CN111916164A

CN111916164A - Implementation method and device of central start investigation system for clinical research

Info

Publication number: CN111916164A
Application number: CN202010802372.1A
Authority: CN
Inventors: 吴文春; 许素贞; 胡杰文; 罗勇
Original assignee: Shanghai Yikai Intelligent Technology Co ltd
Current assignee: Shanghai Yikai Intelligent Technology Co ltd
Priority date: 2020-08-11
Filing date: 2020-08-11
Publication date: 2020-11-10
Anticipated expiration: 2040-08-11
Also published as: CN111916164B

Abstract

The invention provides a method for realizing a central start-up investigation system used in clinical research, which comprises a project participant information form, an item standing and contract information form, an ethical examination information form, a genetic resource management information form, a researcher intention information form and a logic association setting form, and the method comprises the following steps: packaging the components of the design form to obtain JSON data; arranging data corresponding to the components to form a basic component column; performing second-level packaging on elements in the component column to form a form design component responding to clicking and moving operations of a Web end; monitoring components in a form design area; data binding and rendering are carried out on the components; arranging the components; a configuration bar that displays components; receiving operation on a configuration column, wherein a form page formed by configuration comprises a first-level form area, a second-level form area and a third-level form area; and transmitting the data corresponding to the designed form to a server side.

Description

Implementation method and device of central start investigation system for clinical research

Technical Field

The invention mainly relates to the technical field of information, in particular to a method for realizing a central start investigation system used in clinical research.

Background

In clinical research, investigation and screening in clinical trial centers are an important part. A common investigation mode of a clinical test center is that SSU professionals find data of the center and researchers through various channels on line, and many researchers need to go to different local hospitals for long distance to find the researchers.

Disclosure of Invention

The technical problem to be solved by the invention is to provide a method for realizing a center-start investigation system used in clinical research, so that the standardization and the accuracy of the investigation process are realized, the investigation efficiency is improved, and the cost of the center-start investigation is reduced.

In order to solve the technical problems, the invention provides a method for realizing a central start-up research system used in clinical research, wherein the central start-up research system comprises a project participant information form, an establishment and contract information form, an ethical examination information form, a genetic resource management information form, a researcher intention information form and a logic association setting form, and the method comprises the following steps: packaging components of a design project participant information form, an establishment and contract information form, an ethical examination information form, a genetic resource management information form and a researcher intention information form to obtain JSON data; the JSON data formed by the packaging comprises original attribute setting and initial data rendering of the components; the original attribute corresponds to the interactive form and the graphic style of the component; arranging the JSON data corresponding to the components to form a basic component column; performing second-level packaging on the elements in the basic component column to form a form design component responding to clicking and moving operations of a Web end; monitoring the form design components subjected to the second-level packaging in a form design area; when the form design component moves to a form design area in response to the clicking and moving operations of the Web end, data binding and rendering are carried out on the form design component; arranging the form design components in a responsive layout-stacked streaming layout; in response to clicking on a form component of a form design area, displaying a configuration field of the form component; receiving the operation of a Web end on a configuration column, rendering a configuration result to the form design area, wherein a form page formed by configuration comprises a first-level form area, a second-level form area and a third-level form area; and transmitting JSON data corresponding to the designed form to a server for storage.

In an embodiment of the present invention, the first-level form area includes one or more second-level form areas, and the layout information of the second-level form areas in the first-level form area is defined by a first-level form area value; the second-level form areas comprise one or more third-level form areas, and the layout information of the third-level form areas in the second-level form areas is defined by second-level form area values; the third-level form area comprises a data input area and/or a data type identification area, and the layout information of the data input area and/or the data type identification area is defined by a third-level form area value; the data type is determined by the interaction modality of the corresponding component.

In one embodiment of the invention, the third level form area values define data entry types for the third level form areas, including any of: multi-line text, single-line text, numeric values, radio boxes, drop boxes, check boxes, dates, times, file uploads, signatures, and rich text.

In an embodiment of the present invention, configuring the filling items of the project participant information form includes: address, unit name, department, and contact.

In an embodiment of the present invention, configuring the written items of the standing item and the contract information form includes: the system comprises a standing mode, standing mode extension information, contract examination information, CRC source requirements and extramural SMO requirements.

In an embodiment of the present invention, configuring the filling items of the ethical review information form includes: the person in charge of the examination, the frequency of conference holding, the requirements of examination materials, the examination mode, the examination cost and the examination time limit.

In an embodiment of the present invention, configuring the filling items of the genetic resource management information form includes: organization contact, contact details, presence or absence of submission history, submission style, submission cost, and material transfer procedures.

