JP6434449B2 - Research information management system - Google Patents

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 related to clinical research and medical research.

  In recent years, an electronic medical chart system for managing medical chart information by computer 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 care, the three principles of “authenticity”, “readability”, and “preservability” (so-called “three principles of electronic preservation”) are required as medical-specific requirements. It is required to meet. By ensuring these three principles, medical information can be managed with high reliability according to the electronic medical record system.

JP 2005-242395 A

  On the other hand, in the field of clinical research including clinical trials and clinical trials, the systematization of the storage of research data using electronic media 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 (lab notes), and a mechanism for ensuring the authenticity of experimental data obtained from testing equipment is not well prepared. In recent years, some cases of experimental data being suspected have become apparent and have become a major social problem.

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

The first configuration of the present invention is as follows.
A research information management system for managing information related to medical research,
Before a test that requires the consent of the subject or patient, generate an optically readable code that includes at least information identifying the subject or patient and the name of the test, and receive information from the subject or patient that includes the code A means for printing out the power document;
A research information management system comprising: means for imaging the document that the subject or patient has completed 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 configuration of the present invention, in the first or second configuration,
An electronic medical record database that manages subject or patient information including a medical record data file in association with an identifier assigned to each subject or patient;
A researcher terminal connected to the electronic medical record database,
The information specifying the subject or patient is the subject or patient corresponding to the medical record data file opened on the researcher terminal when an instruction to print out the document is input on the researcher terminal. Contains an identifier.

The fourth configuration of the present invention is as follows.
A template storage unit storing a structured document describing a template of a data input screen layout;
A display processing unit that analyzes a structured document corresponding to the selected template and displays a data input screen;
When data is input to the data input screen, the input data storage unit stores at least temporarily the input data and the corresponding tag name in association with each other,
When input of data to the data input screen is completed, the structured data corresponding to the template of the data input screen is referred to, and the input data and tag name stored in the input data storage unit are included. A structured document generator for generating a structured document with data describing the layout of the data entry screen;
An item extraction unit for extracting at least a tag name as a search item from the structured document with data;
A search item extracted from the structured document with data by the item extraction unit, and a database that stores at least a part of the structured document with data in association with each other.
Data relating to 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 as follows.
A research information management system for managing information related to medical research,
Means for reading an identifier identifying the specimen or animal used in the experiment;
A database for recording the identifier in association with experimental data;
The identifier is acquired each time a sample or laboratory animal is processed.

The seventh configuration of the present invention is:
A research information management system for managing information related to medical research,
Means for reading an identifier identifying the testing equipment used in the experiment;
A database for recording the identifier in association with experimental data;
The identifier is acquired every time the inspection device is used.

The eighth configuration of the present invention is:
A research information management system for managing information related to medical research,
A means of reading an identifier identifying the researcher or research assistant conducting the experiment,
A database for recording the identifier in association with experimental data;
The identifier is acquired each time an experiment is performed or a record relating to research is performed.

The ninth configuration of the present invention is:
A research information management system for managing information related to medical research,
Means for obtaining experimental data time stamps from a certification body;
A database for recording the time stamp in association with experimental data;
The time stamp is obtained each time an experiment is performed or a research record is made.

  ADVANTAGE OF THE INVENTION According to this invention, the research information management system which can manage the data which are the result of a research with high reliability also in clinical research and medical research is realizable.

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 consent form output by the research information management system which concerns on 1st Embodiment. The flowchart explaining the process sequence from acquisition of consent form to preservation | save. The functional schematic block diagram of the terminal 10 for researchers and the 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 and output of clinical trial data. The figure which shows an example of input and output of clinical trial data. The figure which shows an example of input and output of clinical trial data. The figure which shows an example of input and output of clinical trial data. The figure which shows an example of input and output of clinical trial data. The figure which shows an example of input and output of clinical trial 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 related to clinical research. Note that clinical research includes tests and research of various contents such as clinical trials and clinical trials, and the contents of the tests and research that are managed by the research information management system according to this embodiment are particularly limited. is not.

