Electronic device for automatically generating and managing electronic case report form and operation method thereof

Abstract

An electronic device for automatically generating and managing an electronic case report form (e-CRF) including various questionnaire input items according to an embodiment of the present invention comprises: a memory for storing one or more instructions; and at least one processor for executing the one or more instructions, wherein a plurality of questionnaire type items are selected and the electronic case report form is automatically generated as a plurality of information input items of a subject correspond to the questionnaire type items, thus having the effect that the electronic case report form can be easily generated.

Description

Electronic device for automatic generation and management of electronic case records and its operating method

[0001] Various embodiments of the present invention relate to an electronic device and an operating method thereof for automatically generating and managing an electronic case report form (e-CRF) including various questionnaire input items, and more specifically, to an electronic device and an operating method thereof for managing an electronic case report form, which automatically generates an electronic case report form by selecting the type of item and entering content into the item, and can easily process editing, searching, history identification, version, audit trail, download, PDF generation, etc. of the generated electronic case report form.

[0002] A "Case Report Form" (CRF) is a printed or electronic document that records the information requested in the clinical trial plan for each subject and delivers it to the clinical trial sponsor (hereinafter referred to as "sponsor" or research subject or subject).

[0003] e-CRF is an electronic CRF (Case Report Form). It refers to a web-based input program that allows subjects to directly or indirectly collect information by creating a case report form using a web program, rather than the traditional document-based method of collecting information from subjects.

[0004] However, in the past, in order to collect information by creating a CRF (Case Report Form) document as an e-CRF because it contains various types of questions, a programmer had to program each question using a web programming language such as Java or JSP and create a CRF that could be input separately in a web format.

[0005] In addition, when creating the above electronic case record, there was a problem that it was difficult to edit and modify the contents of a new electronic case record and manage the history of modified data, and it was difficult to save it in a different format of file, making management difficult.

[0006] The present invention was created to solve the above-mentioned problems, and relates to an electronic device and an operating method thereof that can automatically generate an electronic case record by selecting a type of question and entering content into the question, and that can easily process editing, searching, and history identification of the generated electronic case record, and that can manage different versions of the electronic case record in the same manner.

[0007] In an electronic device for automatically generating and managing an electronic case record including various questionnaire input items according to the present embodiment, a memory for storing one or more instructions; And at least one processor executing the one or more instructions; wherein the at least one processor is configured to generate a plurality of electronic case record books including a first electronic case record book based on a questionnaire type item and a plurality of information input items of a subject, store the generated plurality of electronic case record books in the memory, receive at least one or more first questionnaire result data for the plurality of information input items from a user based on the first electronic case record book, store the at least one or more first questionnaire result data in the memory, receive at least one second questionnaire result data obtained by changing content input by the user in the at least one or more first questionnaire result data, store the second questionnaire result data in the memory, store the first questionnaire result data in a questionnaire result history table, and search for the first electronic case record book among the plurality of electronic case record books based on receiving a request to search for the first electronic case record book from the user.

[0008] According to one embodiment of the present invention, by selecting multiple questionnaire type items and automatically generating an electronic case record by corresponding multiple information input items of the subject according to the questionnaire type items, there is an effect of easily generating an electronic case record.

[0009] According to another embodiment of the present invention, there is an effect of obtaining questionnaire result data from an electronic case record, easily processing editing, searching, and history identification of the questionnaire result data, and managing different versions of the electronic case record in the same manner.

[0010] FIG. 1 illustrates a block diagram of an electronic device and a network according to various embodiments of the present invention.

[0011] FIG. 2 is a flowchart illustrating a method of operating an electronic device according to various embodiments.

[0012] FIGS. 3A to 3L illustrate application program screens for managing electronic case records according to various embodiments.

[0013] FIG. 4 is a diagram for an overall description of an electronic case record according to various embodiments.

[0014] Hereinafter, various embodiments of the present document will be described with reference to the attached drawings. It should be understood that the embodiments and the terms used therein are not intended to limit the technology described in the present document to a specific embodiment, but rather include various modifications, equivalents, and / or substitutes of the embodiments. In connection with the description of the drawings, similar reference numerals may be used for similar components. The singular expression may include plural expressions unless the context clearly indicates otherwise. In this document, expressions such as "A or B" or "at least one of A and / or B" may include all possible combinations of the items listed together. Expressions such as "first," "second," "first," or "second," may modify the corresponding components regardless of order or importance, and are only used to distinguish one component from another, but do not limit the corresponding components. When it is said that a component (e.g., a first component) is “(functionally or communicatively) connected” or “connected” to another component (e.g., a second component), said component may be directly connected to said other component, or may be connected via another component (e.g., a third component).