In one embodiment of the present invention, configuring the filling items of the researcher intention information form comprises: contact, participation intention, knowledge about the study process, disease classification and coding standard selection of HIS, study load assessment, influence on group entry factors and remarks.

In an embodiment of the present invention, a method for implementing a central-initiated research system in clinical research is characterized in that configuring the filling items of the logical association setting form includes: and selecting the relevant filling item field and setting the field of the filling item to be relevant.

In an embodiment of the present invention, the itemized extension information is logically associated with the itemized filling item setting logic.

In an embodiment of the present invention, the setting of the logical association is implemented by the logical association setting form, and the logical association setting form is triggered by a linkage logical configuration button displayed in the configuration bar after clicking a component in a form.

In an embodiment of the present invention, the setting of the logical association is implemented by selecting a field corresponding to a filling item in the logical association setting form and displaying or hiding one or more filling items in the form page.

The invention also provides a device for implementing the central start investigation system in clinical research, which comprises: a memory for storing instructions executable by the processor; and a processor for executing the instructions to implement the method as previously described.

The invention also provides a computer-readable medium having stored thereon computer program code which, when executed by a processor, implements a method as described above.

Compared with the prior art, the invention has the following advantages: according to the requirement of the center start investigation business in the clinical test, the form in the center start investigation system used in the clinical research is designed by self-definition, so that the high efficiency and the convenient operation of the investigation process are realized, the cooperative efficiency of each participant is improved, and the investigation cost is reduced.

Drawings

The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this application, illustrate embodiment(s) of the invention and together with the description serve to explain the principle of the invention. In the drawings:

FIG. 1 is a flowchart of an implementation method of a central start-up research system for use in clinical research according to an embodiment of the present invention.

FIG. 2 is a diagram of a form of investigator intent information in accordance with an embodiment of the present invention.

FIG. 3 is a diagram of a logical association settings form, in accordance with an embodiment of the present invention.

FIG. 4 is a schematic diagram of a system implementation environment of an implementation apparatus for a project distribution and management system in a clinical study according to an embodiment of the present invention

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below.

In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention, but the present invention may be practiced in other ways than those specifically described herein, and thus the present invention is not limited to the specific embodiments disclosed below.

Flow charts are used herein to illustrate operations performed by systems according to embodiments of the present application. It should be understood that the preceding or following operations are not necessarily performed in the exact order in which they are performed. Rather, various steps may be processed in reverse order or simultaneously. Meanwhile, other operations are added to or removed from these processes.

Embodiments of the present invention describe methods and apparatus for implementing a central start-up investigation system for use in clinical studies.

In one embodiment, a Site Start-up (SSU) research system for clinical studies includes a project participant information form, a standing and contract information form, an ethical review information form, a genetic resource management information form, a researcher intention information form, and a logical association settings form. Forms in a central initiated (SSU) research system may be obtained through custom form design.

In one embodiment, a method for implementing a central-initiated research system for use in clinical research includes, step 101, encapsulating components of a design project participant information form, an establishment and contract information form, an ethical review information form, a genetic resource management information form, a researcher intention information form, and a logical association settings form. And 102, performing initial rendering arrangement on JSON data corresponding to the components to form a basic component column. And 103, performing second-level packaging on the elements in the basic component column to form a form design component responding to the clicking and moving operations of the Web end. Step 104, monitoring the form design components subjected to the second-level packaging in a form design area; and when the form design component moves to the form design area in response to the clicking and moving operations of the Web end, performing data binding and rendering on the form design component. Step 105, arranging the form design components in a responsive layout overlay streaming layout. And 106, responding to the clicking of the form component in the form design area, and displaying a configuration column of the form component. And step 107, receiving the operation of the Web end on the configuration column, rendering the configuration result to the form design area, wherein the form page formed by configuration comprises a first-level form area, a second-level form area and a third-level form area. And step 108, transmitting JSON data corresponding to the designed form to a server for storage. FIG. 1 is a flowchart of an implementation method of a central start-up research system for use in clinical research according to an embodiment of the present invention.

In step 101, components of a design project participant information form, an item standing and contract information form, an ethical review information form, a genetic resource management information form, a researcher intention information form, and a logic association setting form are encapsulated to obtain JSON data. JSON (JavaScript Object Notation) is a data storage format. JSON can convert a set of data represented in a JavaScript object into a string, and then pass the string between networks or programs and restore it to a data format supported by each programming language if necessary. And packaging the form design component to form JSON data, wherein the JSON data comprises the original attribute setting and the initial data rendering of the component. Wherein the original property settings of the components correspond to the interactive modalities and graphical styles of the components.