  As shown in FIG. 1, the research information management system 1 according to the present embodiment includes a researcher terminal 10 and a server 20 via a LAN (Local Area Network) 40 of a hospital / clinic or a research institution. , And the scanner 30 are connected to each other. 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 a hub and a router is omitted. 1 shows only one researcher terminal 10, the number of researcher terminals 10 and scanners 30 connected to the research information management system of the present invention is arbitrary.

  The researcher terminal 10 is operated by a doctor or assistant as a researcher, and is installed in a laboratory or a clinic, and as shown in FIG. 1, a display 11, a main body 12, a barcode scanner, and the like. 13. Although not shown in FIG. 1, the researcher terminal 10 may include an input device such as a keyboard and a mouse, and an optional peripheral device such as a printer. In FIG. 1, a desktop personal computer is illustrated as an example of the researcher terminal. However, 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 studies including clinical trials, it is important to keep accurate and accurate test records about what subjects (patients) were tested, when, where, and what kind of content. In addition to this, for example, in each step of a test that may affect the human body, such as administration of drugs, surgery, treatment involving invasion by a medical device, acquisition of a sample from the human body, etc. It is also very important to take a consent form from and keep it until the specified storage period has passed.

  First, a mechanism for managing the consent form of the subject in the research information management system 1 according to this embodiment will be described. It is assumed that a patient is participating in a clinical trial at a medical institution. This 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.) regarding this patient is stored in the server 20 (electronic medical chart system). Server). The server 20 may have a built-in recording medium for recording the subject's basic data and clinical trial data, or may be configured to record these data in an external server (database server).

  In addition, data of various test contents included in the clinical trial is registered in the server 20 in advance. The data of the test content may be in any format, but it is created in accordance with the clinical trial protocol and GCP rules. For example, various data such as test ID, test name, test site, target disease, test type, etc. Contains items. In addition, a clinical trial implementation plan (a flow indicating what tests are performed in what order) is also registered. Further, the format of the consent form necessary for each test is also recorded in the server 20. The format of the consent form includes information for specifying the content of the test to be performed from now on, such as a test ID and a test name, and information for specifying the subject, such as a patient name and a patient ID.

  Then, before conducting a test that requires a consent form, the doctor must operate the researcher terminal 10 to print out the consent form for the test and ask the subject to sign. In addition, this consent form, when one test is completed and proceeding to the next test in accordance with the flow of the clinical trial plan registered in the server 20, A button such as “output consent form” may be displayed on the display of the researcher terminal 10 and may be printed out from a printer when the doctor presses the button.

  Here, as shown in FIG. 2, a barcode is printed on the consent form at a predetermined position (the upper left portion of the paper in the example of FIG. 2). That is, when a doctor performs an operation to print out a consent form of a certain test from the researcher terminal 10, the researcher terminal 10 uniquely identifies the subject, the doctor, the test content, and the like for the test. Generate a specific barcode and print it on the consent form. That is, the barcode includes information such as a subject ID, a doctor ID, and a test ID. In addition to this information, the information included in the barcode is arbitrary. For example, the document type ID indicating that the document is a “consent document”, the acquisition date of the consent document, the location of the test, the department in charge, Various information such as an ID indicating a document storage location, a storage deadline, and an ID of a researcher terminal 10 that has performed an operation of outputting a consent form can be considered. In the example of FIG. 2, a two-dimensional barcode (QR code (registered trademark)) is illustrated, but a one-dimensional barcode may be used, and any other code can be used.

  In addition, as said subject ID, when a doctor pushes the button of consent form output in the terminal 10 for researchers, ID of the patient of the electronic medical record opened on the said terminal is acquired and used.

  As described above, when obtaining the consent form, the doctor operates the researcher terminal 10 on the spot to print out the form of the consent form, and the consent form includes which subject for which test. One of the features of the present system is that a bar code including information that can uniquely identify whether or not it is a consent form is printed. This consent form is read by the scanner after the subject has signed, and stored in the server 20 as an image. At that time, information included in the barcode is stored in the server 20 as tag information of the image file. As a result, it is possible to uniquely identify the consent document image stored in the server 20 from which subject for which test. As a result, the consent document can be managed correctly without the consent document being dissipated.

  In addition, by saving the image file of the consent form together with the tag information (barcode 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 terminal 10. . For example, a list of consent forms for a specific subject, a list of consent forms related to a specific test ID, and the like can be displayed on the researcher terminal 10.

