JP5935488B2 - Information processing apparatus, information processing method, and program - Google Patents

Description

  The present invention relates to a technique for reducing the burden of confirmation of an approver in a re-approval flow.

  Pharmaceutical companies have a task to report individual case safety reports (hereinafter referred to as reports) such as drug side effects to the Pharmaceuticals and Medical Devices Agency (hereinafter referred to as PMDA).

The report is submitted to PMDA as a report through an approval flow within the pharmaceutical company, but the report content is incomplete and PMDA may request resubmission.
In such a case, the person in charge of the pharmaceutical company corrects the report, and the report is resubmitted to PMDA through a re-approval flow in the pharmaceutical company.

  Currently, in the re-approval flow within the pharmaceutical company, when the approver receives an approval request (re-application) from the person in charge, the same confirmation screen (all contents of the report are displayed as a list) Screen).

  However, the total number of items in the report is very large, and in the re-application workflow, the approver takes time and effort to search for confirmation items, and it is impossible to completely prevent omissions. There is.

  Japanese Patent Application Laid-Open No. 2004-228561 discloses a technique for preventing failure recurrence due to the same reason by feeding back defect information in an already applied application in an electronic document examination / approval work system.

JP 2005-18280 A

  However, although the technology described in Patent Document 1 can confirm rejected defect information, when the total number of items is large, it is possible to perform display so that the approver can easily recognize the items to be confirmed. It is not something to be assumed.

  Therefore, the present invention solves the above-described problems, and provides a method by which an approver can easily confirm re-application items in a re-application flow for application documents including a large number of items.

The information processing apparatus of the present invention manages a data file of an application document including a plurality of data items, and manages the contents of the data items included in the data file of the application document that has been re-applied by the management unit. Determining means for determining for each data item whether or not it matches the content of the data item included in the data file of the application document being processed, and determining that any of the data items does not match as a result of the determination by the determining means And generating means for generating screen information capable of identifying the contents of the data items before and after the change, and generating screen information capable of identifying that there is no change when it is determined that all of the data items match. And notification means for notifying the approver to approve the data file of the application document using the screen information generated by the generation means. And features.

  According to the present invention, the approver can easily confirm the re-application items in the re-application flow for application documents including a large number of items.

System configuration diagram showing the configuration of the workflow system Diagram showing hardware configuration of various terminals Flow chart showing the overall processing flow It is a flowchart which shows the flow of the process which produces | generates a reapplication screen. It is a figure which shows an example of a report table. It is a figure which shows the example of a change log | history table. It is a figure which shows an example of a data group table. It is a figure which shows an example of a related data item table. It is an example of a setting screen. It is an example of the screen of a report. It is an example of a screen on which an added part can be identified. It is the example of a screen on which the display which can identify the changed location was performed. It is an example of a screen which makes it possible to further improve readability.

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the drawings.
FIG. 1 is a system configuration diagram showing a configuration of a workflow system according to the present invention.

  In FIG. 1, a workflow system (information processing system) includes at least one workflow server 101 (information processing apparatus), a workflow client 102 (client terminal), and an external server 103 connected via a network.

  The user makes a workflow progress request to the workflow server 101 from the workflow client 102 using, for example, a web browser or client software.

  The workflow server 101 performs workflow processing and management in response to a request, and transmits a result or the like to the workflow client terminal 102 if necessary.

In the present embodiment, an approval flow for a report in a pharmaceutical company is executed by the workflow server 101 and the workflow client 102, and the approved report is transmitted to the external server 103 to the PMDA. It is a flow to be submitted.
FIG. 2 is a diagram showing a hardware configuration of various terminals according to the embodiment of the present invention.
In FIG. 2, the CPU 201 comprehensively controls each device connected to the system bus 204.

The ROM 203 or the external memory 211 stores an operating system (OS) that is a control program of the CPU 201 and programs for realizing various functions described later of each server or each client.
The RAM 202 functions as a main memory, work area, temporary save area, and the like for the CPU 201.

