JP7342605B2 - Display control program, device, and method - Google Patents

Description

The disclosed technology relates to a display control program, a display control device, and a display control method.

When a pharmaceutical company applies for approval of a drug, it submits clinical trial data to the Pharmaceuticals and Medical Devices Agency (PMDA), Japan's regulatory authority. From April 2020, clinical trial data must be submitted to PMDA in electronic data in the format of the electronic application data standard (SDTM: Study Data Tabulation Model) set forth by CDISC (Clinical Data Interchange Standards Consortium). be done.

In order to create electronic data in the SDTM format, source data in various formats, such as data collected by EDC (Electronic Data Capture), a system for collecting clinical trial data, and data collected by a system other than EDC, is required. It is necessary to convert it to SDTM format.

Conventionally, techniques related to converting the format of clinical trial data as described above have been proposed. For example, a method has been proposed in which a metadata file indicating CDISC rules is read, EDC data is obtained, and the obtained EDC data is converted into SDTM-format electronic data based on the read CDISC rules.

Additionally, a mapping support program has been proposed that improves the accuracy of mapping items recorded in case report forms to CDISC items. In this program, the first item entered in the input field is extracted from the first screen having the input field for the first item recorded in the case report form. Then, the second item associated with the extracted first item is identified by referring to a storage unit that stores a plurality of definition data that associates the first item with a second item that specifies the CDISC. Further, the identified second item and the evaluation calculated based on the reliability according to the reference of the second item and the first item are displayed in association with each other on the second screen.

Furthermore, a system has been proposed in which an eCRF form created and saved by an EDC server is described in an associative array with a set of item names related to one data input field and corresponding data input values. ing. In this system, when a data input value of a data input field is output in the CDISC SDTM format, information such as a domain, a variable, a repetition number of the item, etc. is described as metadata of the data input field.

International Publication No. 2015/118878 Japanese Patent Application Publication No. 2017-91105 Japanese Patent Application Publication No. 2014-96132

As mentioned above, clinical trial data is in various formats, such as data collected at EDC and data collected at a site other than EDC. When such source data is manually converted into the SDTM format, there is a possibility that work errors and variations in the SDTM format electronic data may occur due to differences in the skill and understanding of workers.

Further, the above-mentioned conventional technology is based on the premise that the source data is data collected by EDC, and cannot support source data in various formats.

In one aspect, the disclosed techniques are directed to assisting in the creation of standardized transformation definitions for transforming source data in various formats into data in a particular format.

As one aspect, the disclosed technology receives input information including information on items included in first medical data in any one of a plurality of formats. Then, the disclosed technology displays each item included in the first medical data in association with each item included in the second medical data in a format to be submitted to authorities. Further, the disclosed technology is used for a process of converting each item of the first medical data into a corresponding item in the second medical data in association with each item included in the second medical data. Display the transformation formula in an editable manner.

One aspect is that it is possible to support the creation of standardized conversion definitions for converting source data in various formats to data in a specific format.

FIG. 2 is a functional block diagram of a display control device according to the present embodiment. It is a figure showing an example of a creation screen. It is a figure showing an example of item composition of source data. It is a figure showing an example of processing type DB. It is a figure showing an example of narrowing-down DB. FIG. 7 is a diagram illustrating an example of a display for selecting a processing type name. FIG. 7 is a diagram illustrating an example of a display for selecting a processing type name. FIG. 1 is a block diagram showing a schematic configuration of a computer that functions as a display control device according to the present embodiment. It is a flowchart which shows an example of display control processing in this embodiment.

Hereinafter, an example of an embodiment according to the disclosed technology will be described with reference to the drawings.

As shown in FIG. 1, source data is input to the display control device 10. The source data is clinical trial data in one of a plurality of formats, such as clinical trial data collected by EDC (Electronic Data Capture) and clinical trial data collected by a method other than EDC. In addition to the values for each item that makes up the clinical trial data, the source data also includes the item configuration, definition documents that define the data type and units of each item, and a glossary of terms used in the clinical trial data. It will be done. The display control device 10 displays a creation screen for creating a conversion definition document based on the input source data, and outputs the created conversion definition via the creation screen.

