JP6670171B2 - Medical information system - Google Patents

Description

  The present invention relates to a medical information system.

  At present, an electronic medical record system is widely used as an example of a medical information system for electronically storing medical information described in a medical record or the like. The medical information stored in the electronic medical record system is used in various cases in addition to being used for the medical treatment as its main purpose.

  For example, clinical information can be obtained from clinical trials (eg, clinical trials, post-marketing surveillance, post-marketing surveillance (PMS), etc.) conducted to confirm the efficacy or safety of a drug or medical device, Used for research and epidemiological research.

  In a clinical trial, a medical institution creates a case report form (CRF) based on the medical treatment information and submits the case report to the sponsor. The case report includes many items to be described based on medical information.

  A case report is generally created on paper, but has recently been created on electronic data. As a system for creating a case report using electronic data, for example, an EDC (Electronic Data Capture) system is known. The EDC system can transmit the information required for a case report as electronic data, which reduces the time required for submission from a medical institution to the sponsor compared to the conventional paper data transfer. There are benefits.

  By the way, the EDC system and the electronic medical record system have an independent relationship with each other. In other words, the EDC system uses the medical information stored in the electronic medical record system to obtain information necessary for a clinical trial (for example, information corresponding to an item required to be described in a case report. For example, information such as prescriptions and a chief complaint regarding adverse events). And information such as medical interviews) cannot be automatically extracted.

  Therefore, in medical institutions that use electronic medical record systems and EDC systems, medical information is manually entered into the electronic medical record system, and separately from the medical information, some medical information (for items that are required to be described in case reports) Corresponding information) had to be manually entered into the EDC system. Also, the sponsor needed to confirm that the input to the EDC system was performed correctly (called monitoring). Therefore, there is a problem that both the medical institution and the sponsor require time and effort.

  In view of such a problem, an invention has been made in which an attempt is made to link electronic data between an EDC system and an electronic medical record system.

  For example, Patent Literature 1 and Patent Literature 2 disclose a technique for extracting information accumulated in an electronic medical record system for creating a case report.

  For example, Non-Patent Document 1 discloses a technique of creating a progress record template for each trial and creating an electronic medical record and a case report based on the progress record template.

Japanese Patent No. 4171407 JP 2015-153137 A

Health and Labor Sciences Research Grant 2013 (Medical Technology Practical Research Project (Clinical Research / Clinical Trial Promotion Research Project)), "Research on Formulating an Implementation Plan for the Promotion of IT in Clinical Research and Clinical Trials"

  However, if a large change is made to the input form in the medical care information system as in Non-Patent Document 1, for example, a doctor may not be able to input information smoothly or an error may occur in the input information. As a result, there is a problem that the medical practice, which is the main task of the doctor, is adversely affected, and the input information is accumulated with duplication or inconsistency.

  Further, if the application software is largely changed in the electronic medical record system as in Patent Literatures 1 and 2, for example, a great deal of cost will be required for the change work and the backup of the database accompanying the change.

  SUMMARY OF THE INVENTION An object of the present invention is to provide a medical information system in which the information necessary for a clinical trial among the medical information stored in the medical information system is EDC without largely changing the input form of the medical information and without incurring great cost. An object of the present invention is to provide a medical information system that can output to another system such as a system.

  The medical information system of the present invention cooperates with the medical information system, which displays a first input form including predetermined items and input fields in which medical information corresponding to each item can be input, and the medical information system. And a medical information system including: an information linking system, wherein the medical treatment information system receives, from a predetermined device, designated item information indicating a designated item, and an item indicated in the designated item information; A second input form including an input field in which corresponding medical information can be input is generated, the first input form and the second input form are displayed, and the second input form is input to the first input form and the second input form. The information linkage system receives the specified item information from the predetermined device, and stores the medical information stored in the medical information system. Among the information that is input in response to items shown in the specified item information is acquired from the medical information system, after storing the obtained information, and outputs to other systems.

  ADVANTAGE OF THE INVENTION According to this invention, the information required for a clinical trial among the medical information stored in the medical information system is stored in the medical information system without significantly changing the input form of the medical information in the medical information system and without increasing the cost. It can be output to another system such as a system.

FIG. 1 is a block diagram showing an example of a configuration of a medical information system according to an embodiment of the present invention and peripheral components thereof. Diagram showing an example of items that can be specified Diagram showing an example of the item designation screen The figure which shows an example of the file format of item specification information 4 is a flowchart illustrating an example of the operation of the electronic medical record system according to the embodiment of the present invention. The figure which shows an example of the information input screen in the electronic medical record system in embodiment of this invention. 4 is a flowchart showing an example of the operation of the information cooperation system according to the embodiment of the present invention. 4 is a flowchart showing an example of the operation of the information cooperation system according to the embodiment of the present invention.

  Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. The embodiments described below are merely examples, and the present invention is not limited to the embodiments.

  First, the configuration of the medical information system 100 according to the present embodiment and its surroundings will be described using FIG. FIG. 1 is a block diagram showing an example of the configuration of the medical information system 100 and its peripherals (terminal device 1, EDC system 2).

  In FIG. 1, each arrow indicated by a broken line indicates a direction of communication via a predetermined network. The predetermined network may be a wired network, a wireless network, or a network in which a wired network and a wireless network are mixed. In the following, the communication indicated by each arrow in FIG. 1 is expressed as “transmission” and “reception”, but these may be reworded as “output” and “input”, respectively.

  The terminal device 1 is a device used by a sponsor of a pharmaceutical company, a medical device manufacturer, or the like, or a contract research organization (CRO). The terminal device 1 is, for example, a personal computer, a smartphone, a tablet, or the like.

  The sponsor or CRO (hereinafter, referred to as the sponsor) performs an operation on the terminal device 1 to designate an item that is required to be described in the case report (hereinafter, referred to as a trial item). The terminal device 1 transmits information indicating the clinical trial item designated by this operation (hereinafter referred to as designated item information) to the electronic medical record system 3 and the information linkage system 4.

  Here, an example of a trial item that can be designated by the sponsor or the like will be described with reference to FIG. FIG. 2 is a diagram showing clinical trial items based on the CDASH standard of the CDISC (Clinical Data Interchange Standards Consortium) which defines data standards for clinical trials.

  FIG. 2A is a diagram showing classification of trial items. As shown in FIG. 2A, the classification of the trial item includes, for example, “common discriminating variable”, “adverse event”, “pretreatment, combination treatment”, “clinical test result”, and the like.

  FIG. 2B is a diagram illustrating an example of a trial item of “common identification variable”. FIG. 2C is a diagram showing an example of a trial item of “adverse event”. FIG. 2D is a diagram showing an example of a trial item of “pre-treatment, combination treatment”. FIG. 2E is a diagram showing an example of a trial item of “clinical test result”. 2B to 2E, the variable name and the description (in other words, the name of the item) correspond to the clinical trial item.

  The above-mentioned various trial items are displayed on the screen of the terminal device 1 as shown in FIG. 3, for example. The sponsor or the like designates the trial item by inputting a check mark in the check box corresponding to the trial item to be designated on the item designation screen shown in FIG.

  In this way, the sponsor or the like can select, from among the various trial items based on the CDASH standard, items that are common to various trials and that are frequently described in the case report (for example, “harmful”). Event, pre-treatment, combination treatment, patient background, and clinical trial items such as “previous complications”.

  The terminal device 1 generates designated item information indicating the trial item designated on the item designation screen. The designated item information is generated in, for example, a file format defined by CDISC standards, that is, an XML format called “Define” or “ODM” shown in FIG. The designated item information generated in this way is transmitted from the terminal device 1 to both the electronic medical record system 3 and the information linkage system 4. The file format of the designated item information transmitted to the electronic medical record system 3 and the file format of the designated item information transmitted to the information linkage system 4 may be different.

  The example of the trial item has been described above. Hereinafter, the description returns to FIG.

  The EDC system 2 (an example of another system) is a system used for, for example, clinical trials (eg, clinical trials, post-marketing surveillance, post-marketing surveillance), clinical research, or epidemiological research. In the present embodiment, as an example, a case where the EDC system 2 is a system that creates a case report of a clinical trial using electronic data will be described. The EDC system 2 is used, for example, in a medical institution that has received a request for a clinical trial.

  The EDC system 2 receives information necessary for creating a case report from the information linking system 4 (hereinafter referred to as information required for a trial, which will be described in detail later), and creates a case report based on the information required for the trial. Then, the EDC system 2 transmits the created case report to the terminal device 1.

  In the present embodiment, an example in which the output destination of the clinical trial necessary information from the information linkage system 4 is the EDC system 2 will be described. However, the present invention is not limited to this. It may be a system or a database.