In step 102, JSON data corresponding to the components are initially rendered and arranged to form a base component column. JSON data corresponding to components of different interaction forms form component elements in the basic component column. The corresponding base component column may be located on the left or upper side of the form designer interface. The component elements in the base component bar may be identified by the name of the component modality.

At step 103, the elements in the base component column are packaged at the second level to form a form design component that responds to the click and move operations on the Web side. Second level packaging can be achieved by the React DnD (Dragon and Drop for React) suite. React is a framework for building user interfaces. The type of clicking and moving operation, the object of operation and the information of the process of operation are set in the React DnD suite. After packaging, form design components responding to the clicking and moving operations of the Web end are formed in the basic component column.

At step 104, form design components that have undergone second level packaging are listened to in the form design area of the form designer. And when the form design component moves to the form design area in response to the clicking and moving operations of the Web end, performing data binding and rendering on the form design component. After rendering, a specific form of the form component is formed in the form design area.

At step 105, the form design component is arranged in a responsive layout overlay streaming layout. After multiple clicking and moving operations, form components formed in the form design area are increasing. The form design components are then arranged in a responsive layout-stacked streaming layout. In the stream type layout mode, the width of the elements of the form page is adaptively adjusted according to the screen resolution, and meanwhile, the overall layout is unchanged. In order to enable the form layout to adapt to the span of a larger screen dimension, the form design components are arranged through the response type layout and the superposed stream type layout, so that the form page can adapt to the span of the larger screen dimension, and the display effect of page elements can be ensured when the form page is used.

At step 106, in response to clicking on a form component of the form design area, a configuration field for the form component is displayed. The configuration column may be located to the right or lower side of the form designer interface. The configurable items in the configuration column can be set according to actual requirements. The contents of the configuration may include checking the configuration for mandatory and rights configurations. In addition, the configuration types can be increased according to the requirements. For example, more custom configurations can be used to modify the style of form components according to the user's needs. The verification configuration refers to whether the interactive form of the form single component corresponds to the displayed style or not. The permission configuration can configure the permissions of different form components that can be operated, such as the permissions of users with different roles to review and modify the content being filled.

In step 107, receiving an operation of the Web end on the configuration column, and rendering a configuration result to the form design area, where the form page formed by configuration includes a first-level form area, a second-level form area, and a third-level form area.

In one embodiment, the first level form area may include one or more second level form areas, and the layout information of the second level form areas in the first level form area is defined by a first level form area value; the second-level form areas comprise one or more third-level form areas, and the layout information of the third-level form areas in the second-level form areas is defined by second-level form area values; the third-level form area comprises a data input area and/or a data type identification area, and the layout information of the data input area and/or the data type identification area is defined by a third-level form area value; the data type is determined by the interaction modality of the corresponding component.

In one embodiment, the third level form area values define data entry types for the third level form areas, the data entry types including any of: multi-line text, single-line text, numeric values, radio boxes, drop boxes, check boxes, dates, times, file uploads, signatures, and rich text.

In some embodiments, configuring the fill-out items of the project participant information form includes: address, unit name, department, and contact.

In some embodiments, configuring the entries of the treaty and contract information forms includes: the system comprises a standing mode, standing mode extension information, contract examination information, CRC source requirements and extramural SMO requirements. The project establishment mode extension information and the project establishment mode filling terms can be associated logically.

In some embodiments, configuring the fill-out items of the ethical review information form comprises: the person in charge of the examination, the frequency of conference holding, the requirements of examination materials, the examination mode, the examination cost and the examination time limit.

In some embodiments, configuring the fill-out items of the genetic resource management information form comprises: organization contact, contact details, presence or absence of submission history, submission style, submission cost, and material transfer procedures.

In some embodiments, configuring the fill-out of the researcher intention information form includes: contact, participation intention, knowledge about the study procedure, disease classification and coding standard selection of HIS (Hospital Information System), study load assessment, influence on group factors and remarks. In some cases, filling out the item may also include a privacy protocol upload.

FIG. 2 is a schematic diagram of a researcher intention information form. As illustrated in FIG. 2, researcher intention information form 200 may include a first level form area 201. The first level form area 201 may include a second level form area 211. Second level form area 211 may include third

level form areas

221, 223, and 224.

In some embodiments, configuring the fill-out items of the logical association settings form comprises: and selecting the relevant filling item field and setting the field of the filling item to be relevant.