The input controller 205 controls input from the input unit 209. Examples of the input unit 209 include a pointing device such as a keyboard and a mouse in a terminal such as a server or a client. Moreover, in a printing apparatus etc., a touch panel, a button, a switch, etc. are mentioned.
The output controller 206 controls the display of the output unit 210. Examples of the output unit 210 include a CRT and a liquid crystal.

The external memory controller 207 controls access to the external memory 211 that stores a boot program, various applications, font data, user files, edit files, printer drivers, and the like. In addition, various tables and parameters for realizing various functions of each server or each client are stored. Examples of the external memory 211 include a hard disk (HD), a floppy (registered trademark) disk (FD), a compact flash (registered trademark) connected to a PCMCIA card slot via an adapter, and smart media.
The communication I / F controller 208 executes communication control processing with an external device via the system bus 214.

A program 212 for realizing the present invention is recorded in the external memory 211 and is executed by the CPU 201 by being loaded into the RAM 202 as necessary.
Next, the overall processing flow will be described with reference to the flowchart of FIG.
FIG. 3 is a flowchart showing the overall processing flow.

Here, the report is submitted to PMDA once through the approval flow in the pharmaceutical company. However, the content of the report is incomplete, and the flow until re-submission through the re-approval flow will be described.
S301 to S309 is a flow for submitting a report first, and S310 to S324 is a flow for resubmitting a report.

  In S301, the client terminal operated by the person in charge in the pharmaceutical company makes an approval application for the report. Here, the report is attached and the application is made. In the present embodiment, the attached report is an XML format data file.

  In S302, the workflow server accepts an approval application. Here, the requested report is registered in the report table, and version management is performed. An example of the report table is shown in FIG.

FIG. 5 is a diagram illustrating an example of a report table. A report ID 501, version 502, and data 503 are managed in the report table. The report ID 501 is an identifier of the side effect report managed for each case, the version 502 is a numerical value indicating the version number, and the data 503 is XML format data of the side effect report file.
In S303, the workflow server issues an approval request to the approver. The approval request is notified by e-mail or the like.
In S304, the client terminal operated by the approver in the pharmaceutical company accepts the approval request.

In S305, the client terminal performs an approval process. Here, the approver confirms the contents of the applied report and presses the approval button to proceed to the next step. An example of the report screen is shown in FIG.
In S306, the client terminal notifies the processing result.
In step S307, the workflow server receives the processing result.
In S308, when the processing result is approval, the workflow server submits the report to the external server.
In S309, the external server receives the report.
After that, if there are any deficiencies in the contents of the report, PMDA will instruct you to resubmit it and you will be reapplied within the pharmaceutical company.

  In S310, the client terminal operated by the approver in the pharmaceutical company makes a re-approval application for the corrected report. Here, the corrected report will be attached and re-application will be made. The corrected report is also an XML data file.

  In step S311, the workflow server accepts a re-approval application. Here, the submitted XML data file is analyzed, and if the change history table has the same report ID as the report table, the changed data item is recorded in the change history table as compared with the previous report. . An example of the change history table is shown in FIG.

  FIG. 6 is a diagram illustrating an example of the change history table. In the change history table, a report ID 601, a version 602, a data item 603, and a value 604 are managed. The report ID 601 is an identifier of a side effect report managed for each case, the version 602 manages the version number before and after the change, and the data item 603 is defined in an XML format data file. Information specifying the data item is managed, and a value 604 is a value before change and a value after change.

For example, the case where the data item 603 is “/ ichicsr / safetyreport [1] / patient [1] / drug [9] / medicinalproduct [1]” will be described as an example. “/” Is a delimiter. “Icicsr” indicates a side effect report. “Safetyreport [1]” indicates a reporting unit. “Patient [1]” indicates patient characteristics. “Drug [9]” indicates drug information (the drug described in the ninth). medicinal product [1] indicates the name of a pharmaceutical product.
In S312, the workflow server makes a re-approval request to the approver.
In S313, the client terminal operated by the approver in the pharmaceutical company accepts the re-approval request.
In S314, the client terminal requests a screen for confirming the contents of the re-applied report.
In S315, the workflow server accepts the screen request.

In step S316, the workflow server generates screen information for displaying a screen on which the content of the re-applied report can be confirmed. Detailed processing will be described with reference to FIG.
FIG. 4 is a flowchart showing a flow of processing for generating a re-application screen.