Functionally, the display control device 10 includes a reception section 12, a first display control section 14, and a second display control section 16, as shown in FIG. Further, a processing type DB (Database) 22 and a narrowing down DB 24 are stored in a predetermined storage area of the display control device 10.

The reception unit 12 receives input source data and passes it to the first display control unit 14 and the second display control unit 16.

When the first display control unit 14 receives the source data from the reception unit 12, it displays a creation screen 80 as shown in FIG. 2 together with the second display control unit 16. The creation screen 80 includes a source area 82, an SDTM (Study Data Tabulation Model) item area 84, and a conversion definition area 86. The first display control unit 14 controls the display of the source area 82 and the SDTM item area 84.

Specifically, the first display control unit 14 displays each item (hereinafter referred to as "SDTM item") included in the SDTM format data (hereinafter referred to as "SDTM data") in the SDTM item area 84. In the example of FIG. 2, the item name 842 of each SDTM item is displayed together with the DB name 841 of the database (DB) that includes the SDTM item.

The first display control unit 14 also displays each item included in the source data (hereinafter referred to as a "source item") in the source area 82 in association with an SDTM item. Specifically, the first display control unit 14 displays display components for selecting any source item from the list of source items in association with each of the SDTM items.

For example, suppose that it is recognized from the source data definition document that the source data items are configured as shown in FIG. Note that "system" is information indicating which system has collected the corresponding data. In this case, for example, the first display control unit 14 displays pull-down menus 821, 822, and 823 in association with each of the SDTM items, as shown in FIG. The pull-down menu 821 is a display component for selecting the name of the system that collected the data of the corresponding source item from a list. The pull-down menu 822 is a display component for selecting the name of the table containing the relevant source item (“source TB” in FIG. 2) from a list. The pull-down menu 823 is a display component for selecting a source item from a list.

Pull-down menus 821, 822, and 823 associated with one SDTM item are related to each other. For example, when a system is selected in the pull-down menu 821, tables associated with that system are displayed as a list as options in the pull-down menu 822. Furthermore, the source items included in the table are displayed as a list as options in the pull-down menu 823.

The first display control unit 14 associates the source item with the SDTM item by displaying the name of the system, table, and source item selected from each list in each of the pull-down menus 821, 822, and 823. indicate.

Furthermore, if the source data definition document includes information regarding the correspondence between source items and SDTM items, the first display control unit 14 identifies the source item corresponding to each SDTM item based on this information. The first display control unit 14 displays the identified source items in pull-down menus 821, 822, and 823 displayed in association with each SDTM item. That is, the first display control unit 14 automatically displays the source item corresponding to the SDTM item without depending on the selection operation from the user.

Further, the first display control unit 14 estimates the source item corresponding to the SDTM item by mapping each source item and each SDTM item.

In the mapping process, the first display control unit 14 performs mapping between the source data and the SDTM data using at least one of each item, the value of each item, and a related document. Note that the related document can be at least one of a glossary and a definition document.

As the mapping technique, existing techniques such as Dice coefficient, word vector, BM25 cosine similarity, etc. can be used. At this time, appropriate combinations of mapping techniques may be applied, such as using a dice coefficient for item-to-item mapping and BM25 cosine similarity for item-to-value-to-document mapping.

The first display control unit 14 displays the source items estimated by mapping in pull-down menus 821, 822, and 823 displayed in association with each SDTM item. That is, the first display control unit 14 automatically displays the source item corresponding to the SDTM item without depending on the selection operation from the user.

Furthermore, when displaying the source items estimated by mapping, the first display control unit 14 may display the scores of the mapping process in association with each other. Thereby, it is possible to provide a guideline for determining whether or not the user needs to take action such as reselecting the source item from the pull-down menus 821, 822, and 823 depending on the score.

