JP4097277B2 - Trial screening document creation device and clinical trial screening document creation method - Google Patents

Description

  The present invention relates to a clinical trial examination document preparation apparatus that creates a clinical trial examination document that is a document relating to clinical trial examination.

  Clinical trials conducted by medical institutions on subjects are conducted based on compliance with the Pharmaceutical Affairs Law. In conducting the clinical trial, the clinical trial medical institution such as a hospital that has received a request for the clinical trial establishes an Institutional Review Board (IRB) or entrusts it to an IRB established by another medical institution. , It is obliged to undergo a clinical trial review. The Institutional Review Board (hereinafter may be abbreviated as “IRB”) is a body that deliberates acceptance of new clinical trial requests and continuation of ongoing clinical trials. And have the authority to cancel.

  When a clinical trial review is conducted by the IRB, a clinical trial request form (hereinafter simply referred to as the “execution request form”) between the sponsor, the principal investigator, the head of the clinical trial institution, the head of the IRB medical institution, the IRB, etc. ), Clinical trial application form (hereinafter, simply referred to as “execution application form”), clinical trial examination request form (hereinafter, also referred to simply as “review request form”), and examination result report (Hereinafter may be simply referred to as “result report”), examination result notification (hereinafter may be simply referred to as “result notification”), clinical trial instruction determination notification (hereinafter simply referred to as “instruction determination”) Notification ”), changes to the clinical trial plan etc. (hereinafter simply referred to as“ plan change etc. ”), reports on new safety information (hereinafter simply referred to as“ new safety ”) Information ”), clinical trial questionnaire (hereinafter referred to as“ information ”) Sometimes referred to as "ask Form") multiple documents such as would be exchanged in.

  More specifically, a clinical trial request form for requesting a clinical trial is sent from the clinical trial client to the head of the clinical trial medical institution. In addition, the investigator will send an application form for applying for the trial to the head of the trial medical institution. In addition, the sponsor of the trial will receive a new safety information, which is information on the new safety of the investigational drug, and a notification of changes such as a plan that partially revised the trial plan. Sometimes. Similarly, the investigator may send an inquiry form, which is a report related to the clinical trial, to the head of the trial medical institution. In addition, an examination request form requesting examination by the clinical trial examination committee is sent from the head of the clinical trial medical institution to the head of the IRB medical institution. In addition, a similar clinical trial review request form is sent from the head of the IRB medical institution to the IRB. IRB also conducts clinical trial screening and prepares minutes. The IRB will send a report on the results of the examination to the head of the IRB medical institution. The head of the IRB medical institution sends a result notification indicating the contents determined for the clinical trial to the head of the clinical trial institution. An instruction decision notification indicating the contents decided on the clinical trial is sent from the head of the clinical trial medical institution to the trial sponsor and the investigator. As described above, in the clinical trial examination, a very large number of documents are exchanged between the parties. In addition, the name of each document is an example, and different names may be used depending on the clinical trial screening committee.

As a related technique, an apparatus that supports the creation of clinical trial data has been developed (for example, see Patent Document 1).
JP-A-2005-173723 (first page, FIG. 1 etc.)

  Conventionally, however, each of the documents described above has been created by each party using word processor software or the like. The amount of work is enormous and will be described with an example. Consider a case in which new safety information is submitted from the sponsor to the head of the study site as a typical review by a clinical trial review committee (because serious side effects have been reported overseas or in Japan) Based on this information, it is important for the IRB to decide whether or not to continue the trial). One piece of new safety information has about 30 data, which is entered by the sponsor. Next, the head of the trial medical institution that has received the new safety information creates a clinical trial examination request form and submits it to the head of the IRB medical institution, which has about 30 data. In this way, a total of nine types of documents must be created by the sponsor, the investigator, the head of the conducting medical institution, the head of the IRB medical institution, and the IRB for each review item. The total number of data is about 300.

  When creating such documents, if data is input using a keyboard or the like, an input error may occur. In addition, when data is transferred by cutting and pasting from previously held data or the like, there is a risk of a transcription error. Because these documents require strict accuracy, large organizations often have a quality control department to detect mistakes visually. As described above, there is a problem that the burden on the user for creating each document is excessive.

  In addition, the situation as described above causes a delay in the preparation of documents related to the clinical trial examination. As a result, there will be a delay in the processing of side effect information that should be reviewed promptly, and the progress of the trial itself will be delayed. (1) Improvement of trial quality (ensure the safety of subjects), (2) Trial Any of the speeds will have an adverse effect.

  Furthermore, since it is necessary to input a large amount of data and to arrange specialized personnel for finding typographical errors, the cost for conducting the trial is increased as labor costs. In Japan, it has been pointed out that the trial period is longer and the costs are significantly higher than those in Western countries, and this has reduced the international competitiveness of the Japanese pharmaceutical industry. There is a widespread demand from the industry to solve these problems.

  Furthermore, as mentioned above, there are multiple parties involved in the clinical trial review, and there are many types of documents. Therefore, especially when the same party prepares multiple documents, from one party to another until it gets used to it. It was difficult to understand which documents were sent to the parties involved, creating inappropriate documents, which could cause delays in document preparation.

  The present invention has been made to solve the above-described problems, and an object of the present invention is to provide a clinical trial examination document preparation apparatus and the like that support the production of clinical trial examination documents.

In order to achieve the above object, a clinical trial document preparation apparatus according to the present invention is a clinical trial document preparation apparatus for preparing a clinical trial review document, which is a document necessary for a clinical trial review. Two or more clinical trial documents that are buttons displaying two or more nodes to be identified, two or more arrows indicating the moving direction of the clinical trial documents between the nodes, and a clinical trial document identifier for identifying the clinical trial documents A main screen output unit that outputs a screen having a button, a clinical trial document button instruction reception unit that receives an instruction for the clinical trial document button, and an instruction received by the clinical trial document button instruction reception unit when the instruction is received. A screen corresponding to the accepted clinical trial document button, a screen having UI parts that are parts for inputting data and a print button corresponding to the output form A button-corresponding screen output unit that outputs a button-corresponding screen; an input accepting unit that accepts input data for a UI component included in the button-corresponding screen; a storage unit that accumulates and holds the received input data; When a print button instruction receiving unit that receives an instruction for a print button on the screen and the print button instruction receiving unit receives an instruction, the corresponding data is read from the storage unit and corresponds to the print button that has received the instruction. An output form, and a clinical trial document output unit for outputting a clinical trial screening document.
With such a configuration, it is possible to support the creation of a clinical trial examination document, and the user can create an appropriate clinical trial examination document.

  Further, in the clinical trial document preparation apparatus according to the present invention, the two or more nodes may be nodes that identify the sponsor, the investigator, the head of the trial medical institution, the head of the IRB medical institution, and the IRB. .

  Further, in the clinical trial document preparation apparatus according to the present invention, the clinical trial review document includes a clinical trial request form associated with an arrow from the trial requester node to the longest node of the clinical trial medical institution, new safety information , Notification of changes to the clinical trial plan, etc., and the application form, clinical trial inquiry form, and the node of the head of the clinical trial institution associated with the arrow from the investigator's node to the head of the trial medical institution A clinical trial request form associated with the arrow from the head of the IRB medical institution to the node of the IRB medical institution, a clinical trial request form associated with the arrow from the long node of the IRB medical institution to the IRB node, and the IRB The minutes associated with the node of the IRB, the examination result report associated with the arrow from the IRB node to the head of the IRB medical institution, and the head of the IRB medical institution Examination result notification associated with the arrow to the principal node of the conducting medical institution, and instruction determination notification regarding the clinical trial associated with the arrow from the principal node of the conducting medical institution to the sponsor's node And an instruction determination notification regarding the clinical trial associated with the arrow from the node of the principal investigating medical institution to the investigator's node.