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

  In addition, the consent document used in the clinical trial includes a consent document with an explanation in addition to a consent document for simply obtaining a signature from the subject. In the case of written consent with instructions, the doctor prepares two documents (original and duplicate) with the same contents, and after explaining the test contents from the doctor to the subject according to the instructions, both sides sign. One copy is to be stored. In this case, two copies of the agreement with the same barcode may be printed out, and after both have signed, two copies may be scanned and stored. Alternatively, the barcode information may include an identifier that can distinguish between the original and the duplicate.

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

  If the document to be stored covers a plurality of pages, it is preferable to print the barcode on all pages. In this case, it is desirable to provide page information of the document (the total number of pages of the document and the serial number of each page) as barcode information. This page information is also stored in association with a part of the tag information when an image file obtained by scanning the document is stored. This not only prevents the data in the document across multiple pages from being lost, but also allows the page order to be recognized correctly even if the pages are scanned out of order, and the images on each page are displayed according to the page serial number. There is an advantage that it can be rearranged.

  Next, a mechanism for recording the test result in the server 20 in the research information management system 1 of the present embodiment will be described. As described above in the present embodiment, in the case of clinical research including clinical trials, etc., it is necessary to leave exactly the test data such as when, where, and what kind of content was tested for which subject. Don't be.

  Therefore, the research information management system 1 manages test data (case cards) by using the “stamp” function of the electronic medical record system. Here, the “stamp” of the electronic medical chart system is disclosed in detail in a previous patent (Japanese Patent No. 5204534, Japanese Patent Application No. 2008-99577) by the applicants of the present application. That is, a data input screen layout template is described in a structured document (structured description language) such as XML, and when data is input to the data input screen, the layout of the data input screen including the input data is displayed. Generate a structured document with data to be described, extract at least a tag name as a search item from the generated structured document with data, and associate the extracted search item with at least a part of the structured document with data Is stored in the database.

  The function of displaying the template of this data entry screen on the terminal screen and inputting the necessary data is compared with the act of pressing a medical record stamp (rubber stamp) and filling in the data on the paper chart. This is called the “stamp” function of the chart system.

  FIG. 4 shows a schematic functional configuration of the researcher terminal 10 and the server 20 for realizing the stamp function. As shown in FIG. 4, the researcher 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. 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 an internal hard disk), but these are external to the researcher terminal 10. (For example, on a disk device or a file server accessible from the researcher terminal 10). 2 shows an example in which the template storage unit 111 is provided in the researcher terminal 10, the template storage unit is arranged in the server 20, and the data input person selects a template (stamp). Sometimes, the 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 receiving 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 that are not necessarily required to be implemented as separate and independent hardware.

  The communication processing unit 110 communicates with the server 20 and other user terminals as necessary 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 terminal 10. When each template is created for the first time, the inspection items of the stamp can be obtained from the inspection result database of the electronic medical record system.

  Here, a mechanism for storing data input using a stamp in an electronic medical record system will be described first. For example, in the data input screen shown in FIG. 5, various templates (stamps) for data input can be selected in the document selection field 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 “clinical trial” and the data input screen is displayed on the main screen 32. That is, the display processing unit 112 extracts the XML that defines the template selected by the doctor in the document selection field 31 from the template storage unit 111, and analyzes the XML of the extracted template to display the data input screen as a researcher. Displayed on the terminal 10. The XML that defines 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. 4A to 4H of Japanese Patent No. 5204534, a portion including the XML description of the tag corresponding to the input field of the data input screen is surrounded by a frame.

  The input data receiving unit 113 detects input data for the data input screen displayed on the researcher terminal 10, and sends the detected input data to the input data storage unit 114 together with the tag name for which the data is input. Remember at least temporarily. 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 generates an XML file containing data describing the layout of the data input screen including the input data. Generate. The generated XML file with data is sent from the researcher terminal 10 to the server 20 via the LAN 40.

  For example, assume that data input as shown in FIG. 7 is made on the data input screen of “demographic data” shown in FIG. 5 opened in the electronic medical record of a subject. In this case, the date data input as the observation date includes the character string data input to the tag (control) “observation date.year” defined in the XML and the tag “observation date.month”. And the character string data input to the tag “observation date.day”. The input data receiving 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.date”, respectively, and the input data storage unit 114 is stored. Other data entered on the data entry screen, that is, birth date, gender, height, weight, race, and initials are processed in the same manner by the input data receiving unit 113, 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 a subject, a doctor in charge, and the like is also stored in association with the input data.