The logic association setting is realized through the logic association setting form, and the logic association setting form is triggered through a linkage logic configuration button displayed in the configuration bar after one component in one form is clicked. Specifically, the setting of the logical association can be realized by selecting a field corresponding to a filling item in the logical association setting form and displaying or hiding one or more filling items in the form page.

As illustrated in fig. 3, in the logical association settings form, the logical association settings may be set by selecting the association entry 301 and setting the fields of the entry to be associated to be displayed or hidden. In particular to the logic association of the filling items of the standing mode and the extension information of the standing mode. For example, the to-

be-associated filling items

311, 312, 313, and 314 in fig. 3, and the like. The to-

be-associated filling items

311, 312 and 313 are checked as display fields when the associated filling item is "GCP office", and the to-be-associated filling item 314 is checked as a hidden field. When the associated entry is "unable to stand," the to-be-associated entry 314 may be checked as a display field. The setting of logical associations may make the display and collection of information more targeted and accurate.

In step 108, the JSON data corresponding to the designed and formed form is transmitted to a server for storage. In some embodiments, the JSON data corresponding to the base component column and the JSON data formed during the design process can also be transmitted to the server side as needed and set. The form formed by the design can be acquired from a server side by a Web side or a mobile side, so that the research data is filled and collected. The form can also be transmitted to the server after being filled, so that the content information of the filled form can be recorded as a trace, and further, the information can be tracked and circulated according to the requirement, such as the subsequent auditing and approving processes.

According to the implementation method of the center start investigation system used in clinical research, the form in the center start investigation system used in clinical research is designed by self-definition according to the requirement of the center start investigation business in clinical tests, so that the high efficiency and convenience of the investigation process are realized, the cooperative efficiency of each participant is improved, the time consumption of the investigation process is shortened, and the investigation cost is reduced.

FIG. 4 illustrates a system implementation environment diagram of an implementation apparatus for a project distribution and management system in a clinical study, according to an embodiment of the present application. An apparatus 400 implementing a system for distribution and management of items in a clinical study may include an internal communication bus 401, a Processor (Processor)402, a Read Only Memory (ROM)403, a Random Access Memory (RAM)404, and a communication port 405. The implementation apparatus 400 is connected to the network through the communication port and is connected to the server side. The internal communication bus 401 may enable data communication among the implementing device 400 components of the project distribution and management system in a clinical study. The processor 402 may make the determination and issue the prompt. In some embodiments, processor 402 may be comprised of one or more processors. The communication port 405 may enable sending and receiving information and data from the network. In fig. 4, the communication port 405 may be connected to the server a 306, the server data storage a 407, the server B408, and the server data storage B409 of the server through a network, so as to implement transmission of JSON data corresponding to the form. The implementation means 400 of the project distribution and management system in clinical research may also comprise different forms of program storage units and data storage units, such as a Read Only Memory (ROM)403 and a Random Access Memory (RAM)404, capable of storing various data files for computer processing and/or communication use, and possibly program instructions for execution by the processor 402. The processor executes these instructions to implement the main parts of the method. The results processed by the processor are communicated to the user device through the communication port and displayed on the user interface.

The apparatus for implementing the project distribution and management system in clinical research may be implemented as a computer program, stored in a memory, and executed by the processor 402 to implement the method for implementing the project distribution and management system in clinical research according to the present application.

Aspects of the present application may be embodied entirely in hardware, entirely in software (including firmware, resident software, micro-code, etc.) or in a combination of hardware and software. The above hardware or software may be referred to as "data block," module, "" engine, "" unit, "" component, "or" system. The processor may be one or more Application Specific Integrated Circuits (ASICs), Digital Signal Processors (DSPs), digital signal processing devices (DAPDs), Programmable Logic Devices (PLDs), Field Programmable Gate Arrays (FPGAs), processors, controllers, microcontrollers, microprocessors, or a combination thereof. Furthermore, aspects of the present application may be represented as a computer product, including computer readable program code, embodied in one or more computer readable media. For example, computer-readable media may include, but are not limited to, magnetic storage devices (e.g., hard disk, floppy disk, magnetic strips … …), optical disks (e.g., Compact Disk (CD), Digital Versatile Disk (DVD) … …), smart cards, and flash memory devices (e.g., card, stick, key drive … …).

The computer readable medium may comprise a propagated data signal with the computer program code embodied therein, for example, on a baseband or as part of a carrier wave. The propagated signal may take any of a variety of forms, including electromagnetic, optical, and the like, or any suitable combination. The computer readable medium can be any computer readable medium that can communicate, propagate, or transport the program for use by or in connection with an instruction execution system, apparatus, or device. Program code on a computer readable medium may be propagated over any suitable medium, including radio, electrical cable, fiber optic cable, radio frequency signals, or the like, or any combination of the preceding.

