation control to be displayed at a terminal of a second user.

9. The method of claim 8, wherein displaying the updated first form comprises displaying fields and corresponding field values in different colors with different states based on fields, wherein the different states comprise at least two of: no challenge, waiting for response, responded, confirmed.

10. The method of any of claims 1-9, further comprising, after storing the first form confirmed by a second user:

displaying the first form confirmed by a second user at a terminal of a third user for the third user to perform a question operation or a confirmation operation, wherein the third user has a third identity type different from both the first identity type and the second identity type;

in response to receiving the challenge content from the third user:

receiving second response content from the first user;

displaying the second response content at the terminal of the second user for the second user to perform a question operation or a confirmation operation based on the second response content; and

In response to receiving a confirmation from the second user based on the second response content, displaying the second response content at a terminal of the third user for the third user to perform a question operation or a confirmation operation based on the second response content; and is also provided with

In response to receiving a confirmation of the first form from the third user, the first form confirmed by the third user is stored.

11. The method of claim 10, wherein the first form is associated with a first topic, and further comprising, after storing the first form confirmed by a third user:

in response to determining that all forms related to the first topic are confirmed to be complete, displaying the first form confirmed by a third user at a terminal of a fourth user for the fourth user to sign, wherein the fourth user has a fourth identity type different from the first identity type, the second identity type, and the third identity type.

12. The method of claim 11, further comprising:

in response to determining that all forms associated with the first topic are signed, checking signature validity; and

And in response to the completion of signature validity checking, displaying all forms related to the first topic at the terminal of the fourth user for the fourth user to perform a library locking operation.

13. The method of any of claims 9-12, wherein storing the first form validated by a third user includes associating the first form validated by a third user with the third user and the fourth user for at least one of the third user and the fourth user to at least one of: form freeze operation, form cancel freeze operation.

14. A data management device for a medical clinical trial, comprising:

a form obtaining unit for obtaining a first form from a first user, the first form comprising a corresponding at least one field value for at least one field with respect to a first subject, wherein the first user has a first identity type;

a logic verification unit, configured to determine whether the first form meets a first requirement;

a form verification unit configured to display, in response to determining that the first requirement is satisfied, the first form at a terminal of a second user for the second user to question a field value in the first form or to confirm the first form, wherein the second user has a second identity type different from the first identity type;

A form response unit, configured to respond to receiving, from the second user, a challenge content of a first field value of a first field in the first form:

receiving response content from the first user; and

displaying the response content at the terminal of the second user for the second user to perform a question operation or a confirmation operation again based on the response content; and

and a form storage unit configured to store the first form confirmed by the second user in response to receiving a confirmation of the first form from the second user.

15. An electronic device, comprising:

at least one processor; and

a memory communicatively coupled to the at least one processor; wherein the method comprises the steps of

The memory stores instructions executable by the at least one processor to enable the at least one processor to perform the method of any one of claims 1-13.

16. A non-transitory computer readable storage medium storing computer instructions for causing the computer to perform the method of any one of claims 1-13.

17. A computer program product comprising a computer program, wherein the computer program, when executed by a processor, implements the method of any of claims 1-13.