JP2019050017A - Research information management system - Google Patents

Abstract

To provide a research information management system capable of managing a research deliverables with high reliability in clinical research and medical research.SOLUTION: A research information management system for managing information on medical research includes: means for generating an optically readable code including information identifying at least a subject or patient and a test name before a test requiring agreement of the subject or patient and printing out a document including the code and to be filled out by the subject or patient; and means for making the document which the subject or patient filled out into an image and storing the information read from the code as tag information together with the imaged document.SELECTED DRAWING: Figure 3

Description

   The present invention relates to a system for managing research data and the like, and more particularly to a research information management system for managing information on clinical research and medical research.

   In recent years, an electronic medical record system for computer management of medical record information is widely used in many hospitals and clinics (see, for example, Patent Document 1 below). Since the electronic medical record system handles information related to medical treatment, the three principles of "authenticity", "readability" and "preservation" (so-called "three principles of electronic preservation") as medical specific requirements It is required to meet. By securing these three principles, according to the electronic medical record system, medical information can be managed with high reliability.

Unexamined-Japanese-Patent No. 2005-242395

   On the other hand, in the field of clinical research including clinical trials and clinical trials, systematization of electronic data storage of research data has not progressed so much, and there is a concern that research data may be inconsistent or dissipated.

   Similarly, in medical research, research records are often recorded exclusively on paper media (labo notes), and mechanisms for securing the authenticity of experimental data obtained from examination instruments are not sufficiently prepared. In recent years, some cases in which falsification of experimental data has been suspected have become apparent, which has become a socially serious problem.

   An object of the present invention is to provide a research information management system capable of managing research products with high reliability even in clinical research and medical research in view of the problems as described above.

The first configuration of the present invention is
A research information management system that manages information on medical research
Prior to testing where consent from the subject or patient is required, an optically readable code including information identifying at least the subject or patient and the test name is generated, including the code received from the subject or patient. Means to print out the document to be printed,
And a means for imaging the document completed by a subject or a patient and storing the information read from the code as tag information together with the imaged document.

According to a second configuration of the present invention, in the first configuration,
The code is a one-dimensional barcode or a two-dimensional barcode.

According to a third aspect of the present invention, in the first or second aspect,
An electronic medical record database for managing subject or patient information including a chart data file in association with an identifier assigned to each of the subject or patient;
And a researcher terminal connected to the electronic medical record database.
The information for identifying the subject or patient is the subject or patient corresponding to the medical record data file opened on the researcher's terminal when an instruction to print out the document is input on the researcher's terminal Contains the identifier of

The fourth configuration of the present invention is
A template storage unit storing a structured document describing a template of the data input screen layout;
A display processing unit that analyzes a structured document corresponding to the selected template and displays a data input screen;
An input data storage unit that at least temporarily stores input data and a tag name corresponding thereto when the data is input on the data input screen;
When the data input to the data input screen is completed, the structured document corresponding to the template of the data input screen and the input data and tag name stored in the input data storage unit are referred to and include the input data. A structured document generation unit that generates a data-containing structured document that describes the layout of the data input screen;
An item extraction unit for extracting at least a tag name as a search item from the data-containing structured document;
It further comprises a database for storing the search item extracted from the data-containing structured document by the item extraction unit and at least a part of the data-containing structured document in association with each other;
Data on the test is input as the input data.

According to a fifth configuration of the present invention, in the fourth configuration,
The input data is classified and stored in the database according to a predetermined classification structure.

The sixth configuration of the present invention is
A research information management system that manages information on medical research
Means for reading an identifier identifying a sample or experimental animal used in the experiment;
A database for associating and recording the identifier with experimental data;
The identifier is obtained each time the sample or experimental animal is processed.

The seventh configuration of the present invention is
A research information management system that manages information on medical research
A means for reading an identifier identifying an inspection device to be used in the experiment;
A database for associating and recording the identifier with experimental data;
The identifier is obtained each time the inspection device is used.

The eighth configuration of the present invention is
A research information management system that manages information on medical research
Means for reading an identifier identifying the researcher or research assistant performing the experiment;
A database for associating and recording the identifier with experimental data;
The identifier is obtained each time an experiment is performed or each time a study is performed.

The ninth configuration of the present invention is
A research information management system that manages information on medical research
A means for obtaining a time stamp of experimental data from a certification authority;
A database for recording the time stamp in association with experimental data;
The time stamp is obtained each time an experiment is performed or each time a record regarding a study is performed.

   According to the present invention, it is possible to realize a research information management system capable of managing data which is a product of research with high reliability even in clinical research and medical research.