[0015] In this document, "configured to" may be used interchangeably with, for example, "suitable for," "capable of," "modified to," "made to," "capable of," or "designed to," either in hardware or software. In some contexts, the phrase "a device configured to" may mean that the device is "capable of" doing something together with other devices or components. For example, the phrase "a processor configured to perform A, B, and C" may mean a dedicated processor (e.g., an embedded processor) for performing the operations, or a general-purpose processor (e.g., a CPU or application processor) that can perform the operations by executing one or more software programs stored in a memory device.

[0016] An electronic device according to various embodiments of the present document may include, for example, at least one of a smartphone, a tablet PC, a desktop PC, a laptop PC, a netbook computer, a workstation, and a server.

[0017] FIG. 1 illustrates a block diagram of an electronic device and a network according to various embodiments of the present invention.

[0018] Referring to FIG. 1, an electronic device (101) within a network environment (100) according to various embodiments is described. The electronic device (101) may include a bus (110), a processor (120), a memory (130), an input / output interface (150), a display (160), and a communication interface (170). In some embodiments, the electronic device (101) may omit at least one of the components or additionally include other components. The bus (110) may include a circuit that connects the components (110-170) to each other and transmits communication (e.g., control messages or data) between the components. The processor (120) may include one or more of a central processing unit, an application processor, or a communication processor (CP). The processor (120) may, for example, execute operations or data processing related to control and / or communication of at least one other component of the electronic device (101). Additionally, the processor (120) may be configured with at least one or more processors and may execute one or more instructions.

[0019] The memory (130) stores one or more instructions and may include volatile and / or non-volatile memory. The memory (130) may store, for example, commands or data related to at least one other component of the electronic device (101). According to one embodiment, the memory (130) may store software and / or programs (140). The programs (140) may include, for example, a kernel (141), middleware (143), an application programming interface (API) (145), and / or an application program (or “application”) (147). At least a portion of the kernel (141), middleware (143), or API (145) may be referred to as an operating system. The kernel (141) may control or manage system resources (e.g., a bus (110), a processor (120), or a memory (130)) used to execute operations or functions implemented in other programs (e.g., middleware (143), API (145), or application programs (147)). In addition, the kernel (141) may provide an interface that allows the middleware (143), API (145), or application programs (147) to control or manage system resources by accessing individual components of the electronic device (101).

[0020] The middleware (143) may, for example, act as an intermediary to enable the API (145) or the application program (147) to communicate with the kernel (141) to exchange data. In addition, the middleware (143) may process one or more task requests received from the application program (147) according to priority. For example, the middleware (143) may give at least one of the application programs (147) a priority to use the system resources (e.g., bus (110), processor (120), memory (130), etc.) of the electronic device (101) and process the one or more task requests. The API (145) is an interface for the application (147) to control functions provided by the kernel (141) or the middleware (143), and may include, for example, at least one interface or function (e.g., command) for file control, window control, image processing, or character control. The input / output interface (150) can, for example, transmit commands or data input from a user or another external device to other component(s) of the electronic device (101), or output commands or data received from other component(s) of the electronic device (101) to the user or another external device.

[0021] The display (160) may include, for example, a liquid crystal display (LCD), a light emitting diode (LED) display, an organic light emitting diode (OLED) display, a micro electro mechanical systems (MEMS) display, or an electronic paper display. The display (160) may, for example, display various contents (e.g., text, images, videos, icons, and / or symbols) to the user. The display (160) may include a touch screen and may receive, for example, a touch, gesture, proximity, or hovering input using an electronic pen or a part of the user's body. The communication interface (170) may, for example, establish communication between the electronic device (101) and an external device (e.g., a first external electronic device (102), a second external electronic device (104), or a server (106)). For example, the communication interface (170) can be connected to a network (162) via wireless communication or wired communication to communicate with an external device (e.g., a second external electronic device (104) or a server (106)).