The second display control unit 16 controls the display of the conversion definition area 86 on the creation screen 80. Specifically, the second display control unit 16 editably displays a conversion formula used in the process of converting a source item into an SDTM item in association with each SDTM item displayed in the SDTM item area 84.

Specifically, the second display control unit 16 selectably displays the processing type name of the conversion process in association with each SDTM item. For example, the second display control unit 16 displays a pull-down menu 862, which is a display component for selecting a processing type name from a list, as shown in FIG. The second display control unit 16 selects the processing type name to be displayed in the list that is an option of the pull-down menu 862 based on the selection state of the check box 861 (“All” column in FIG. 2), the processing type DB 22, and the narrowing down DB 24. to be determined.

A check box 861 is a display component for selecting whether or not to display all process type names. Further, in the process type DB 22, for example, as shown in FIG. 4, a "process type name" and a "conversion formula" used in the conversion process indicated by the process type name are stored in association with each other. A conversion formula is an instruction (method) embedded in a program and executed. Furthermore, in the example of FIG. 4, a "processing ID" which is identification information is assigned to each conversion process.

Further, the narrowing down DB 24 is a database in which the processing type name of a conversion process that can be applied as a process for converting a source item into an SDTM item is defined for each SDTM item. For example, as shown in FIG. 5, the narrowing down DB 24 stores an "SDTM item" in association with a "processing ID" of a conversion process that can be applied to the SDTM item. In addition, in the example of FIG. 5, a process ID marked with "*" is used for the initial display of the pull-down menu 862 in which the process type name indicated by the process ID is displayed in association with the corresponding SDTM item. represents something.

As shown in FIG. 6, when the check box 861 is checked, the second display control unit 16 displays all process type names included in the process type DB 22 in a list 862A of the pull-down menu 862. Further, as shown in FIG. 7, if the checkbox 861 is not checked, the second display control unit 16 narrows down the process ID of the conversion process corresponding to the SDTM item indicated by the item name 842 displayed in association. Extract from DB24. Then, the second display control unit 16 acquires the process type name corresponding to the extracted process ID from the process type DB 22 and displays it in the list 862A of the pull-down menu 862. This improves the convenience for the user when selecting an appropriate conversion process corresponding to the SDTM item.

Further, the second display control unit 16 arranges a text box 863 in association with the pull-down menu 862, as shown in FIG. The second display control unit 16 acquires the conversion formula corresponding to the process type name displayed in the pull-down menu 862 from the process type DB 22, and displays the acquired conversion formula in the text box 863 in an editable manner.

Further, the second display control unit 16 arranges an output button 88 on the creation screen 80. When the output button 88 is selected, the second display control unit 16 outputs the content displayed on the creation screen 80 as a conversion definition.

The display control device 10 can be realized by a computer 40 shown in FIG. 8, for example. The computer 40 includes a CPU (Central Processing Unit) 41, a memory 42 as a temporary storage area, and a nonvolatile storage section 43. The computer 40 also includes an input/output device 44 such as an input section and a display section, and an R/W (Read/Write) section 45 that controls reading and writing of data to and from a storage medium 49 . The computer 40 also includes a communication I/F (Interface) 46 connected to a network such as the Internet. The CPU 41, memory 42, storage section 43, input/output device 44, R/W section 45, and communication I/F 46 are connected to each other via a bus 47.

The storage unit 43 can be realized by an HDD (Hard Disk Drive), an SSD (Solid State Drive), a flash memory, or the like. A display control program 50 for causing the computer 40 to function as the display control device 10 is stored in the storage unit 43 as a storage medium. The display control program 50 includes a reception process 52, a first display control process 54, and a second display control process 56. Furthermore, the storage unit 43 includes an information storage area 60 in which information constituting each of the processing type DB 22 and the narrowing-down DB 24 is stored.