BRIEF DESCRIPTION OF THE DRAWINGS The figure which shows the whole structure of the research information management system which concerns on 1st Embodiment. The figure which shows an example of the written consent form output by the research information management system which concerns on 1st Embodiment. The flowchart which explains the processing procedure from acquisition of agreement to preservation. The functional schematic block diagram of researcher's terminal 10 and server 20 for implement | achieving a stamp function. The figure which shows an example of the data input screen displayed by a stamp function. The figure which shows an example of input-output of clinical-test data. The figure which shows an example of input-output of clinical-test data. The figure which shows an example of input-output of clinical-test data. The figure which shows an example of input-output of clinical-test data. The figure which shows an example of input-output of clinical-test data. The figure which shows an example of input-output of clinical-test data.

First Embodiment
A first embodiment of the present invention will be described with reference to the drawings.

   The research information management system according to the first embodiment is a computer system that manages data on clinical research. The clinical research includes tests and research of various contents such as clinical trials and clinical trials, and the contents of the tests and research to be managed by the research information management system according to the present embodiment are particularly limited. is not.

   As shown in FIG. 1, the research information management system 1 according to the present embodiment includes the researcher terminal 10 and the server 20 via a LAN (Local Area Network) 40 of a hospital / clinic office or a research institute. , And the scanner 30 are mutually connected. In addition, as the server 20, an electronic medical record system server of a hospital or clinic where clinical research is performed can be used. In FIG. 1, illustration of network connection devices such as hubs and routers is omitted. Although only one researcher terminal 10 is shown in FIG. 1, the number of researcher terminals 10 and scanners 30 connected to the research information management system of the present invention is arbitrary.

   The researcher's terminal 10 is operated by a doctor or assistant as a researcher, and is installed in a laboratory or a doctor's office etc., and as shown in FIG. 1, the display 11, the main body 12, and the barcode scanner It has 13 and. Although not shown in FIG. 1, the researcher's terminal 10 may be provided with an input device such as a keyboard or a mouse, or any peripheral device such as a printer. Although FIG. 1 exemplifies a desktop personal computer as an example of the researcher terminal, the hardware configuration of the researcher terminal is not limited to this and is arbitrary. Further, the scanner 30 may be connected to the researcher terminal 10.

   In the case of clinical research including clinical trials etc., it is important to keep accurate and complete the test record, such as what subject (patient), when, where, what kind of test was conducted. In addition to this, for example, in each step of the test that may affect the human body, in particular, the administration of medicines, surgery, medical treatment involving invasion by medical equipment, etc., acquisition of samples from human body, etc. It is also extremely important to take a written consent from and keep the written consent until the prescribed storage period has elapsed.

   Therefore, first, in the research information management system 1 according to this embodiment, a mechanism for managing a written consent of a subject will be described. As a premise, a patient is participating in a clinical trial at a certain medical institution. The patient is an inpatient or outpatient of the medical institution, and basic data (name, gender, age, address, health insurance information, patient ID at the medical institution, etc.) of the patient can be obtained from the server 20 (electronic medical record system) Server) has already been registered. The server 20 may have a built-in recording medium for recording basic data and clinical trial data of a subject, or may be configured to record these data in an external server (database server).

   Further, data of various test contents included in the clinical trial are registered in the server 20 in advance. Although the data of the test content may be in any format, it is prepared according to the clinical trial protocol and GCP rules, and various data such as test ID, test name, test area, target disease, type of test, etc. Contains items. In addition, a clinical trial plan (flow indicating which tests are to be conducted in what order) is also registered. Furthermore, the format of the consent form required for each test is also recorded on the server 20. The format of the written consent includes information specifying the content of the test to be conducted, such as the test ID and the test name, and information specifying the subject such as the patient name and the patient ID.

   Then, before conducting a test requiring a written consent, the doctor must operate the researcher terminal 10, print out the written consent of the test, and ask the subject to sign. In addition, when the consent is required to conduct the next test when one test is completed and the next test is performed according to the flow of the clinical trial execution plan registered in the server 20, this written consent is A button such as "consent statement output" may be displayed on the display of the researcher's terminal 10, and the doctor may print out a button from the printer by pressing the button.

   Here, in the consent form, as shown in FIG. 2, a barcode is printed at a predetermined position (the upper left portion of the sheet in the example of FIG. 2). That is, when the doctor performs an operation to print out the consent form of a certain test from the researcher's terminal 10, the researcher's terminal 10 uniquely identifies the subject, the doctor, the test content, etc. for the test. Generate a barcode to be identified and print it to the consent form. That is, the barcode includes information such as a subject ID, a doctor ID, and a test ID. Other than the above information, the information contained in the bar code is optional, but for example, a document type ID indicating that the document is “agreement”, acquisition date of a written agreement, place of examination, department in charge, Various information such as an ID indicating a storage location of a document, a storage expiration date, and an ID of a researcher terminal 10 that has performed an output operation of a written consent can be considered. In addition, in the example of FIG. 2, although a two-dimensional barcode (QR code (trademark)) is illustrated, a one-dimensional barcode may be used and arbitrary code | cords other than this can be utilized.

   As the subject ID, when the doctor presses the consent sheet output button on the researcher terminal 10, the ID of the patient of the electronic medical chart opened on the terminal is obtained and used.