[0022] The wireless communication may include, for example, cellular communication using at least one of LTE, LTE-A (LTE Advance), CDMA (code division multiple access), WCDMA (wideband CDMA), UMTS (universal mobile telecommunications system), WiBro (Wireless Broadband), or GSM (Global System for Mobile Communications). In one embodiment, the wireless communication may include, for example, at least one of WiFi (wireless fidelity), Bluetooth, Bluetooth low energy (BLE), Zigbee, near field communication (NFC), Magnetic Secure Transmission, radio frequency (RF), or body area network (BAN). In one embodiment, the wireless communication may include GNSS. The GNSS may be, for example, GPS (Global Positioning System), Glonass (Global Navigation Satellite System), Beidou Navigation Satellite System (hereinafter "Beidou"), or Galileo, the European global satellite-based navigation system. Hereinafter, in this document, "GPS" may be used interchangeably with "GNSS." Wired communication may include at least one of, for example, USB (universal serial bus), HDMI (high definition multimedia interface), RS-232 (recommended standard 232), power line communication, or POTS (plain old telephone service).The network (162) may include at least one of a telecommunications network, for example, a computer network (e.g., a LAN or WAN), the Internet, or a telephone network.

[0023] Each of the first and second external electronic devices (102, 104) may be the same or a different type of device as the electronic device (101). According to various embodiments, all or part of the operations executed in the electronic device (101) may be executed in another one or more electronic devices (e.g., electronic devices (102, 104), or server (106). According to one embodiment, when the electronic device (101) needs to perform a certain function or service automatically or upon request, the electronic device (101) may request at least some functions related thereto from another device (e.g., electronic device (102, 104), or server (106)) instead of executing the function or service by itself or in addition. The other electronic device (e.g., electronic device (102, 104), or server (106)) may execute the requested function or additional function and transmit the result to the electronic device (101). The electronic device (101) may process the received result as is or additionally to provide the requested function or service. For this purpose, for example, cloud computing, distributed computing, or client-server computing technology may be used.

[0024]

[0025] FIG. 2 is a flowchart illustrating a method of operating an electronic device according to various embodiments.

[0026] FIGS. 3A to 3L illustrate application program screens for managing electronic case records according to various embodiments.

[0027] FIG. 4 is a diagram for an overall description of an electronic case record according to various embodiments.

[0028] In operation 201, the electronic device (101) (e.g., processor (120)) may generate a plurality of electronic case records including a first electronic case record (330) based on a questionnaire type item (310) and a plurality of information input items (320) of the subject, and store the generated plurality of electronic case records in the memory (130).

[0029] Here, the electronic case record form can generate basic research information based on the clinical trial research plan related to the clinical trial study. The basic research information can include basic clinical trial information determined during the clinical trial design process. Required input items can include, for example, study identification information (e.g., study ID or protocol ID), study name, study content (e.g., summary information, keywords, etc.), expected start date, study period, etc. Furthermore, the first electronic case record form (330) can be functionally identical to other electronic case record forms, but created by the user and displayed as an example on the screen.

[0030] As an example, the electronic device (101) of the present invention (e.g., processor (120)) can display a questionnaire type item (310) and a plurality of information input items (320) of a subject to a user through a display (160), referring to FIG. 3A, and can designate a plurality of questionnaire type items (310) based on a command input from the user.

[0031] Here, the questionnaire type item (310) may be composed of a numeric input type item (311), a text (String) input type item (313), a Boolean type item (315), a multiple choice (List) type item, a multiple choice (List) type item (317), a multiple data (Array) input type item (319), a data type item, a phone type item, an email type item, a matrix type item, a file type item, a multiple file (FileArray) type item, a composite data (Object) input type item, and a multiple composite data (ObjectArray) type input item, with reference to FIGS. 3b to 3f. In addition, the electronic device (101) (e.g., processor (120)) may have a feature in which attribute information for each type is configured differently for each attribute based on a command input from a user. That is, as in the example above, the electronic device (101) (e.g., processor (120)) can specify the format of the answer to be input according to the type of each questionnaire item.

[0032] More specifically, the 'Numeric input type question (311)', referring to Fig. 3b, is a question for storing numeric data, storing numbers such as integers and real numbers, and can also input numeric expression formats such as 1, 1.123, 1.123e10, 1.123d10, etc. When a Numeric input type question is selected, a question for inputting a term definition question and a Numeric type attribute can be created. The Numeric type attribute is expressed as an input control, and the input range and unit of the numeric value can be displayed on both sides of the input control according to the input of a numeric value range including a minimum value and a maximum value, whether boundary values ​​are allowed, whether an error range is allowed, and the unit. In addition, if interval division is allowed, a UI that can be set through a simulation workbench when executing an analysis or simulation can be provided.

