JP2009110425A - Clinical trial support device and clinical trial support program - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a clinical trial support device and a clinical trial support program, capable of efficiently checking a clinical trial even when a pharmaceutical company is remote from a medical institution. <P>SOLUTION: The clinical trial support device 4 for providing a clinical trial support site via a network W for a medical institution computer 2 installed at medical institutions A and B and a pharmaceutical company computer 3 installed at a pharmaceutical company C, includes: a database means for storing charte information, charte identification information, clinical trial identification information, execution facility identification information, and subject identification information uploaded from the medical institution computer 2 in association with one another; and a page control means for generating a page which includes a hierarchical tree-display data of the clinical trial identification information, the execution facility identification information, the subject identification information, and the charte identification in this order and transmitting the charte information to the pharmaceutical company computer 3 when the charte identification information is designated from the pharmaceutical company computer 3 and a browsing request of the charte information is received. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a clinical trial support apparatus and a clinical trial support program capable of conducting a clinical trial requested by a pharmaceutical company as a client at a medical institution far from the pharmaceutical company.

The clinical trial is conducted according to the following procedure. First, a pharmaceutical company that develops a new drug serves as a client and requests a clinical trial from a medical institution that is the implementation facility, and the medical institution reports information on subjects who have received the new drug to the pharmaceutical company as the results of the trial. The pharmaceutical company representative then visits the medical institution to confirm that the reported clinical trial results are based on the subject's medical records stored at the medical institution. Make contact with medical records. Then, the person in charge of the pharmaceutical company adjusts the date to visit in advance with the medical institution when performing the above confirmation, and browses the medical record of the subject prepared by the medical institution that is the visited site.
However, it is a heavy burden for the pharmaceutical company in terms of time and cost to visit the medical institution each time the person in charge of the pharmaceutical company performs the above confirmation. If the medical institution is far away, the burden on the pharmaceutical company is even greater. In addition, doctors of medical institutions must be prepared so that the subject's chart can be viewed at each visit, and it is also necessary to secure a viewing space, which is a burden.
For example, Patent Document 1 discloses a clinical trial support apparatus that allows a pharmaceutical company person to easily read a medical chart even when a medical institution is located far away. Patent Document 1 extracts an electronic medical record database and a case report item associating means, means for designating a trial patient based on clinical trial information added to the electronic medical record database, normal medical information input means, and clinical trial data. Therefore, there is described a clinical trial data output device including search means based on the conditions obtained by the association means and means for outputting case information of the extracted clinical trial data.

JP 2004-348271 A

By the way, when a person in charge of a pharmaceutical company refers to clinical trial information such as a medical record that describes the status of a clinical trial using a clinical trial support device, the relevant clinical trial can be found with a simple operation and the content of the clinical trial information can be confirmed. It is desirable to be able to do it. By doing so, the clinical trial information to be browsed can be accurately selected and the browsing time can be shortened, so that the clinical trial confirmation work can be performed efficiently.
Therefore, an object of the present invention is to provide a clinical trial support apparatus and a clinical trial support program capable of efficiently confirming a clinical trial even when a pharmaceutical company is located far from a medical institution.

  The clinical trial support apparatus of the present invention provides a clinical trial support site via a network to a medical institution computer installed in a medical institution where a clinical trial is conducted and a pharmaceutical company computer installed in a pharmaceutical company that is the requester of the clinical trial. A clinical trial information uploaded from the medical institution computer, medical chart identification information for identifying the medical chart information, clinical trial identification information for identifying the type of the clinical trial, and the medical institution A database means for storing the association identification information for identifying the subject and the subject identification information for identifying the subject, the clinical trial identification information, the implementation facility identification information, the subject identification information, and the A page including tree display data hierarchized in the order of medical record identification information is generated, and the pharmaceutical company computer Page control means for transmitting medical chart information corresponding to the specified medical chart identification information to the pharmaceutical company computer when the medical chart information browsing request is received by specifying the medical chart identification information. .

  The clinical trial support program of the present invention is connected to a medical institution computer installed in a medical institution where the clinical trial is conducted and a pharmaceutical company computer installed in the pharmaceutical company requesting the clinical trial via a network. A clinical trial support program for causing a computer to function as a clinical trial support device for providing a clinical trial support site, wherein the computer is a computerized chart for identifying electronic chart information uploaded from the medical institution computer and the chart information. Database in which identification information, clinical trial identification information for identifying the type of clinical trial, implementation facility identification information for identifying the medical institution, and subject identification information for identifying the subject are stored in association with each other Means, clinical trial identification information, implementation facility identification information, subject identification information, and previous Generate a page including tree display data layered in the order of medical record identification information, specify the medical record identification information from the pharmaceutical company computer, and receive a medical record information browsing request, the specified medical record identification information It is made to function as a page control means which transmits corresponding medical chart information to the said pharmaceutical company computer.