   Thus, when obtaining a written consent, the doctor operates the researcher's terminal 10 on the spot to print out the written consent form, and, in this written consent, which subject for which test is One of the features of this system is that a bar code is printed that includes information that uniquely identifies whether or not the consent form for. The written consent is read by a scanner and stored in the server 20 as an image after the subject has signed it. At this time, the information contained in the barcode is stored in the server 20 as tag information of the image file. This makes it possible to uniquely identify which subject the image of the consent form stored in the server 20 is obtained from which subject. As a result, the written consent can be properly managed without losing the written consent.

   In addition, by storing the image file of the written consent together with the tag information (bar code information) in the server 20, the information contained in the tag information can be used as a keyword to facilitate the search from the researcher's terminal 10 . For example, the researcher terminal 10 can display a list of consent documents for a specific subject, a list of consent documents related to a specific test ID, and the like.

   FIG. 3 is a flow chart for explaining the processing procedure from acquisition of the above-mentioned consent form to storage. As shown in FIG. 3, in the research information management system 1 of the present embodiment, in the flow of the clinical trial execution plan, it is determined that the test to be performed next is a test for which a written consent is required (step YES in S1), a barcode including necessary information is generated (step S2), and a written consent form including the generated barcode is printed out (step S3). Then, the image of the signed consent form is captured by the scanner (step S4), and the image file of the consent form is recorded on the server 20 as tag information as information read from the bar code (step S5).

   The written consents used in clinical trials include written consents in addition to written consents for obtaining signatures from subjects alone. In the case of written consent form, the doctor prepares two documents (main and duplicate) with the same contents, and after explaining the contents of the test from the doctor to the subject according to the manual, both parties sign and It is supposed to store one by one. In this case, two copies of the agreement with the same barcode may be printed out, and after both parties have signed, two copies may be scanned and stored. Alternatively, the barcode information may include an identifier capable of distinguishing between the original and the duplicate.

   Furthermore, information (such as the doctor's login ID and login date and time) indicating which doctor outputted the consent document using the user authentication service etc. by the external authentication server, and authentication by a third party The attached information may be embedded in the barcode information. According to this, it is impossible to add the written consent later if the written consent has not been obtained at the appropriate timing, so that fraud can be prevented. The authentication server for providing the user authentication service is not limited to the external authentication server by a third party organization, but may be an authentication server provided in the same facility (for example, in a laboratory).

   When the document to be stored spans multiple pages, it is preferable to print a barcode on all pages. In this case, it is desirable that the page information (the total number of pages of the document and the serial number of each page) of the document is also provided as barcode information. This page information is also stored as a part of the tag information when storing the image file obtained by scanning the document. This not only prevents the data of the document over multiple pages from being dissipated, but even if the pages are scanned out of order, the order of each page can be correctly recognized, and the image of each page is ordered according to the page serial number There is an advantage that it becomes possible to rearrange.

   Next, in the research information management system 1 of the present embodiment, a mechanism for recording a test result on the server 20 will be described. As described above in the present embodiment, in the case of a clinical study including a clinical trial etc., it is necessary to accurately leave test data such as to what subject, when, where, and what kind of test was conducted. It does not.

   Therefore, the research information management system 1 manages test data (case card) using the “stamp” function of the electronic medical record system. Here, the details of the “stamp” of the electronic medical record system are disclosed in the prior patents (Japanese Patent No. 5204534, Japanese Patent Application No. 2008-99577) by the applicants of the present application. That is, the template of the data input screen layout is described in a structured document (structured description language) such as XML, and when data is input to this data input screen, the layout of the data input screen including the input data is A data-containing structured document to be described is generated, at least a tag name is extracted as a search item from the generated data-containing structured document, and the extracted search item is associated with at least a part of the data-containing structured document. Stored in the database.

   This function of displaying a template of this data entry screen on the screen of the terminal and entering the necessary data is compared to the act of pressing a chart stamp (rubber stamp) on a paper chart and writing data on it, here Called the "stamp" function of the chart system.

   A functional schematic configuration of the researcher terminal 10 and the server 20 for realizing the stamp function is shown in FIG. As shown in FIG. 4, the researcher's terminal 10 includes a communication processing unit 110, a template storage unit 111, a display processing unit 112, an input data reception unit 113, an input data storage unit 114, and an XML file generation unit (structured A document generation unit) 115 is provided. In the example of FIG. 4, the template storage unit 111 and the input data storage unit 114 are provided inside the researcher terminal 10 (for example, on the built-in hard disk), but these are external to the researcher terminal 10 (For example, on a disk device or file server accessible from the researcher's terminal 10). In the example of FIG. 2, the template storage unit 111 is provided in the researcher terminal 10, but the template storage unit is disposed in the server 20, and the data input person selects the template (stamp). At the same time, XML corresponding to the selected template may be transmitted from the server 20 to the researcher terminal 10.

