JP6751128B2 - Research information management system - Google Patents

Description

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

In recent years, an electronic medical record system that manages medical record information by a computer is widely used in many hospitals and clinics (for example, refer to Patent Document 1 below). Since the electronic medical record system handles information related to medical treatment, the three principles of "authenticity", "readability", and "preservability" (so-called "three principles of electronic preservation") are specified as medical requirements. It is required to meet. Since these three principles are secured, the electronic medical record system can manage medical information with high reliability.

JP, 2005-242395, A

On the other hand, in the field of clinical research including clinical trials and clinical trials, the storage of research data by electronic media has not been systematized so much, and there is a concern that research data may be inconsistent or lost.

Similarly, in medical research as well, research records are often recorded exclusively on paper media (lab notebooks), and a mechanism for ensuring the authenticity of experimental data obtained from a testing device is not sufficiently prepared. In recent years, some cases in which alteration of experimental data is suspected have become apparent, which has become a major social problem.

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

The first configuration of the present invention is
A research information management system for managing information related to medical research,
Generate an optically readable code containing at least information identifying the subject or patient and the study name, and including the code and completed by the subject or patient prior to the study requiring consent of the subject or patient. Means for printing out the desired document,
A research information management system, comprising: 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.

A second configuration of the present invention is the same as the first configuration,
The code is a one-dimensional bar code or a two-dimensional bar code.

A third configuration of the present invention is the above first or second configuration,
An electronic medical record database that manages subject or patient information including a medical record data file in association with identifiers assigned to each subject or patient, and
Further comprising a researcher terminal connected to the electronic medical record database,
The information identifying the subject or patient is the subject or patient corresponding to the medical chart data file opened on the researcher's terminal when the 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 that stores a structured document that describes 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, an input data storage unit that stores the input data and the tag name corresponding to the input data at least temporarily in association with each other,
When the input of the data to the data input screen is completed, the structured document corresponding to the template of the data input screen and the input data and the tag name stored in the input data storage unit are referred to and the input data is included. A structured document generation unit that generates a structured document containing data that describes the layout of the data input screen,
An item extraction unit that extracts at least a tag name as a search item from the structured document containing data,
Further comprising a search item extracted from the data-containing structured document by the item extracting unit, and a database that stores at least a part of the data-containing structured document in association with each other,
Data relating to the test is input as the input data.

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

A sixth configuration of the present invention is
A research information management system for managing information related to medical research,
A means for reading an identifier for identifying a specimen or an experimental animal used in the experiment,
A database that records the identifier in association with experimental data,
The identifier is obtained each time a sample or an experimental animal is processed.

The seventh configuration of the present invention is
A research information management system for managing information related to medical research,
A means for reading an identifier that identifies the test equipment used in the experiment,
A database that records the identifier in association with experimental data,
Each time the inspection device is used, the identifier is acquired.

The eighth configuration of the present invention is
A research information management system for managing information related to medical research,
Means for reading an identifier that identifies the researcher or research assistant conducting the experiment;
A database that records the identifier in association with experimental data,
The identifier is obtained each time an experiment is performed or a research-related record is made.

A ninth configuration of the present invention is
A research information management system for managing information related to medical research,
A means to obtain the time stamp of the experimental data from the 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-related record is made.

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.

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 processing procedure from acquisition of consent to storage. FIG. 3 is a functional schematic configuration diagram of a researcher's terminal 10 and a server 20 for realizing a stamp function. The figure which shows an example of the data input screen displayed by the stamp function. The figure which shows an example of input/output of clinical trial data. The figure which shows an example of input/output of clinical trial data. The figure which shows an example of input/output of clinical trial data. The figure which shows an example of input/output of clinical trial data. The figure which shows an example of input/output of clinical trial data. The figure which shows an example of input/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 various types of tests/research such as clinical trials and clinical trials, and the contents of the tests/research 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 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 chart system server of a hospital/clinic where clinical research is conducted can be used. In FIG. 1, network connection devices such as a hub and a router are not shown. 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 an assistant as a researcher, is installed in a research room, a clinic, etc., and as shown in FIG. 1, a display 11, a main body 12, and a barcode scanner. 13 and. Although not shown in FIG. 1, the researcher's terminal 10 may include input devices such as a keyboard and a mouse, and arbitrary peripheral devices such as a printer. Although a desktop personal computer is illustrated as an example of the researcher's terminal in FIG. 1, the hardware configuration of the researcher's terminal is not limited to this and is arbitrary. Further, the scanner 30 may be connected to the researcher's terminal 10.