  The database means includes the chart information uploaded from the medical institution computer, the chart identification information for identifying the chart information, the trial identification information for identifying the type of the trial, and the facility identification information indicating the medical institution. The subject identification information for identifying the subject is stored in association with each other. The page control means generates a page including tree display data. A person in charge at the pharmaceutical company who is the client can display a page including tree display data by operating the pharmaceutical company computer. Since this tree display data is hierarchized in the order of clinical trial identification information, conducting facility identification information, subject identification information, and chart identification information, the chart identification information identifying the chart information indicates who the subject is. , Easily identify visually where the facility is and what type of trial. Then, when the page control means specifies the chart identification information from the pharmaceutical company computer and receives the chart information browsing request, the page control means transmits the chart information corresponding to the designated chart identification information to the pharmaceutical company computer. The chart information desired by the person in charge of the company can be easily viewed on the pharmaceutical company computer.

  Furthermore, the present invention provides a registration means for registering authentication information for identifying a viewer who operates the pharmaceutical company computer in association with clinical trial identification information related to the viewer, and the viewer registers the pharmaceutical company computer. Authentication means for authenticating by inputting authentication information when operating, and the page control means includes clinical trial identification information associated with the inputted authentication information and the implementation facility associated with the clinical trial identification information Only the identification information, the subject identification information, and the chart identification information can be transmitted as tree display data to the pharmaceutical company computer. In this way, only the requester registered by the registration unit and authenticated by the authentication unit can browse only the clinical trial information related to the viewer.

  Furthermore, the present invention preferably includes a mail transmission means for notifying that the chart information is uploaded to the e-mail address of the viewer by e-mail when clinical trial information is uploaded from the medical institution computer. . By doing so, it is possible to easily recognize that the clinical trial information has been uploaded.

  According to the present invention, the chart information can easily identify visually who the subject is, where the conducting facility is, and what kind of clinical trial, and can easily browse the chart information desired by the client. Therefore, even if the client is located far away from the medical institution, it is possible to efficiently confirm the clinical trial.

  A clinical trial support apparatus according to an embodiment of the present invention will be described with reference to the drawings. FIG. 1 is a diagram showing a configuration of a clinical trial support system using a clinical trial support apparatus according to an embodiment of the present invention.

As shown in FIG. 1, the clinical trial support system 1 supports smooth clinical trials performed between medical institutions A and B and a pharmaceutical company C using a clinical trial support site.
The clinical trial support system 1 includes a medical institution computer 2 installed in the medical institutions A and B where the doctor who is conducting the trial is located, a pharmaceutical company computer 3 installed in the pharmaceutical company C which is the client, and an SMO (Site Management Organization), which includes a clinical trial support apparatus 4 that provides a clinical trial support site and an SMO computer 5, each of which is connected to the Internet W, which is an example of a network.

  The medical institution computer 2 is a computer for uploading medical chart image information, which is image data of a paper chart indicating the content and status of the clinical trial, to the clinical trial support apparatus 4. Although the medical institution computer 2 is for uploading medical chart image information, it is possible to view the medical chart image information when confirming whether the medical chart image information has been uploaded correctly. The pharmaceutical company computer 3 is a computer in which a person in charge of the pharmaceutical company becomes a viewer (monitor) and accesses the clinical trial support apparatus 4 to browse medical chart image information uploaded by the medical institution computer 2. The SMO computer 5 is used to maintain a clinical trial support site provided by the clinical trial support apparatus 4 by being operated by a person in charge of SMO (SMO staff). The SMO computer 5 can be omitted by directly operating the clinical trial support apparatus 4.

  The medical institution computer 2, the pharmaceutical company computer 3, and the SMO computer 5 are browsing software that operates on the respective computers, and specify and access a URL (Uniform Resource Locator) indicating a clinical trial support site provided by the clinical trial support apparatus 4. .

The clinical trial support apparatus 4 is a web page providing server that provides each clinical trial support page of the clinical trial support site by being accessed by browsing software. The computer which is this server functions as a clinical trial support apparatus by operating a clinical trial support program.
Here, the clinical trial support apparatus 4 will be described in detail with reference to FIG. FIG. 2 is a diagram showing the configuration of the clinical trial support apparatus shown in FIG.