  The medical information system 100 includes an electronic medical record system 3 (an example of a medical care information system) and an information linkage system 4. The electronic medical record system 3 and the information cooperation system 4 are devices used in a medical institution that has received a request for a clinical trial. In the present embodiment, a case will be described as an example where the system that cooperates with the information cooperation system 4 is the electronic medical record system 3. However, the present invention is not limited to this. Any device can be used as long as it stores the information.

  The electronic medical record system 3 includes a communication unit 31, an input unit 32, a display unit 33, a storage unit 34, and a control unit 35.

  The communication unit 31 is an interface device for communication, and transmits and receives predetermined information.

  For example, the communication unit 31 receives the designated item information from the terminal device 1.

  In addition, for example, the communication unit 31 transmits the clinical trial necessary information to the information cooperation system 4.

  The input unit 32 is an input device such as a touch panel, a keyboard, and a mouse. The input unit 32 receives an operation of a person related to a medical institution (hereinafter, referred to as a doctor) and outputs the content of the received operation to the control unit 35.

  For example, the input unit 32 receives an operation of instructing display of a screen for inputting medical information (hereinafter, referred to as an input screen), an operation of inputting medical information, and the like.

  The display unit 33 is a display device such as a display, and displays predetermined information under the control of the control unit 35.

  For example, the display unit 33 displays an input screen. The input screen includes, for example, a normal input screen (not shown) showing only an electronic medical chart input form (an example of a first input form), an electronic medical chart input form and a clinical trial input form (an example of a second input form). There is a dedicated input screen (see FIG. 6 described later). The input form for electronic medical records is, for example, a form in which an input field for inputting medical information is associated with each electronic medical record item name (see FIG. 6 described later). The trial input form is, for example, a form in which an input field for inputting medical information is associated with each trial item name (see FIG. 6 described later).

  The storage unit 34 is a storage device such as a memory and a hard disk device, and stores predetermined information.

  For example, the storage unit 34 stores the specified item information received by the communication unit 31 from the terminal device 1.

  Further, for example, the storage unit 34 stores screen information. The screen information includes normal input screen information for displaying a normal input screen and dedicated input screen information for displaying a dedicated input screen.

  In addition, for example, the storage unit 34 stores the medical information input in the electronic medical record input form and the clinical trial input form. In this sense, the storage unit 34 can be referred to as a “medical information storage unit”.

  The control unit 35 is a control device such as a processor, and controls each process performed by the electronic medical record system 3. Details of the control by the control unit 35 will be described later with reference to FIG.

  The information cooperation system 4 includes a communication unit 41, an input unit 42, a display unit 43, a storage unit 44, and a control unit 45.

  The communication unit 41 is an interface device for communication, and transmits and receives predetermined information.

  For example, the communication unit 41 receives the specified item information from the terminal device 1.

  Further, for example, the communication unit 41 receives the clinical trial required information from the electronic medical record system 3.

  In addition, for example, the communication unit 41 transmits the trial necessary information to the EDC system 2.

  The input unit 42 is an input device such as a touch panel, a keyboard, and a mouse, and receives, for example, a doctor's operation, and outputs the content of the received operation to the control unit 45.

  For example, the input unit 42 accepts an operation of instructing the display of the clinical trial necessary information on the screen.

  The display unit 43 is a display device such as a display, and displays predetermined information under the control of the control unit 45.

  For example, the display unit 43 displays a screen indicating the information necessary for the trial.

  The storage unit 44 is a storage device such as a memory and a hard disk device, and stores predetermined information. As shown in FIG. 1, the storage unit 44 is a storage unit independent of the storage unit 34 of the electronic medical record system 3.

  For example, the storage unit 44 stores the specified item information received by the communication unit 41 from the terminal device 1.

  In addition, for example, the storage unit 44 stores the trial necessary information received by the communication unit 41 from the electronic medical record system 3. Since the clinical trial necessary information is information extracted from the electronic medical record system 3, the storage unit 44 can be referred to as an “extracted information storage unit”.

  The control unit 45 is a control device such as a processor, and controls each process performed by the information cooperation system 4. Details of the control by the control unit 45 will be described later with reference to FIG.

  The configuration of the medical information system 100 and its peripheral components has been described above.

  Hereinafter, the operations of the electronic medical record system 3 and the information cooperation system 4 constituting the medical information system 100 will be described.

  An operation example of the electronic medical record system 3 will be described with reference to FIG. FIG. 5 is a flowchart illustrating an operation example of the electronic medical record system 3.

  First, when the communication unit 31 receives the specified item information from the terminal device 1, the control unit 35 stores the specified item information in the storage unit 34 (Step S11).

