JP2011107844A - Clinical research chart browsing system and clinical research volunteer server - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a clinical research chart browsing system having high versatility in a near future and having security for preventing leakage of information at as low cost as possible. <P>SOLUTION: A clinical research chart is scanned by a scanner (S12), and the content is OCRed (S13). Matching between the results of the OCR with all data in a test number list in a clinical research volunteer server is executed (S14). A clinical research volunteer server 20 is accessed in order to store the data of the scanned clinical research chart in a test number folder whose matching degree is the highest among the test number folders whose matching degree is equal to or more than a fixed degree (S15). When the clinical research volunteer server 20 is accessed, the data of the scanned clinical research chart are stored in the test number folder whose matching degree is the highest in a reading image storage part 23a (S24). After the content of data of a reading image stored in the reading image storage part 23a is visually confirmed by a person in charge of clinical research, it is moved to a disclosed image storage part 23b. A PDF moved to the disclosed image storage part is disclosed from the clinical research volunteer server 20 (S25). <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a clinical chart browsing system and a trial practitioner server, and more particularly to a clinical chart browsing system and a trial practitioner server that are versatile and inexpensive in the near future.

  A system for managing clinical trial data is described in, for example, Japanese Patent Application Laid-Open No. 2007-140895 (hereinafter referred to as “Patent Document 1”) and Japanese Patent Application Laid-Open No. 2005-157626 (hereinafter referred to as “Patent Document 2”). .

  Patent Document 1 discloses a clinical trial data management method in which information processing apparatuses are connected to a pharmaceutical company, a hospital, and a clinical trial data management center via a network. According to this document, in the conventional case report form, since the clinical trial data was printed on paper, it was an indispensable system for manual checks (seal stamps). Is disclosed in terms of electronic data exchange.

Patent Document 2 discloses a comprehensive monitoring system in which a clinical trial client terminal, a clinical trial institution terminal, a laboratory terminal, and a clinical trial information server can communicate with each other via a network. . This document can reduce the labor required for the clinical trial, reduce the time required for the clinical trial, and improve the reliability of the information related to the clinical trial and thus the case report form (CRF). A comprehensive monitoring system is disclosed. Also in this document, clinical trial data is digitized and transmitted between terminals.
JP 2007-140895 A (summary) Japanese Patent Laying-Open No. 2005-157626 (Abstract)

The current system for managing clinical trial data for which patents have been applied has been configured as described above. In these systems, all clinical trial data use electronic medical records. On the other hand, since there is no standardized format for electronic medical records, the coding for making electronic medical records suitable for users varies from company to company, and clinical trials are conducted from electronic medical records created by clinical trial institutions. Even if the data is obtained, it is necessary to adapt it to the format of the CRF provided by the sponsor, and there is a problem that both the trial medical institution and the sponsor must spend a lot of time for this work. .
It is necessary to match the clinical trial data from the electronic medical record in the clinical trial medical institution to the format of the CRF of the sponsor. In other words, the trial medical institution needs to match the clinical record data of the electronic medical record with the CRF coding format of the sponsor.

  The present invention has been made in view of the above problems, and has a high versatility in the near future, and has a security for preventing information leakage at the lowest possible cost and a trial practitioner. The purpose is to provide a server.

  The clinical chart viewing system according to the present invention includes a client terminal possessed by a clinical trial client and a clinical trial server connected to the clinical trial client terminal via a network. The investigator server scans a clinical record of a paper medium having a folder preparing means for preparing a plurality of public folders having a character string for identifying a sponsor for each publication target and a character string for identifying the sponsor. Image file creation means for creating an image file, PDF conversion means for converting the created image file into a PDF file while recognizing characters by OCR, character recognition results by OCR, and a plurality of prepared public folders A degree-of-matching discriminating means for discriminating the degree of coincidence with the character string, and a storing means for automatically classifying and storing the PDF file in one of the plurality of public folders based on the discrimination result by the degree-of-matching discriminating means And a publishing means for publishing the PDF file stored by the storage means on the network based on a predetermined condition. No. The clinical trial requester can browse the PDF file released by the public means via the client terminal.

  Preferably, the coincidence degree discriminating means discriminates the coincidence degree depending on whether or not the character strings described in the clinical trial chart match.

  More preferably, the character string includes a plurality of characters, and the coincidence determination unit determines the coincidence based on the number of matching characters among the plurality of characters.