The CPU 41 reads the display control program 50 from the storage unit 43, expands it into the memory 42, and sequentially executes the processes included in the display control program 50. The CPU 41 operates as the reception unit 12 shown in FIG. 1 by executing the reception process 52. Further, the CPU 41 operates as the first display control section 14 shown in FIG. 1 by executing the first display control process 54. Further, the CPU 41 operates as the second display control section 16 shown in FIG. 1 by executing the second display control process 56. Further, the CPU 41 reads information from the information storage area 60 and develops each of the processing type DB 22 and the narrowing down DB 24 in the memory 42 . Thereby, the computer 40 that has executed the display control program 50 functions as the display control device 10. Note that the CPU 41 that executes the program is hardware.

Note that the functions realized by the display control program 50 can also be realized by, for example, a semiconductor integrated circuit, more specifically, an ASIC (Application Specific Integrated Circuit).

Next, the operation of the display control device 10 according to this embodiment will be explained. When the source data is input to the display control device 10, the display control process shown in FIG. 9 is executed in the display control device 10. Note that the display control process is an example of a display control method of the disclosed technology.

In step S12, the reception unit 12 receives the input source data and passes it to the first display control unit 14 and the second display control unit 16.

Next, in step S14, the first display control section 14 and the second display control section 16 perform initial display of the creation screen 80. Specifically, the first display control unit 14 displays the item name 842 of each SDTM item and the DB name 841 of the database containing the SDTM item in the SDTM item area 84. Further, the first display control unit 14 displays pull-down menus 821, 822, and 823 for selecting a source item in association with each SDTM item in the source area 82, with nothing selected. Further, the second display control unit 16 displays the processing type name used for the initial display in association with each SDTM item in the conversion definition area 86, and then displays a process type name for selecting the processing type name of the conversion process. Display a pull-down menu 862.

Next, in step S16, the first display control unit 14 specifies the source item corresponding to each SDTM item based on the source data definition document or estimates it by mapping processing. Then, the first display control unit 14 displays the identified or estimated source items in pull-down menus 821, 822, and 823 displayed in association with each SDTM item.

Next, in step S18, the second display control unit 16 determines whether the output button 88 has been selected. If the output button 88 is selected, the process moves to step S24, and if it is not selected, the process moves to step S20.

In step S20, the first display control section 14 and the second display control section 16 determine whether or not each display component has been operated. Specifically, the first display control unit 14 determines whether the source item displayed in association with the SDTM item has been changed using the pull-down menus 821, 822, and 823. The second display control unit 16 also determines whether the processing type name displayed in association with the SDTM item has been changed using the pull-down menu 862, and whether the conversion formula has been changed by editing the text box 863. Determine. If an operation has been performed on any display component, the process moves to step S22, and if no operation has been performed, the process returns to step S18.

In step S22, the first display control section 14 and the second display control section 16 change the display of each display component according to the operation on the display component, and the process returns to step S18.

In step S24, the second display control unit 16 outputs the content displayed on the creation screen 80 as a conversion definition, and the display control process ends.

As described above, the display control device according to the present embodiment accepts source data in various formats and associates each source item included in the source data with each SDTM item included in SDTM format data. Display. In addition, the conversion formula used for the process of converting each source item into the corresponding SDTM item is displayed in an editable manner in association with each STDM item. This makes it possible to support the creation of standardized conversion definitions for converting source data in various formats to data in a specific format.

In addition to the information displayed on the creation screen 80 described in the above embodiment, other information necessary for the approval application, such as arbitrary text and information regarding restrictions on the values of each item, may also be included.

Further, in the above embodiment, a case has been described in which a source item identified from a source data definition document in association with an SDTM item and a source item estimated by a mapping process are automatically displayed, but these processes are not essential. do not have. It is also possible to adopt only the case where the user selects the source item to be displayed from a pull-down menu. In this case, it is not necessary to input the definition book or glossary, and it is sufficient that at least the information of the source item is input to the display control device.