  With such a configuration, an arrow indicating the flow of the clinical trial document and the clinical trial document button corresponding to the clinical trial document are associated with each other. It is easy to identify which one is, and the document can be created accurately and quickly.

  In the clinical trial document preparation apparatus according to the present invention, the first stage clinical trial examination document and the attached material of the clinical trial examination document may be attached to the subsequent stage clinical trial examination document.

  With this configuration, in the clinical trial document, it is not necessary to manually set the previous clinical trial document and the attached material of the clinical trial document as the attached material of the subsequent clinical study document, which improves user convenience. ing.

In the clinical trial document preparation apparatus according to the present invention, the main screen output unit may include the two or more clinical trial document button so that a completed clinical trial document and an incomplete clinical trial document can be visually distinguished. May be displayed.
With such a configuration, it is possible to easily know which clinical trial document has been completed and which clinical trial document has not been completed by simply looking at the main screen.

  According to the clinical trial document preparation apparatus and the like according to the present invention, it is possible to support the preparation of the clinical trial screening document and to enable the user to create an appropriate clinical trial screening document. As a result, it is possible to significantly shorten the time required for preparing the clinical trial examination document, and to substantially eliminate errors.

  Hereinafter, a clinical trial examination document preparation apparatus according to the present invention will be described using embodiments. In the following embodiments, components and steps denoted by the same reference numerals are the same or equivalent, and repetitive description may be omitted.

(Embodiment 1)
A clinical trial examination document creation apparatus according to Embodiment 1 of the present invention will be described with reference to the drawings.
FIG. 1 is a block diagram showing the configuration of a clinical trial document preparation apparatus 1 according to this embodiment. In FIG. 1, a clinical trial document creating apparatus 1 according to the present embodiment is a device that creates a clinical trial screening document that is a document necessary for clinical trial screening. A unit 12, a button corresponding screen output unit 13, an input reception unit 14, a storage unit 15, a print button instruction reception unit 16, and a clinical trial examination document output unit 17.

  The main screen output unit 11 outputs the main screen. Here, the main screen refers to two or more nodes that identify the person or organization involved in the clinical trial, two or more arrows that indicate the direction of movement of the clinical trial document between the nodes, and the clinical trial screening that identifies the clinical trial screening document. It is a screen having two or more clinical trial document buttons, which are buttons displaying document identifiers. The person or organization related to the clinical trial is, for example, the clinical trial sponsor, the investigator, the head of the clinical institution, the head of the IRB medical institution, or the IRB. The clinical trial document identifier that identifies the clinical trial document may be, for example, the name of the clinical trial document. The name of the clinical trial examination document may be the formal name of the clinical trial examination document, or may be an abbreviation or common name. The clinical trial examination document button is associated with an arrow or a node. The main screen may be composed of, for example, HTML data, flash data, or the like. The main screen output unit 11 is a recording medium that stores data constituting the main screen (this recording medium may be included in the main screen output unit 11 and can be accessed by the main screen output unit 11). The element may have), the data is read out to form the main screen, and the main screen is output. Here, the output may be, for example, display on a display device (for example, a CRT or a liquid crystal display) or transmission via a communication line to a predetermined device. The main screen output unit 11 may or may not include an output device (for example, a display device or a modem). The main screen output unit 11 may be realized by hardware, or may be realized by software such as a driver that drives these devices. In the present embodiment, the main screen output unit 11 displays the main screen on the display 23.

  The clinical trial document button instruction receiving unit 12 receives an instruction for the clinical trial document button. The instruction for the clinical trial document button is an instruction for selecting a specific clinical trial document button. For example, the clinical trial document button may be clicked using an input device such as a mouse, or double-clicked. It is also possible to select a clinical trial examination document button and then press the “Enter” key on the keyboard. The clinical trial document button instruction receiving unit 12 may receive information input from an input device (for example, a keyboard, a mouse, a touch panel, etc.), and receives information transmitted via a wired or wireless communication line. May be. The clinical trial document button instruction receiving unit 12 may or may not include a device for receiving (for example, an input device or a network card). Further, the clinical trial examination document button instruction receiving unit 12 may be realized by hardware, or may be realized by software such as a driver that drives a predetermined device. In the present embodiment, it is assumed that the clinical trial examination document button instruction receiving unit 12 receives an input from the keyboard 21 or the mouse 22.

  The button corresponding screen output unit 13 outputs a button corresponding screen when the clinical trial examination document button instruction receiving unit 12 receives an instruction. Here, the button-corresponding screen is a screen corresponding to the clinical trial document button for which the clinical trial document button instruction receiving unit 12 has received an instruction, and is a UI part that is a part for inputting data and a print corresponding to the output form. A screen having at least a button. UI (user interface) parts include, for example, buttons other than print buttons, text input fields, check boxes, radio buttons, and input menus. The output form will be described later. In a recording medium (not shown), a clinical trial document button and a button corresponding screen corresponding to the button are stored in association with each other. The button corresponding screen output unit 13 is instructed by the clinical trial document button instruction receiving unit 12. A button corresponding screen corresponding to the accepted clinical trial document button is read from the recording medium and output. The recording medium may be included in the button corresponding screen output unit 13 or may be included in another component accessible by the button corresponding screen output unit 13. Here, the output may be, for example, display on a display device (for example, a CRT or a liquid crystal display) or transmission via a communication line to a predetermined device. The button corresponding screen output unit 13 may or may not include an output device (for example, a display device or a printer). Moreover, the button corresponding | compatible screen output part 13 may be implement | achieved by hardware, or may be implement | achieved by software, such as a driver which drives those devices. In the present embodiment, it is assumed that the button corresponding screen output unit 13 displays the button corresponding screen on the display 23.

  The input receiving unit 14 receives input data for UI parts included in the button corresponding screen. The input data may be, for example, text data input in the input field, data regarding the presence / absence of the check input in the check box, and data indicating the result of the check in the check box ( For example, if the check box indicates that “there is no attachment”, it may be data indicating that there is no attachment, etc.). Data for selecting a menu or data for selecting a predetermined radio button may be used. For example, the input reception unit 14 may receive information input from an input device (for example, a keyboard, a mouse, a touch panel, etc.), or may receive information transmitted via a wired or wireless communication line. . Note that the input receiving unit 14 may or may not include a device for receiving (for example, an input device or a network card). The input receiving unit 14 may be realized by hardware, or may be realized by software such as a driver that drives a predetermined device. In the present embodiment, the input receiving unit 14 receives input from the keyboard 21 and the mouse 22.

  The storage unit 15 stores and holds the data received by the input receiving unit 14 in a predetermined recording medium. This recording medium may be, for example, a semiconductor memory, an optical disk, a magnetic disk, or the like.

  The print button instruction receiving unit 16 receives an instruction for a print button included in the button correspondence screen. The instruction for the print button is an instruction for selecting the print button. For example, the print button may be clicked using an input device such as a mouse, or may be double-clicked. It is also possible to press the “Enter” key on the keyboard after selecting the print button. For example, the print button instruction receiving unit 16 may receive information input from an input device (for example, a keyboard, a mouse, a touch panel, etc.), and may receive information transmitted via a wired or wireless communication line. Also good. The print button instruction receiving unit 16 may or may not include a device (for example, an input device or a network card) for receiving. Further, the print button instruction receiving unit 16 may be realized by hardware, or may be realized by software such as a driver that drives a predetermined device. In the present embodiment, the print button instruction accepting unit 16 accepts input from the keyboard 21 and the mouse 22.