   In the researcher terminal 10, each of the communication processing unit 110, the display processing unit 112, the input data reception unit 113, and the XML file generation unit 115 is realized by the processor of the researcher terminal 10 executing a predetermined program. Functional means, which do not necessarily have to be implemented as separate and independent hardware.

   The communication processing unit 110 communicates with the server 20 and other user terminals as needed via the LAN 40.

   The template storage unit 111 stores a document definition described in XML as a template (stamp) of a data input screen used in the researcher's terminal 10. When creating each template first, inspection items of stamps and the like can be acquired from inspection result databases of electronic medical record systems and the like.

   Here, first, in the electronic medical record system, a mechanism for storing data input using a stamp will be described. For example, in the data input screen shown in FIG. 5, various templates (stamps) for data input can be selected in the document selection column 31 on the left side of the screen. The example of FIG. 5 shows a state in which "demographic data" is selected as one of the data input screens related to "trial trials" and the data input screen is displayed on the main screen 32. That is, the display processing unit 112 extracts the XML defining the template selected by the doctor in the document selection column 31 from the template storage unit 111, and analyzes the XML of the extracted template to search the data input screen as a researcher. It displays on the terminal 10. The XML defining the template of “demographic data” shown in FIG. 5 is as shown in FIGS. 4 (a) to 4 (h) of Japanese Patent No. 5204534. In FIGS. 4 (a) to 4 (h) of Japanese Patent No. 5204534, the portion including the XML description of the tag corresponding to the input field of the data input screen is shown surrounded by a frame.

   The input data reception unit 113 detects input data for the data input screen displayed on the researcher's terminal 10, and the detected input data is input to the input data storage unit 114 together with the tag name that is the input target of the data. At least temporarily store. When the data input to the data input screen is completed, the XML file generation unit 115 refers to the template storage unit 111 and the input data storage unit 114, and inputs a data-containing XML file in which the layout of the data input screen including the input data is described. Generate The generated data-containing XML file is sent from the researcher's terminal 10 to the server 20 via the LAN 40.

   For example, it is assumed that data input as shown in FIG. 7 is performed with respect to the data input screen of “demographic data” shown in FIG. 5 opened in an electronic medical record of a subject. In this case, the date data input as the observation date is the character string data input to the tag (control) "observation date. Year" defined in the XML, and the tag "observation date. Month" And the string data input to the tag "observation date.day". The input data reception unit 113 acquires these character string data as input data, and associates them with the tags “observation date. Year”, “observation date. Month”, and “observation date. The data is stored in 114. The same process is performed by input data accepting unit 113 for other data input to the data input screen, ie, date of birth, gender, height, weight, race, initials, and the input data is associated with the tag name. And at least temporarily stored in the input data storage unit 114. At this time, information specifying the subject, the doctor in charge, etc. is also stored in association with the input data.

   Thus, when data input to the data input screen is completed, the XML file generation unit 115 refers to the XML of the template of the data input screen and the input data and tag name stored in the input data storage unit 114. And generate an XML file that describes the layout of the data entry screen including the input data. The generated XML file is transmitted to the server 20 by the communication processing unit 110 of the researcher terminal 10.

   On the other hand, as shown in FIG. 4, the server 20 includes a communication processing unit 120, an item extraction unit 121, an XML database 122, a search condition setting unit 123, a search execution unit 124, and a display processing unit 125. In the example of FIG. 4, the XML database 122 is built inside the server 20 (for example, on the built-in hard disk), but the XML database 122 can be accessed outside the server 20 (for example, a disk device accessible from the server 20) Or on a file server. The communication processing unit 120, the item extracting unit 121, the search condition setting unit 123, the search executing unit 124, and the display processing unit 125 are functional means realized by the processor of the server 20 executing a predetermined program. Yes, and they do not necessarily have to be implemented as separate and independent hardware.

   The communication processing unit 120 communicates with the researcher's terminal 10 via the LAN 40.

   The item extraction unit 121 extracts the tag name corresponding to the input field of the data input screen from the data-containing XML file sent from the researcher's terminal 10. The XML database 122 stores the data-containing XML file sent from the user terminal in association with the tag name extracted by the item extraction unit 121 from the XML file.

   The search condition setting unit 123 acquires a search item from the XML database 122 and displays it, causes the search executor to select a search item as necessary, and receives a search condition regarding the search item. The search execution unit 124 searches the XML database 122 based on the search condition received from the search executor. The search result is presented to the search executor by the display processing unit 125 in an appropriate format or in the form of a data input screen including the input data. Although the input of the search conditions and the display of the search results may be performed using an input device and a display device included in the server 20, an input device and a display device included in any of the researcher's terminals 10 may be used. It may be possible to use it. Alternatively, the search may be performed using a terminal other than the researcher's terminal 10 and the server 20 and accessible to the server 20 via the LAN 40.