  After that, when the input unit 32 receives a display instruction operation of the normal input screen (step S12: normal), the control unit 35 reads the normal input screen information from the storage unit 34, and performs the normal input screen based on the normal input screen information. The screen is displayed on the display unit 33 (step S13). As described above, the normal input screen is a screen representing only the electronic medical record input form (see FIG. 6 described later).

  On the other hand, when the input unit 32 receives a display instruction operation of the dedicated input screen (step S12: dedicated), the control unit 35 reads the normal input screen information and the specified item information from the storage unit 34, and based on the information. The dedicated input screen information is generated (Step S14).

  Here, the process of generating the dedicated input screen information in step S14 will be specifically described.

  First, the control unit 35 acquires information on the name of the trial item (“description” shown in FIGS. 2 and 3) indicated in the read designated item information.

  Next, the control unit 35 creates a trial input form in which an input field for medical information is associated with each trial item name. At this time, the clinical trial input form is generated such that items and input fields are displayed on the screen in a one-to-one correspondence, similarly to the electronic medical record input form. A specific example of the trial input form will be described later with reference to FIG.

  Further, for example, when the clinical trial item indicated in the designated item information is included in the electronic medical record input form in advance, the clinical trial input form does not include the name of the clinical trial item and the input fields corresponding thereto. Is generated.

  Items that are included in the electronic medical record input form in advance and may be designated as clinical trial items include, for example, each item of “patient background”, each item of “vital sign”, “pretreatment, concomitant use” A part of the item of “combination drug” which is the item of “treatment” or the item of “clinical test result” is included.

  In addition, for example, items of “subject ID of clinical trial”, items of “breakdown of test subjects” regarding obtaining consent to participate in the clinical trial, items of “adverse events”, “drug exposure”, that is, items of prescription of test drug Are generally included in an input form for an electronic medical record (for example, an input form describing a chief complaint), and medical information may be input using a natural language. However, when information is input in a natural language, it becomes difficult for the information cooperation system 4 described later to extract the information as clinical trial necessary information. Therefore, for these items, input columns are generated so as to accept input of information other than the input method using a natural language.

  Next, the control unit 35 generates the dedicated input screen information by adding the created clinical trial input form to the electronic medical record input form of the normal input screen information. Next, the control unit 35 causes the storage unit 34 to store the generated dedicated input screen information.

  Hereinabove, the processing for generating the dedicated input screen information has been specifically described. Hereinafter, it returns to description of the flow of FIG.

  Next, the control unit 35 reads the dedicated input screen information from the storage unit 34, and displays the dedicated input screen on the display unit 33 based on the dedicated input screen information (step S15).

  Here, a display example of the dedicated input screen will be described with reference to FIG. FIG. 6 is a diagram showing a display example of the dedicated input screen.

  As shown in FIG. 6, personal information (for example, name, age, gender, etc.) of the patient is displayed at the top of the dedicated input screen, and a list of menus that can be selected by a doctor as a user is displayed at the right end of the dedicated input screen. Is displayed.

  As shown in FIG. 6, an electronic medical record input form F1 and a clinical trial input form F2 are displayed adjacent to each other on the dedicated input screen. The input form F1 for electronic medical records is associated with an input field for medical information for each name of an electronic medical record item (including an item also serving as a clinical trial item). In the trial input form F2, an input column for medical information is associated with each trial item name. As shown in FIG. 6, numerical values, character strings, and the like corresponding to the names of the respective items are input as medical care information in the respective input fields of the respective input forms. The information input method in each input field is the same.

  As shown in FIG. 6, in the electronic medical record input form F1 and the clinical trial input form F2, one item and one input field are displayed as one set, and a plurality of sets are displayed in a table format (list format). Is displayed. Therefore, the doctor can easily recognize the correspondence between the items and the input fields, and can input the medical information smoothly and accurately, which adversely affects the medical practice, which is the main task of the doctor, or the input medical information. It is possible to prevent duplication or inconsistency in information. Further, it is not necessary to largely change the application software in the electronic medical record system 3. Therefore, it is possible to reduce the cost of the work of changing the application software and the backup of the database due to the change of the application software.

  The display example of the dedicated input screen has been described above. Hereinafter, it returns to description of the flow of FIG.

  After the dedicated input screen is displayed, the input unit 32 accepts an operation for inputting medical information (step S16). Here, the input operation is an operation of inputting medical care information into input fields of the electronic medical record input form F1 and the clinical trial input form F2. After the input operation is completed, the input unit 32 may receive an approval operation in which the doctor approves the input medical information.