  The clinical trial support apparatus 4 includes a communication unit 41, a display unit 42, an input unit 43, a storage unit 44, and a control unit 45.

  The communication means 41 has a function of communicating with the Internet W. The communication means 41 is preferably a LAN that can communicate with the Internet W at high speed.

  The display means 42 can use a CRT (Cathode Ray Tube), an LCD (Liquid Crystal Display) or the like, and displays display data from the control means 45. The input means 43 can be a keyboard or a mouse, and the input data is output to the control means 45.

  The storage means 44 can be a large-capacity hard disk drive that is non-volatile and capable of reading and writing at high speed. The hard disk drive stores an OS (Operating System), a clinical trial support program, and other application software. The storage unit 44 includes a registrant data storage unit 44a and a database unit 44b.

  In the registrant data storage means 44a, in order to identify those who can operate this clinical trial support site, doctors of medical institutions A and B and medical institutions A and B, pharmaceutical company C and the person in charge of pharmaceutical company C ID information indicating an ID and password information indicating a password are associated with each information indicating SMO and SMO staff and registered as authentication information. That is, in the registrant data storage means 44a, the implementation facility person in charge identification information for identifying the doctor in the implementation facility identification information for identifying the medical institutions A and B is the requester identification for identifying the pharmaceutical company. The information includes the monitor identification information for identifying the person in charge of the pharmaceutical company, the SMO identification information for identifying the SMO, the SMO staff identification information for identifying the SMO staff, together with the ID information and the password information. It is associated and registered.

  The database means 44b uses clinical chart image information, medical chart identification information, clinical trial identification information, implementation facility identification information, subject identification information, and information indicating parties related to the clinical trial as clinical trial information. Stored in association.

  The chart image information is an electronic version of the chart and is image information obtained by reading a paper chart with an image scanner. The chart image information can be in JPEG (Joint Photographic Experts Group) format, GIF (Graphic Interchange Format) format, PNG (Portable Network Graphics) format, and BMP (Bit MaP) format. In this embodiment, the paper chart is taken as the chart image information read by the image scanner, but it is only necessary to include the information of the subject to whom the new drug is administered, so the document file format, the table file format, the text file format, Or it can be the chart information in the original format.

  The chart identification information is information for identifying chart image information. As the chart identification information, for example, the last update date when the contents of the paper chart are updated or the date when the chart image information is uploaded, the person in charge of the pharmaceutical company C who is the viewer can easily identify the old and new of the chart image information. So desirable. The clinical trial identification information is information for identifying the type of clinical trial, and can be, for example, only one type of letters, alphabets, numbers, symbols, or a combination thereof. The implementation facility identification information is information indicating a medical institution and can be the name of the medical institution. The subject identification information is information for identifying the subject. For example, letters and numbers can be combined with the characters “subject”. If there is no problem with the subject's privacy, the name of the subject can be used.

  The control unit 45 controls the entire clinical trial support apparatus 4 as a whole, and includes a page control unit 45a, a registration unit 45b, an authentication unit 45c, and a mail transmission unit 45d.

  The page control unit 45 a has a function of generating and transmitting each page of the clinical trial support site via the communication unit 41 in response to access from the medical institution computer 2, the pharmaceutical company computer 3, or the SMO computer 5. . Each page data is stored in the storage means 44.

  The registration means 45b assigns information indicating medical institutions A, B and doctors who have requested registration based on the registration page, persons in charge of the pharmaceutical company C and pharmaceutical company C, and SMO and SMO staff. A function of storing the ID and password in the registrant data storage means 44a is provided.

  The authentication unit 45c has a function of performing authentication with the ID information and password information stored in the registrant data storage unit 44a based on the ID and password input through the login page and requested to be authenticated.

  The mail transmission unit 45d has a function of sending an e-mail notifying that the chart image information has been uploaded to a designated transmission destination.

  Returning to FIG. 1, the medical institution computer 2, the pharmaceutical company computer 3 or the SMO computer 5 includes a USB (Universal Serial Bus) key (not shown). This USB key is used by being attached to a USB provided in each of the medical institution computer 2, the pharmaceutical company computer 3, or the SMO computer 5. By attaching the USB key as one condition for obtaining authentication from the login page, higher security is achieved.