Further, in the above embodiment, a mode in which the display control program is stored (installed) in the storage unit in advance has been described, but the present invention is not limited to this. The program according to the disclosed technology can also be provided in a form stored in a storage medium such as a CD-ROM, DVD-ROM, or USB memory.

Regarding the above embodiments, the following additional notes are further disclosed.

(Additional note 1)
Accepting input information including information on items included in the first medical data in one of a plurality of formats,
displaying each item included in the first medical data in association with each item included in the second medical data in a format to be submitted to authorities;
Editably displaying a conversion formula used in the process of converting each item of the first medical data into a corresponding item in the second medical data in association with each item included in the second medical data. A display control program that causes a computer to perform processing that includes

(Additional note 2)
A process type name of the process to be converted is displayed in a selectable manner in association with each item included in the second medical data, and the conversion formula corresponding to the selected process type name is displayed in an editable manner. The display control program described in Appendix 1.

(Additional note 3)
The display control program according to Supplementary Note 2, which displays the processing type name in a selectable manner by displaying a list including one or more processing type names from which any one of the processing type names can be selected.

(Additional note 4)
The display control program according to appendix 3, wherein the processing type name included in the list is the processing type name determined based on the corresponding item of the second medical data among all the processing type names.

(Appendix 5)
A processing type name of a process that can be applied as a process for converting each item of the first medical data into a corresponding item in the second medical data, a process determined based on the items of the second medical data. The display control program described in Supplementary Note 4, which is a type name.

(Appendix 6)
A supplementary note that displays a list of items included in the input information, and displays items selected from the list as items included in the first medical data that correspond to each item included in the second medical data. The display control program according to any one of Items 1 to 5.

(Appendix 7)
receiving the input information including information regarding correspondence between each item included in the first medical data and each item included in the second medical data;
Any one of Supplementary Notes 1 to 6 that displays items specified based on the information regarding the response as items included in the first medical data that correspond to each item included in the second medical data. The display control program described in .

(Appendix 8)
As items included in the first medical data corresponding to each item included in the second medical data, each item included in the first medical data and each item included in the second medical data The display control program according to any one of Supplementary Notes 1 to 7, which displays items estimated by mapping processing with .

(Appendix 9)
Display control according to appendix 8, wherein in the mapping process, mapping is performed between the first medical data and the second medical data using at least one of each item, the value of each item, and a related document. program.

(Appendix 10)
The display control program according to appendix 9, wherein the related document includes at least one of a glossary and a definition document.

(Appendix 11)
The display control program according to any one of appendices 8 to 10, in which the mapping process uses dice coefficients, word vectors, or BM25 cosine similarity.

(Appendix 12)
When each item included in the first medical data is displayed in association with each item included in the second medical data in a format to be submitted to authorities, a supplementary note that displays the score of the mapping process in association with each other. The display control program according to any one of Items 8 to Supplementary Note 11.

(Appendix 13)
a reception unit that receives input information including information on items included in the first medical data in one of a plurality of formats;
a first display control unit that displays each item included in the first medical data in association with each item included in second medical data in a format to be submitted to authorities;
Editably displaying a conversion formula used in the process of converting each item of the first medical data into a corresponding item in the second medical data in association with each item included in the second medical data. a second display control unit that
Display control device including.

(Appendix 14)
The second display control unit selectably displays the process type name of the process to be converted in association with each item included in the second medical data, and the process type name corresponding to the selected process type name. The display control device according to supplementary note 13, which displays the conversion formula in an editable manner.

(Appendix 15)
The display according to supplementary note 14, wherein the second display control unit displays the processing type name in a selectable manner by displaying a list including one or more processing type names from which any one of the processing type names can be selected. Control device.

(Appendix 16)
The second display control unit sets the processing type name included in the list to be the processing type name determined based on the corresponding second medical data item among all the processing type names. The display control device described.