[0033] In addition, a 'text (String) input type item (313)', referring to FIG. 3c, can be created as an item for inputting a term definition item and a text (String) type attribute. The term definition can include information input fields for a variable name, a term version, a term name, a term definition, synonyms, and a tooltip. The text (String) type attribute can be created as an input field for a minimum length, a maximum length, whether multiple lines are allowed, and a validation rule. A string term is a term for storing a general string and can be displayed as a text area control. For data validation, attributes such as the length of the string and a validation rule using a regular expression can be provided.

[0034] In addition, the 'Boolean type question (315)', as shown in FIG. 3d, is a question in which true and false values ​​can be entered. When a Boolean type question is selected, a question in which a term definition question and a Boolean type attribute can be entered can be created. The Boolean type attribute can be output as a checkbox, radio button, and select box depending on the UI output style.

[0035] In addition, 'multiple-choice (List) type items' and 'multiple-choice (List) type items (317)', referring to Fig. 3e, define a data list consisting of display name and value pairs so that a value can be selected from a list of data type structure definitions, and the UI output style can be specified to express the list in one of the formats of a select box or radio button.

[0036] In addition, the 'multi-data (Array) input type item (319)', referring to Fig. 3f, is an item for inputting multiple identical types of data and may include one element of either String or Numeric. For the Numeric type, the unit of the element and the uncertainty tolerance properties may be provided. If the String type is selected, the above properties may not be input.

[0037] Additionally, the term "Data Type Item" may refer to a UI that allows users to select and input dates in the Data Type Structure Definer. There may be no attributes for the type.

[0038] Additionally, the 'Phone type item' is for entering a phone number in the data type structure definer, and when entering a phone number, you can choose whether to use the country code, and the UI may be configured differently depending on whether the country code is used.

[0039] Additionally, the 'Email type item' is used when entering an Email in the data type structure definer. It is a UI-only term to enable domain selection, and there may be no attributes for the type. When saving an Email, it can be saved as a String.

[0040] Additionally, the 'Matrix type item' is for expressing a matrix, and by inputting the number of x and y dimensions of the matrix, you can output the UI according to the number of dimensions in the data type structure definer. If the y dimension is 1, it can mean a vector.

[0041] Additionally, the 'File type item' is intended to represent a File, and can have attributes such as the path, URL, and URI where the file is located. The path refers to the relative path where the file is located within the platform, and refers to the relative path from the user's home folder, the data storage root, or the science app installation location. The URL is a path accessible via the network, and the URI can be a unique object identifier such as a DOI.

[0042] In addition, the 'multi-file (FileArray) type item' is a term for an array format that has File types as elements, and the length of the array can be entered to verify the data of the array, and information about each file element can be entered.

[0043] In addition, the 'composite data (Object) input type item' is a term that has an object as an element, the structure of the object can be managed by defining it as a data type, and it has a list of data types to be referenced as an attribute, and the data types to be used can be selected from the list in the data type structure definer to configure the object.

[0044] In addition, the 'multiple composite data (ObjectArray) type input item' is a term that expresses an array that has objects as elements, and the structure of the object can be managed by defining it as a data type, and it has a list of data types to be referenced as an attribute, and the data types to be used can be selected from the list in the data type structure definer to configure the object. The multiple composite data (ObjectArray) type attribute can create an array by repeatedly entering data according to the structure of the configured object when entering data, and the length of the array can be entered to verify the data of the array.

[0045] Here, the plurality of information input items (320) are composed of a name, a version, a display name, a definition, a tool tip, synonyms, a default value, a minimum value, a maximum value, a unit of value, a placeholder, and the plurality of information input items (320) selected by the user, and can be set to correspond to the plurality of survey type items (310).

[0046] As an example, referring to FIG. 3g, the electronic device (101) (e.g., processor (120)) may output a questionnaire type item (310) and a plurality of information input items (320) to one end of the display (160), output questionnaire type items (310) selected by the user to one end of the display (160), output some of the selected questionnaire type items (310) to the other end of the display (160), and when the selection of the plurality of questionnaire type items (310) by the user is completed, generate a first electronic case record (330) including the completed plurality of questionnaire type items (310).

