CN111916164B

CN111916164B - Method and device for realizing center-started investigation system in clinical research

Info

Publication number: CN111916164B
Application number: CN202010802372.1A
Authority: CN
Inventors: 吴文春; 许素贞; 胡杰文; 罗勇
Original assignee: Shanghai Taimei Nebula Digital Technology Co ltd
Current assignee: Shanghai Taimei Nebula Digital Technology Co ltd
Priority date: 2020-08-11
Filing date: 2020-08-11
Publication date: 2023-06-16
Anticipated expiration: 2040-08-11
Also published as: CN111916164A

Abstract

The invention provides a method for realizing a center-initiated investigation system in clinical research, which comprises a project participant information form, a stand 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 comprises the following steps: packaging 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 the Web terminal; monitoring the components in a form design area; carrying out data binding and rendering on the components; arranging the components; a configuration bar for displaying the 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 form formed by design to a server side.

Description

Method and device for realizing center-started investigation system in clinical research

Technical Field

The invention mainly relates to the technical field of information, in particular to a method for realizing a center-started investigation system in clinical research.

Background

In clinical research, research and screening of clinical test centers is an important part. The common clinical test center investigation mode is that SSU specialists search center and researcher data through various channels on line, and many of the data even go to hospitals in different places for searching researchers for long distance, and the investigation mode is original, the investigation efficiency is low, and the investigation cost is quite high.

Disclosure of Invention

The invention aims to solve the technical problem of providing a method for realizing a center-started investigation system in clinical research, which realizes the standardization and accuracy of the investigation process, improves the investigation efficiency and reduces the center-started investigation cost.

In order to solve the technical problems, the invention provides a realization method of a center-initiated research system for clinical research, wherein the center-initiated research system comprises a project participant information form, a stand 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, a standing 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 encapsulation comprises original attribute setting and initial data rendering of the component; the original attribute corresponds to the interaction 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 the Web terminal; monitoring the form design component passing through the second level package in a form design area; when the form design component moves to a form design area in response to 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 superposition flow layout; responding to a form component of a clicking form design area, and displaying a configuration column of the form component; receiving operation of the Web end on a configuration column, and 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 formed 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 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 area comprises one or more third level form areas, and layout information of the third level form areas in the second level form area 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 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 field value defines a data entry type for the third level form field, the data entry type comprising any one of: multiple lines of text, single line of text, numeric, radio boxes, drop down boxes, check boxes, date, time, file upload, signature, and rich text.

In one embodiment of the present invention, configuring the filling-in item of the item-party information form includes: address, unit name, department, and contact.

In one embodiment of the present invention, configuring the terms and filling out terms of the contract information form includes: the setback style, setback style extension information, contract review information, CRC source requirements, and extra-hospital SMO requirements.

In one embodiment of the present invention, configuring the entry of the ethical review form includes: screening responsible person, frequency of meetings, screening material requirements, screening mode, screening cost and screening time limit.

In one embodiment of the present invention, configuring the filling item of the genetic resource management information form includes: the organization contacts, contact ways, whether there is a history of submittal, the manner of submittal, the payment of the submittal and the material passing flow.

In one embodiment of the present invention, configuring the filling-in item of the researcher intent information form includes: contact, intent to attend, knowledge of study procedure, disease classification and coding criteria selection for HIS, study load assessment, influencing group factors and notes.

In an embodiment of the present invention, a method for implementing a center-initiated research system in clinical research, wherein configuring a filling item of the logical association setting form includes: associating filling item field selection and setting of filling item fields to be associated.

In one embodiment of the invention, the setback style extension information is logically associated with the setback style fill item settings.

In one embodiment of the present invention, the setting of the logical association is implemented through the logical association settings form triggered by a linked logical configuration button displayed in the configuration column after clicking a component in a form.

In one embodiment of the invention, the setting of the logical association is accomplished by displaying or hiding one or more fields corresponding to fill-in items in a form page corresponding to a fill-in item in the logical association settings form selection.

The invention also provides a device for realizing the center starting 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 described above.

The invention also provides a computer readable medium storing 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-started investigation business in the clinical test, the form in the center-started investigation system in the clinical study is designed in a self-defined mode, so that the efficient and convenient implementation of the investigation process is 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 application and are incorporated in and constitute a part of this application, illustrate embodiments of the application and together with the description serve to explain the principles of the invention. In the accompanying drawings:

FIG. 1 is a flow chart of an implementation method of a center-initiated research system for clinical research in accordance with an embodiment of the present invention.