  Next, for example, when an approval operation is performed, the control unit 35 causes the storage unit 34 to store the medical information input to the electronic medical chart input form F1 and the clinical trial input form F2 (Step S17).

  The operation example of the electronic medical record system 3 has been described above.

  Next, an operation example of the information cooperation system 4 will be described with reference to FIG. FIG. 7 is a flowchart illustrating an operation example of the information cooperation system 4.

  First, when the communication unit 41 receives the specified item information from the terminal device 1, the control unit 45 stores the specified item information in the storage unit 44 (Step S21).

  Next, the control unit 45 extracts clinical trial necessary information from the medical care information stored in the electronic medical record system 3 (Step S22). Note that “extraction” may be rephrased as “acquisition”.

  Here, the process of extracting the clinical trial necessary information in step S22 will be specifically described.

  First, the control unit 45 reads out the specified item information from the storage unit 44, and transmits the specified item information from the communication unit 41 to the electronic medical record system 3.

  Next, when the communication unit 31 receives the designated item information from the information linkage system 4, the control unit 35 of the electronic medical record system 3 sets the medical information input corresponding to the name of the trial item indicated in the designated item information. From the storage unit 34. The medical information read out here is the information necessary for the clinical trial.

  Next, the control unit 35 transmits the read clinical trial necessary information from the communication unit 31 to the information cooperation system 4.

  Next, the communication unit 41 of the information linkage system 4 receives the clinical trial necessary information from the electronic medical record system 3.

  Next, the control unit 45 causes the storage unit 44 to store the trial necessary information received by the communication unit 41, and completes the extraction processing.

  The extraction process of the clinical trial necessary information has been specifically described above. Hereinafter, the description returns to the flow of FIG.

  The control unit 45 causes the storage unit 44 to store the clinical trial necessary information received by the communication unit 41 (Step S23). At this time, the control unit 45 converts the information necessary for the clinical trial received by the communication unit 41 that does not conform to the format for the clinical trial (for the case report) into the format for the clinical trial (for the case report). Convert. Formats for clinical trials (for case reports) include, for example, CDISC standards.

  For example, if the clinical trial necessary information is a Japanese calendar (for example, “H28.4.22” or the like input corresponding to the “date of onset” shown in FIG. 6), the control unit 45 sets the Japanese calendar to the Christian era Convert to

  Further, for example, when the information necessary for the clinical trial is the content indicating the prescription amount and usage per day (for example, “6 tablets a day, 3 minutes, after lunch in the morning, afternoon and night”), the control unit 45 executes the content once. Per day and the frequency per day (eg, “2 tablets at a time, 3 times a day”).

  In the above conversion process, the control unit 45 refers to the dictionary data in which terms normally used for electronic medical records and controlled terms conforming to various CDISC standards are referred to in advance, so that the electronic medical record input form can be used. The term input to F1 may be converted to a controlled term.

  Next, the control unit 45 reads out the trial necessary information from the storage unit 44 and transmits the trial required information to the EDC system 2 (Step S24).

  Thereafter, the EDC system 2 creates a case report based on the clinical trial necessary information received from the information cooperation system 4, and transmits the case report to the terminal device 1.

  In preparing the above case report, if the EDC system 2 lacks the necessary trial information received from the information linkage system 4 (the trial information required to be described in the case report, If there is clinical trial necessary information that has not been received), the information of the lack may be input in the EDC system 2 as before.

  The terminal device 1 stores the case report received from the EDC system 2 in a predetermined storage unit, and displays the case report when a display instruction operation of the case report is performed. Thereby, the sponsor can visually recognize the case report on the terminal device 1.

  The operation example of the information cooperation system 4 has been described above.

  As described above, according to the medical information system 100 of the present embodiment, the electronic medical record system can be used without greatly changing the input form of the medical care information in the electronic medical record system 3 and without increasing the cost. The information necessary for the clinical trial can be extracted from the medical information accumulated in the third medical information and output to the EDC system.

  Note that the present invention is not limited to the above embodiment, and various modifications are possible. Hereinafter, modified examples of the embodiment will be described.

<Modification 1>
In the above-described embodiment, an example will be described in which dedicated input screen information is generated by adding a trial input form created based on designated item information to an electronic medical record input form prepared in advance. Although described, it is not limited to this.

  For example, a special input screen information in which a trial input form including all trial items is added to an electronic medical record input form in advance is generated, and when the designated item information is received, the designated entry information is displayed. The trial input form may be changed so that only the trial items to be included are included.