In the case of clinical research including clinical trials, it is important to keep accurate test records of which subjects (patients) when, where, and what kind of tests were conducted. In addition to this, in particular, in each step of the test that may affect the human body, such as administration of drugs, surgery, treatment involving invasion by medical devices, acquisition of samples from the human body, etc. It is also very important that you take the consent form from and keep it until the prescribed storage period elapses.

Therefore, first, in the research information management system 1 according to this embodiment, a mechanism for managing the consent form of the subject will be described. As a premise, it is assumed that a patient participates in a clinical trial at a medical institution. This patient is an inpatient or outpatient of the medical institution, and the basic data (name, sex, age, address, health insurance information, patient ID in the medical institution, etc.) regarding the patient is stored in the server 20 (electronic medical record system). Server). It should be noted that the server 20 may have a built-in recording medium for recording the basic data and clinical trial data of the subject, 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 are 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 implementation plan and GCP rules. For example, various data such as the study ID, study name, study area, target disease, and study type can be used. Contains items. In addition, a clinical trial implementation plan (flow showing which trials are to be conducted and in what order) is also registered. Furthermore, the format of the consent form required for each test is also recorded in the server 20. The format of this consent form includes information that specifies the content of the test to be performed, such as the test ID and test name, and information that specifies the subject, such as the patient name and patient ID.

Then, before conducting a test requiring a consent form, the doctor must operate the researcher's terminal 10 to print out the consent form for the test and request the subject to sign. Note that this consent form is written in accordance with the flow of the clinical trial implementation plan registered in the server 20 when one consent is required to perform the next test when one test is completed and the next test is performed. A button such as “output consent form” may be displayed on the display of the researcher's terminal 10 and the doctor may press the button to print out from the printer.

Here, as shown in FIG. 2, a bar code 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 the doctor performs an operation of printing out the consent form for 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 specific barcode and print it on the consent form. That is, this barcode includes information such as the subject ID, the doctor ID, and the examination ID. In addition to these pieces of information, the information included in the barcode is arbitrary, but for example, the document type ID indicating that the document is a “consent form”, the acquisition date of the consent form, the place where the test is conducted, the department in charge Various information such as the ID indicating the storage location of the document, the storage deadline, the ID of the researcher terminal 10 that performed the operation of outputting the consent form, and the like are conceivable. In the example of FIG. 2, a two-dimensional bar code (QR code (registered trademark)) is illustrated, but a one-dimensional bar code may be used or any other code may be used.

As the subject ID, the ID of the patient of the electronic medical record opened on the terminal when the doctor presses the consent form output button on the researcher's terminal 10 is used.

Thus, when obtaining the consent form, the doctor operates the researcher's terminal 10 on the spot to print out the form of the consent form, and in addition, the consent form indicates which test subject for which test. One of the features of this system is that a bar code containing information that can uniquely identify whether it is a consent form or the like is printed. This consent form is read by the scanner and stored in the server 20 as an image after the subject signs it. At that time, the information included in the barcode is stored in the server 20 as the tag information of the image file. This makes it possible to uniquely identify the image of the consent document stored in the server 20 as the consent document obtained from which subject for which test. As a result, the consent form can be managed correctly without being scattered.

Further, by storing the image file of the consent form in the server 20 together with the tag information (barcode information), 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, 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 illustrating 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, in the flow of the clinical trial implementation plan, it is determined that the next test to be performed is a test that requires a consent form (step). A YES in S1), a barcode including necessary information is generated (step S2), and a 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 in the server 20 using the information read from the barcode as tag information (step S5).

Note that the consent forms used in clinical trials include a consent form with instructions in addition to a consent form for simply obtaining a signature from a subject. In the case of a consent form with instructions, the doctor prepares two copies of the same content (original and duplicate), and after the doctor explains the test content to the subject according to the instructions, both parties sign it. It is supposed to store one copy at a time. In this case, two consent forms with the same bar code may be printed out and signed by both parties, and then two copies may be scanned and saved. Alternatively, the barcode information may include an identifier that allows the original and the duplicate to be distinguished.

Further, the information (which is the login ID and login date and time of the doctor) indicating which doctor has output the consent form by using the user authentication service by the external authentication server, etc. The information attached may be embedded in the barcode information. According to this, if the consent form has not been acquired at an appropriate timing, it is impossible to add the consent form later, and thus 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, and may be an authentication server provided in the same facility (for example, in a laboratory).