  When the print button instruction receiving unit 16 receives an instruction, the clinical trial document output unit 17 reads the corresponding data from the storage unit 15 and outputs the clinical trial document in an output form corresponding to the print button that has received the instruction. To do. The clinical trial document output from the clinical trial document output unit 17 is identified by the clinical trial document identifier displayed on the clinical trial document button corresponding to the button corresponding screen having the print button for which the print button instruction receiving unit 16 has received the instruction. This is a clinical trial review document. In a recording medium (not shown), an attribute value to be output and an output form that is information on the layout of each attribute are stored for each clinical trial document, and the clinical trial document output unit 17 uses the output form. Output clinical trial document. Specifically, the clinical trial screening document output unit 17 interprets and executes the output form, and creates and outputs a clinical trial screening document. To interpret and execute an output form is to acquire an attribute value corresponding to an attribute included in the output form by searching the storage unit 15. The processing of the clinical trial examination document output unit 17 can be realized by using, for example, a report writer function in a database. The recording medium may be included in the clinical trial document output unit 17, or may be included in another component accessible by the clinical trial document output unit 17. Here, the output may be, for example, display on a display device (for example, CRT or liquid crystal display), transmission via a communication line to a predetermined device, printing by a printer, or a predetermined recording medium. It may be accumulated in The clinical trial document output unit 17 may or may not include an output device (for example, a display device or a printer). Further, the clinical trial examination document output unit 17 may be realized by hardware, or may be realized by software such as a driver that drives these devices. In the present embodiment, the clinical trial screening document output unit 17 displays a button corresponding screen on the display 23.

  In the storage unit 15 of the clinical trial document preparation apparatus 1, before the clinical trial screening document is output by the clinical trial screening document output unit 17, the name of the IRB, the name of the IRB member, the name of the sponsor, the investigator It is assumed that information such as the name is stored. This accumulation may be performed by reading from the recording medium storing the data, or may be performed by the input receiving unit 14 receiving the input data. Data transmitted from other devices or the like may be stored. It may be done by receiving, and the process of accumulation does not matter. In the present embodiment, it is assumed that data received by the input receiving unit 14 is accumulated.

Next, the operation of the clinical trial examination document creation apparatus 1 according to the present embodiment will be described using the flowchart of FIG.
(Step S101) The main screen output unit 11 determines whether to output the main screen. And when outputting a main screen, it progresses to step S102, and when that is not right, it progresses to step S103. Here, the timing at which the main screen output unit 11 determines to output the main screen does not matter. For example, the main screen output unit 11 determines to output the main screen triggered by the occurrence of a predetermined event (for example, the occurrence of an event that the clinical trial document preparation apparatus 1 has received an instruction to output the main screen). Alternatively, other timing may be used.

  (Step S102) The main screen output unit 11 outputs the main screen. Then, the process returns to step S101.

  (Step S103) The clinical trial document button instruction receiving unit 12 determines whether an instruction for the clinical trial document button has been received. If an instruction for the clinical trial document button is accepted, the process proceeds to step S104. If not, the process proceeds to step S110.

  (Step S104) The button corresponding screen output unit 13 outputs a button corresponding screen corresponding to the clinical trial document button for which the clinical trial document button instruction receiving unit 12 has received the instruction.

  (Step S <b> 105) The print button instruction accepting unit 16 determines whether an instruction for the print button in the button corresponding screen output by the button corresponding screen output unit 13 has been received. If an instruction for the print button is accepted, the process proceeds to step S106, and if not, the process proceeds to step S107.

  (Step S106) The clinical trial document output unit 17 outputs the clinical trial document corresponding to the print button for which the print button instruction receiving unit 16 has received the instruction. Then, the process returns to step S105.

  (Step S107) The input receiving unit 14 determines whether or not input data for the UI component on the button corresponding screen output by the button corresponding screen output unit 13 has been received. If input data is accepted, the process proceeds to step S108, and if not, the process proceeds to step S109.

  (Step S108) The storage unit 15 stores the input data received by the input receiving unit 14. In this case, the storage unit 15 may store the input data in association with the attribute corresponding to the UI component corresponding to the input data received by the input receiving unit 14. Then, the process returns to step S105.

  (Step S109) The button corresponding screen output unit 13 determines whether or not to close the button corresponding screen. If the button corresponding screen is closed, the process returns to step S101. Otherwise, the process returns to step S105.

(Step S <b> 110) The input receiving unit 14 determines whether information stored in the storage unit 15 has been received. If the information is accepted, the process proceeds to step S111. If not, the process returns to step S101.
In the flowchart of FIG. 2, the process is terminated by powering off or a process termination interrupt.

  Next, the operation of the clinical trial examination document creation apparatus 1 according to the present embodiment will be described using a specific example. In this specific example, it is assumed that the clinical trial examination document creation apparatus 1 is a PC (Personal Computer).

  First, a description will be given of an operation in which a user who operates the clinical trial examination document creation apparatus 1 inputs information such as the IRB and the investigator. It is assumed that the user operates the clinical trial examination document creation apparatus 1 to display a screen for inputting information regarding IRB. FIG. 3 shows the screen. The screen is displayed on the display 23 by an input screen output unit (not shown) of the clinical trial document creation apparatus 1. On the screen, the user operates the keyboard 21 to input the IRB name, IRB location, and the like. The data is received by the input receiving unit 14 (step S110). When the input is completed, the user operates the mouse 22 and clicks the “Save” button. Then, the input data is stored by the storage unit 15 (step S111). 4 and 5 are diagrams showing data input in this way. When the user operates the mouse 22 and clicks the “Close” button, the data input screen regarding IRB is closed.

  Similarly, the user inputs information regarding the investigator. 6 and 7 are diagrams showing information related to the investigator input by the user and accumulated by the accumulation unit 15. In these figures, it can be seen that “XYZ” doctor is set as the investigator, and “XYXY” doctor of the XYZ hospital is set as the investigator.

  Next, the user inputs information related to the clinical trial requester. FIG. 8 is a diagram showing information related to the clinical trial requester input by the user and stored by the storage unit 15. In the figure, “ABC Pharmaceutical” is set as the clinical trial requester.

  The user then enters information about the protocol. FIG. 9 and FIG. 10 are diagrams showing information related to protocols input by the user and stored by the storage unit 15. In these figures, records having the same record ID are the same record. That is, for the sake of space, only one table is described in two figures. In these figures, the protocol “BBB study” for the investigational drug “BBB drug” is set.

  Next, the user inputs information related to the examination items. FIG. 11 is a diagram showing information on examination items input by the user and stored by the storage unit 15. FIG. 11 shows a part of the examination item table. In the examination item table, the examination item ID is an ID that is automatically set to identify the examination item. When two or more investigators are set in the protocol table, specific investigators selected from the two or more are included in the examination item table. In the protocol table, when two or more investigators are set in one record, the names of two or more investigators and planned subjects as in the case of the IRB committee list table 001 in FIG. It is also possible to provide a personal protocol table having a number, clinical trial doctor, etc., and associate the personal protocol table with each record of the protocol table. Examination items with the attribute value “1” in the examination items in the examination item table are examination items selected by clicking a check box on the input screen. The examination items for which the attribute value “0” is set are examination items that have not been selected.

  Next, the user inputs information regarding the clinical trial review meeting. FIG. 12 is a diagram showing information related to the clinical trial review meeting inputted by the user and accumulated by the accumulation unit 15. In the figure, the examination classification, the date and place of the meeting, the examination item ID for identifying the examination item to be examined at the meeting, the number of meetings, etc. are set.