<Modification 2>
In the above embodiment, the information linkage system 4 may display the trial necessary information extracted from the electronic medical record system 3. FIG. 8 shows a flowchart in this case. FIG. 8 differs from FIG. 7 in having a step S31 between steps S22 and S23. Hereinafter, step S31 will be described.

  In step S31, the control unit 45 causes the display unit 43 to display the trial necessary information extracted from the electronic medical record system 3. Thereby, a doctor or a clinical research coordinator (CRC) can check information necessary for a clinical trial.

  In addition, in step S31, the input unit 42 may receive a correction (for example, change, deletion, addition, etc.) operation of the clinical trial necessary information by the doctor or the clinical trial coordinator. Then, the control unit 45 causes the storage unit 44 to store the trial necessary information reflecting the instruction content of the correction operation (hereinafter, referred to as the corrected trial required information) and the trial required information before the correction in association with each other. As a result, the clinical trial necessary information before correction and the clinical trial necessary information after correction are classified and stored.

  Thereafter, the control unit 45 reads the post-correction clinical trial necessary information and the pre-correction clinical trial necessary information from the storage unit 44, and displays the information on the display unit 43 or transmits the information to the EDC system 2. .

  According to the present modification, a doctor or a trial coordinator can confirm trial necessary information extracted from the electronic medical record system 3 before transmitting to the EDC system 2. In addition, the doctor or the trial coordinator can correct the trial necessary information extracted from the electronic medical record system 3 as necessary.

  Further, according to the present modification, for example, before the monitoring at the medical institution is started, the worker (monitoring person) writes the electronic medical record and the EDC on the display unit 43 of the information cooperation system 4. Items that are expected to match exactly and items that do not exactly match but are expected to show similar events, or items that are listed on the EDC but not in the electronic medical record Can be recognized separately in advance.

<Modification 3>
In addition, when the clinical trial necessary information is corrected as described in the second modification, the control unit 45 stores the corrector information capable of identifying the user who made the correction together with the corrected clinical trial necessary information in the storage unit. 44. The corrector information is received by the input unit 42 when the corrective operation is performed. The corrector information is, for example, the name or ID of the doctor or trial coordinator who performed the corrective operation.

  After that, the control unit 45 reads the corrector information from the storage unit 44, causes the display unit 43 to display the information, or transmits the information to the EDC system 2.

  According to this modification, it is possible to confirm the user who has corrected the clinical trial necessary information. For example, at the time of monitoring, it becomes easier to confirm the intention of correcting the clinical trial necessary information.

<Modification 4>
In the above-described embodiment, the control unit 45 of the information linkage system 4 determines that the trial necessary information extracted from the electronic medical record system 3 includes information whose content is duplicated (for example, the name of an adverse event is duplicated and input). In such a case, the information may be displayed on the display unit 43.

  Thereby, the doctor or the trial coordinator can confirm the trial necessary information whose contents are duplicated and input. In this case, as described in the second modification, the doctor or the trial coordinator can correct the duplicated content by performing the correction operation of the trial necessary information.

<Modification 5>
In the above embodiment, the control unit 45 of the information linkage system 4 indicates a situation outside the predefined range (for example, the prescription amount of an abnormal value) in the trial necessary information extracted from the electronic medical record system 3. When the out-of-range status information is included, the out-of-range status information may be displayed on the display unit 43. Further, the control unit 45 may cause the display unit 43 to display correspondence suggestion information (for example, a message prompting the user to correct the value of the prescribed amount) that suggests a response to a situation outside the range.

  According to the present modification, a doctor or a trial coordinator can confirm trial necessary information indicating a situation outside a predefined range. Thereby, the physician or the trial coordinator, for example, if the information necessary for the trial, such as patient basic information, medical history, complications, concomitant medication, clinical test results, etc., indicates a situation outside the predefined range, select Compliance / departure with criteria or exclusion criteria can be ascertained. In addition, the physician or the trial coordinator can grasp important side effects when the information necessary for the trial, such as a clinical test result or an adverse event, indicates a situation outside a predefined range.

<Modification 6>
In step S22 of FIG. 7 or FIG. 8 described in the above embodiment, the control unit 35 of the electronic medical record system 3 uses an input form other than the electronic medical record input form and the clinical trial input form (hereinafter, referred to as a third input form). A text search may be performed on the medical information input in (1), and the clinical trial information may be acquired from the medical information.