  When the data input to the data input screen is completed in this way, 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. Then, an XML file describing the layout of the data input screen including the input data is generated. 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 illustrated 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 is a disk device that can be accessed outside the server 20 (for example, accessible from the server 20). Or on a file server). The communication processing unit 120, the item extraction unit 121, the search condition setting unit 123, the search execution unit 124, and the display processing unit 125 are functional means that are realized when the processor of the server 20 executes a predetermined program. Yes, it does not necessarily have to be implemented as separate and independent hardware.

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

  The item extraction unit 121 extracts a tag name corresponding to the input field of the data input screen from the XML file with data sent from the researcher terminal 10. The XML database 122 stores the XML file with data 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 and displays a search item from the XML database 122, causes the search performer to select the search item as necessary, and accepts a search condition related to the search item. The search execution unit 124 searches the XML database 122 based on the search condition received from the search performer. 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. It should be noted that the input of search conditions and the display of search results may be performed using the input device and display device provided in the server 20, but the input device and display device provided in any one of the researcher 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 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 the XML file. 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, and stores the extracted tag name in the XML database 122 in association with the XML file. The tag name extracted by the item extraction unit 12 is used as an option for allowing a search executor to select a search item in a later search process. In order to save the storage capacity when the received XML file is stored in the XML database 122, for example, a description part not related to input data in the XML file is removed, and a part including a description about significant input data is included. May be stored in the XML database 122.

  Through the above procedure, the test data input from the researcher terminal 10 can be collected in the XML database 122 of the server 20 as an XML file. In the above description, the process of extracting the tag name corresponding to the input data item from the XML file is performed in the item extraction unit 121 provided in the server 20, but the tag name extraction process is performed for the researcher. The configuration may be such that the extracted tag name is sent to the server 20 together with the XML file and stored in the XML database 122 on the terminal 10 side.

  Here, FIGS. 6 to 11 show examples of input / output of clinical trial data. FIG. 6 is a display example of the screen of the researcher terminal 10 in a state where an electronic medical record of a 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 patient test data is read and read. Based on the XML file thus obtained, an input window for the template (stamp) is opened as shown in FIG. In the example of FIG. 7, a window of “(article) dialysis prevention stamp” is shown. The physician can enter test data on this window.

  At this time, as shown in FIG. 7, when the “(article) dialysis prevention stamp” window is opened, the data of the test and examination performed in the past on the patient are already displayed on the stamp together with the date of the examination. It is in the displayed state. This is because the input data is recorded in the XML file stored in the XML database 122 together with the tag name related to the input item. For example, in the example of the display screen shown in FIG. 7, the date when this stamp is called is May 29, 2013 as displayed on the screen, but in the past (May 23, 2013) As a result of the broken test, the values of HbA1c, creatinine, and urine protein are respectively displayed. Therefore, the doctor does not need to input the already examined data again on the stamp, and only needs to input data for the newly examined items. For example, in the example of FIG. 7, it is only necessary to perform a test on blood pressure and input the test result.

  Note that even if an item has already been input, if the inspection is performed again, 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 order to leave the history accurately, it is desirable that past numerical values cannot be edited, and when the numerical values are rewritten, the date of “inspection date” is desirably automatically rewritten. Even if the numerical value is rewritten, the past numerical value may be stored as a history together with the past date when the inspection was performed.

  Note that when the result (stamp) of a test performed in the past is called on the screen, the latest test date may be automatically called. When it is desired to call a stamp having a date before the most recent examination date, a list of dates on which examinations are performed on the patient may be displayed and selected from the list.

  Then, when the doctor enters the necessary test data and clicks the “Confirm” button at the bottom right of the window, the data entered in this stamp is associated with the tag name of the input item by the mechanism of the stamp function described above. It is saved in the state. Then, as shown in FIG. 9, the data is displayed together with the stamp name in the S column of the SOAP article of the subject's electronic medical record. In addition, the doctor can appropriately input other fields. In the example of FIG. 9, the text of diagnosis is entered in the A column. In this state, after pressing the “Confirm” button, all records of the day can be displayed as shown in FIG. In the example shown in FIG. 10, the test data entered with the stamp and the diagnostic article are displayed on the left side of the main window, and the content of the prescription instruction given by the doctor on the day is displayed on the right side by looking at the test result. Yes.