[0047] In operation 203, the electronic device (101) (e.g., processor (120)) may receive at least one first questionnaire result data (331) for multiple information input items (320) from the user based on the first electronic case record (330), and store at least one first questionnaire result data (331) in the memory (130).

[0048] As an example, referring to FIG. 3h, multiple questionnaire type items (310) may be set to at least one of a Numeric input type item (311), a Text input type item (313), a Boolean type item (315), a Multiple Choice (List) type item, a Multiple Choice (List) type item (317), a Multiple Data (Array) input type item (319), a Data type item, a Phone type item, an Email type item, a Matrix type item, a File type item, a Multiple File (FileArray) type item, a Composite Data (Object) input type item, and a Multiple Composite Data (ObjectArray) type input item. In addition, the plurality of information input items (320), referring to FIG. 3h, may be configured to correspond to the plurality of questionnaire type items, each of which may be composed of a name, a version, a display name, a definition, a tool tip, synonyms, a default value, a minimum value, a maximum value, a unit of value, a placeholder, and the plurality of information input items selected by the user. In addition, the electronic device (101) (e.g., the processor (120)) may provide the subject with information regarding at least one questionnaire type item (310) and the plurality of information input items (320) requested to be selected by the user, and may receive at least one first questionnaire result data (331) input by the subject. Additionally, the electronic device (101) (e.g., processor (120)) can store at least one first survey result data (331) in the memory (130).

[0049] In operation 205, the electronic device (101) (e.g., processor (120)) may receive at least one second survey result data (341) that has changed the content entered by the user in at least one first survey result data (331), store the second survey result data (341) in the memory (130), and store the first survey result data (331) in a screen (350) that supports the function of the survey result history table.

[0050] For example, the electronic device (101) (e.g., processor (120)) may display a screen (340) that supports an editing function for changing at least one first survey result data (331), as shown in FIG. 3i. In addition, as another example, the electronic device (101) (e.g., processor (120)) may change at least one first survey result data (331) into at least one second survey result data (341) based on content input by a user, as shown in FIG. 3j. In addition, the electronic device (101) (e.g., processor (120)) may store at least one second survey result data (341) that has been input, as shown in FIG. 3i, in the memory (130).

[0051] In operation 207, the electronic device (101) (e.g., processor (120)) may be configured to search for the first electronic case record (330) among a plurality of electronic case records based on receiving a request to search for the first electronic case record (330) from a user.

[0052] As an example, the electronic device (101) (e.g., processor (120)), referring to FIG. 3i, may drive a screen (360) that supports a search function to search using a list of at least one of a plurality of information input items (320) stored in the first electronic case record (330) (e.g., name, purpose, date, etc.), and may search using a list of at least one of a plurality of questionnaire type items (310) (e.g., height, weight, multiple choice, etc.).

[0053] In addition, the electronic device (101) (e.g., processor (120)), referring to FIGS. 3i and 3k, may output a plurality of second survey result data (341) and first survey result data (331) stored within the memory (130) to the screen (350) supporting the function of the history table based on receiving a request from the user to access the screen (350) supporting the function of the history table.

[0054] As an example, the electronic device (101) (e.g., processor (120)), referring to FIG. 3l, may drive a screen (371) supporting a PDF conversion function among screens (370) supporting a CRF conversion function, and, based on receiving a request for PDF file conversion from a user, convert a stored first electronic case record (330) into a PDF file and store the converted PDF file.

[0055] Also, as an example, the electronic device (101) (e.g., processor (120)) may drive a screen (372) supporting an EXCEL conversion function from screens (370) supporting a CRF conversion function, as shown in FIG. 3l, and, based on receiving a request for conversion of an EXCEL file from a user, convert the stored first electronic case record into an EXCEL file and store the converted EXCEL file.

[0056] In addition, the screen (370) supporting the CRF conversion function includes a screen supporting a PDF conversion function (371) and a screen supporting an EXCEL conversion function (372), as well as a screen supporting other conversion functions, and examples thereof are not limited thereto.

[0057] For example, an electronic device (101) (e.g., processor (120)) may be configured to manage multiple electronic case records, multiple first questionnaire result data (331), and multiple second questionnaire result data (341) as the same version, while being compatible with multiple electronic case records of different versions. In addition, the electronic device (101) (e.g., processor (120)) may compare the latest version received from the server (106) with the installed version, and if the installed version is not the latest version as a result of the comparison, the electronic device (101) may be driven to update to the latest version.