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

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

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

Detailed Description

In order to make the above objects, features and advantages of the present invention more 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 as described herein, and therefore the present invention is not limited to the specific embodiments disclosed below.

Flowcharts are used in this application to describe the 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 order precisely. Rather, the various steps may be processed in reverse order or simultaneously. At the same time, other operations are added to or removed from these processes.

Embodiments of the present invention describe methods and apparatus for implementing a center-initiated research system in clinical research.

In one embodiment, a Site Start-up (SSU) research system for clinical research includes a project participant information form, a stand and contract information form, an ethical review information form, a genetic resource management information form, a researcher intent information form, and a logical association settings form. Forms in a center-initiated (SSU) investigation system may be derived by custom form design.

In one embodiment, the method for implementing a center-initiated research system in clinical research includes the steps of 101 packaging components of design project participant information forms, standing and contract information forms, ethical review information forms, genetic resource management information forms, researcher intent information forms, and logical association settings forms. And 102, performing initial rendering arrangement on JSON data corresponding to the components to form a basic component column. And step 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 operation of the Web end. 104, monitoring the form design components passing through the second level package in a form design area; and when the form design component moves to the form design area in response to the clicking and moving operation of the Web end, the form design component carries out data binding and rendering. Step 105, arranging the form design components in a responsive layout overlay flow layout. And 106, responding to the form components in the clicking form design area, and displaying configuration columns of the form components. And step 107, receiving the operation of the Web end on the configuration column, and 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 formed form to a server for storage. FIG. 1 is a flow chart of an implementation method of a center-initiated research system for clinical research in accordance with an embodiment of the present invention.

In step 101, components of the design project participant information form, the standing and contract information form, the ethical examination information form, the genetic resource management information form, the researcher intention information form and the logic association setting form are packaged to obtain JSON data. JSON (JavaScript Object Notation ) is a data storage format. JSON may convert a set of data represented in JavaScript objects into a string, then pass the string between networks or programs, and restore it to the data format supported by each programming language if needed. And the JSON data formed by packaging the form design component comprises original attribute setting and initial data rendering of the component. The original attribute setting of the component corresponds to the interaction form and the graphic style of the component.

In step 102, initial rendering and arrangement are performed on JSON data corresponding to the components to form a basic component column. The JSON data corresponding to the 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 top side of the form designer interface. The component elements in the base component column may be identified by the name of the component modality.

In step 103, the elements in the base component column are second-level packaged to form a form design component that responds to the click and move operations of the Web end. The second level of packaging may be implemented by a compact DnD (Drag and Drop for React) kit. React is a framework for building a user interface. The types of the click and move operations, the objects of the operations and the information of the processes of the operations are set in the exact DnD suite. After packaging, form design components responsive to click and move operations of the Web end are formed in the base component column.

In step 104, the form design components that have undergone the second level of packaging are monitored 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 operation of the Web end, the form design component carries out data binding and rendering. And after rendering, forming a specific form of the form component in the form design area.

At step 105, the form design components are arranged in a responsive layout overlay flow layout. Form components formed in the form design area continue to increase through multiple clicking and moving operations. The form design components are arranged in a responsive layout overlay flow layout at this time. In the stream layout mode, the width of the elements of the form page is adjusted in an adapting way according to the screen resolution, and meanwhile, the whole layout is unchanged. In order to adapt the form layout to the span of a larger screen scale, the form design components are arranged through the responsive layout superposition flow layout, so that the form page can adapt to the span of the larger screen scale, and the display effect of page elements can be ensured during use.

In step 106, in response to clicking on the form component of the form design area, the configuration column of the form component is displayed. The configuration bar may be located on 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 whether the configuration is a mandatory entry and a rights configuration. In addition, the configuration type can be increased according to the requirement. For example, more custom configurations to modify the style of the form component according to the needs of the user. Checking configuration refers to checking whether the interaction form of the form component corresponds to the displayed style. Rights configuration may configure rights that may be manipulated for different form components, such as review and modification rights for filled content by users of different roles.

In step 107, the operation of the Web terminal on the configuration column is received, the configuration result is rendered to the form design area, and the form page formed by configuration comprises a first-level form area, a second-level form area and a third-level form area.