  Also, the test data input with the stamp can be aggregated in time series or processed into a table or graph in the researcher terminal 10 or the server 20. For example, as shown in FIG. 11, data input so far for the subject with “(article) dialysis prevention stamp” is automatically tabulated in a table software and displayed in an easy-to-understand manner for each item. . As can be seen from a comparison between FIG. 8 and FIG. 11, the data input with the stamps of FIG. 8 is organized for each item. Of course, it is easy to graph these data.

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

  Further, the data input with the stamp may be further classified in the server 20 according to the classification structure for research or medical use, and may be recorded or output as a group of each classified item or plural items. good. That is, the data of the subject (patient) includes basic information of the subject such as name and gender, and current findings data, but the current findings data includes clinical subjects (eg, neurology, gastroenterology, circulatory organs). For example, in the case of gastroenterology, subdivision data such as the esophagus and stomach are included. The data of those subdivision items is also composed of data of a finer classification. Generally, such data is configured as one or a plurality of tree-structured or net-structured data. Then, it is preferable to record and output the test data input with the stamp in the server 20 in association with such tree structure or net structure data.

  In addition to the XML file, a stamp image in a state where the test data is input may be stored 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, search by item name or the like cannot be performed, but at least the obligation to store test data can be fulfilled.

  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 item in which the data is input The tag names are extracted and stored in the server 20 together with the XML file including the input data. As a result, test data, clinical data (including findings), etc. can be stored as data in the electronic medical record system, so test data can be stored in a state that satisfies the three principles of authenticity, readability, and storability. It becomes possible to manage. In addition, since the clinical trial subject is also a patient being treated, conventionally, the same information entered on the clinical trial case card (test data) must be entered in the electronic medical record system as a treatment record. There was annoyance. On the other hand, according to the research information management system 1, since a clinical trial case card is created and managed using the stamp function of the electronic medical record system, the electronic medical record is not required to input duplicate data. There is an advantage that test data and clinical data can be stored in the system. In addition, search data can be easily searched, tabulated, and processed.

  In the above description, the mechanism for creating the test data case card on the electronic medical record system is exemplified. However, the test data case card may be created outside the electronic medical chart system, and only the finally created data may be stored in the server 20 of the electronic medical chart system. Alternatively, the finally created data may be stored in an external server, and a link may be established from the electronic medical record system so that the data can be accessed immediately. If comprised in this way, it will not be necessary to make a big change to the existing electronic medical chart system.

  As described above, according to the research information management system 1 according to the first embodiment, clinical trial data (case card) 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, it is possible to manage clinical trial data without omission and in a state where subsequent retrieval and processing are easy. 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) or the like can be created and output based on this data.

  Moreover, in the research information management system 1 of this embodiment, an examination schedule may be automatically managed using a stamp. For example, after prescribing a certain drug to a subject, when the subject (patient) revisits after a certain period of time, a template that should be filled in at the time of the current examination based on the previous prescription record, inspection request record, etc. It is preferable to automatically extract (stamp) and display the stamp on the researcher terminal 10 or display a message notifying that the template should be filled.

  In addition, the research information management system 1 according to the first embodiment outputs the subject's consent form with a barcode when the consent form is required at each step of the test, and the signed consent form. Are stored together with barcode information as an image file. Therefore, the consent form is not dissipated in clinical trials, and there is an advantage that proper management can be performed.

  In addition, although this embodiment demonstrated as the research information management system 1 which manages the data regarding a clinical research, the use of a system is not limited to a research purpose, Use such a system also for a medical examination or a treatment purpose. Can do.

[Second Embodiment]
The research information management system according to the second embodiment is the same as the research information management system 1 according to the first embodiment in the basic system configuration, but is particularly a computer system that manages data related to medical research. . In this embodiment, an example in which data related to medical research is managed is described. However, the present invention can be applied not only to medical research but also to management of research data in various fields.