   In the server 20 configured as described above, when the XML file is transmitted from the researcher terminal 10, the communication processing unit 120 receives this. The received XML file is stored in the XML database 122. At this time, the item extraction unit 121 extracts a tag name corresponding to the input data item from the XML file, associates the extracted tag name with the XML file, and stores the tag name in the XML database 122. The tag name extracted by the item extraction unit 12 is used as an option for causing a searcher to select a search item in a later search process. In addition, when storing the received XML file in the XML database 122, in order to save the storage capacity, for example, the description portion etc. which is not related to the input data in the XML file is removed and the portion including the description regarding the significant input data Only may be stored in the XML database 122.

   According to the above procedure, test data input from the researcher's terminal 10 can be collected as an XML file into the XML database 122 of the server 20. In the above description, although the process of extracting the tag name corresponding to the input data item from the XML file is performed by the item extraction unit 121 provided in the server 20, the process of extracting the tag name is for researchers Alternatively, the extracted tag name may be sent to the server 20 together with the XML file and stored in the XML database 122.

   Here, FIGS. 6 to 11 show an example of input / output of clinical test data. FIG. 6 is a display example of the screen of the researcher's terminal 10 in the state where the electronic medical record of a certain subject is opened. When the doctor selects and clicks a desired template (stamp) from the "stamp group" in the left column of the screen, the XML file stored in the XML database 122 as the test data of the patient is read out and read out. Based on the XML file, as shown in FIG. 7, an input window of the template (stamp) is opened. In the example of FIG. 7, the window of "(article) dialysis prevention stamp" is shown opened. The physician can enter test data on this window.

   At this time, as shown in FIG. 7, when the window of “(Article) Dialysis Prevention Stamp” is opened, the data of the test or test performed for the patient in the past is already on the stamp together with the date of the test. It is in the displayed state. This is because in the XML file stored in the XML database 122, the input data is also recorded along with the tag name for the input item. For example, in the example of the display screen shown in FIG. 7, the date when calling this stamp is May 29, 2013 as it is displayed on the screen, but in the past (May 23, 2013) The numerical values of HbA1c, creatinine and urine protein are displayed as a result of the examination. Therefore, the doctor does not have to re-enter already-tested data on the stamp, and only needs to enter data for newly-tested items. For example, in the example of FIG. 7, it is sufficient to test only for blood pressure and to input the test result.

   Even if the item has already been input, if the inspection is repeated, if a numerical value is input for the item on the screen, the input numerical value and the inspection date are overwritten and updated. In addition, in order to leave the history accurately, it is desirable that editing of past numerical values is not possible, and when numerical values are rewritten, it is desirable to automatically rewrite the date of “inspection date”. In addition, even when the numerical value is rewritten, the past numerical value may be stored as a history together with the past date of the examination.

   When the result (stamp) of the examination performed in the past is called on the screen, the latest examination date may be automatically called. In addition, when it is desired to recall a stamp of a date earlier than the latest examination date, a list of dates on which examinations have been performed for the patient may be displayed so that it can be selected from the list.

   Then, after the doctor inputs the necessary test data, when the “OK” button on the lower right of the window is clicked, the data input to this stamp is associated with the tag name of the input item by the mechanism of the stamp function described above Stored in the Then, the data is displayed together with the stamp name in the S column of the SOAP article of the subject's electronic medical record, as shown in FIG. In addition, the doctor can appropriately input in other fields. In the example of FIG. 9, the text of the diagnostic content is input in the A column. After pressing the "confirm" button further in this state, as shown in FIG. 10, all the records of the day can be displayed. In the example shown in FIG. 10, the test data and the diagnostic article are displayed on the left side of the main window with the stamp displayed, and the content of the prescription instruction issued by the doctor on the day is displayed on the right There is.

   The test data input in the stamp can also be summarized in time series or processed into a table or graph in the researcher's terminal 10 or the server 20. For example, as shown in FIG. 11, data entered so far for the subject in the "(article) dialysis prevention stamp" is automatically tabulated into table software and displayed in an easy-to-understand manner for each item . As can be understood by comparing FIG. 8 with FIG. 11, the data input with the stamp of FIG. 8 is organized by item. Of course, it is easy to graph these data.

   That is, the test data input as a stamp can be displayed or printed on the researcher terminal 10 as a stamp image, and can be output and used as a structured document or CSV data.

   Further, even if the data input by the stamp is further classified in the server 20 according to the classification structure for research or medical use, and the grouped or grouped items of the classified items are recorded or output. good. That is, although the data of the subject (patient) includes the subject's basic information such as the name and the gender, and the present finding data, the present finding data is a medical care subject (for example, neurology, digestive department, circulatory system For example, in the case of gastroenterology, data of subdivision items such as esophagus, stomach, etc. are included as finer classifications for each item. The data of these subdivision items are also constituted by data of further detailed classification. Typically, such data is organized as data in one or more tree or net structures. Then, it is preferable that the test data input by the stamp be recorded and output in the server 20 in association with the data of such tree structure or net structure.