  Next, the user operates the keyboard 21 and the mouse 22 to input an instruction to output the main screen to the clinical trial examination document creation apparatus 1. Then, the main screen output unit 11 determines that it is time to output the main screen (step S101), reads out the data from the recording medium storing the data constituting the main screen, and configures the main screen. The main screen is displayed on the display 23 (step S102). FIG. 13 is a diagram showing the main screen displayed as described above.

  Here, processing for creating the main screen of FIG. 13 will be described. The main screen background data shown in FIG. 14 is stored in a recording medium (not shown) accessible by the main screen output unit 11. The main screen background data may be, for example, bitmap data or vector data, and the data format is not limited. Further, the button management table shown in FIG. 15 is stored in a recording medium (not shown) accessible by the main screen output unit 11. The button management table is information indicating the configuration of the clinical trial document button and information for specifying the button corresponding screen to jump to when an instruction for the clinical trial document button is accepted. In the button management table, the document name displayed on the clinical trial document button, the position to display the clinical trial document button, and the jump screen that shows the screen to jump to when an instruction for the clinical trial document button is accepted It is attached. For example, the button corresponding screen 1 is a button corresponding screen corresponding to the implementation request, and the button corresponding screen 2 is a button corresponding screen corresponding to the new safety information. The main screen output unit 11 reads the main screen background data shown in FIG. 14, and displays the clinical trial examination document button on the main screen background data according to the button management table of FIG. The main screen displayed in this way is shown in FIG. Note that the button management table shown in FIG. 16 may be used instead of the button management table of FIG. In the button management table shown in FIG. 16, an arrow ID for identifying an arrow on which main screen background data is displayed is set instead of the button position. When the button management table of FIG. 16 is used, the main screen output unit 11 may display the buttons so as to be uniform between the coordinates of the start point and end point of the arrow. In this case, it is assumed that the coordinates of the start point and end point of each arrow are stored in a recording medium (not shown) accessible by the main screen output unit 11.

  As shown in FIG. 13, when the user selects “first” as the number of meetings, the record of the number of times “1” is retrieved from the meeting table, and the examination item ID of the retrieved record is the examination item ID. Appears in the list. Next, it is assumed that the user has selected by clicking the examination item ID “200510_007” from the list of examination item IDs. Then, the protocol name “BBB study” is acquired from the examination item table corresponding to the examination item ID, and the protocol table is searched using the protocol name as a key, so that the trial sponsor “ABC Pharmaceutical” and the clinical trial subject are searched. “Study of the significance of BBB” is acquired and displayed as shown in FIG.

  In FIG. 13, an arrow 301 from the trial requester node 101 to the trial medical institution head node 103 includes a trial examination document button 201 of the trial request document, a trial examination document button 202 of the new safety information, Corresponding to a clinical trial examination document button 203 for notification of change of the plan or the like. In addition, an arrow 302 from the investigator's node 102 to the head of the investigating medical institution head node 103 is associated with an investigation application document button 204 in the application form and an investigation examination document button 205 in the inquiry form. Yes. Further, an examination screening document button 208 of the examination request form is associated with an arrow 303 from the node 103 of the trial medical institution head to the node 104 of the IRB medical institution head. Further, an examination review document button 209 of the examination request form is associated with an arrow 304 from the node 104 of the IRB medical institution to the node 105 of the IRB. The IRB node 105 is associated with a clinical trial examination document button of the minutes. In addition, a clinical trial examination document button 211 of the result report is associated with an arrow 305 from the IRB node 105 to the node 104 of the head of the IRB medical institution. Further, an investigation examination document button 212 of the result notification is associated with the arrow 306 from the IRB medical institution head node 104 to the trial medical institution head node 103. In addition, the examination examination document button 206 for notification of instruction determination is associated with the arrow 307 from the node 103 of the head of the clinical trial institution to the node 101 of the trial sponsor. In addition, an examination examination document button 207 for notification of instruction determination is associated with an arrow 308 from the node 103 of the head of the clinical trial institution to the node 102 of the investigator.

  In the screen of FIG. 13, when the user clicks the clinical review document button 201 in the implementation request document, the clinical trial document button instruction receiving unit 12 determines that an instruction for the button has been received (step S103), and the button corresponding screen output unit 13 Referring to the button management table of FIG. 15, the button corresponding screen 1, that is, the button corresponding screen corresponding to the execution request is displayed on the display 23 (step S104).

  FIG. 17 is a diagram showing a button corresponding screen corresponding to the execution request document displayed on the display 23 by the button corresponding screen output unit 13. In FIG. 17, a print button and other UI parts are displayed. Other UI parts include, for example, an issue date input menu, a text input field describing attachments, a “delete attachment” button, a “save” button, a “close” button, and a check box without attachments. Etc. Note that on the button corresponding screen, as shown in FIG. 17, a text other than a print button, UI parts, or the like may be displayed. It is assumed that the user operates the keyboard 21 and inputs the attached material “XXXXXX (2005/9/15)” in the input field of the attached material as shown in FIG. Further, it is assumed that the user operates the mouse 22 to select the issue date “2005/10/26” from the pull-down input menu. Then, the data is received by the input receiving unit 14 (step S107), and the button corresponding screen output unit 13 also displays the input data on the display 23.

  Thereafter, when the user operates the mouse 22 and clicks the “save” button, the storage unit 15 stores and holds the input data received by the input receiving unit 14 in a recording medium (not shown) (step S108). FIG. 18 is a diagram illustrating the input data accumulated by the accumulation unit 15. FIG. 18 shows data constituting a part of the examination item table. In FIG. 18, the issue date “2005/10/26”, presence / absence of attached material “1”, and attached material “XXXXXX (2005/9/15)” are the record ID “ It is included in the record identified by “1”. The presence / absence “1” of the attached material indicates that the attached material exists. In FIG. 17, when the check box for no attached material is set, the attribute value of the attribute “presence / absence of attached material” is “0” in the examination item table.

  Next, it is assumed that the user clicks the print button in FIG. Then, the print button instruction accepting unit 16 determines that an instruction for the print button has been accepted (step S105), and sends an implementation request form corresponding to the button corresponding screen currently displayed on the display 23 to the clinical trial examination document output unit 17. Give instructions to output. Then, the clinical trial examination document output unit 17 interprets and executes the output form corresponding to the implementation request form, displays the trial implementation form shown in FIG. 19 on the display 23, and records it on a recording medium (not shown) (step S106). ). In FIG. 19, the name of the director, the address of the trial client, the name, and the like are information acquired by searching the storage unit 15. Further, the date on the upper right and the display of the attached material in the attached material column are information input on the button corresponding screen of FIG.

  As described above, by acquiring information necessary for preparing the clinical trial examination document (in this case, the clinical trial application form) from the database accumulated by the accumulation unit 15, it is possible to prevent the clinical trial examination document from being erroneously written. it can. In addition, by outputting a button corresponding screen for requesting input of newly required data that is data other than the data accumulated by the accumulating unit 15 among the data necessary for preparing the clinical trial examination document, the user can It is only necessary to input the minimum necessary data, and the labor of the user is reduced. The user can also print out the clinical trial request form.

  In the display of FIG. 17, when the user operates the mouse 22 and clicks the “Close” button, the button corresponding screen output unit 13 stops outputting the button corresponding screen (step S109). Then, the main screen output unit 11 determines that it is time to output the main screen (step S101), and the main screen of FIG. 13 is displayed on the display 23 (step S102).

  Next, when the user clicks the clinical review document button 204 in the implementation application form on the screen of FIG. 13, the clinical trial document button instruction receiving unit 12 determines that an instruction for the button has been received (step S103), and the button corresponding screen output The unit 13 displays a button corresponding screen corresponding to the execution application on the display 23 (step S104).