In an embodiment, a first level form area may include one or more second level form areas, and 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 area comprises one or more third level form areas, and layout information of the third level form areas in the second level form area 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 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 an embodiment, the third level form area value defines a data entry type for the third level form area, the data entry type comprising any one of: multiple lines of text, single line of text, numeric, radio boxes, drop down boxes, check boxes, date, time, file upload, signature, and rich text.

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

In some embodiments, the configuration standpoint and the filling in of the contract information form include: the setback style, setback style extension information, contract review information, CRC source requirements, and extra-hospital SMO requirements. The setback style extension information is logically associated with the setback style fill item.

In some embodiments, configuring the entry of the ethical review information form includes: screening responsible person, frequency of meetings, screening material requirements, screening mode, screening cost and screening time limit.

In some embodiments, configuring the entry of the genetic resource management information form includes: the organization contacts, contact ways, whether there is a history of submittal, the manner of submittal, the payment of the submittal and the material passing flow.

In some embodiments, configuring the fill-in item of the researcher intent information form includes: contact, intent to attend, knowledge of study procedure, disease classification and coding criteria selection for HIS (Hospital Information System ), study load assessment, influencing group factors and notes. In some cases, the filling-in item may also include a security protocol upload.

FIG. 2 is a schematic diagram of a researcher intent information form. As illustrated in FIG. 2, the researcher intent 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. The second level form area 211 may include third

level form areas

221, 223, and 224.

In some embodiments, configuring the filling out items of the logical association settings form includes: associating filling item field selection and setting of filling item fields to be associated.

The setting of the logic association is realized through the logic association setting form, and the logic association setting form is triggered by a linkage logic configuration button displayed in the configuration column after clicking a component in a form. In particular, the setting of the logical association may be achieved by displaying or hiding the fields corresponding to one or more filling items in the form page corresponding to a filling item in the logical association setting form selection.

As illustrated in fig. 3, in the logical association settings form, logical association settings may be displayed or hidden by selecting the association fill-in 301 and the setting to be associated fill-in fields. The method specifically comprises the steps of filling out the logical association of the item and the item expansion information in the item mode. For example, the to-

be-associated filling items

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

be-associated filling items

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

In step 108, JSON data corresponding to the formed form is transmitted to the server for storage. In some embodiments, JSON data corresponding to the basic component column and JSON data formed in the design process may also be transmitted to the server side according to the requirements and settings. The form formed by design can be obtained from a server by a Web end or a mobile end, so that filling and collecting of investigation data are carried out. The form can also be transmitted to the server after being filled in, so that the filled-in form content information can be used as a trace record, and further information tracking and circulation can be carried out according to the needs, such as follow-up auditing and approval processes and the like.

According to the method for realizing the center-started investigation system in the clinical study, the forms in the center-started investigation system in the clinical study are designed by self definition according to the requirements of the center-started investigation business in the clinical study, so that the efficient and convenient implementation of the investigation process is realized, the cooperative efficiency of all the participants is improved, the time consumption in the investigation process is shortened, and the investigation cost is reduced.

Fig. 4 shows a schematic diagram of a system implementation environment of an implementation apparatus of an item distribution and management system for clinical research according to an embodiment of the present application. The implementation 400 of the project distribution and management system in clinical studies 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 device 400 is connected to a network through a communication port and is connected to a server. The internal communication bus 401 may enable data communication between components of the implementation apparatus 400 of the project distribution and management system in clinical studies. The processor 402 may make the determination and issue the prompt. In some embodiments, the processor 402 may be comprised of one or more processors. Communication port 405 may enable sending and receiving information and data from a network. In fig. 4, the communication port 405 may be connected to a server a 306, a server data storage a 407, a server B408, and a server data storage B409 at a server end through a network, so as to implement transmission of JSON data corresponding to a form. The implementation 400 of the project distribution and management system in clinical studies may also comprise program storage units of different forms as well as data storage units, such as Read Only Memory (ROM) 403 and Random Access Memory (RAM) 404, capable of storing various data files for computer processing and/or communication, and possible program instructions for execution by the processor 402. The processor executes these instructions to implement the main part of the method. The result processed by the processor is transmitted to the user equipment through the communication port and displayed on the user interface.