When the document to be stored has a plurality of pages, it is preferable to print the bar code on all pages. In this case, it is desirable to include page information of the document (total page number of the document and serial number of each page) as the barcode information. This page information is also stored as a part of the tag information when the image file obtained by scanning the document is stored. This not only prevents the data of the document over multiple pages from being scattered, but also allows you to correctly recognize the order of each page even if you scan the pages in an out-of-order state, and to display the image of each page according to the page serial number. There is an advantage that it can be rearranged.

Next, a mechanism of 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, test data such as when, where, and what kind of test was performed for which test subject must be accurately recorded without omission. I won't.

Therefore, the research information management system 1 manages the 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 previous patents (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 set. Generate a structured document containing data to be described, extract at least a tag name as a search item from the generated structured document containing data, and associate the extracted search item with at least a part of the structured document containing data. To be stored in the database.

The function of displaying the template of this data input screen on the screen of the terminal and inputting the necessary data is likened to the act of pressing a medical record stamp (rubber stamp) on a paper medical record and writing the data on it. It is called the "stamp" function of the chart system.

FIG. 4 shows a functional schematic configuration of the researcher's terminal 10 and the server 20 for realizing the stamp function. 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. The 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 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's terminal 10). In the example of FIG. 2, the template storage unit 111 is provided in the researcher's terminal 10, but the template storage unit is arranged in the server 20 and the data input person selects the template (stamp). At this time, the XML corresponding to the selected template may be transmitted from the server 20 to the researcher's 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. It is a functional means to be performed and does not necessarily need 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's terminal 10. When initially creating each template, stamp inspection items and the like can be acquired from an inspection result database or the like of the electronic medical chart system.

Here, first, a mechanism for saving the input data using the stamp in the electronic medical record system 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 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 for “clinical trial” 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 field 31 from the template storage unit 111 and analyzes the extracted XML to display the data input screen on the researcher's side. It is displayed on the display 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. 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 the input data on the data input screen displayed on the researcher's terminal 10, and stores the detected input data in the input data storage unit 114 together with the tag name of the data input target. Store 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 creates a data-containing XML file that describes the layout of the data input screen including the input data. To generate. The generated XML file containing data is sent from the researcher's terminal 10 to the server 20 via the LAN 40.

For example, it is assumed here that the data input as shown in FIG. 7 is performed on the data input screen of “demographic data” shown in FIG. 5 opened in the electronic chart 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 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, associates them with tags “observation date.year”, “observation date.month”, and “observation date.day”, respectively, and stores them in the input data storage unit 113. It is stored in 114. Other data entered on the data entry screen, that is, the date of birth, gender, height, weight, race, and initials are also processed by the input data accepting unit 113 in a similar manner, and the input data is associated with the tag name. It is stored in the input data storage unit 114 at least temporarily. At this time, information identifying the subject, the doctor in charge, etc. 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 the tag name stored in the input data storage unit 114. Then, an XML file that describes 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's terminal 10.

On the other hand, the server 20 includes a communication processing unit 120, an item extracting unit 121, an XML database 122, a search condition setting unit 123, a search executing unit 124, and a display processing unit 125, as shown in FIG. In the example of FIG. 4, the XML database 122 is built inside the server 20 (for example, on an internal hard disk), but the XML database 122 is 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, these do 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 extracting unit 121 extracts the tag name corresponding to the input field on the data input screen from the XML file containing data sent from the researcher's terminal 10. The XML database 122 stores an XML file containing data sent from a user terminal in association with a tag name extracted by the item extracting unit 121 from the XML file.

The search condition setting unit 123 acquires and displays the search items from the XML database 122, allows the search executor to select the search items as necessary, and receives the search conditions regarding the search items. 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 format of a data input screen including the input data. The input of the search condition and the display of the search result may be performed using the input device and the display device included in the server 20, but the input device and the display device included in any of the researcher terminals 10 may be used. You may make it possible to use it. Alternatively, the search may be performed by using a terminal other than the researcher's terminal 10 and the server 20 that is accessible to the server 20 via the LAN 40.