  The use state of the clinical trial support site provided by the clinical trial support apparatus 4 according to the embodiment of the present invention configured as described above will be described with reference to the drawings. FIG. 3 is a diagram showing a page configuration of the clinical trial support site. FIG. 4 is a diagram illustrating an example of a login page. FIG. 5 is a diagram illustrating an example of the menu page. FIG. 6 is a diagram illustrating an example of a requester registration page. FIG. 7 is a diagram illustrating an example of a monitor registration page. FIG. 8 is a diagram showing an example of a clinical trial information registration page. FIG. 9 is a diagram illustrating an example of a file registration page before uploading medical chart image information. FIG. 10 is a diagram illustrating an example of a file registration page after uploading medical chart image information. FIG. 11 is a diagram illustrating an example of an electronic mail transmitted by the mail transmission unit. FIG. 12 is a diagram illustrating an example of a chart viewing page when there is one implementation facility. FIG. 13 is a diagram illustrating an example of a chart image display page. FIG. 14 is a diagram illustrating an example of a chart viewing page when there are two implementation facilities.

  The clinical trial support site provided by the clinical trial support apparatus 4 includes pages as shown in FIG. The clinical trial support site has a login page, a menu page, registration pages for “master settings” for setting authentication information and various setting information, and a “registration function” for registering clinical trial image information and medical chart image information. Each page, a page for the “browsing function” for referring to the log, a page for the “form function” for outputting data to the outside, and a browsing for the person in charge of the pharmaceutical company to view the medical chart image information And a page.

  First, in order to operate the clinical trial support site, it is necessary to register authentication information on each page of “master setting”. For this reason, the administrator of the clinical trial support site consists of the pharmaceutical company (client) and the person in charge of the pharmaceutical company (monitor), the medical institution (implementation facility) and the doctor of the medical institution (implementation facility staff), SMO and SMO staff And register authentication information. It is desirable for the SMO staff to perform the management.

When registering the authentication information, the SMO staff as the administrator logs in using his / her ID and password registered in advance. This login is performed by logging in from a login page displayed by specifying and accessing a URL indicating a clinical trial support site by a browser operating on the SMO computer 5. An example of this login page is shown in FIG.
The login page shown in FIG. 4 is generated by the page control means 45 a in response to a request from the SMO computer 5 and transmitted via the communication means 41, so that it is displayed on the browser of the SMO computer 5. The SMO staff inputs the assigned ID and password in the ID input field R1 and the password input field R2 displayed on the login page, and presses the “Login” button B1.

When the “Login” button B1 is pressed, the SMO computer 5 transmits the input ID information and password information to the clinical trial support apparatus 4.
Upon receiving the ID and password, the clinical trial support apparatus 4 determines whether or not the ID information and password information are registered in the registrant data storage unit 44a by the authentication unit 45c. By notifying, a page prompting re-input is transmitted.

  When the authentication is completed by the authentication unit 45c and the user logs in, the SMO computer 5 displays the menu page shown in FIG. First, the “requester registration” button B2 is pressed to register a pharmaceutical company. When the “requester registration” button B2 is pressed, a requester registration page shown in FIG. 6 is displayed.

  Since the requester registration page is a new registration, first, the “new” button B3 is pressed. The official name of the pharmaceutical company is entered in the “requester name” (pharmaceutical company name) input field R3. For example, if the official name of the pharmaceutical company is “ABC Pharmaceutical Co., Ltd.”, “Kabushiki Gaisha ABC SEYAK” is entered as the kana character of the pharmaceutical company name in the “Requester Kana” input field R4, and the “Requester abbreviation name” is entered. In the input field R5, “ABC Pharmaceutical” is entered as an abbreviated name that omits corporations and limited companies. Then, by pressing the “update” button B4 that is made effective by pressing the “new” button B3, various information relating to the input pharmaceutical company “ABC Pharmaceutical Co., Ltd.” is registered as requester identification information. By 45b, it is stored in association with the registrant data storage means 44a and displayed in the requester display field R6. At this time, client ID information for identifying the pharmaceutical company assigned by the registration unit 45b is displayed in the “client ID”. When registration of the various information of the input pharmaceutical company is completed, the “close” button B5 is pressed to return to the menu page.

  Next, in order to register the person in charge of the pharmaceutical company, a “monitor registration” button B6 is pressed on the menu page shown in FIG. In the monitor registration page shown in FIG. 7 generated by the page control means 45a, first, the pharmaceutical company to which the person in charge belongs is selected from the pull-down menu in the “requester ID” input field R7. In this pull-down menu, a list of pharmaceutical companies registered on the requester registration page is displayed. For example, “ABC Pharmaceutical Co., Ltd.” is selected.

  After selecting the pharmaceutical company, the name of the person in charge is registered. Since this is a new registration, the “New” button B7 is pressed. The “new” button B7 may be pressed before the selection of the pharmaceutical company.