   In addition to the XML file, an image of a stamp in a state in which test data is input may be saved as image data in the server 20 or an external server. Furthermore, only the input data may be extracted and stored as text data in the server 20 or an external server. Since such image data or text data does not have tag information, it is not possible to search by item name, but at least it can fulfill the duty to save test data.

   As described above, in the research information management system 1, various data such as clinical trial data and doctor's findings are input to the case card template (data input screen) described in XML, and the data is input items Tag names are extracted and stored in the server 20 together with an XML file containing input data. In this way, test data and clinical data (including findings) can be stored as data of the electronic medical record system, so the test data can be stored while satisfying the three principles of authenticity, readability, and storage. It becomes possible to manage. In addition, since the subject of the clinical trial is also a patient being treated, conventionally, the same thing as the content (trial data) entered on the case card of the clinical trial must be input as a treatment record to the electronic medical record system There was a bother. On the other hand, according to the research information management system 1, since the case card of the clinical test is created and managed using the stamp function of the electronic medical record system, the electronic medical record is not required without the need for the duplicate input of data. There is an advantage that the system can store test data and clinical data. In addition, it is easy to search, tabulate and process test data.

   In the above description, the mechanism for creating a case card of test data on an electronic medical chart system has been exemplified. However, the case card of test data may be created outside the electronic medical record system, and only data finally generated may be stored in the server 20 of the electronic medical record system. Alternatively, the data finally created may be stored in an external server, and a link may be provided from the electronic medical record system so that the data can be accessed immediately. With this configuration, it is not necessary to make major changes to the existing electronic medical record system.

   As described above, according to the research information management system 1 of the first embodiment, data (case card) of a clinical test is created using the stamp function of the electronic medical record system, and managed according to the standard of the electronic medical record system can do. Therefore, the data of the clinical trial can be managed without omission and in a state where it can be easily retrieved and processed later. Furthermore, since the test data is correctly managed by the electronic medical record system for each subject and for each item, a CRF (case report) and the like can be created and output based on this data.

   Further, in the research information management system 1 of the present embodiment, the inspection schedule may be automatically managed using a stamp. For example, after prescribing a certain drug for a certain subject, when the subject (patient) returns to the hospital after a predetermined period, a template to be filled in at the current examination based on the previous prescription record, examination request record, etc. Preferably, the (stamp) is automatically extracted, and the stamp is displayed on the researcher terminal 10 or a message indicating that the template should be filled is displayed.

   In addition, the research information management system 1 according to the first embodiment outputs a subject consent form with a bar code when the consent form is required at each step of the test, and the signed consent form Is stored together with barcode information as an image file. Therefore, there is also an advantage that the written consent is not lost in the clinical trial and appropriate management can be performed.

   Although the present embodiment has been described as the research information management system 1 which manages data related to clinical research, the application of the system is not limited to the research purpose, and such a system may be used for medical examination and treatment purposes. Can.

Second Embodiment
The research information management system according to the second embodiment has a basic system configuration similar to that of the research information management system 1 according to the first embodiment, but in particular is a computer system that manages data related to medical research. . In this embodiment, an example in which data on medical research is managed is described. However, the present invention can be applied to management of research data in various fields as well as medical research.

   In the case of medical research, as in the case of research in other academic fields, it is an experiment that clarified when, where, what kind of experiments, how and how the results were obtained, etc. Records are required to be detailed and accurate based on the truth. In recent years, the authenticity of experimental records has become a serious question as well, as several instances of suspected alteration of experimental data have become apparent.

   However, in the past, it was mainstream that experimental records were left exclusively in handwriting in “Lab Notes”, for example, even if items described later were corrected or items not written were found, There is a problem that is difficult.

   In view of such a problem, the research information management system 1 according to the present embodiment aims to accurately record experimental content based on the truth and to make it impossible to falsify experimental data. is there.

   In order to achieve this purpose, the research information management system 1 according to the present embodiment (1) a function of identifying specimens and experimental animals used in experiments and recording them in association with experimental data (2) used in experiments It provides a function to identify the inspection equipment that has been tested, (3) a function to identify the researcher who executed the experiment, and (4) a function to save the experimental data so that it can be understood if it is tampered with. In addition, although it is preferable to have all these functions, it is not essential to have all these functions.

   First, the function of identifying the sample or experimental animal used in the experiment and recording it in association with the experimental data will be described.

   In order to achieve this function, the research information management system 1 applies a barcode including an individual identification ID to each of the sample and the experimental animal, and the researcher or research assistant performs an experiment using the sample and the experimental animal. Every time the sample or experimental animal is treated in any way other than the experiment (experimental preparation etc.), the barcode scanner 13 should attach a barcode attached to the sample or experimental animal, preferably a researcher or research assistant. The bar code (given to the name tag etc.) given to the person is read, and the record is left on the server 20. At this time, it is preferable that a record of what has been performed on the sample or experimental animal is input from the researcher terminal 10 or the like, and stored in the server 20 in association with the above-described ID.