  FIG. 20 is a diagram illustrating a button corresponding screen corresponding to the implementation application displayed on the display 23 by the button corresponding screen output unit 13. In FIG. 20, a print button and other UI parts are displayed. If there is no attached material in the case of the implementation application form, the user clicks the check box of “No attached material” to check it. Also in the implementation application form, as in the case of the implementation request form, the user selects an issue date (step S107).

  Thereafter, when the user operates the mouse 22 and clicks the “save” button, the storage unit 15 stores and holds the input data received by the input receiving unit 14 in a recording medium (not shown) (step S108). FIG. 21 is a diagram illustrating the input data accumulated by the accumulation unit 15. FIG. 21 shows data constituting a part of the examination item table. In FIG. 21, a record in which the issue date “2005/10/26”, presence / absence of attached material “0”, attached material “NULL”, and remarks “NULL” are identified by the record ID “1” in the examination item table Included. Here, NULL indicates that no attribute value is input. The presence / absence “0” of the attached material indicates that no attached material exists. In FIG. 20, since the check box for no attached material is set, the attribute value of the field “existence of attached material” is “0” in the examination item table.

  Next, assume that the user clicks the print button in FIG. Then, the print button instruction accepting unit 16 determines that an instruction for the print button has been accepted (step S105), and sends an application for implementation corresponding to the button corresponding screen currently displayed on the display 23 to the clinical trial examination document output unit 17. Give instructions to output. Then, the clinical trial examination document output unit 17 interprets and executes the output form corresponding to the application for implementation, displays the clinical trial request form shown in FIG. 22 on the display 23, and records it on a recording medium (not shown) (step S106). ). In FIG. 22, the name of the director, the name of the clinical trial client, and the like are information acquired by searching the storage unit 15. Further, the date in the upper right and the display of the attached material in the attached material column are information input on the button corresponding screen of FIG. In this specific example setting, since the length of the trial medical institution and the length of the IRB medical institution are the same, it is not necessary to output the examination request form corresponding to the trial examination document button 208. This time, it was deliberately explained to explain each clinical trial review document. In addition, even if the principal investigator and the head of the trial medical institution are the same, an implementation application form and an inquiry form will be issued.

  Next, when the user clicks the examination examination document button 208 in the examination request form on the screen in FIG. 13, the button corresponding screen in FIG. 23 is displayed on the display 23 in the same manner as described above (steps S103 and S104). ). When the user inputs a check into the check box or selects an issue date and clicks the “Save” button, the input data is accumulated by the accumulation unit 15 (steps S107 and S108). FIG. 24 is a diagram showing a part of the examination item table showing the accumulated input data. When the print button is clicked, the clinical trial request form shown in FIG. 25 is displayed on the display 23 and recorded on a recording medium (not shown) (steps S105 and S106). In FIG. 25, “Clinical Trial Application Form”, “XXXXX” (2005/9/15), “Clinical Trial Application Form”, and Clinical Trial Application Form. Attachments (not present at this time) will be automatically displayed as attachments to the clinical trial request form. In FIG. 23, when an additional attached material is input in the attached material column, the attached material is also displayed in FIG. In FIG. 25, since the head of the clinical trial institution and the head of the IRB medical institution are the same, it is not necessary to output a clinical trial examination request form.

  In this way, the output of the button corresponding screen, the input of the input data, the output of the clinical trial examination document, and the like are sequentially performed. In addition, in this specific example, the case where the implementation request document and the attached material of the implementation request document become the attached document in the examination request document has been explained. For example, in the new safety information, the inquiry form, and the new safety information The attached material entered on the corresponding button correspondence screen and the attached material entered on the button correspondence screen corresponding to the inquiry may be attached to the examination request form. As described above, the clinical trial examination document in the former stage and the attached material of the clinical trial examination document may be attached to the clinical trial examination document in the subsequent stage. Note that the clinical trial examination document in the previous stage is a clinical trial examination document associated with an arrow or a node before the clinical trial examination document focused on the main screen. In addition, a document or the like becomes an attached material in the clinical trial examination document means that the name of the document or the like is described in the column of the attached material in the clinical trial examination document. In addition, the process of making the clinical trial examination document in the previous stage and the attached material of the clinical trial examination document as an attachment in the subsequent clinical trial examination document may be performed on the clinical trial examination document up to the examination request form sent to the IRB. Good. That is, it is not necessary to carry out the clinical trial document after the result report sent from the IRB.

  Here, the situation where the clinical trial examination document creation apparatus 1 according to the present embodiment is used will be briefly described. For example, the clinical trial screening document creation apparatus 1 may be used to create a clinical trial screening document in a specific node. For example, it may be used by IRB medical institutions to prepare review request documents, minutes, results reports, and result notifications, and clinical trial medical institutions to create inquiry forms, review request documents, and instruction decision notifications. It may be used by the clinical trial client to create an implementation request form, new safety information, and the like. In such a case, the IRB master table, the investigator master table, the trial sponsor master, the protocol table, the examination item table, etc. are first input using the input device in the clinical trial document preparation apparatus 1 of each node. Alternatively, an IRB master table or the like input at another node may be read into the clinical trial document creation apparatus 1 via a recording medium or the like. In addition, for example, when a specific person acts on behalf of office work for creating a clinical trial examination document, the clinical trial examination document creation apparatus 1 may be used. For example, a clinical trial support company (SMO) or the like may create each clinical trial examination document on behalf of the office of each node. In this case, the clinical trial examination document may be created as a blank field for a field in which no result is obtained, or the clinical trial examination document may be created after receiving the result.

  In addition, every time a new meeting is held, various clinical trial examination documents are created using the clinical trial examination document creating apparatus 1, and in this case, the attribute values such as the protocol table are changed. It is possible. For example, the affiliation of the investigator may be changed, the planned number of subjects may be changed, or the name of the sponsor may be changed. In such a case, check whether such changes are reflected in the protocol table or the like before creating the clinical trial document using the main screen in FIG. In this case, the clinical trial examination document is created after changing the attribute value of the protocol table or the like.

  In addition, in this specific example, as described above, the case where the investigator, the head of the clinical institution, and the head of the IRB medical institution are the same is described, but the investigator, the head of the clinical institution, IRB Naturally, the head of the medical institution may be separate.

  As described above, according to the clinical trial document preparation apparatus 1 according to the present embodiment, the nodes of the clinical trial sponsor and the investigator, the arrows between the nodes, the clinical trial examinations associated with the arrows and the nodes. By outputting a main screen with a document button and selecting the desired clinical trial document button on the main screen, you can input information corresponding to the clinical trial document button and output a clinical trial document. Even an unfamiliar user can appropriately create a clinical trial review document exchanged between a plurality of parties. Further, by storing the input information by the storage unit 15 and using the information in other clinical examination documents, it is possible to prevent the creation of an inconsistent clinical trial examination document. For example, by using protocol data or the like held in the storage unit 15, it is possible to prevent erroneous writing. For example, by setting a form or the like for creating a query that can display a list of protocol version numbers from the database held in the storage unit 15, various general inspections can be performed. The accuracy may be further improved. In addition, since a request for inputting information necessary for preparing the clinical trial examination document is made on the button-corresponding screen, it is possible to reduce input omissions and input errors. In addition, one or more clinical trial documents will be created by each party, but even in that case, the clinical trial document should be created and output using the main screen showing the flow of the clinical trial document. Therefore, it is possible to create a clinical trial review document without making a mistake.

  As a result, it is possible to rapidly proceed with the clinical trial examination process and to speed up the clinical trial process itself. Therefore, it can contribute to ensuring the safety of the subject, shorten the period until the investigational drug is approved and prescribed to patients who need the drug, and contribute to the maintenance and promotion of the national health It will contribute to the welfare of the people. In addition, the speeding up of clinical trial review is a national policy, which is consistent with the national policy.