  In another aspect of the present invention, the investigator server prepares a folder preparation means for preparing a plurality of public folders having a character string for identifying a sponsor for each publication target, and a character string for identifying a sponsor. Image file creation means for creating an image file by scanning a clinical record of a paper medium, PDF conversion means for converting the created image file into a PDF file while recognizing characters by OCR, and character recognition results by OCR And a matching degree discriminating means for discriminating the degree of coincidence between the prepared public folders and the character strings of the prepared public folders, and the PDF file is automatically assigned to one of the plural public folders based on the discrimination result by the matching degree discriminating means. Storage means for categorizing and storing, and a PDF file stored by the storage means on the basis of a predetermined condition And a public means to be published on the over-click.

  In the present invention, after an image file obtained by scanning a clinical trial chart of a paper medium having a character string for identifying a sponsor is converted into a PDF file, it is stored in a public folder prepared for each sponsor. The clinical chart image data is automatically stored and published in an appropriate public folder according to the degree of coincidence between the character recognition result by OCR and the character string set in the folder at the time of conversion to a PDF file.

  Therefore, the image PDF file obtained by scanning the clinical chart without using an electronic medical chart or a special apparatus is opened only to a folder dedicated to the sponsor, that is, only to a regular user.

  As a result, it is possible to provide a clinical chart browsing system and a trial server that have high versatility in the near future and have security that prevents information leakage at the lowest possible cost.

1 is a block diagram showing an overall configuration of a clinical chart browsing system according to an embodiment of the present invention. It is a block diagram which shows the structure of an investigator server. It is a flowchart which shows operation | movement with an investigator server and a client personal computer. It is a flowchart which shows the process of matching. It is a flowchart which shows a folder disclosure process.

  Hereinafter, an embodiment of the present invention will be described with reference to the drawings. FIG. 1 is a block diagram showing the overall configuration of a clinical chart browsing system according to an embodiment of the present invention. Referring to FIG. 1, the clinical chart browsing system according to this embodiment is a trial provider server 20 which is a client terminal 10 of a client who requests a clinical trial and a server provided in a clinical trial medical institution performing the clinical trial. Are connected via a network such as the Internet 30, the client terminal 10 can access the trial server and browse the files in the trial server 20.

  FIG. 2 is a diagram showing the overall configuration of the trial practitioner server 20. Referring to FIG. 2, the investigator server 20 includes a CPU 21 that controls the entire investigator server 20, a scanner 22 connected to the CPU 21, a database (DB) 23, and a display device 24 such as a display. And a network connection device 25 for connecting to the network 30. In addition to this, an input device such as a keyboard is included, but these are not shown.

  The scanner 22 scans a clinical record of a paper medium. The clinical record of the clinical trial scanned by the scanner 22 is displayed on the display device 25 and stored in the database 23.

  The database 23 includes a public image storage unit that performs certain processing on the image read by the scanner 22 and stores an image to be disclosed to the client terminal 10.

  The trial server 20 is connected to a plurality of trial client computers 26 a to 26 c via the network connection device 25. The client personal computers 26a to 26c can access the investigator server 20 using a LAN or the like, and can use the scanner 22 and the database 23.

  The trial server 20 has document management software that stores the clinical chart PDF of the trial in the database 23 and plays a role of publishing on the Internet. The document management software can perform the following operations by managing the database 23 and the like on the investigator server 20.

  (1) It is possible to browse a PDF file stored in the database 23 in response to a request from the client terminal 10 via an external network including the Internet. However, the PDF file cannot be downloaded to the client terminal 10.

  (2) When a PDF file is created by using the scanner 22, if a plurality of PDF files are created at different times due to correction of the contents, the versions of the PDF files can be managed differently.

  (3) A different authority can be given to the user who accesses the investigator server 20 with respect to the processing content.

  Next, operations performed by the CPU 21 of the trial server 20 and the CPU (not shown) of the client personal computers 26a to 26c will be described. In the following description, it is assumed that the clinical trial person in charge of the clinical trial medical institution accesses the trial investigator server 20 using the client personal computers 26a to 26c and operates the clinical trial chart browsing system.

  FIG. 3 is a flowchart showing operations performed by the CPU 21 and the CPUs of the client personal computers 26a to 26c in this embodiment. In this embodiment, the trial investigator conducts the trial based on the request from the trial sponsor. At that time, a trial number is assigned to each trial, and only the trial sponsor is the requester for each trial number. A public folder accessible from the terminal 10 is created.