Enter the name of the person in charge in Kanji or English in the “Monitor name” (pharmaceutical company person in charge) input field R8, and enter the kana character in the name of the person in charge in the “Monitor name kana” input field R9. To do. Also, the ID for the person in charge is entered in the “login ID” input field R10, the password is entered in the “password” entry field R11, the e-mail address is entered in the “mail address” entry field R12, and the serial number information of the USB key is “USB serial”. Enter each in the “key” input field R13.
In addition, when this monitor (person in charge of a pharmaceutical company) is an administrator, the “manager classification” check box C1 is validated.

  Then, by pressing the “update” button B8 enabled by pressing the “new” button B7, the registration unit 45b associates each piece of information with the requester ID information as requester identification information. Stored in the registrant data storage means 44a. When registration is completed, the “close” button B9 is pressed to return to the menu page.

  Similarly, the SMO staff who is the administrator presses the “Register for Facility” button B10 on the menu page shown in FIG. 5 to register information regarding the medical institution as the facility identification information, and “Register for Facility Manager”. The button B11 is pressed to register the information regarding the doctor as the identification information for the person in charge of the facility. Further, by pressing the “SMO staff registration” button B12, information regarding other SMO staff is registered as SMO staff identification information. In the case of registering another SMO, the “SMO registration” button B13 is pressed to register it as SMO identification information related to the other SMO.

  When registration of the parties operating the clinical trial support site is completed, next, clinical trial information that is various information related to the clinical trial is registered. Various information related to the clinical trial can be registered on the clinical trial information registration page displayed by pressing the “registration of clinical trial information” button B14 on the menu page shown in FIG.

  As shown in FIG. 8, the clinical trial information registration page includes the clinical trial identification information indicating the type of clinical trial, the person in charge of the pharmaceutical company involved in the clinical trial (requester identification information), and the medical institution (implementation facility identification) where the clinical trial is conducted. Information), a medical institution doctor (implementation facility staff identification information), and an SMO staff (SMO staff identification information). When newly registering a clinical trial, the SMO staff first presses a “new” button B15. By pressing the “new” button B15, the page control means 45a causes the “clinical facility” selection display field R14, the “performing facility person” selection display field R15, the “monitor” selection display field R16, and “ The implementation facility identification information, the implementation facility person in charge identification information, the monitor identification information, and the SMO staff identification information registered in the registrant data storage means 44a are read and displayed in the “SMO staff” selection display field R17.

  The SMO staff enters a symbol assigned to the investigational drug in the “investigation drug symbol” input field R18. In addition, a comment about the investigational drug is entered in the “trial name” input field R19, and the number of the clinical trial plan assigned for conducting the clinical trial is entered in the “trial trial plan number” input field R20. In the present embodiment, the combination of the symbol of the investigational drug entered in the “study drug symbol” input field R18 and the number of the clinical trial protocol entered in the “trial protocol number” input field R20, This is clinical trial identification information for identifying the type of clinical trial. However, since it is sufficient that the type of clinical trial can be identified, the clinical trial identification information can be only the symbol of the clinical trial drug or only the number of the clinical trial plan.

  Then, from the displayed “clinical facility” selection display field R14, “performing facility person” selection display field R15, “monitor” selection display field R16, and “SMO staff” selection display field R17, By selecting the related parties (pharmaceutical staff, doctors, and SMO staff) and pressing the “Update” button B16, the page control means 45a registers these information as clinical trial information in the database means 44b. To do. When the clinical trial information is registered, the page control means 45a generates tree display data based on the clinical trial information, and displays it in the clinical trial information display area Sx.

  In the example illustrated in FIG. 8, “YAK15” is input as the “study drug symbol” and “KEI15” is input as the “trial study plan number”, and thus “YAK15_KEI15” is the clinical trial identification information. Therefore, in the clinical trial information display area Sx, “Clinical trial YAK15_KEI15” indicating the type of clinical trial is displayed on the route that is the first hierarchy, and the clinical trials A and B that are conducting clinical trials are indicated in this clinical trial identification information. Facility identification information is displayed as the second hierarchy. And the implementation facility identification information indicating the medical institutions A and B, the requester identification information indicating the pharmaceutical company C, and the SMO identification information indicating the SMO, which are related parties in this clinical trial, are displayed as the third hierarchy. . And the implementation facility person in charge identification information indicating the doctor, the monitor identification information indicating the person in charge of the pharmaceutical company C, and the SMO identification information indicating the SMO staff are displayed as the fourth hierarchy under the corresponding third hierarchy.