Similarly, it should be noted that in the preceding description of embodiments of the application, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure aiding in the understanding of one or more of the embodiments. This method of disclosure, however, is not intended to require more features than are expressly recited in the claims. Indeed, the embodiments may be characterized as having less than all of the features of a single embodiment disclosed above.

Although the present application has been described with reference to the present specific embodiments, it will be recognized by those skilled in the art that the foregoing embodiments are merely illustrative of the present application and that various changes and substitutions of equivalents may be made without departing from the spirit of the application, and therefore, it is intended that all changes and modifications to the above-described embodiments that come within the spirit of the application fall within the scope of the claims of the application.

Claims

1. A method for implementing a centrally initiated research system for use in clinical research, said centrally initiated research system comprising a project participant information form, an establishment and contract information form, an ethical review information form, a genetic resource management information form, a researcher intention information form, and a logical association settings form, said method comprising the steps of:

packaging components of a design project participant information form, an establishment and contract information form, an ethical examination information form, a genetic resource management information form and a researcher intention information form to obtain JSON data;

the JSON data formed by the packaging comprises original attribute setting and initial data rendering of the components; the original attribute corresponds to the interactive form and the graphic style of the component;

arranging the JSON data corresponding to the components to form a basic component column;

performing second-level packaging on the elements in the basic component column to form a form design component responding to clicking and moving operations of a Web end;

monitoring the form design components subjected to the second-level packaging in a form design area; when the form design component moves to a form design area in response to the clicking and moving operations of the Web end, data binding and rendering are carried out on the form design component;

arranging the form design components in a responsive layout-stacked streaming layout;

in response to clicking on a form component of a form design area, displaying a configuration field of the form component;

receiving the operation of a Web end on a configuration column, rendering a configuration result to the form design area, wherein a form page formed by configuration comprises a first-level form area, a second-level form area and a third-level form area;

and transmitting JSON data corresponding to the designed form to a server for storage.

2. The method of claim 1, wherein said first level form area comprises one or more second level form areas, and wherein said second level form areas have layout information defined by first level form area values in said first level form area; the second-level form areas comprise one or more third-level form areas, and the layout information of the third-level form areas in the second-level form areas is defined by second-level form area values; the third-level form area comprises a data input area and/or a data type identification area, and the layout information of the data input area and/or the data type identification area is defined by a third-level form area value; the data type is determined by the interaction modality of the corresponding component.

3. The method of claim 2, wherein the third level form area values define a data entry type for the third level form area, the data entry type comprising any of: multi-line text, single-line text, numeric values, radio boxes, drop boxes, check boxes, dates, times, file uploads, signatures, and rich text.

4. The method of claim 1, wherein configuring the fill-out items of the project participant information form comprises: address, unit name, department, and contact.

5. The method of claim 1, wherein configuring the entries of the standing and contract information form comprises: the system comprises a standing mode, standing mode extension information, contract examination information, CRC source requirements and extramural SMO requirements.

6. The method of claim 1, wherein configuring the entries of the ethical review information form comprises: the person in charge of the examination, the frequency of conference holding, the requirements of examination materials, the examination mode, the examination cost and the examination time limit.

7. The method of claim 1, wherein configuring the entries of the genetic resource management information form comprises: organization contact, contact details, presence or absence of submission history, submission style, submission cost, and material transfer procedures.

8. The method of claim 1, wherein configuring the fill-out of the researcher intention information form comprises: contact, participation intention, knowledge about the study process, disease classification and coding standard selection of HIS, study load assessment, influence on group entry factors and remarks.

9. The method of claim 1, wherein configuring the entries of the logical association setup form comprises: and selecting the relevant filling item field and setting the field of the filling item to be relevant.

10. The method of claim 5, wherein the stereotactic extension information is logically associated with the stereotactic fill setting.

11. The method of claim 10, wherein the setting of the logical association is performed by a logical association setup form triggered by clicking on a linked logical configuration button displayed in the configuration bar after clicking on a component in a form.

12. The method of claim 10, wherein the setting of the logical association is performed by selecting a field corresponding to a filling item in the logical association setup form and displaying or hiding one or more filling items in the form page.

13. An apparatus for implementing a center-initiated research system for use in clinical research, comprising:

a memory for storing instructions executable by the processor; and

a processor for executing the instructions to implement the method of any one of claims 1-12.

14. A computer-readable medium having stored thereon computer program code which, when executed by a processor, implements the method of any of claims 1-12.