In the server 20 configured as 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 extracting unit 121 extracts the tag name corresponding to the input data item from the XML file, stores the extracted tag name in the XML database 122 in association with the XML file. The tag name extracted by the item extracting unit 12 is used as an option for allowing the search executor to select a search item in the subsequent search process. When the received XML file is stored in the XML database 122, in order to save the storage capacity, for example, a portion including a description regarding significant input data is removed by removing a description portion that is not related to the input data in the XML file. Only the XML database 122 may be stored.

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

Here, FIGS. 6 to 11 show examples of input/output of clinical test data. FIG. 6 is a display example of a screen of the researcher's terminal 10 in a state in which an electronic chart 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 test data of the patient is read and read. An input window of the template (stamp) opens as shown in FIG. 7 based on the created XML file. In the example of FIG. 7, a state in which the window of “(article) dialysis prevention stamp” is opened is shown. The doctor can enter the 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 tests and tests performed in the past for the patient are already recorded on the stamp together with the date of the test. 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 it has been changed to the past (May 23, 2013). The values of HbA1c, creatinine, and urinary protein are displayed as the results of the inspections performed. Therefore, the doctor does not need to input the already-examined data again on the stamp, but only needs to input the data for the newly inspected item. For example, in the example of FIG. 7, only the blood pressure may be tested and the test result may be input.

Note that even if the item has already been input, when the inspection is redone, by inputting a numerical value for the item on the screen, the input numerical value and the inspection date are overwritten and updated. In addition, in order to accurately retain the history, it is desirable that past numerical values cannot be edited, and that when the numerical values are rewritten, the date of “inspection date” is also automatically rewritten. Further, even when the numerical value is rewritten, the past numerical value may be stored as a history together with the past date of the inspection.

When the result (stamp) of the inspection performed in the past is called on the screen, the one with the latest inspection date may be automatically called. Further, if a user wants to call a stamp dated earlier than the latest examination date, a list of dates when the examination was performed on the patient may be displayed so that the patient can be selected from the list.

Then, after the doctor has entered the required test data and then clicks the “OK” button at the bottom right of the window, the stamp function mechanism described above associates the data entered in this stamp with the tag name of the input item. It is saved in the opened state. Then, as shown in FIG. 9, the data is also displayed in the column S of the SOAP article of the electronic medical record of the subject together with the stamp name. Further, the doctor can also make appropriate entries in other fields. In the example of FIG. 9, the diagnostic content is text input in the A column. After further pressing the "confirm" button in this state, all records of the day can be displayed as shown in FIG. In the example shown in FIG. 10, the test data entered with a stamp and the diagnostic article are displayed on the left side of the main window, and the content of the prescription instruction issued by the doctor on the day of the test result is displayed on the right side. There is.

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

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

Further, the data input by the stamp may be further classified in the server 20 according to the classification structure for research or medical purposes, and may be recorded or output as each classified item or a plurality of classified items. good. That is, the data of a subject (patient) includes basic information about the subject such as name and sex, and current finding data, but the current finding data includes clinical subjects (for example, neurology, gastroenterology, cardiology). For example, in the case of gastroenterology, subdivided data such as esophagus, stomach, etc. is included as a more detailed classification for each item. The data of these subdivision items are also composed of data of finer classification. Generally, such data is configured as one or more tree-structured or net-structured data. Then, it is preferable that the server 20 associates the test data input by the stamp with the data of the tree structure or the net structure and records and outputs the test data.

In addition to the XML file, an image of a stamp in which test data is input may be stored as image data in the server 20 or an external server. Further, 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 cannot be searched by item name, but at least the test data storage obligation 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 data is input. The tag name of is 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 saved as data of the electronic medical record system, so the test data can be saved while satisfying the three principles of authenticity, readability, and storability. It becomes possible to manage. In addition, since the subject of the clinical trial is also a patient who is undergoing treatment, conventionally, the same content (test data) entered in the case card of the clinical trial must be input to the electronic medical chart system as the treatment record. There was a hassle. On the other hand, according to the research information management system 1, since the case card of the clinical trial is created and managed by using the stamp function of the electronic medical record system, the electronic medical record can be saved without the need for duplicate data input. There is an advantage that the system can store test data and clinical data. In addition, it is easy to search, aggregate, and process test data.

In the above description, the mechanism for creating the case card of the test data on the electronic medical record system has been illustrated. However, the case card of the test data may be created outside the electronic medical record system, and only the finally created data may be stored in the server 20 of the electronic medical record 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 immediately accessed. With this configuration, it is possible to make no major changes to the existing electronic medical record 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, clinical trial data can be managed without omission and in a state where it can be easily searched and processed later. Further, since the test data is properly managed by the electronic medical chart system for each subject and each item, a CRF (case report form) or the like can be created and output based on this data.