As described above, the parties related to the clinical trial are displayed in the clinical trial information display area Sx as a tree, so that the affiliations and names of all the related parties can be easily grasped.
When registration is completed, the “close” button B17 is pressed to return to the menu page.

Next, a procedure for a doctor to upload chart image information using a paper chart as image data will be described. When the doctor operates the clinical trial support site, the login page shown in FIG. 4 is displayed by operating the medical institution computer 2 and accessing the clinical trial support site. Therefore, the ID and password assigned to the doctor are input. And get certified.
When the “file registration” button B18 is pressed on the menu page (see FIG. 5) displayed after receiving authentication, the file registration page shown in FIG. 9 is displayed.

  The file registration page is divided into a tree display area S1, a directory designation area S2, and a file operation area S3.

  The doctor selects the type of clinical trial from the clinical trial identification information displayed in the pull-down menu of the “Clinical trial” selection field R21 provided in the directory designation area S2. By doing so, the page control means 45a reads the clinical trial information registered in the clinical trial information registration page (see FIG. 8) in the tree display area S1 from the database means 44b, and uses the clinical trial identification information “Clinical trial_YAK15_KE115” as the first hierarchy. Hierarchical tree display data is generated and displayed with the implementation facility identification information “medical institution A” indicating the implementation facility in which this clinical trial is being implemented as the second layer. The clinical trial identification information is displayed with an icon representing a capsule, and the implementation facility identification information is displayed with an icon representing a folder that sandwiches a document.

  Further, the page control means 45a displays the comment entered in the “Clinical trial name” input field R19 (see FIG. 8) of the clinical trial information registration page in the “Clinical trial name” display field R22 of the directory designation area S2. Furthermore, the page control means 45a displays the implementation facility identification information that is the medical institution to which the doctor belongs based on the ID assigned to the doctor, in the “Clinical trial facility” display field R23. In the example of FIG. 9, since the doctor belongs to the medical institution A, “medical institution A” is displayed.

  In the implementation facility identification information displayed in the “Clinical trial facility” display field R23, only the medical institution (implementation facility) to which this doctor belongs is displayed if logged in with the doctor's ID. However, if it is an SMO staff, since all the medical institutions that are conducting clinical trials with the clinical trial drug selected in the “Clinical trial” selection field R21 are displayed, they are displayed as the second hierarchy of the tree display area S1. The implementation facility identification information can be selected by using a mouse or the like, or can be changed by selecting from the pull-down menu of the “Clinical trial facility” display field R23.

  The doctor inputs a symbol made up of letters and numbers indicating the subject in the “directory name” input field R24 and presses the “update” button B19. By pressing the “update” button B19, the page control unit 45a takes the subject information input in the “directory name” input field R24 as the third hierarchy and imitates a folder sandwiching documents under the implementation facility identification information. Tree display with icons. In FIG. 8, “Student D” is displayed as the subject information.

  Then, the doctor inputs the file name “2007/10/17”, which is the chart identification information for specifying the chart image information, in the “file name” input field R25 of the file operation area S3, and the “file” designation field R26. The path and file in the medical institution computer 2 in which the medical chart image information is stored (for example, “c: \ Karte \ subject D \ 2007_10_17.jpg”) are designated. If necessary, enter a comment in the “comment” input field R27, and check the “mail transmission destination” designation check box group C2 for designating transmission of an e-mail for notification of uploading. . The person in charge of the request (the person in charge of the pharmaceutical company), the person in charge of the implementation (doctor), and the SMO staff specified in the “mail transmission destination” designation check box group C2 are shown in the “Execution Information Registration” page shown in FIG. The person in charge related to the clinical trial selected from the “facility manager” selection display field R15, the “monitor” selection display field R16, and the “SMO staff” selection display field R17.

  When the doctor completes the input, the doctor presses the “update” button B20, so that the medical chart image information, which is the image data of the paper chart designated in the “file” designation field R26, is transferred from the medical institution computer 2 to the clinical trial support apparatus 4. Uploaded to

  The page control unit 45a that has received the chart image information stores the chart identification information input as the file name and the chart image information as image data in the database unit 44b in association with the implementation facility identification information and the subject information. The medical chart identification information “2007/10/17” is displayed as a tree in the fourth hierarchy of the tree display area S1 together with an icon representing a paper chart sandwiched between clips. FIG. 10 shows the file registration page displayed as a tree in the fourth hierarchy.