  For example, it is assumed that a keyword is defined in advance for each clinical trial item. When receiving the designated item information from the information linkage system 4, the control unit 35 reads out the medical information corresponding to the keyword defined corresponding to the clinical trial item indicated in the information from the storage unit 34 as clinical trial necessary information. Then, the control unit 35 controls the read medical care information to be transmitted to the information cooperation system 4 as clinical trial necessary information. Here, examples of the keyword may be a term representing the trial item itself (for example, weight, blood pressure, body temperature, etc.) or a term representing an adverse event (for example, abdominal pain, headache, etc.).

  According to the present modification, for example, when a doctor or the like erroneously inputs trial necessary information in the third input form, the trial necessary information can be extracted.

<Variation 7>
In the above embodiment, after the information linkage system 4 extracts the clinical trial information from the electronic medical record system 3, the clinical trial information is updated (corrected or rewritten) in the electronic medical record system 3 by an operation of a doctor or the like. Good), the information linkage system 4 may display that the clinical trial necessary information has been updated in the electronic medical record system 3.

  For example, when the predetermined clinical trial necessary information stored in the storage unit 34 is updated, the control unit 35 of the electronic medical record system 3 transmits update notification information indicating that the clinical trial necessary information has been updated to the information linkage system. The communication unit 31 is controlled so as to be transmitted to the communication unit 4.

  When the communication unit 41 receives the update notification information from the electronic medical record system 3, the control unit 45 of the information linkage system 4 causes the display unit 43 to display a message or the like indicating that the clinical trial necessary information has been updated in the electronic medical record system 3. .

  In the above description, the case where the clinical trial information is updated in the electronic medical record system 3 is described as an example. However, the case where the clinical trial information is updated in the information linkage system 4 is also applicable. That is, after the information linkage system 4 extracts the clinical trial required information from the electronic medical record system 3 and then updates the clinical trial required information in the information linkage system 4 by an operation of a doctor or a trial coordinator, the electronic medical record system 3 It may be displayed that the information necessary for the clinical trial has been updated in the information linkage system 4.

  For example, when predetermined trial necessary information stored in the storage unit 44 is updated, the control unit 45 of the information cooperation system 4 sends update notification information indicating that the trial required information has been updated to the electronic medical record system. The communication unit 31 is controlled so as to be transmitted to the communication unit 3.

  When the communication unit 31 receives the update notification information from the information linkage system 4, the control unit 35 of the electronic medical record system 3 causes the display unit 33 to display a message or the like indicating that the clinical trial required information has been updated in the information linkage system 4. .

  According to the present modification, a doctor or the like or a clinical trial coordinator can know that predetermined clinical trial necessary information has been updated in the electronic medical record system 3 or the information linkage system 4.

<Modification 8>
In the above-described modification 7, the electronic medical record system 3 or the information linkage system 4 may display the clinical trial necessary information before the update and the clinical trial necessary information after the update.

  First, a case where the clinical trial necessary information is updated in the electronic medical record system 3 will be described.

  For example, when the predetermined clinical trial information stored in the storage unit 34 is updated, the control unit 35 of the electronic medical record system 3 communicates to transmit the updated clinical trial required information to the information linkage system 4. The unit 31 is controlled.

  When the communication unit 41 receives the updated clinical trial necessary information from the electronic medical record system 3, the control unit 45 of the information cooperation system 4 reads out the clinical trial necessary information before the update of the information from the storage unit 44. Then, the control unit 45 causes the display unit 43 to display the required trial information after the update and the required trial information before the update.

  Further, the control unit 45 causes the storage unit 44 to store the required trial information after the update and the required trial information before the update. Then, the control unit 45 reads out the required clinical trial information after the update and the required clinical trial information before the update from the storage unit 44 at a predetermined timing, and controls the communication unit 41 to transmit the information to the EDC system 2.

  Next, a case where information required for a clinical trial is updated in the information linkage system 4 will be described.

  For example, the control unit 45 of the information linking system 4 communicates so as to transmit the updated clinical trial necessary information to the electronic medical record system 3 when the predetermined clinical trial necessary information stored in the storage unit 44 is updated. The section 41 is controlled.

  When the communication unit 31 receives the updated clinical trial necessary information from the information linkage system 4, the control unit 35 of the electronic medical record system 3 reads out the clinical trial necessary information before updating the information from the storage unit 34. Then, the control unit 35 causes the display unit 33 to display the updated trial necessary information and the updated trial required information before the update.

  In addition, the control unit 35 causes the storage unit 34 to store the required trial information after the update and the required trial information before the update.