Further, in the research information management system 1 of the present embodiment, stamps may be used to automatically manage the examination schedule. For example, after prescribing a certain drug to a certain subject, when the subject (patient) returns to the hospital after a predetermined period of time, based on the prescription record and the examination request record of the previous time, the template to be filled in at the time of this examination It is preferable to automatically extract (stamp) and display the stamp on the researcher's terminal 10 or display a message notifying that the template should be entered.

In addition, the research information management system 1 according to the first embodiment outputs the consent form of the subject with a bar code and the signed consent form when the consent form is required in each step of the test. Is stored as an image file together with barcode information. Therefore, there is also an advantage that proper management can be performed without the consent form being scattered in clinical trials.

Although the present embodiment has been described as the research information management system 1 that manages data relating to clinical research, the use of the system is not limited to research purposes, and such a system may be used for medical examination and treatment purposes. You can

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

In medical research, as in research in other academic fields, researchers conducted experiments that clarified when, where, what experiments, how they were conducted, and what results were obtained. It is required to keep records in detail and accurately based on truth. In recent years, the authenticity of experimental records has come to be rigorously questioned because some cases in which the tampering of experimental data is suspected have become apparent.

However, in the past, it has been the mainstream that the experiment records are left alone in the "lab note" by hand. For example, even if you modify the items to be described later or add items that were not written, you will find them. 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 the contents of the experiment based on the truth and to make it impossible to falsify the experiment data. is there.

In order to achieve this purpose, the research information management system 1 according to the present embodiment uses (1) a function of identifying a specimen or an experimental animal used in an experiment and recording it in association with experimental data, (2) used in the experiment It provides a function of specifying the inspection equipment, (3) a function of identifying a researcher who performed the experiment, and (4) a function of storing the experiment data so that it can be known when the experiment is falsified. Although it is preferable to have all of these functions, it is not essential to have all of these functions.

First, the function (1) of identifying the specimen or the 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 bar code including an individual identification ID to each of the sample and the experimental animal, and the researcher or the research assistant conducts the experiment using the sample and the experimental animal. Each time you perform a test or perform some kind of processing (preparation, etc.) other than an experiment on a sample or an experimental animal, the barcode scanner 13 attaches the barcode attached to the sample or experimental animal, preferably a researcher or research assistant. The barcodes (given to name tags, etc.) given to the person are read, and the records are left in the server 20. At this time, it is preferable that a record of what has been done to the sample or the experimental animal be input from the researcher terminal 10 or the like and stored in the server 20 in association with the ID.

A sticker or tag printed with a bar code may be attached to a specimen container for a specimen and a cage, a collar, an ear tag, etc. for an experimental animal. It is also possible to use RFID instead of the barcode. Alternatively, a microchip embedded in the body of an experimental animal may be used.

In this way, by assigning an individual identification ID to a sample or experimental animal, a record of who accessed the sample or experimental animal each time a researcher or research assistant accessed the sample or experimental animal Therefore, if the sample or the experimental animal is mistaken or replaced, the fact can be easily detected.

Furthermore, when saving data related to specimens and experimental animals, the user authentication service of an external authentication server is used to obtain third-party authentication of the person who has accessed the specimens and experimental animals, as well as access time information. It is more desirable to acquire and record the data 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, and 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 experimental animals. For example, even in the case of a mouse or a rat, the size and shape of the eyes and nose are subtly different depending on the individual, so 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, an image of the face is acquired and recorded with a digital camera, and whenever the researcher or the like accesses the experimental animal, the face is photographed with the digital camera and recorded. It can be confirmed by comparing with the face image that is displayed (using human face recognition technology) to check whether the experimental animal is confused or replaced. In addition to this, depending on the type of animal, tooth shape, nose print, etc. may be used for individual identification.

As described above, since the above-mentioned (1) has a function of identifying the sample or experimental animal used in the experiment and recording it in association with the experimental data, which sample or experimental animal is used when the experimental data is obtained You can leave exactly what you did 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 authentication together, more reliable evidence can be left as to which researcher has accessed the sample or experimental animal.