In step S401, the workflow server compares revisions. Specifically, it is checked whether there is a data item that has been changed (added / changed / deleted) under the following conditions in the change history table.
(1) If there is no data before change and there is data after change, “Add”
(2) If there is data before change and data after change, “Change”
(3) If there is data before change and there is no data after change, “Delete”

In S402, the workflow server determines whether there has been a change. If YES, the process proceeds to S404, and if NO, the process proceeds to S403. Here, if “addition”, “change”, and “deletion” are confirmed in S401, the determination is YES.
In step S <b> 403, the workflow server generates confirmation screen information capable of displaying an annotation indicating that there has been no change, and ends the process.
On the other hand, in S404, the workflow server extracts a data item that has been changed.

  In step S405, the workflow server determines whether the setting for displaying the data group has been made. If YES, the process proceeds to S406, and if No, the process proceeds to S407. Here, the administrator sets whether to display the data group.

  In S406, the workflow server acquires the group of the changed data item from the data group table, and acquires all the data belonging to the group. This is because data items included in the same data group are closely related to each other. An example of the data group table is shown in FIG.

  FIG. 7 is a diagram illustrating an example of the data group table. A drug name 701, a data item 702, and a group 703 are managed in the data group table. The drug name 701 manages the name of the drug, the data item 702 manages the data item name, and the group 703 manages the group. For example, if the changed data item is “/ ichicsr / safetyreport / serial”, the group is managed as “/ ichicksr / safetyreport”, so it is included in “/ ichicksr / safetyreport” from the submitted XML format data. Get the data item to be saved.

  In step S407, the workflow server determines whether related data items that cannot be omitted are set. If yes, then continue with S408, otherwise continue with S409. The related data item that cannot be omitted here is set in advance by the administrator. The related data item that cannot be omitted refers to an item for extracting and displaying related data items regardless of the data group setting when the meaning of the changed data item is difficult to understand.

  An example of setting by the administrator will be described with reference to FIG. FIG. 9 is an example of a setting screen. The administrator can arbitrarily edit the default setting. The association can be performed by selecting the data item name and moving it from the unassociated data items to the associated data item. In this example, if the “B.2.10 Side Effects / Adverse Events Reported by Primary Source” is changed, “A.1.5 Seriousness”, “A.1.5 .1 Serious? ”And“ A.1.5.2 Seriousness Criteria ”are displayed. The set association is managed in the related data item table. An example of the related data item table is shown in FIG.

  FIG. 8 is a diagram illustrating an example of a related data item table. In the related data item table, a medicine name 801, a data item 802, and a related data item 803 are managed. The drug name 801 manages the drug name, the data item 802 manages the data item, and the related data item 803 manages the related data item.

In step S <b> 408, the workflow server acquires data items that cannot be omitted from the related data item table and related to the changed data item, and acquires all data that cannot be omitted. This is because the data items that cannot be omitted related to the changed data items must be confirmed.
Note that the items to be confirmed differ depending on the drug, so the data group and related data items are set for each drug.
In step S409, the workflow server determines whether the change content is only addition. If yes, then continue with S410, otherwise continue with S411.
In S410, confirmation screen information that can be displayed to identify the added location is generated, and the process is terminated (FIG. 11).
On the other hand, in S411, confirmation screen information that can be displayed to identify the changed location is generated, and the process is terminated (FIG. 12).
Note that the screen information generated in S409 and S410 includes information that can change the screen layout by an operation on the client terminal.
The flow of processing for generating the re-application screen has been described above with reference to FIG.

In step S317, the workflow server transmits screen information that allows confirmation of the contents of the re-applied report. Here, whether the screen information to be transmitted is sent as screen information that enables display of all data items, or whether it is sent as screen information that enables display of only related data items or related data items that cannot be omitted. Can be set arbitrarily.
In S318, the client terminal receives screen information.
In S319, the client terminal displays on the display device using the screen information.
An example of a display screen is shown in FIGS.