[0058] For example, when the electronic device (101) (e.g., processor (120)) is operating multiple electronic case records of version 1.05, multiple first questionnaire result data (331), and multiple second questionnaire result data (341), and receives the first questionnaire result data (331) and multiple second questionnaire result data (341) of version 1.10 from the server (106), the electronic device (101) (e.g., processor (120)) may change to the same version. In addition, when the electronic device (101) (e.g., processor (120)) confirms that the currently installed version 1.05 is for version 1.10 received from the server (106), the electronic device (101) may proceed with an update to version 1.10 by the user.

[0059] As an example, referring to FIG. 4, an electronic device (101) (e.g., a processor (120)) may generate a first electronic case record (330) based on a questionnaire type item (310) and a plurality of information input items (320) associated with the questionnaire type item (310), operate an input device and / or an editor (340) using the generated first electronic case record (330) to modify the acquired questionnaire, and check the first electronic case record (330) and the modified questionnaire history on a screen (360) that supports a search function. In addition, the electronic device (101) (e.g., processor (120)), referring to FIG. 4, can drive a screen (371) that supports a PDF conversion function to convert the first electronic case record (330) into a PDF file, or can drive a screen (372) that supports an EXCEL conversion function to convert the first electronic case record (330) into an EXCEL file, and can drive a screen (370) that supports a CRF conversion function, and can manage according to versions and drive multiple functions within a single program so as to download multiple electronic case records and survey data.

[0060]

[0061] According to an embodiment of the present invention, an electronic device for automatically generating and managing an electronic case report form (e-CRF) including various questionnaire input items, comprises: a memory for storing one or more instructions; And at least one processor executing the one or more instructions; wherein the at least one processor is configured to generate a plurality of electronic case record books including a first electronic case record book based on a questionnaire type item and a plurality of information input items of a subject, store the generated plurality of electronic case record books in the memory, receive at least one or more first questionnaire result data for the plurality of information input items from a user based on the first electronic case record book, store the at least one or more first questionnaire result data in the memory, receive at least one second questionnaire result data obtained by changing content input by the user in the at least one or more first questionnaire result data, store the second questionnaire result data in the memory, store the first questionnaire result data in a questionnaire result history table, and search for the first electronic case record book among the plurality of electronic case record books based on receiving a request to search for the first electronic case record book from the user.

[0062] According to an embodiment of the present invention, the questionnaire type items are composed of a text (String) input type item, a numeric input type item, a Boolean type item, a multiple-choice (List) type item, a multiple-choice (List) type item, a multiple-data (Array) input type item, a data (Data) type item, a phone type item, an email type item, a matrix type item, a file type item, a multiple file (FileArray) type item, a composite data (Object) input type item, and a multiple composite data (ObjectArray) type input item, and are included in the first electronic case record based on the plurality of questionnaire type items selected by the user.

[0063] According to an embodiment of the present invention, the plurality of information input items are configured to correspond to the plurality of questionnaire type items, and the plurality of information input items are configured to include a name, a version, a display name, a definition, a tool tip, synonyms, a default value, a minimum value, a maximum value, a unit of value, a placeholder, and the plurality of information input items selected by the user, and the plurality of information input items are output to one end of the display, and when the user sets the questionnaire type item output to one end of the display and the plurality of information input items are set, a part of the first electronic case record is output to the other end of the display, and when the selection of the plurality of questionnaire type items selected by the user is completed, the plurality of completed questionnaire type items are configured to generate the first electronic case record. According to an embodiment of the present invention, based on receiving a request to search the first electronic case record from the user, The first electronic case record stored in the memory is output to the display, and based on receiving a request for PDF file conversion from the user, the stored first electronic case record is converted into a PDF file, and the converted PDF file is stored, and based on receiving a request for EXCEL file conversion from the user, the stored first electronic case record is converted into an EXCEL file, and the converted EXCEL file is stored.

[0064] According to an embodiment of the present invention, the processor is configured to manage the plurality of electronic case records, the plurality of first questionnaire result data, and the plurality of second questionnaire result data as the same version while being compatible with the plurality of electronic case records of different versions, and is driven to compare the latest version received from the server with the installed version, and to update to the latest version if the installed version is not the latest version as a result of the comparison.