  In medical research, as in other academic fields, researchers clarified when, where, what experiments, how they were performed, what results were obtained, etc. There is a need to keep records detailed and accurate based on truth. In recent years, the authenticity of experimental records has been rigorously questioned due to the emergence of several cases in which experimental data is suspected of being altered.

  However, in the past, experiment records have been mainly written by hand in the “lab note”, and for example, you can find it even if you modify the written items later or add items that were not written. There is a problem that it is difficult.

  In view of such problems, the research information management system 1 according to the present embodiment is intended to accurately record the contents of experiments based on the truth and to make it impossible to tamper with experimental data. is there.

  In order to achieve this object, the research information management system 1 according to the present embodiment includes (1) a function for identifying and recording specimens and experimental animals used in experiments, and (2) using them in experiments. (3) a function for identifying a researcher who has performed an experiment, and (4) a function for storing experimental data so that it can be understood if tampered. In addition, although it is preferable to provide all of these functions, it is not essential to provide all of these functions.

  First, the function (1) of specifying the specimen 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 attaches a barcode including an individual identification ID to each specimen and experimental animal, and the researcher or research assistant conducts an experiment using the specimen or experimental animal. Each time a sample or laboratory animal is subjected to some processing other than an experiment (such as preparation for an experiment), the barcode attached to the sample or laboratory animal and, preferably, a researcher or research assistant with the barcode scanner 13 Each bar code (given to a name tag or the like) given to the user is read, and the record is left in the server 20. At this time, it is preferable that a record of what has been performed on the specimen or experimental animal is input from the researcher terminal 10 or the like and stored in the server 20 in association with the ID.

  For specimens, stickers or tags printed with barcodes may be attached to specimen containers and for laboratory animals to cages, collars, ear tags, etc. It is also possible to use an RFID instead of a bar code. Alternatively, a microchip embedded in the body of a laboratory animal may be used.

  In this way, by assigning an individual identification ID to a specimen or laboratory animal, each time a researcher or research assistant accesses the specimen or laboratory animal, a record of who and when accessed the specimen or laboratory animal. Therefore, it is easy to detect the fact that the specimen or the experimental animal is mixed or replaced.

  In addition, when storing data related to specimens and laboratory animals, third-party authentication is obtained for the person who accessed the specimen or laboratory animals using a user authentication service of an external authentication server, and access time information is also provided. More preferably, it is acquired and recorded in association with the data. The authentication server that provides the user authentication service is not limited to an external authentication server provided 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, human face recognition technology may be applied as a method for identifying individual laboratory animals. For example, even in the case of a mouse or a rat, the size and shape of eyes and nose differ slightly depending on the individual, and it is considered that individual identification based on a face image is possible to some extent. Therefore, when an experimental animal arrives in the laboratory, a face image is acquired and recorded with a digital camera, and each time a researcher or the like accesses the experimental animal, the face is photographed and recorded. Compared with the face image (applying human face recognition technology), it can be confirmed that there is no mistake or replacement of the experimental animals. In addition, depending on the type of animal, it may be possible to use a tooth profile, a nose pattern, or the like for individual identification.

  As described above, the specimen or experimental animal used in the experiment in (1) above is specified and recorded in association with the experimental data, which specimen or experimental animal is used when obtaining the experimental data. It is possible to leave exactly as it is. This makes it possible to use this data as evidence even if the authenticity of the experimental data may be asked later. In addition, by using third-party authentication, it is possible to leave more reliable evidence as to which researcher accessed the specimen or experimental animal.

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

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

  Alternatively, in addition to the method of reading the barcode of the inspection device ID, the following method is also conceivable. When the inspection device is a device that can be connected to the LAN 40, it is also preferable to acquire the address on the network of the inspection device 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 also desirable to acquire the authentication information and use it as the inspection device ID.

  Further, the output data from the inspection device is not limited to being recorded as it is, and 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, the inspection device used in the experiment in (2) above is specified, and the function of recording in association with the output data from the inspection device is provided. Can be left as data. This makes it possible to use this data as evidence even if the authenticity of the experimental data may be asked later. In addition, by using third-party authentication, it is possible to leave more reliable evidence as to which researcher accessed the specimen or experimental animal.