  FIG. 11 shows an example of a screen on which the added part can be identified. By making the background and characters of 1101 different from the background and characters of other areas, it is easy to confirm the added portion. In the example of FIG. 11, “102” is added to the “birth date / format” column, and “July 14, 1789 (17889014)” is added to the “birth date / value” column.

FIG. 12 shows an example of a screen on which the changed part can be identified. Reference numeral 1201 indicates that an item has been deleted at the time of re-application and a character string input before being deleted. Reference numeral 1202 displays characters input at the time of re-application and a character string input at the previous application. Similarly to FIG. 11, the background and characters of each item are made different from the background and characters of other areas. The example of FIG. 12 indicates that the “age / value at the time of occurrence of side effect / adverse fact” column has been deleted, and “99 years old (99)” has been input before the deletion. In addition, “12.0” is input in the “medDRA version of associated treatment history and associated state” column, and “11.0” is input before correction.
FIG. 13 is an example of a screen that makes it possible to further improve readability.

Here, in order to improve the legibility, it is possible to expand and fold the display of items (implemented by selecting “+” 1302 and “−” 1301). The data group having no change is displayed in a collapsed manner, and the data group having the change is expanded and displayed.
In addition, even in the folded state, the confirmation work is facilitated by highlighting the items and change data so that the change points can be seen.

The expansion can be a function as a whole (all or changed data only) and a function as a selected node (selected node only or selected node and all child nodes).
Folding can be a function as a whole (all or all except changed data) and a function as a selected node (only selected nodes).
The jump function can be the first change / last change, the next change / previous change, or a specified data item.
The print function can be selected as PDF or CSV.

  In addition, as the target data narrowing, the target data to be displayed is narrowed down with the following settings. All, only the changed data group, only the changed data item (however, if it is difficult to understand alone, the related data item is also supplemented).

  In this way, if there are a large number of items, and re-application is made for multiple items, re-apply from a large number of confirmation items, omitting items that do not require confirmation other than added / deleted / changed information This makes it easier to check the items.

  In addition, items that make it easier to check with the unit, such as “changed component amount” and “mg”, are automatically supplemented to determine whether the item is not required for confirmation, such as when the component amount is changed. Can be displayed.

In S320, the client terminal performs an approval process. Here, the approver confirms the contents of the applied report and presses the approval button to proceed to the next step. In addition, the approver performs the confirmation work while pressing down the folding display button added in order to improve the legibility of the corrected part of the re-applied report.
In S321, the client terminal notifies the processing result.
In step S322, the workflow server receives the processing result.
In S323, when the processing result is approval, the workflow server submits the report to the external server.
In S324, the external server receives the report.
The overall flow has been described above.
As described above, according to the present invention, the approver can easily confirm the re-application items in the re-application flow for application documents including a large number of items.

  Although the embodiments have been described in detail above, the present invention can take embodiments as, for example, a system, an apparatus, a method, a program, or a storage medium (recording medium). The present invention may be applied to a system composed of a single device or an apparatus composed of a single device.

  In the present invention, a software program (in the embodiment, a program corresponding to the flowchart shown in the figure) that realizes the functions of the above-described embodiment is directly or remotely supplied to the system or apparatus, and the computer of the system or apparatus Is also achieved by reading and executing the supplied program code.

  Accordingly, since the functions of the present invention are implemented by computer, the program code installed in the computer also implements the present invention. In other words, the present invention includes a computer program itself for realizing the functional processing of the present invention.

  In that case, as long as it has the function of a program, it may be in the form of object code, a program executed by an interpreter, script data supplied to the OS, or the like.

  As a recording medium for supplying the program, for example, floppy (registered trademark) disk, hard disk, optical disk, magneto-optical disk, MO, CD-ROM, CD-R, CD-RW, magnetic tape, nonvolatile memory card ROM, DVD (DVD-ROM, DVD-R) and the like.

  As another program supply method, a client computer browser is used to connect to an Internet homepage, and the computer program of the present invention itself or a compressed file including an automatic installation function is downloaded from the homepage to a recording medium such as a hard disk. Can also be supplied. It can also be realized by dividing the program code constituting the program of the present invention into a plurality of files and downloading each file from a different homepage. That is, a WWW server that allows a plurality of users to download a program file for realizing the functional processing of the present invention on a computer is also included in the present invention.