  First, the person in charge of the trial accesses the trial person server 20 by using, for example, the client personal computer 26a (step S11, hereinafter, steps are omitted). If there is an access from the client personal computer (YES in S21), the clinical trial operator server 20 permits the access, and allows the clinical trial person to use the document management software in the client personal computer.

  The clinical trial person first creates a public folder in the database 23 of the clinical trial server 20 for each trial number which is a character string for identifying the clinical trial client (S22). As a result, a public folder is prepared. Next, the investigator is allowed to access the scanner 22 of the investigator server 20 from the client personal computer 26a, and the scanner 22 is used to scan the clinical chart including the clinical trial data with the scanner to create an image file. (S23), the file is converted into a PDF file, and the content is recognized by OCR (S13). Here, the test number written in the clinical chart of the clinical trial is recognized.

  As described above, the CPU 21 of the investigator server prepares a plurality of publication folders having a character string for identifying a trial client for each publication target, and a paper having a character string for identifying a trial client. Image file creation means for creating an image file by scanning a medical record of a clinical trial, PDF conversion means for converting the created image file into a PDF file while recognizing characters by OCR, and character recognition results and preparation by OCR It operates as a coincidence degree discriminating means for discriminating the degree of coincidence with the character strings of the plurality of public folders.

  Next, the OCR character recognition result is matched with all the cases in the test number list (S25), and the clinical chart PDF scanned in the test number folder having the highest matching degree among those having a certain matching degree or higher. Is stored (S26). Therefore, the CPU 21 operates as storage means. Thereafter, the stored PDF is transmitted to the client personal computer 26a (S26). These transmitted PDFs are stored in a hard disk (not shown) of the client personal computer 26a.

  The person in charge of the trial stores the number of the subject who actually conducted the trial, the version number of the created PDF, and the like along with the trial number of the clinical chart in the client personal computer 26a. The investigator uses the client personal computer 26a to access each folder and perform personal computer-side processing to add the subject number, PDF version number, and the like (S12).

  When the processing on the personal computer side is completed, the folder is transmitted to the investigator server 20 and stored in the database 23. The PDF to which the predetermined information is added is stored in the test number folder that has been matched as described above, and the stored PDF file is released on the network under the predetermined conditions described below (S27). Therefore, the CPU 21 operates as a disclosure unit.

  At this time, a visual check is also performed to determine whether the PDF is stored in the correct folder. For example, if the OCR misidentifies test number 444PB2 as 444PB3, a matching test number cannot be automatically determined depending on the result of OCR. In this case, since there is a possibility that it may be mistaken for another step of the same test, the investigator performs a double check by visual inspection before storing the folder (S27) after storing the folder.

  Next, the matching process described in S25 will be described. FIG. 4 is a flowchart showing the contents of the matching process. Referring to FIG. 4, first, a test number list is acquired (S251). The degree of coincidence between the test number list and the reading result by the OCR of the scanner 22 is determined (S252), and if the degree of coincidence is a certain level or more, the clinical chart PDF read in the folder having the matched test number is stored. (S253).

  For example, if the number of trials listed in the clinical trial chart is 6 digits, the match is the same among the 3 digits in the first half and the character string in the second half that matches one or more characters. Place it in the test number folder with the highest degree.

  Note that if the first three digits match, even if the second half is different, the test is always performed by the same client.

  If the degree of coincidence with the OCR reading result in S252 in FIG. 4 is below a certain level, the trial person in charge receives a test NO input through visual confirmation (S254) and stores it in the corresponding test NO folder.

  Next, the operation procedure of the trial investigator in the clinical trial chart browsing system will be described. A predetermined contract with a clinical trial client such as a pharmaceutical company is completed in advance, and registration of an IP address that permits connection to the clinical trial server 20 and a user name and password of the clinical trial client are registered.

  In addition, the risk of hacking due to unspecified number of people is avoided by limiting the disclosure range of the login screen itself to the contracted clinical trial clients. Also, by setting a user name and password for each user, it is possible to finely set the disclosure period, browsing authority, etc. for each user.

  In the clinical record, personal information such as name is masked before scanning by the scanner 22. By masking information such as name that is easy to identify individuals and is not required as SDV (Source Data Verification) information, even if a screen shot of this clinical record is leaked, Information leakage can be prevented.