  Then, the page control unit 45a transmits the e-mail to the transmission destination designated in the “mail transmission destination” designation check box group C2. Here, FIG. 11 shows an example of an e-mail notifying that uploading has been performed.

  In the e-mail shown in FIG. 11, the statement that the medical chart image information has been uploaded, the clinical trial identification information “YAK15” (study drug symbol) and “KEI15” (trial protocol number), and the investigational drug “Problem 15” (trial name), “medical institution A” (clinical facility) as identification information, “student D” (directory name) as subject information, and chart identification information “2007/10/17” (file name) and “administration first day” (comment) which is a comment sentence from the doctor regarding the chart image information are described. Thus, by receiving the e-mail, the related person can easily recognize that the clinical trial information has been uploaded.

  When confirming the uploaded chart image information, the chart identification information icon displayed as a tree in the fourth layer of the tree display area S1 is clicked with a mouse or the like. By this click, a browsing request is transmitted from the medical institution computer 2 to the clinical trial support apparatus 4. The page control means 45a of the clinical trial support apparatus 4 that has received the browsing request from the medical institution computer 2 reads the corresponding chart image information from the database means 44b and displays it as a chart image display page in a separate window. Details of the chart image display page will be described later.

  Next, when the person in charge of the pharmaceutical company who has received the e-mail at the pharmaceutical company computer 3 recognizes that the clinical trial information has been updated by uploading the medical chart image information, the browser operating on the pharmaceutical company computer 3 uses the browser. Then, access to the clinical trial support site 4.

  The person in charge of the pharmaceutical company accesses the clinical trial support site 4 and logs in from the login page shown in FIG. The authentication unit 45c determines whether or not the input ID and password are registered in the registrant data storage unit 44a. The page control means 45a reads the clinical trial information from the database means 44b and generates a chart reading page on condition that the entered ID and password are authenticated as registered and are in charge of a pharmaceutical company. To the pharmaceutical company computer 3. With the ID registered as the person in charge of the pharmaceutical company, the menu page shown in FIG. 5 is not displayed, and the chart reading page shown in FIG. 12 is displayed first. In other words, from the logged-in ID, if the ID is a person in charge of a pharmaceutical company registered as “monitor”, the chart viewing page is displayed after logging in.

  In this way, only the person in charge of the pharmaceutical company registered by the registration means 45b and authenticated by the authentication means 45c can browse only the clinical trial information related to the person in charge. Therefore, high security can be achieved.

  The chart browsing page is disabled by graying out the update button B19 of the directory designation area S2 from the file registration page shown in FIG. Is a page that is possible.

  When a person in charge of a pharmaceutical company wants to view medical chart image information that is image data of a medical chart, an icon corresponding to the desired chart identification information displayed as the fourth hierarchy is displayed on the mouse of the pharmaceutical company computer 3 or the like. Use and click (for example, “2007/10/17”).

  When detecting this click, the page control unit 45a reads the corresponding chart identification information from the database unit 44b and displays it as a chart image display page in a separate window.

  Here, the chart image display page will be described in detail with reference to FIG. As shown in FIG. 13, image data that is chart image information is displayed on the chart image display page. In the upper part of the chart image display page, a “clinical trial” display column R28, a “clinical trial facility” display column R29, a “directory name” display column R30, and a “file name” display column R31 are displayed. Also, display size change buttons B21 and B22 are provided in the middle of the chart image display page. By pressing the display size change buttons B21 and B22, the image data is reduced or enlarged step by step. When the image data is too large to fit in the display range, the image data is shifted by operating the vertical scroll bar B23 or the horizontal scroll bar B24, and the mouse pointer is positioned on the image data and dragged. Data movement can be performed.

  When the browsing of the chart image information is completed, the window is closed by pressing the “close” buttons B25 and B26 located in the middle stage or the lower stage.

  In the medical chart viewing page shown in FIG. 12, there is one medical institution that is a clinical trial facility, but FIG. 14 shows a case where there are two medical institutions, for example. The clinical trial may be performed not only in the medical institution A but also in the medical institution B. In this case, the person in charge of the pharmaceutical company C needs to confirm medical chart image information in the medical institution B.

  When there are two implementation facilities, the medical institution A and the medical institution B are displayed under the clinical trial identification information “YAK15_KEI15” as the same second hierarchy in the tree display area S1 of the chart reading page. The medical institution A and the medical institution B each have subject identification information (“Clinical Trial D” and “Clinical Trial E”) indicating the subject and medical chart image information (“ 2007/10/17 "and" 2007/10/18 ") are displayed in a tree view. The person in charge of the pharmaceutical company who is the viewer can easily view the contents of the chart image information by selecting the chart image information desired by the subject located in the implementation facility.