  Next, the function (3) for specifying the researcher who performed the experiment will be described. As described above, each time a certain process related to an experiment or a research record is performed, the researcher or research assistant reads the barcode attached to the name tag with the barcode scanner 13. The information is recorded on the server 20 together with information indicating what has been done. Of course, the means for identifying an individual is not limited to a barcode, and biometric authentication can be used, for example, and an experimental record with higher authenticity can be left. The “information indicating what has been done” may be experimental data, or text input about what the person has done. Similarly to the above, by using third party authentication together, it is possible to leave more reliable evidence as to who did what and when.

  In the case of a research information management system that employs single sign-on, once login to the system is authenticated, the resources on this system can be used without logging in again. In this case, the login information when logging in for the first time is stored as information for identifying the researcher. Therefore, in the case of a system that employs single sign-on, the researcher can proceed with the research work without logging in or reading the barcode of the researcher ID each time.

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

  Next, the function (4) of storing the experimental data so that it can be understood when the experimental data is falsified will be described.

  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 externally recognized third party certification body. By giving a time stamp, the proof that the experimental data has not been tampered with thereafter can be obtained by using the hash value together with the proof of the time when the experimental data was obtained. In addition, not only experimental data but also the information obtained by the functions (1) to (3) described above can be added to the time stamp to further improve the evidence.

  In this embodiment as well, it is preferable to have a researcher input experimental data using the stamp function of the electronic medical record system described in the first embodiment. This is because input items and data can be managed in association with each other, and subsequent data search and processing become easy. In other words, by recording the laboratory notebook using the stamp function of the electronic medical record system, the three principles of authenticity, readability and storability are ensured, so that the evidence of the experimental data is also ensured. 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 note or a board as an experiment record. By attaching a time stamp 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 to be falsified.

  In addition, in the research information management system 1 according to the present embodiment, it is desirable to introduce a mechanism that prevents subsequent operations when necessary IDs are not read. For example, when using the ID of the specimen or laboratory animal in (1), if the ID of the specimen or laboratory animal is not read, the operation of the testing equipment is restricted so that the examination using the specimen or laboratory animal cannot be performed. And so on. Or when using ID of the test | inspection apparatus used for experiment of (2), you may make it apply operation | movement restriction to the said test | inspection apparatus until ID reading of a test | inspection apparatus is made.

  As described above, according to the research information management system 1 according to the present embodiment, it is possible to improve the evidence of experimental records and experimental data in medical research.

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

1 Research Information Management System 10 Researcher Terminal 11 Display 12 Main Body 13 Barcode Reader 20 Server 30 Scanner 40 LAN

Claims (3)

A research information management system using an electronic medical record system,
The electronic medical record system
A template storage unit storing a structured document describing a template of a data input screen layout;
A display processing unit that analyzes a structured document corresponding to the selected template and displays a data input screen;
When data is input to the data input screen, the input data storage unit stores at least temporarily the input data and the corresponding tag name in association with each other,
When input of data to the data input screen is completed, the structured data corresponding to the template of the data input screen is referred to, and the input data and tag name stored in the input data storage unit are included. A structured document generator for generating a structured document with data describing the layout of the data entry screen;
An item extraction unit for extracting at least a tag name as a search item from the structured document with data;
A search item extracted from the structured document with data by the item extraction unit, and a database that stores at least a part of the structured document with data in association with each other;
The research information management system includes:
Data related to medical research tests are input as the input data,
A reading means for reading at least one of an identifier for identifying a specimen or a test animal used for the test, an identifier for identifying a test device used for the test, and an identifier for identifying a researcher or research assistant performing the test,
Storing the identifier in association with test data in the database of the electronic medical record system;
Each time a sample or test animal is processed, each time a testing device is used, each time a test is performed, or each time a research record is recorded, the corresponding identifier is acquired by the reading means, and the required identifier is not read. Is a research information management system that makes subsequent operations impossible .   The research information management system according to claim 1, wherein the input data is classified and stored in a database of the electronic medical record system according to a predetermined classification structure. Means for obtaining a time stamp of the test data from the certification body;
The database includes an area for recording the time stamp in association with test data;
The research information management system according to claim 1, wherein the time stamp is acquired each time a test is performed or a record relating to research is performed.

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