  Furthermore, since errors in the clinical trial document can be significantly reduced, personnel involved in checking the clinical trial document can be reduced, and the cost for preparing the clinical trial document can be reduced.

  Furthermore, in Japan, the cost of clinical trials is much higher than in Europe and the United States, but by preparing clinical trial screening documents using the clinical trial screening document preparation apparatus 1 according to the present embodiment, a suitable clinical trial screening document can be obtained. It can be easily created, and as a result, the cost of clinical trials can be reduced, and it can contribute to enhancing the international competitiveness of the Japanese pharmaceutical industry.

  The above will be described in the case of new safety information. Consider the case where each party (sponsor, clinical trial institution, IRB medical institution) prepares a stand-alone document (the investigator and the head of the clinical trial institution, and the head of the IRB medical institution and the IRB are the same) Think of it as a computer.) As described above, it is necessary to input about 300 data for one examination of new safety information. However, when the clinical trial examination document preparation apparatus 1 according to the present embodiment is used, the input by the trial sponsor is about 25. Reduce from 5 to 5. The total number of input at the clinical trial medical institution is reduced to about 100, which is 4 (including a written inquiry, a clinical trial examination request form, and an instruction decision notification form), and only 5 times. At the IRB medical institution, 150 is 5 and the number of attachments is reduced to one.

(Embodiment 2)
A clinical trial examination document creation apparatus according to Embodiment 2 of the present invention will be described with reference to the drawings. In the clinical trial document creation apparatus according to the present embodiment, the clinical trial document button is displayed so that the clinical trial screening document completed by the main screen output unit and the incomplete clinical trial screening document can be visually distinguished.

  The configuration and operation of the clinical trial document preparation apparatus according to the present embodiment is such that the main screen output unit has a clinical trial document button so that the completed clinical trial document and the incomplete clinical trial document can be visually distinguished. Except for the display, the second embodiment is the same as the first embodiment, and the description thereof is omitted.

  In the present embodiment, as described above, the main screen output unit 11 displays two or more clinical review document buttons so that a completed clinical review document and an incomplete clinical review document can be visually distinguished. To do.

  First, it will be described how to determine whether or not a clinical trial examination document has been completed. Whether or not the clinical trial examination document is completed is made by comparing completion condition information, which is information indicating whether or not the clinical trial examination document is completed, with information constituting the clinical trial examination document. Here, the case of the specific example of Embodiment 1 is demonstrated. In the case of an execution request form, it is assumed that completion condition information is determined as shown in FIG. In FIG. 26, Condition 1 is a condition that the date of issue of the clinical trial request form is not NULL, that is, some information is input on the date of issue. In condition 1, “! =” Means not equal. Condition 2 is that the presence / absence of an attachment in the clinical trial request form is “0”, that is, no attachment is present, or the presence / absence of the clinical trial request form is “1”, that is, the attached document is This is a condition that the attached material of the clinical trial request form is not NULL, that is, that some information is input to the attached material.

  Therefore, the main screen output unit 11 refers to the examination item table, and whether the execution request form is completed depending on whether both conditions 1 and 2 of the completion condition information of the execution request form are satisfied. Judge whether. When both condition 1 and condition 2 are satisfied, that is, when the completion condition is satisfied, it is judged that the clinical trial examination document is completed and the completion condition is not satisfied Is judged that the clinical trial review document has not been completed. Whether or not each clinical trial review document has been completed by determining whether or not the completion condition information corresponding to each clinical trial review document is set, and whether or not the completion condition indicated by the completion condition information is satisfied. It shall be judged. For example, in the case of an examination request form sent from the head of the trial medical institution to the head of the IRB medical institution, the issuance date of the trial examination request form is entered, and whether or not there is an attached document of the trial examination request form. 0 ”or the presence / absence of the attached document is“ 1 ”, and the attached material is entered. In addition, whether or not the trial is appropriate, whether or not the trial is continued, or any other From the head of the clinical trial institution that it is “1”, that is, a check has been entered in any of the check boxes for the suitability for conducting the trial, the suitability for continuing the trial, and other check boxes. This is a condition for completing the examination request form sent to the head of the IRB medical institution. In addition, a check box indicating whether or not the document is completed is provided on the button correspondence screen in association with the clinical trial document so that it can be easily determined whether or not the clinical trial document is completed. It may be judged whether or not the clinical trial examination document has been completed depending on whether or not the box is checked (information on the presence or absence of the check is held in the examination item table).

Next, a method for displaying a clinical trial document button so that a completed clinical trial document and an incomplete clinical trial document can be visually distinguished will be described. The main screen output unit 11 may display, for example, a clinical trial document button corresponding to a completed clinical trial document and a clinical trial document button corresponding to an incomplete clinical trial document in different colors. The clinical trial document button corresponding to the clinical trial document may be highlighted, and the clinical trial document button corresponding to the completed clinical trial document may be displayed in a light (pale) manner. For example, when the implementation request form and the implementation application form are completed, in FIG. 13, the main screen output unit 11 displays the clinical trial examination document button 201 of the implementation request form and the clinical trial examination document button 204 of the implementation application form. May be displayed in red, and other clinical review document buttons may be displayed in green. In the same case, the main screen output unit 11 may highlight the clinical trial examination document buttons corresponding to the clinical trial examination documents other than the implementation request form and the implementation application form by flashing them. The document button may be highlighted by displaying it with a thick frame or a double frame. In the same case, the main screen output unit 11 may display the clinical trial examination document button corresponding to the implementation request form or the implementation application form thinner than other clinical trial examination document buttons.

  As described above, in the clinical trial screening document creation apparatus according to the present embodiment, the main screen output unit 11 allows the clinical trial screening document to be visually distinguished from the completed clinical screening document and the incomplete clinical screening document. Since the button is displayed, the user can easily know which clinical trial document is completed and which clinical trial document is not completed by looking at the main screen. For example, even if the clinical trial document preparation device is terminated when the implementation request form and the implementation application form are created, the main screen is output after the clinical trial document preparation device is started next time. It becomes clear at a glance which documents have been created and which documents must be created next. Thus, the convenience of the user who creates the clinical trial examination document is improved.

  It should be noted that the completion condition information described in the present embodiment is an example, and it is needless to say that the completion condition information can be appropriately set according to the clinical trial examination document. In the above description, only the information input on the button corresponding screen is determined, but other information may be determined. For example, a condition as to whether or not an investigational drug code or a general name of the investigational drug, which is information necessary for outputting the clinical trial examination document, may be set in the completion condition information related to the clinical trial execution request form. In addition, the completion condition information may be information indicating the condition that the clinical trial document is completed, as long as the result indicates the condition that can determine whether or not the clinical trial document is completed. Alternatively, it may be information indicating a condition that the clinical trial examination document is not completed.

  In each of the above-described embodiments, a case has been described in which two or more nodes on the main screen are nodes that identify the trial requester, the investigator, the head of the trial medical institution, the head of the IRB medical institution, and the IRB. It goes without saying that each node may be changed in accordance with a change in the clinical trial examination regulations.

  In each of the above-described embodiments, the clinical trial review document is changed to an implementation request document, new safety information, a plan document, and the like associated with the arrow from the trial requester node to the head node of the trial medical institution. Notification, the application form and the inquiry form associated with the arrow from the investigator's node to the head of the trial medical institution, and the node of the head of the trial medical institution to the node of the head of the IRB medical institution The review request document associated with the arrow to the IRB, the review request document associated with the arrow from the IRB medical institution head node to the IRB node, and the minutes associated with the IRB node And a result report associated with an arrow from the IRB node to the IRB medical institution head node, and an arrow from the IRB medical institution head node to the trial medical institution head node. A notification of the results, an instruction decision notification associated with the arrow from the trial medical institution head node to the sponsor node, and the trial medical institution head node to the investigator node Although the case where the notification is an instruction determination notification associated with an arrow has been described, it goes without saying that the clinical trial examination document associated with the arrow or node may be changed in accordance with changes in the clinical trial examination regulations. Yes.