   A label or tag printed with a bar code may be attached to the sample container for the sample, and to the cage, collar, ear tag or the like for the experimental animal. It is also possible to use RFID instead of barcodes. Alternatively, a microchip to be implanted in the experimental animal may be used.

   Thus, by assigning an individual identification ID to a sample or experimental animal, a record of who accessed the sample or experimental animal when and when the researcher or research assistant accesses the sample or experimental animal This makes it easy to detect that fact if there is a change or replacement of the sample or experimental animal.

   Furthermore, when storing data on a sample or experimental animal, the user authentication service of the external authentication server or the like is used to obtain third party authentication for the person who accessed the sample or experimental animal, and also to obtain information on access time. It is more desirable to acquire and associate and record data. The authentication server for providing the user authentication service is not limited to the external authentication server by a third party organization, but may be an authentication server provided in the same facility (for example, in a laboratory).

   In addition to barcodes, it is also conceivable to apply human face recognition technology as a method of identifying individuals of experimental animals. For example, even in the case of mice and rats, the size and shape of eyes and nose slightly differ depending on the individual, so individual identification based on face images is considered to be possible to some extent. Therefore, when an experimental animal arrives in the laboratory, an image of the face is acquired and recorded with a digital camera, and whenever a researcher etc. accesses the experimental animal, the face is photographed with the digital camera and recorded. Compare with the face image of the subject (human face recognition technology is applied), and it is sufficient to confirm whether there is no interchange or replacement of experimental animals. Besides this, depending on the type of animal, it is also possible to use a tooth shape, a nasal pattern, etc. for individual identification.

   As described above, when the experimental data is obtained by specifying the sample used in the experiment and the experimental animal described in (1) above and having the function of recording in association with the experimental data, which sample or experimental animal is used You can leave exactly as data. This makes it possible to use this data as evidence, even if the authenticity of the experimental data may later be questioned. In addition, by using third party certification together, more reliable evidence can be left as to which researcher has accessed the sample or experimental animal.

   Next, the function (2) for specifying the inspection device used in the experiment will be described. The “examination device” includes any device in addition to the medical device used for a specific medical application. For example, common digital cameras are also included in the inspection equipment.

   An inspection device ID uniquely identifying the device is assigned to all the inspection devices used in the laboratory, and a barcode including the ID is attached to the inspection device. Then, every time the inspection device is used, the barcode scanner 13 reads the barcode attached to the inspection device and the barcode (assigned to the name tag etc.) for identifying the researcher or the research assistant. Then, the information of the read barcode is associated with the data output from the inspection device, and stored in the server 20. Also in this case, using the user authentication service of the external authentication server or the like, the third party authentication of the person using the inspection device is acquired, and the information of the access time is also acquired, and the output from the inspection device It is more desirable to record in association with data. The authentication server for providing the user authentication service is not limited to the external authentication server by a third party organization, but may be an authentication server provided in the same facility (for example, in a laboratory).

   Alternatively, the following method may be considered other than the method of reading the barcode of the inspection device ID. When the inspection device is a device that can be connected to the LAN 40, it is also preferable to acquire the address of the inspection device on the network as the inspection device ID and record it in association with the output data. Furthermore, when the inspection device is node-authenticated on the network, it is desirable to obtain the authentication information and use it as the inspection device ID.

   Further, the output data from the inspection device is not limited to recording as it is, but data obtained by performing some data processing on the output from the inspection device may be recorded in association with the inspection device ID.

   As described above, by providing the function of specifying the inspection device used in the experiment of the above (2) and associating it with the output data from the inspection device and recording it, it is accurate from which inspection device the inspection data was obtained Can be left as data. This makes it possible to use this data as evidence, even if the authenticity of the experimental data may later be questioned. In addition, by using third party certification together, more reliable evidence can be left as to which researcher has accessed the sample or experimental animal.

   Next, the function (3) for identifying the researcher who performed the experiment will be described. Regarding this, as described above, every time the researcher or research assistant makes a barcode reader 13 read the barcode attached to the name tag etc. every time the laboratory performs some processing or records about the research. The information is recorded on the server 20 together with information indicating what has been done. Of course, as a means to specify an individual, it is possible not only to use a barcode but also to use biometrics, for example, and it is possible to leave experimental records with higher authenticity. The above-mentioned "information indicating what has been done" may be experimental data, or the person may enter text on what has been done. Also, in the same manner as described above, by using third party authentication together, more reliable evidence of who did what and when can be left.

   In addition, in the case of a research information management system adopting single sign-on, once log-in authentication is performed on the system, it is possible to use resources on this system without logging in again. In this case, login information when the user first logs in is stored as information for identifying a researcher. Therefore, in the case of a system adopting single sign-on, the researcher can proceed with the research work without having to log in and read the bar code of the researcher ID each time.