  According to this modification, the doctor or the trial coordinator can recognize the difference between the trial necessary information before the update and the trial required information after the update by visually recognizing the information.

<Modification 9>
In the above embodiment, the electronic medical record system 3 may store information according to a prescribed data set structure. For example, among the medical information input on the dedicated input screen shown in FIG. 6, information corresponding to the trial item indicated in the designated item information may be stored in the storage unit 34 according to a rule such as SS-MIX. .

  According to the present modification, the information linkage system 4 can extract information necessary for a clinical trial regardless of the structure of the electronic medical record input form.

  As above, each modification has been described. These modifications may be appropriately combined.

  INDUSTRIAL APPLICABILITY The present invention is applicable to a technology in which a medical information system to which medical information is input and another system that performs a predetermined process based on the medical information cooperate.

DESCRIPTION OF SYMBOLS 1 Terminal device 2 EDC system 3 Electronic medical record system 4 Information cooperation system 31, 41 Communication part 32, 42 Input part 33, 43 Display part 34, 44 Storage part 35, 45 Control part 100 Medical information system

Claims (16)

A medical information system that includes a medical information system that displays a first input form including predetermined items and input fields in which medical information corresponding to each item can be input, and an information linking system that links with the medical information system An information system,
The medical information system,
Receiving specified item information indicating a specified item from a predetermined device,
Generating a second input form including an item indicated in the designated item information and an input field in which medical information corresponding to each item can be input; displaying the first input form and the second input form;
Storing the medical information input to the first input form and the second input form,
The information linkage system,
Receiving the specified item information from the predetermined device,
Of the medical information stored in the medical information system, information input corresponding to the item indicated in the designated item information is obtained from the medical information system,
After storing the acquired information, output it to other systems,
Medical information system. The medical information system,
When the predetermined item of the first input form includes an item indicated by the specified item information, an item included in the first input form among the items indicated by the specified item information Generating the second input form to include items other than
The medical information system according to claim 1. The medical information system,
A medical information storage unit that stores medical information input to the first input form and the second input form,
The information linkage system,
The medical treatment information system of the medical treatment information storage unit stores information acquired from the medical treatment information stored in the medical treatment information storage unit, the medical treatment information storage unit has an independent acquisition information storage unit,
The medical information system according to claim 1. The information linkage system,
Converting information that does not conform to a predetermined format among the information acquired from the medical information system to the predetermined format,
The medical information system according to claim 1. The information linkage system,
Displaying information obtained from the medical information system,
Accepting an operation to correct the acquired information,
The medical information system according to claim 1. The information linkage system,
When the operation is received, the information before correction and the information after correction are stored,
The medical information system according to claim 5. Further storing the identification information of the user who performed the operation,
The medical information system according to claim 6. The information linkage system,
When the information obtained from the medical information system includes information having duplicate contents, the information is displayed,
The medical information system according to claim 1. The information linkage system,
When the information obtained from the medical information system includes information indicating a situation outside a predefined range, the information is displayed, and information indicating a response to the situation outside the range is displayed.
The medical information system according to claim 1. The medical information system,
Performing a text search on medical information input to a third input form other than the first input form and the second input form;
The information linkage system,
Acquiring the information obtained by the text search from the medical information system,
The medical information system according to claim 1. The medical information system,
After the acquisition of information is performed by the information cooperation system, the medical information system is stored, if the update of the information link information acquired by the system is performed, the fact that the update has been performed Notify the information linkage system,
The information linkage system,
Based on the notification from the medical information system, displaying information that the update has been performed in the medical information system,
The medical information system according to claim 1. The medical information system,
Transmitting the updated information to the information linkage system,
The information linkage system,
Storing the updated information received from the medical care information system,
The medical information system according to claim 11. The information linkage system,
After acquiring the information from the medical information system, if the information stored in the information linkage system is updated, the information acquired from the medical information system is updated. Notify the information system,
The medical information system,
Based on the notification from the information linkage system, displaying information that the update has been performed in the information linkage system,
The medical information system according to claim 1. The information linkage system,
Transmitting the updated information to the medical information system,
The medical information system,
Storing the updated information received from the information linkage system ,
The medical information system according to claim 13. The medical information system,
Information corresponding to the item indicated in the specified item information of the input medical information, is stored according to a prescribed data set structure,
The medical information system according to any one of claims 1 to 14. The medical treatment information system is an electronic medical record system,
The other system is an EDC system;
The medical information system according to claim 1.

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