  In each of the above embodiments, the case where the clinical trial document preparation apparatus is a stand-alone has been described. However, the clinical trial document preparation apparatus may be a stand-alone apparatus or a server apparatus in a server / client system. Also good. In the latter case, the output unit or the reception unit receives an input or outputs a screen via a communication line. In the case of using the clinical trial document preparation apparatus in the server / client system, each party uses the same database, and it is expected that the accuracy will be further improved.

  In addition, a database file (an IRB master table, an investigator master table, an investigator master, a protocol table, an examination item table, etc.) held in the storage unit 15 may be transmitted and received between the nodes. Here, the transmitted / received database file may be information including schema information, or may be information of only data not including schema information. For example, a clinical trial requester inputs a database file using a clinical trial examination document creation device and creates an implementation request form. Then, the database file is transmitted from the clinical trial examination document creation apparatus of the clinical trial client to the clinical trial examination document creation apparatus of the head of the trial medical institution. In this transmission, for example, various protocols such as electronic mail, HTTP, and FTP can be used. The head of the clinical trial medical institution creates an examination request form by using a trial examination document creation apparatus that incorporates the transmitted database file. In this way, it is possible to omit the input of the attached material by transmitting and receiving the database file between the nodes. For example, in the clinical trial document preparation apparatus head of the clinical trial medical institution, the database file transmitted from the clinical trial document preparation apparatus of the clinical trial client can be used, and therefore the input of the attached document may be omitted. Further, when transmitting / receiving a database file, the database file may be divided into two or more, and only necessary portions may be transmitted / received. When the database file is divided, it may be divided in units of records or may be divided in units of attributes.

  Needless to say, the clinical trial document preparation apparatus according to each of the above embodiments may handle clinical trial screening documents other than those described in the respective embodiments. For example, “report to IRB”, “completion report”, “completion notification”, etc. may be handled in the clinical trial examination document preparation apparatus. The report to the IRB is a document sent from the head of the trial medical institution to the head of the IRB medical institution and sent from the head of the IRB medical institution to the IRB. The completion report is a document sent from the investigator to the head of the trial medical institution. The termination notice is a document that is sent from the head of the trial medical institution to the sponsor, sent from the head of the trial medical institution to the head of the IRB medical institution, and sent from the head of the IRB medical institution to the IRB. .

  In each of the above embodiments, each processing or each function may be realized by centralized processing by a single device or a single system, or distributed processing by a plurality of devices or a plurality of systems. May be realized.

  In each of the above embodiments, each component may be configured by dedicated hardware, or a component that can be realized by software may be realized by executing a program. For example, each component can be realized by a program execution unit such as a CPU reading and executing a software program recorded on a recording medium such as a hard disk or a semiconductor memory. The software that realizes the information processing apparatus in each of the above embodiments is a program as described below. In other words, this program is a program for causing a computer to execute a process of creating a clinical trial examination document that is a document necessary for a clinical trial examination, and two or more nodes for identifying persons or organizations involved in the clinical trial. A screen having two or more arrows indicating the moving direction of the clinical trial document between the nodes and two or more clinical review document buttons that are buttons displaying a clinical trial document identifier for identifying the clinical trial document. The main screen output step, the clinical trial document button instruction receiving step for receiving an instruction for the clinical trial document button, and the clinical trial document button that has received the instruction when the instruction is received in the clinical trial document button instruction receiving step Is a UI part that is a part that inputs data, and a print button that corresponds to the output form. A button-corresponding screen output step for outputting a button-corresponding screen which is a screen having; an input accepting step for accepting input data for UI parts possessed by the button-corresponding screen; an accumulating step for accumulating the accepted input data; A print button instruction receiving step for receiving an instruction for a print button included in the screen, and when an instruction is received in the print button instruction receiving step, the corresponding data is read from the data stored in the storage step, and the instruction is received. An output form corresponding to the button is used to execute a clinical trial screening document output step of outputting a clinical trial screening document.

  In the above program, the output step for outputting information and the accepting step for receiving information do not include at least processing performed only by hardware, for example, processing performed by a modem or an interface card in the output step. .

  Further, this program may be executed by being downloaded from a server or the like, and a program recorded on a predetermined recording medium (for example, an optical disk such as a CD-ROM, a magnetic disk, a semiconductor memory, or the like) is read out. May be executed by

  Further, the computer that executes this program may be singular or plural. That is, centralized processing may be performed, or distributed processing may be performed.

  Further, the present invention is not limited to the above-described embodiment, and various modifications are possible, and it goes without saying that these are also included in the scope of the present invention.

  As described above, according to the clinical trial examination document preparation apparatus and the like according to the present invention, the clinical trial examination document can be appropriately created, and it is effective as an information processing apparatus information processing system for creating a clinical trial examination document.

FIG. 1 is a block diagram showing the configuration of a clinical trial document creation apparatus according to Embodiment 1 of the present invention. Flowchart showing the operation of the clinical trial document preparation apparatus according to the embodiment The figure which shows an example of the input screen by the embodiment The figure which shows an example of the data by the embodiment The figure which shows an example of the data by the embodiment The figure which shows an example of the data by the embodiment The figure which shows an example of the data by the embodiment The figure which shows an example of the data by the embodiment The figure which shows an example of the data by the embodiment The figure which shows an example of the data by the embodiment The figure which shows an example of the data by the embodiment The figure which shows an example of the data by the embodiment The figure which shows an example of the main screen by the embodiment The figure which shows an example of the data by the embodiment The figure which shows an example of the data by the embodiment The figure which shows an example of the data by the embodiment The figure which shows an example of the button corresponding | compatible screen by the embodiment The figure which shows an example of the data by the embodiment The figure which shows an example of the clinical trial examination document by the embodiment The figure which shows an example of the button corresponding | compatible screen by the embodiment The figure which shows an example of the data by the embodiment The figure which shows an example of the clinical trial examination document by the embodiment The figure which shows an example of the button corresponding | compatible screen by the embodiment The figure which shows an example of the data by the embodiment The figure which shows an example of the clinical trial examination document by the embodiment The figure which shows an example of the completion condition information in Embodiment 2 of this invention

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Examination examination document preparation apparatus 11 Main screen output part 12 Examination examination document button instruction | indication reception part 13 Button corresponding | compatible screen output part 14 Input acceptance part 15 Accumulation part 16 Print button instruction | indication reception part 17 Examination examination document output part

Claims (9)