(Appendix 17)
The second display control unit converts a process type name of a process that can be applied as a process of converting each item of the first medical data into a corresponding item in the second medical data into a process that converts each item of the first medical data into a corresponding item in the second medical data. The display control device according to appendix 16, wherein the processing type name is determined based on the item.

(Appendix 18)
The first display control unit displays a list of items included in the input information, and selects items from the list as items included in the first medical data corresponding to each item included in the second medical data. The display control device according to any one of Supplementary notes 13 to 17, which displays the selected item.

(Appendix 19)
Accepting input information including information on items included in the first medical data in one of a plurality of formats,
displaying each item included in the first medical data in association with each item included in the second medical data in a format to be submitted to authorities;
Editably displaying a conversion formula used in the process of converting each item of the first medical data into a corresponding item in the second medical data in association with each item included in the second medical data. A display control method in which a computer performs processing that includes

(Additional note 20)
Accepting input information including information on items included in the first medical data in one of a plurality of formats,
displaying each item included in the first medical data in association with each item included in the second medical data in a format to be submitted to authorities;
Editably displaying a conversion formula used in the process of converting each item of the first medical data into a corresponding item in the second medical data in association with each item included in the second medical data. A storage medium that stores a display control program that causes a computer to perform processing that includes

10 Display control device 12 Reception unit 14 First display control unit 16 Second display control unit 22 Processing type DB
24 Narrowing down DB
40 Computer 41 CPU
42 Memory 43 Storage unit 49 Storage medium 50 Display control program 80 Creation screen 82 Source area 84 SDTM item area 86 Conversion definition area 88 Output button

Claims (10)

Accepting input information including information on items included in the first medical data in one of a plurality of formats,
displaying each item included in the first medical data in association with each item included in the second medical data in a format to be submitted to authorities;
Editably displaying a conversion formula used in the process of converting each item of the first medical data into a corresponding item in the second medical data in association with each item included in the second medical data. A display control program that causes a computer to perform processing that includes A process type name of the process to be converted is displayed in a selectable manner in association with each item included in the second medical data, and the conversion formula corresponding to the selected process type name is displayed in an editable manner. The display control program according to claim 1. 3. The display control program according to claim 2, wherein the processing type name is displayed in a selectable manner by displaying a list including one or more processing type names from which any one of the processing type names can be selected. 4. The display control program according to claim 3, wherein the processing type name included in the list is a processing type name determined based on a corresponding item of the second medical data among all the processing type names. A processing type name of a process that can be applied as a process for converting each item of the first medical data into a corresponding item in the second medical data, a process determined based on the items of the second medical data. 5. The display control program according to claim 4, which uses a type name. A claim for displaying a list of items included in the input information, and displaying items selected from the list as items included in the first medical data corresponding to each item included in the second medical data. The display control program according to any one of claims 1 to 5. receiving the input information including information regarding correspondence between each item included in the first medical data and each item included in the second medical data;
Any one of claims 1 to 6, wherein items specified based on the information regarding the response are displayed as items included in the first medical data corresponding to each item included in the second medical data. The display control program according to item 1. As items included in the first medical data corresponding to each item included in the second medical data, each item included in the first medical data and each item included in the second medical data 8. The display control program according to any one of claims 1 to 7, which displays items estimated by mapping processing with. a reception unit that receives input information including information on items included in the first medical data in one of a plurality of formats;
a first display control unit that displays each item included in the first medical data in association with each item included in second medical data in a format to be submitted to authorities;
Editably displaying a conversion formula used in the process of converting each item of the first medical data into a corresponding item in the second medical data in association with each item included in the second medical data. a second display control unit that
Display control device including. Accepting input information including information on items included in the first medical data in one of a plurality of formats,
displaying each item included in the first medical data in association with each item included in the second medical data in a format to be submitted to authorities;
Editably displaying a conversion formula used in the process of converting each item of the first medical data into a corresponding item in the second medical data in association with each item included in the second medical data. A display control method in which a computer performs processing that includes