   As described above, it is possible to leave reliable information as to who did what and when by having the function of identifying the person who performed the experiment or the experiment preparation described in (3) above and recording it each time. it can.

   Next, the function of storing experimental data will be described so that if the experimental data is tampered with, the above (4) can be understood.

   In the research information management system 1 according to the present embodiment, each time experimental data is obtained, a time stamp is given to the data. This time stamp is preferably obtained from an external certified third party certification body. By providing a timestamp, along with the proof of the time when the experimental data was obtained, the use of the hash value also provides a proof that the experimental data has not been falsified thereafter. In addition, not only experimental data but also information obtained by the functions of the above (1) to (3) can be added to further improve the evidence.

   Also in the present embodiment, it is preferable to allow the researcher to input experimental data using the stamp function of the electronic medical record system described in the first embodiment. This is because the input items and data can be associated and managed, and later data search, processing, and the like become easy. That is, by recording the laboratory note using the stamp function of the electronic medical record system, the three principles of authenticity, readability, and preservation are secured, and the evidence of experimental data is also secured. In addition to using the input by the stamp function of the electronic medical record system, it is of course possible to use an image obtained by scanning a handwritten notebook or a board draft as an experiment record. By giving a time stamp also to such an image or an output image from an inspection device, it is easy to verify the fact even if the image is suspected of being tampered with.

   In addition, in the research information management system 1 according to the present embodiment, it is desirable to introduce a mechanism in which the subsequent operation can not be performed when reading of the necessary ID is not performed. For example, when using the ID of the sample or experimental animal in (1), if the ID of the sample or experimental animal is not read, the operation is limited to the testing device so that the test using the sample or experimental animal can not be performed. And so on. Alternatively, when using the ID of the inspection device used in the experiment of (2), the operation of the inspection device may be restricted until the ID of the inspection device is read.

   As described above, according to the research information management system 1 of the present embodiment, the evidence of experimental records and experimental data in medical research can be improved.

   As mentioned above, although some embodiment of this invention was described, the embodiment of this invention is not limited to an above-described specific example, A various change is possible within the range of invention.

1 Research Information Management System 10 Terminal for Researchers 11 Display 12 Main Body 13 Bar Code Reader 20 Server 30 Scanner 40 LAN

Claims (9)

A research information management system that manages information on medical research
Prior to testing where consent from the subject or patient is required, an optically readable code including information identifying at least the subject or patient and the test name is generated, including the code received from the subject or patient. Means to print out the document to be printed,
A research information management system, comprising: means for imaging the document completed by a subject or a patient, and storing the information read from the code as tag information together with the imaged document.    The research information management system according to claim 1, wherein the code is a one-dimensional barcode or a two-dimensional barcode. An electronic medical record database for managing subject or patient information including a chart data file in association with an identifier assigned to each of the subject or patient;
And a researcher terminal connected to the electronic medical record database.
The information for identifying the subject or patient is the subject or patient corresponding to the medical record data file opened on the researcher's terminal when an instruction to print out the document is input on the researcher's terminal The research information management system according to claim 1 or 2, comprising an identifier of. A template storage unit storing a structured document describing a template of the data input screen layout;
A display processing unit that analyzes a structured document corresponding to the selected template and displays a data input screen;
An input data storage unit that at least temporarily stores input data and a tag name corresponding thereto when the data is input on the data input screen;
When the data input to the data input screen is completed, the structured document corresponding to the template of the data input screen and the input data and tag name stored in the input data storage unit are referred to and include the input data. A structured document generation unit that generates a data-containing structured document that describes the layout of the data input screen;
An item extraction unit for extracting at least a tag name as a search item from the data-containing structured document;
It further comprises a database for storing the search item extracted from the data-containing structured document by the item extraction unit and at least a part of the data-containing structured document in association with each other;
The research information management system, wherein data on the test is input as the input data.    The research information management system according to claim 4, wherein said input data is classified and stored in said database according to a predetermined classification structure. A research information management system that manages information on medical research
Means for reading an identifier identifying a sample or experimental animal used in the experiment;
A database for associating and recording the identifier with experimental data;
The research information management system which acquires the identifier each time the sample or the experimental animal is processed. A research information management system that manages information on medical research
A means for reading an identifier identifying an inspection device to be used in the experiment;
A database for associating and recording the identifier with experimental data;
The research information management system which acquires the said identifier, whenever a test | inspection apparatus is used. A research information management system that manages information on medical research
Means for reading an identifier identifying the researcher or research assistant performing the experiment;
A database for associating and recording the identifier with experimental data;
A research information management system, which acquires the identifier each time an experiment is performed or a record on a research is performed. A research information management system that manages information on medical research
A means for obtaining a time stamp of experimental data from a certification authority;
A database for recording the time stamp in association with experimental data;
A research information management system which acquires the time stamp each time an experiment is performed or each time a record on a research is performed.