A clinical trial document preparation apparatus for preparing a clinical trial review document that is a document necessary for a clinical trial review,
Two or more nodes that identify the person or organization involved in the clinical trial, and the direction in which the clinical trial document is moved between the nodes, and from the node of the clinical trial document creator, and 2 or more arrows indicating the direction to the node, a button institutional review document identifier identifying the institutional review document is displayed, with button associated with the said arrow by information associating the arrows and buttons A main screen output unit for outputting a screen having two or more clinical trial document button;
A clinical trial document button instruction receiving unit that receives instructions for the clinical trial document button;
This is information that associates a clinical trial examination document button with a UI part that is a part that inputs data and a button corresponding screen that is a screen having a print button corresponding to an output form. A button management information storage unit for storing button management information;
A button-corresponding screen output unit that outputs a button-corresponding screen associated with the clinical trial document button that has accepted the instruction by the button management information when the clinical trial document button instruction accepting unit accepts the instruction;
An input accepting unit for accepting input data for a UI part included in the button correspondence screen;
A storage unit that stores and holds the input data received by the input receiving unit in association with an attribute corresponding to the UI component for which the input data is received;
A print button instruction accepting unit for accepting an instruction for a print button included in the button correspondence screen;
An output form storage unit for storing an output form, which is information on an attribute value attribute to be output and a layout of each attribute, for each clinical trial examination document;
When the print button instruction accepting unit accepts an instruction, the trial examination document identifier displayed on the clinical trial examination document button associated with the button management information on the button corresponding screen having the print button that accepted the instruction. An output form of the clinical trial document to be identified, the data corresponding to the attribute included in the output form stored in the output form storage unit is read from the storage unit, and the clinical trial document is output in the output form A clinical trial screening document output unit ,
The main screen output unit, on the screen output by the main screen output unit, displays a button associated with the arrow on the arrow according to information associating the arrow with the button, and a clinical trial examination document creation device . The main screen output unit, on the screen output by the main screen output unit, distributes the button associated with the arrow according to the information associating the arrow with the button between the start point and end point coordinates of the arrow. The clinical trial examination document preparation apparatus according to claim 1, which is displayed at a position where The two or more nodes are:
3. The clinical trial document preparation apparatus according to claim 1 or 2 , wherein the clinical trial requester, the investigator, the head of the clinical trial institution, the head of the IRB (institutional review board) medical institution, and a node for identifying the IRB. The clinical trial document button is
Notification of changes to the clinical trial request form, new safety information, clinical trial plan, etc. associated with the arrow from the sponsor's node to the head node of the trial medical institution in association with the arrow and button A clinical trial document button displaying a clinical trial document identifier for identifying the
The clinical trial document identifier that identifies the application form and clinical trial inquiry form, which is associated with the arrow from the investigator's node to the head node of the trial medical institution, is associated with the arrow and button. Clinical review document button,
The clinical trial document identifier for identifying the clinical trial examination request document is displayed, which is associated with the arrow from the trial medical institution head node to the IRB medical institution head node by information associating the arrow with the button . Trial review document button,
A clinical trial document button displaying a clinical trial document identifier for identifying a clinical trial request document, which is associated with the arrow from the head of the IRB medical institution to the IRB node by the information associating the arrow with the button; ,
A clinical trial document button displaying a clinical trial document identifier for identifying the minutes, which is graphically associated with the IRB node;
A clinical trial document button displaying a clinical trial document identifier for identifying a screening result report, which is associated with an arrow from the IRB node to the head node of the IRB medical institution by the information associating the arrow with the button; ,
The clinical trial document identifier for identifying the examination result notice is displayed, which is associated with the arrow from the IRB medical institution head node to the trial medical institution head node by information associating the arrow and the button . Trial review document button,
The clinical trial document identifier that identifies the instruction decision notification regarding the clinical trial, which is associated with the arrow from the head of the clinical trial medical institution to the sponsor's node by the information that associates the arrow with the button, is displayed. Trial review document button,
The clinical trial review document identifier for identifying the instruction decision notification related to the clinical trial, which is associated with the arrow from the head of the trial medical institution to the investigator's node by the information for associating the arrow with the button, is displayed. The clinical trial document preparation apparatus according to claim 3 , wherein the clinical trial document button is a clinical trial document button. The main screen output unit displays the two or more clinical review document buttons so that a completed clinical review document and an incomplete clinical review document can be visually distinguished from each other. Any of the clinical trial screening document preparation devices described. 6. The clinical trial document creation apparatus according to claim 5, wherein the main screen output unit highlights a clinical trial document button corresponding to an incomplete clinical trial document. 6. The clinical trial screening according to claim 5, wherein the main screen output unit displays a clinical trial screening document button corresponding to a completed clinical trial screening document and a clinical trial screening document button corresponding to an incomplete clinical trial screening document in different colors. Document creation device. A clinical trial document preparation method for preparing a clinical trial review document, which is a document necessary for a clinical trial review,
Two or more nodes that identify the person or organization involved in the clinical trial, and the direction in which the clinical trial document is moved between the nodes, and from the node of the clinical trial document creator, and 2 or more arrows indicating the direction to the node, a button institutional review document identifier identifying the institutional review document is displayed, with button associated with the said arrow by information associating the arrows and buttons A main screen output step for outputting a screen having two or more clinical trial document buttons;
A clinical trial document button instruction receiving step for receiving instructions for the clinical trial document button;
When an instruction is received in the clinical trial document button instruction receiving step, the clinical trial document button stored in the button management information storage unit and the clinical trial document button stored in the button management information storage unit are received. Button correspondence screen that is a corresponding screen and is associated by button management information that is information that associates a UI component that is a component for inputting data with a button correspondence screen that is a screen having a print button corresponding to an output form. Button corresponding screen output step to output
An input accepting step for accepting input data for the UI component of the button corresponding screen;
An accumulation step of accumulating the input data received in the input reception step in association with an attribute corresponding to the UI component for which the input data is received;
A print button instruction receiving step for receiving an instruction for a print button included in the button corresponding screen;
When an instruction is received in the print button instruction receiving step, the clinical trial document identifier displayed on the clinical trial document button associated with the button management information on the button corresponding screen having the print button that has received the instruction. An output form of the clinical trial document to be identified, which is stored in an output form storage unit in which an output form that is information on the attribute value attribute to be output and the layout of each attribute is stored for each clinical trial document Reading out data corresponding to attributes included in the form from the data accumulated in the accumulation step, and outputting a clinical trial examination document in the output form,
In the main screen output step,
A method for preparing a clinical trial screening document , wherein a button associated with the arrow is displayed on the arrow by information associating the arrow with the button on a screen output in the main screen output step . On the computer,
A program for executing a process of creating a clinical trial document, which is a document necessary for a clinical trial,
Two or more nodes that identify the person or organization involved in the clinical trial, and the direction in which the clinical trial document is moved between the nodes, and from the node of the clinical trial document creator, and 2 or more arrows indicating the direction to the node, a button institutional review document identifier identifying the institutional review document is displayed, with button associated with the said arrow by information associating the arrows and buttons A main screen output step for outputting a screen having two or more clinical trial document buttons;
A clinical trial document button instruction receiving step for receiving instructions for the clinical trial document button;
When an instruction is received in the clinical trial document button instruction receiving step, the clinical trial document button stored in the button management information storage unit and the clinical trial document button stored in the button management information storage unit are received. Button correspondence screen that is a corresponding screen and is associated by button management information that is information that associates a UI component that is a component for inputting data with a button correspondence screen that is a screen having a print button corresponding to an output form. Button corresponding screen output step to output
An input accepting step for accepting input data for the UI component of the button corresponding screen;
An accumulation step of accumulating the input data received in the input reception step in association with an attribute corresponding to the UI component for which the input data is received;
A print button instruction receiving step for receiving an instruction for a print button included in the button corresponding screen;
When an instruction is received in the print button instruction receiving step, the clinical trial document identifier displayed on the clinical trial document button associated with the button management information on the button corresponding screen having the print button that has received the instruction. An output form of the clinical trial document to be identified, which is stored in an output form storage unit in which an output form that is information on the attribute value attribute to be output and the layout of each attribute is stored for each clinical trial document Read out data corresponding to the attributes included in the form from the data accumulated in the accumulation step, and output the clinical trial document in the output form, and execute the clinical trial document output step ,
In the main screen output step,
The program which displays on the said arrow the button matched with the said arrow by the information which matches the said arrow and the button on the screen output in the said main screen output step .

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