The implementation device of the project distribution and management system in clinical research can be implemented as a computer program, stored in a memory, and recorded in the processor 402 for execution, so as to implement the implementation method of the project distribution and management system in clinical research of the application.

Some aspects of the present application may be performed entirely by hardware, entirely by software (including firmware, resident software, micro-code, etc.) or by a combination of hardware and software. The above hardware or software may be referred to as a "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 take the form of a computer product, comprising computer-readable program code, embodied in one or more computer-readable media. For example, computer-readable media can include, but are not limited to, magnetic storage devices (e.g., hard disk, floppy disk, tape … …), optical disk (e.g., compact disk CD, digital versatile disk DVD … …), smart card, 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 on a variety of forms, including electro-magnetic, optical, etc., or any suitable combination thereof. A computer readable medium can be any computer readable medium that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device. Program code located on a computer readable medium may be propagated through any suitable medium, including radio, cable, fiber optic cable, radio frequency signals, or the like, or a combination of any of the foregoing.

Likewise, it should be noted that in order to simplify the presentation disclosed herein and thereby aid in understanding one or more inventive embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof. This method of disclosure, however, is not intended to imply that more features than are presented in the claims are required for the subject application. Indeed, less than all of the features of a single embodiment disclosed above.

While the present application has been described with reference to the present specific embodiments, those of ordinary skill in the art will recognize that the above embodiments are for illustrative purposes only, and that various equivalent changes or substitutions can be made without departing from the spirit of the present application, and therefore, all changes and modifications to the embodiments described above are intended to be within the scope of the claims of the present application.

Claims

1. A method for implementing a center-initiated research system for use in clinical research, the center-initiated research system including a project participant information form, a stand and contract information form, an ethical review information form, a genetic resource management information form, a researcher intent information form, and a logical association settings form, the method comprising the steps of:

packaging components of a design project participant information form, a standing 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 encapsulation comprises original attribute setting and initial data rendering of the component; the original attribute corresponds to the interaction 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 the Web terminal;

monitoring the form design component passing through the second level package in a form design area; when the form design component moves to a form design area in response to 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 superposition flow layout;

responding to a form component of a clicking form design area, and displaying a configuration column of the form component;

receiving operation of the Web end on a configuration column, and 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; wherein the first level form area comprises one or more second level form areas, and layout information of the second level form areas in the first level form area is defined by the first level form area values; the second level form area comprises one or more third level form areas, and layout information of the third level form areas in the second level form area 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 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 form of the corresponding component;

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

2. The method of claim 1, wherein the third level form area values define a data entry type for the third level form area, the data entry type comprising any one of: multiple lines of text, single line of text, numeric, radio boxes, drop down boxes, check boxes, date, time, file upload, signature, and rich text.

3. The method of claim 1, wherein configuring the entry of the project participant information form comprises: address, unit name, department, and contact.

4. The method of claim 1, wherein configuring the stand and the entry of the contract information form comprises: the setback style, setback style extension information, contract review information, CRC source requirements, and extra-hospital SMO requirements.

5. The method of claim 1, wherein configuring the entry of the ethical review form comprises: screening responsible person, frequency of meetings, screening material requirements, screening mode, screening cost and screening time limit.

6. The method of claim 1, wherein configuring the entry of the genetic resource management information form comprises: the organization contacts, contact ways, whether there is a history of submittal, the manner of submittal, the payment of the submittal and the material passing flow.

7. The method of claim 1, wherein configuring the entry of the researcher intent information form comprises: contact, intent to attend, knowledge of study procedure, disease classification and coding criteria selection for HIS, study load assessment, influencing group factors and notes.

8. The method of claim 1, wherein configuring the filling-in items of the logical association settings form comprises: associating filling item field selection and setting of filling item fields to be associated.

9. The method of claim 4, wherein the setback extension information is logically associated with the setback filling item setting.

10. The method of claim 9, wherein the setting of the logical association is performed by the logical association settings form triggered by a linked logical configuration button displayed in the configuration bar after clicking on a component in a form.

11. The method of claim 9, wherein the setting of the logical association is performed by displaying or hiding one or more fields corresponding to a filling item in a form page corresponding to a filling item in the logical association setting form selection.

12. An implementation apparatus for a center-initiated research system 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 to 11.

13. A computer readable medium storing computer program code which, when executed by a processor, implements the method of any one of claims 1 to 11.