  In addition, the program of the present invention is encrypted, stored in a storage medium such as a CD-ROM, distributed to users, and key information for decryption is downloaded from a homepage via the Internet to users who have cleared predetermined conditions. It is also possible to execute the encrypted program by using the key information and install the program on a computer.

  In addition to the functions of the above-described embodiments being realized by the computer executing the read program, the OS running on the computer based on the instruction of the program is a part of the actual processing. Alternatively, the functions of the above-described embodiment can be realized by performing all of them and performing the processing.

  Furthermore, after the program read from the recording medium is written in a memory provided in a function expansion board inserted into the computer or a function expansion unit connected to the computer, the function expansion board or The CPU or the like provided in the function expansion unit performs part or all of the actual processing, and the functions of the above-described embodiments are realized by the processing.

101 Workflow server 102 Workflow client 103 External server

Claims (11)

A management means for managing a data file of an application document including a plurality of data items;
For each data item, whether or not the content of the data item included in the data file of the application document that has been re-applied matches the content of the data item included in the data file of the application document managed by the management means. Determination means for determining;
When it is determined that any of the data items do not match as a result of the determination by the determination unit, screen information that can identify the contents of the data item before and after the change is generated , and it is determined that all of the data items match Generating means for generating screen information that can identify that there has been no change ;
Notification means for notifying the approver to approve the data file of the application document using the screen information generated by the generation means;
An information processing apparatus comprising:   The information processing apparatus according to claim 1, wherein the re-application is a separate application. Each time the application process is performed, it further includes an assigning means for assigning a version number to the data file of the application document,
3. The information processing apparatus according to claim 1, wherein, when the same identifier is included in the application information of the application process, the assigning unit counts up and assigns a version number. 4.   The determination means includes the contents of the data items included in the data file of the re-applied application document and the data included in the data file of the version number before the version number of the data file of the re-applied application document. The information processing apparatus according to any one of claims 1 to 3, wherein the determination is based on the content of the item.   5. The information processing according to claim 1, wherein the generation unit generates screen information that can identify a data item that has been changed and a data item that has not been changed. 6. apparatus.   The management means also manages related information capable of specifying data items related to each other among a plurality of data items,
  The generation unit generates screen information that can also identify contents of the related data item when a data item related to the changed data item is specified from management information of the management unit. The information processing apparatus according to any one of claims 1 to 5. Multiple data items are divided into multiple groups,
Said generating means, according to claim 1, wherein generating a group and, identifiable and do not contain groups that screen information change to a data item contained in said group includes made data item The information processing apparatus according to any one of the above.   The generating unit expands and displays a group including the changed data item, and displays a group that does not include the changed data item as a collapsed display. The information processing apparatus according to claim 7, wherein a group that is not included can be identified. It said generating means includes a data item of which has been changed, to claim 6 or 7, characterized in that to produce together displayable screen information and data items that belong to the same groups and data items that were made changes The information processing apparatus described. An information processing method in an information processing apparatus,
A management step of managing a data file of an application document including a plurality of data items by a management means;
For each data item, whether or not the content of the data item included in the data file of the application document that has been re-applied matches the content of the data item included in the data file of the application document managed by the management means. A determination step for determining;
When it is determined that any of the data items does not match as a result of the determination in the determination step, screen information that can identify the contents of the data items before and after the change is generated , and it is determined that all of the data items match A step of generating screen information for identifying that there has been no change ,
A notification step of notifying the approver to approve the data file of the application using the screen information generated in the generation step;
An information processing method comprising: A program executable in the information processing apparatus,
Management means for managing data files of application documents containing multiple data items,
For each data item, whether or not the content of the data item included in the data file of the application document that has been re-applied matches the content of the data item included in the data file of the application document managed by the management means. Determination means for determining,
When it is determined that any of the data items do not match as a result of the determination by the determination unit, screen information that can identify the contents of the data item before and after the change is generated , and it is determined that all of the data items match Generating means for generating screen information that can identify that there has been no change ,
Notification means for notifying the approver to approve the data file of the application document using the screen information generated by the generation means;
A program for causing the information processing apparatus to function.

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