  Thus, according to the clinical trial support site provided by the clinical trial support apparatus 4, the chart information can easily identify visually who the subject is, where the conducting facility is, and what kind of clinical trial is performed. Therefore, even if the client is located far away from the medical institution, it is possible to efficiently confirm the clinical trial.

  The clinical trial support apparatus and the clinical trial support program of the present invention are suitable for clinical trials when developing new drugs. In particular, the present invention can be used not only when a medical institution and a pharmaceutical company are in the vicinity, but also from the pharmaceutical company because the chart information uploaded from the medical institution computer can be viewed from the pharmaceutical company computer via the network. The effect can be exerted even when the medical institution is far away.

It is a figure which shows the structure of the clinical trial support system using the clinical trial support apparatus which concerns on embodiment of this invention. It is a figure which shows the structure of the clinical trial support apparatus shown in FIG. It is a figure which shows the page structure of a clinical trial support site. It is a figure which shows an example of a login page. It is an example of a menu page. It is a figure which shows an example of a requester registration page. It is a figure which shows an example of a monitor registration page. It is a figure which shows an example of a clinical trial information registration page. It is a figure which shows an example of the file registration page before uploading medical chart image information. It is a figure which shows an example of the file registration page after uploading medical chart image information. It is a figure which shows an example of the email which a mail transmission means transmits. It is a figure which shows an example of the medical chart browsing page in case implementation facilities are one place. It is a figure which shows an example of a medical chart image display page. It is a figure which shows an example of the medical chart browsing page in case implementation facilities are two places.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Clinical trial support system 2 Medical institution computer 3 Pharmaceutical company computer 4 Clinical trial support apparatus 41 Communication means 42 Display means 43 Input means 44 Storage means 44a Registrant data storage means 44b Database means 45 Control means 45a Page control means 45b Registration means 45c Authentication means 45d Mail transmission means 5 SMO computer A, B Medical institution C Pharmaceutical company W Internet

Claims (4)

A clinical trial support apparatus that provides a clinical trial support site via a network to a medical institution computer installed in a medical institution where a clinical trial is performed and a pharmaceutical company computer installed in a pharmaceutical company that is a requester of the clinical trial,
Medical chart information uploaded from the medical institution computer, medical chart identification information for identifying the medical chart information, clinical trial identification information for identifying the type of clinical trial, and implementation facility identification for identifying the medical institution Database means for storing information and subject identification information for identifying the subject in association with each other;
Generate a page including tree display data layered in the order of the clinical trial identification information, the implementation facility identification information, the subject identification information, and the chart identification information, and specify the chart identification information from the pharmaceutical company computer. A clinical trial support apparatus comprising: page control means for transmitting medical chart information corresponding to designated medical chart identification information to the pharmaceutical company computer when a medical chart information browsing request is received. Registration means for registering authentication information for identifying a viewer who operates the pharmaceutical company computer in association with clinical trial identification information related to the viewer,
When the viewer operates the pharmaceutical company computer, authentication means for authenticating by inputting authentication information,
The page control means displays only the clinical trial identification information associated with the input authentication information, the implementation facility identification information associated with the clinical trial identification information, the subject identification information, and the medical chart identification information, as tree display data. The clinical trial support apparatus according to claim 1, wherein the clinical trial support apparatus outputs to the pharmaceutical company computer.   The mail transmission means which notifies by e-mail the notification that the chart information has been uploaded to the e-mail address of the viewer when the medical chart information is uploaded from the medical institution computer. Clinical trial support equipment. A clinical trial providing a clinical trial support site with a computer connected to a medical institution computer installed in a medical institution where the clinical trial is conducted and a pharmaceutical company computer installed in the pharmaceutical company requesting the clinical trial via a network. A clinical trial support program that functions as a support device,
Computer
Electronic medical chart information uploaded from the medical institution computer, medical chart identification information for identifying the medical chart information, clinical trial identification information for identifying the type of clinical trial, and for identifying the medical institution Database means for storing the facility identification information of and the subject identification information for identifying the subject in association with each other,
Generate a page including tree display data layered in the order of the clinical trial identification information, the implementation facility identification information, the subject identification information, and the chart identification information, and specify the chart identification information from the pharmaceutical company computer. A clinical trial support program, which functions as a page control means for transmitting medical chart information corresponding to designated medical chart identification information to the pharmaceutical company computer when a medical chart information browsing request is received.

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