  Also, by publishing as a PDF file, information leakage can be prevented by making maximum use of the security functions that can be set in the PDF file. Specifically, only browsing from the trial investigator server 20 is effective, and files can be viewed but cannot be downloaded, and printing cannot be performed. Therefore, information leakage due to redistribution can be prevented. If a PDF file that cannot be read due to a scan error or the like is generated, a rescan request is received and a PDF with a different version is published again in the public folder.

  By placing the previous history file that cannot be read as a comparative material, it is possible to indicate that the information is not intentionally concealed or falsified.

  Next, the contents of the folder disclosure process shown in S27 of FIG. 3 will be described with reference to FIG. As described above, registration of the user name and password of the client who can be accessed in advance is accepted (S271). It is determined whether there is an access from the client (S272). If there is an access (YES in S272), the input of the user name and password is accepted to determine whether the content is correct (S273). At this time, confidentiality of data between paths is ensured by performing encrypted communication by SSL. In addition, since decryption is performed automatically, work such as decryption is unnecessary. By using the user name and password set for each user, only the information necessary for the user can be displayed.

  If it is correct (YES in S273), only the contents of the folder permitted for the user are disclosed (S274). In this way, the trial sponsor can browse the published PDF file.

  If the user name and the password do not match, the process ends as it is (NO in S273, END).

  The PDF contained in the folder disclosed here has the same format as the clinical trial chart of the paper medium, which is the format of the booklet for each subject. Can be reduced.

  If there is a file that cannot be browsed such as a scan error or disorder, or if there are doubtful items, the trial server 20 can be inquired. By specifying the URL on the document management software, it becomes possible to obtain a questionable matter in a document, which allows quick understanding of the pointed out part.

  In the above embodiment, the case where the scanner is provided in the trial investigator server has been described. However, the present invention is not limited to this, and the scanner may be provided in the client personal computer.

  In the above-described embodiment, the scanner is used to scan the clinical chart. However, the present invention is not limited to this, and a multifunction machine having a scanner function may be used.

  As mentioned above, although embodiment of this invention was described with reference to drawings, this invention is not limited to the thing of embodiment shown in figure. Various modifications and variations can be made to the illustrated embodiment within the same range or equivalent range as the present invention.

  The clinical chart browsing system according to the present invention has high versatility in the near future and has security to prevent information leakage at the lowest possible cost, and is therefore advantageously used as a clinical chart browsing system.

10 client terminal, 20 clinical trial server 30 network, 21 CPU, 22 scanner, 23 database, 24 display device, 25 network connection device, 26 personal computer, 30 network.

Claims (4)

A clinical chart browsing system including a client terminal of a clinical trial client and a clinical trial server connected to the clinical trial client terminal via a network,
The investigator server is
Folder preparation means for preparing a plurality of public folders having a character string for identifying a sponsor for each publication target;
Image file creation means for creating an image file by scanning a clinical trial record of a paper medium having a character string for identifying a sponsor;
PDF conversion means for converting a created image file into a PDF file while recognizing characters by OCR;
A degree of coincidence determination means for determining a degree of coincidence between the character recognition result by the OCR and the character strings of the prepared public folders
Storage means for automatically classifying and storing PDF files in any of the plurality of public folders based on the determination result by the matching degree determination means;
Publishing means for publishing the PDF file stored by the storage means on a network under a predetermined condition,
A clinical trial chart browsing system in which a clinical trial requester can browse the PDF file published by the publication means via the client terminal. The clinical chart browsing system according to claim 1, wherein the matching degree determination unit determines the matching degree based on whether or not the character strings described in the clinical chart match. The clinical chart browsing system according to claim 2, wherein the character string includes a plurality of characters, and the matching degree determination unit determines a matching degree based on a number of matching characters among the plurality of characters. Folder preparation means for preparing a plurality of public folders having a character string for identifying a sponsor for each publication target;
Image file creation means for creating an image file by scanning a clinical trial record of a paper medium having a character string for identifying a sponsor;
PDF conversion means for converting a created image file into a PDF file while recognizing characters by OCR;
A degree of coincidence determination means for determining a degree of coincidence between the character recognition result by the OCR and the character strings of the prepared public folders
Storage means for automatically classifying and storing PDF files in any of the plurality of public folders based on the determination result by the matching degree determination means;
A trial investigator server, comprising: a publishing unit that publishes the PDF file stored by the storage unit on a network based on a predetermined condition.

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