Next, the function (2) of specifying the inspection device used in the experiment will be described. The “inspection device” includes any device other than a 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 given to all of the inspection devices used in the laboratory, and a barcode including the ID is attached to the inspection device. Then, each time the inspection equipment is used, the barcode scanner 13 reads the barcode attached to the inspection equipment and the barcode (given to the name tag or the like) for identifying the researcher or the research assistant. Then, the read barcode information is stored in the server 20 in association with the data output from the inspection device. Even in this case, the user authentication service of the external authentication server is used to obtain third-party authentication of the person who used the inspection device, 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, and may be an authentication server provided in the same facility (for example, in a laboratory).

Alternatively, in addition to the method of reading the bar code of the inspection device ID, the following method can be considered. When the inspection device is a device connectable 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. Further, 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 be recorded as it is, and the 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 (2) specifying the inspection device used for the experiment and recording it in association with the output data from the inspection device, it is possible to accurately determine 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 authentication together, more reliable evidence can be left as to which researcher has accessed the sample or experimental animal.

Next, the function (3) of specifying the researcher who has performed the experiment will be described. Regarding this, as described above, every time a process related to an experiment or a record related to research is performed, a researcher or a research assistant causes the bar code scanner 13 to read the bar code attached to the name tag or the like. The information is recorded in the server 20 together with the information indicating what was done. Of course, the means for identifying an individual is not limited to a barcode, but biometrics can be used, for example, and an experiment record with higher authenticity can be left. The above-mentioned "information indicating what has been done" may be experimental data, or may be a text input of what the person has done. Further, similarly to the above, by using the third party authentication together, it is possible to leave more reliable evidence of who did what and when.

Further, in the case of a research information management system that adopts single sign-on, once the user is logged in and authenticated in the system, 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 saved as the information identifying the researcher. Therefore, in the case of the system adopting the single sign-on, the researcher can proceed with the research work without logging in each time or reading the bar code of the researcher ID.

As described above, by providing the function of (3) identifying the person who performed the experiment or the preparation for the experiment and recording 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 will be described so that the experimental data can be recognized if it is tampered with.

In the research information management system 1 according to the present embodiment, each time experimental data is obtained, a time stamp is added to the data. This time stamp is preferably obtained from an external, accredited third party certification body. By adding a time stamp, a proof that the experimental data was not tampered with can be obtained by using the hash value together with the proof of the time when the experimental data was obtained. It is possible to further improve the evidence by adding a time stamp including not only the experimental data but also the information obtained by the functions (1) to (3).

Also in this embodiment, it is preferable that the researcher input experimental data by using the stamp function of the electronic medical record system described in the first embodiment. This is because it is possible to manage the input items and the data in association with each other, which facilitates later data retrieval and processing. In other words, by recording the lab note using the stamp function of the electronic medical record system, the three principles of authenticity, readability, and storability are secured, so that 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 blackboard as an experiment record. By adding a time stamp to such an image or an image output from the inspection device, it becomes easy to verify the fact even if the image is tampered with.

Further, in the research information management system 1 according to the present embodiment, it is desirable to introduce a mechanism in which subsequent operations cannot be performed when the necessary ID is not read. For example, in the case of using the ID of the sample or the experimental animal in (1), the operation of the inspection device is restricted so that the test using the sample or the experimental animal cannot be performed unless the ID of the sample or the experimental animal is read. 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 according to the present embodiment, it is possible to improve the evidence of experimental records and experimental data in medical research.

Although some embodiments of the present invention have been described above, the embodiments of the present invention are not limited to the specific examples described above, and various modifications can be made within the scope of the invention.

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

Claims (3)

A research information management system for managing information on research,
Accepts , as input data, information about tests conducted on the study or records on the study,
A reading means for reading at least one identifier of an identifier for identifying a specimen or test animal used for the test, an identifier for identifying a test device used for the test, an identifier for identifying a researcher or a research assistant who conducts the test,
Storing a database of the identifier in association with said input data,
When the required identifier is not read by the reading means each time the sample or test animal is processed, the test equipment is used, the test is performed, or the research record is recorded, each time the necessary identifier is not read. Is a research information management system that disables subsequent operations on devices connected to the research information management system. The research information management system according to claim 1, wherein the input data is classified and stored in the database according to a predetermined classification structure. Further comprising means for obtaining a time stamp of the input data from a certification authority,
The database comprises an area for recording the time stamp in association with the input data,
The research information management system according to claim 1 or 2, wherein the time stamp is acquired each time a test is performed or a record regarding research is performed.