[0065]

[0066] The term "module" or "part" used in this document includes a unit composed of hardware, software, or firmware, and can be used interchangeably with terms such as logic, logic block, component, or circuit, for example. The "module" or "part" can be an integrally configured component or a minimum unit or a part thereof that performs one or more functions. The "module" or "part" can be implemented mechanically or electronically, and can include, for example, an ASIC (application-specific integrated circuit) chip, FPGAs (field-programmable gate arrays), or a programmable logic device, known or to be developed in the future, that performs certain operations, and can be executed by the processor (120). At least a part of the device (e.g., modules or functions thereof) or method (e.g., operations) according to various embodiments can be implemented as instructions stored in a computer-readable storage medium (e.g., memory (130)) in the form of a program module. When the above command is executed by a processor (e.g., processor (120)), the processor can perform a function corresponding to the command. The computer-readable recording medium may include a hard disk, a floppy disk, a magnetic medium (e.g., a magnetic tape), an optical recording medium (e.g., a CD-ROM, a DVD, a magneto-optical medium (e.g., a floptical disk), a built-in memory, etc. The command may include a code generated by a compiler or a code executable by an interpreter. A module or program module according to various embodiments may include at least one or more of the above-described components, some of which may be omitted, or other components may be further included. Operations performed by a module, a program module, or other components according to various embodiments may be executed sequentially, in parallel, iteratively, or heuristically, or at least some operations may be executed in a different order, omitted, or other operations may be added.

[0067] The embodiments disclosed in this document are presented for the purpose of explaining and understanding the disclosed technical content, and do not limit the scope of the present disclosure. Therefore, the scope of the present disclosure should be interpreted to include all modifications or various other embodiments based on the technical concepts of the present disclosure.

Claims

1. In an electronic device for automatically generating and managing an electronic case report form (e-CRF) including various questionnaire input items, memory that stores one or more instructions; and At least one processor executing one or more of the above instructions; At least one processor, Generating a plurality of electronic case records including a first electronic case record based on a questionnaire type item and a plurality of information input items of a subject, and storing the generated plurality of electronic case records in the memory, Based on the first electronic case record, at least one first questionnaire result data for the plurality of information input items is received from the user, and the at least one first questionnaire result data is stored in the memory. Receive at least one second survey result data that has changed the content entered by the user in the at least one first survey result data, store the second survey result data in the memory, and store the first survey result data in a survey result history table. Based on receiving a request to search for the first electronic case record from the user, the first electronic case record is set to be searched among the plurality of electronic case records. Electronic devices.

2. In paragraph 1, The above questionnaire type items are composed of text (String) input type items, numeric (Numeric) input type items, Boolean type items, multiple choice (List) type items, multiple choice (List) type items, multiple data (Array) input type items, data (Data) type items, phone (Phone) type items, email (Email) type items, matrix (Matrix) type items, file (File) type items, multiple file (FileArray) type items, complex data (Object) input type items, and multiple complex data (ObjectArray) type input items. The processor is set to generate the first electronic case record based on the questionnaire type items selected by the user. Electronic devices.

3. In paragraph 2, Includes a display, The plurality of information input items are composed of a name, a version, a display name, a definition, a tool tip, synonyms, a default value, a minimum value, a maximum value, a unit of value, a placeholder, and the plurality of information input items selected by the user, and are set to correspond to the survey type items, respectively. The above processor, The above questionnaire type items and the above multiple information input items are output on one side of the above display, When the user sets the questionnaire type items output on one end of the display and the plurality of information input items, a portion of the first electronic case record is output on the other end of the display, When the selection of the above questionnaire type items is completed by the above user, the first electronic case record is set to be created using the completed questionnaire type items. Electronic devices.

4. In paragraph 3, The above processor, Based on receiving a request to retrieve the first electronic case record from the user, outputting the first electronic case record stored in the memory to the display, Based on receiving a request for PDF file conversion from the user, converting the stored first electronic case record into a PDF file, Based on receiving a request for conversion of an EXCEL file from the user, the stored first electronic case record is set to be converted into an EXCEL file. Electronic devices.

5. In paragraph 4, The above processor, The above plurality of electronic case records, the above plurality of first questionnaire result data, and the above plurality of second questionnaire result data are managed as the same version, and are set to be mutually compatible with other versions of the above plurality of electronic case records. Compare the installed version with the latest version received from an external server, If the installed version is not the latest version as a result of comparison, it will be driven to update to the latest version. Electronic devices.

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