Clinical trial systems, mobile devices, blood testing equipment, and clinical trial servers

Abstract

To provide a clinical trial system, a portable terminal, a blood examination device, and a clinical trial server for reducing the burden on a subject taking an examination for a clinical trial.SOLUTION: A clinical trial system includes: a portable terminal held by a subject; a blood examination device placed at each of a plurality of examination facilities in which the subject's blood examination can be conducted; a clinical trial server for storing an examination result of the subject obtained by the blood examination device in association with the subject's information that identifies the subject. The clinical trial system displays on the portable terminal route information to at least one examination facility where the subject's blood examination can be performed, retrieved on the basis of the subject's clinical trial plan and the subject's location information.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure relates to a clinical trial system, a mobile terminal, a blood test device, and a clinical trial server.

Background Art

[0002] Regarding the manufacture and sale of pharmaceuticals or medical devices, clinical trials, i.e., clinical studies, are conducted on humans in order to obtain approval under the Pharmaceutical and Medical Device Act. In a clinical study, after a subject takes the drug that is the subject of the study, it is necessary to collect blood at a predetermined timing. For this reason, various methods have been proposed to reduce the burden on the subject who collects blood. For example, Patent Document 1 proposes a method of providing a subject with a blood test kit, registering with a server by associating an identification number given to the blood test kit with the subject value, and providing the subject with a recommended date and time for blood collection.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] However, the method described in Patent Document 1 requires sending the collected blood to a testing institution. In a clinical study, it is often necessary to collect blood multiple times during a day, and performing the procedure of sending blood each time places a heavy burden on the subject. For this reason, it is conceivable to perform an examination hospitalization for the clinical study, but restraining the subject at the testing institution all day also places a heavy burden on the subject. Furthermore, the examination date may span multiple days, and in such a case, the burden on the subject becomes even greater.

[0005] The present invention has been made in view of the above circumstances, and an object thereof is to reduce the burden on a subject who undergoes a blood test for a clinical study. [Means for solving the problem]

[0006] The clinical trial system described in this disclosure involves a mobile device owned by the subject, Blood testing equipment installed in each of multiple testing facilities capable of performing blood tests on subjects, The system includes a clinical trial server that stores the test results of subjects obtained by a blood testing device in association with subject information that identifies the subjects. Based on the subject's clinical trial plan and location information, route information to at least one laboratory where the subject can undergo blood testing will be displayed on the mobile device.

[0007] Furthermore, in the clinical trial system described in this disclosure, the clinical trial server searches for at least one testing facility from multiple testing facilities based on the subject's location information and transmits the search results for the testing facility to the mobile terminal. The mobile device may display route information to the searched testing facility.

[0008] Furthermore, in the clinical trial system described herein, the mobile device may search for at least one testing facility from among multiple testing facilities based on the subject's location information and display route information to the searched testing facility.

[0009] Furthermore, in the clinical trial system described herein, the subject's location information may represent the subject's current location.

[0010] Furthermore, in the clinical trial system described herein, the searched testing facilities may be those located within a predetermined range from the location represented by the subject's location information.

[0011] Furthermore, in the clinical trial system described herein, if no testing facility is found within a predetermined range from the location represented by the subject's location information, the clinical trial server will set up a new clinical trial plan for the subject. The search for testing facilities may also be based on a new clinical trial plan and the location information of the subjects.

[0012] Furthermore, in the clinical trial system described in this disclosure, if no testing facility is found within a predetermined range from the location represented by the subject's location information, the clinical trial personnel may be notified accordingly.

[0013] "Clinical trial personnel" include clinical trial coordinators who develop clinical trial plans, as well as medical professionals. Medical professionals include doctors, nurses, and other healthcare workers involved in the clinical trial.

[0014] Furthermore, the clinical trial system described in this disclosure may also provide subjects with information on how to use blood testing equipment installed at the searched testing facility via a mobile device.

[0015] Furthermore, in the clinical trial system described in this disclosure, the subject's test results and subject information are transmitted from a mobile terminal or blood testing device to the clinical trial server. If there are abnormalities in the test results, search for a new testing facility. This could also involve displaying route information to a new testing facility on a mobile device.

[0016] Furthermore, in the clinical trial system described in this disclosure, the subject's test results and subject information are transmitted from a mobile terminal or blood testing device to the clinical trial server. After the test results are submitted, the mobile device or clinical trial server may process the payment for the test based on the subject's information.

[0017] Furthermore, in the clinical trial system described in this disclosure, the subject's test results and subject information are transmitted from a mobile terminal or blood testing device to the clinical trial server. After the test results are sent, the clinical trial server may provide payment information to the mobile device for settling the test fees.

[0018] Also, in the clinical trial system according to the present disclosure, a mobile terminal may notify a subject of precautions regarding an examination.

[0019] The mobile terminal according to the present disclosure is used in the clinical trial system according to the present disclosure.

[0020] The blood test device according to the present disclosure is used in the clinical trial system according to the present disclosure.

[0021] The clinical trial server according to the present disclosure is used in the clinical trial system according to the present disclosure.

Advantages of the Invention

[0022] According to the present disclosure, the burden on a subject who undergoes a blood test for a clinical trial can be reduced.

Brief Description of the Drawings

[0023] [Figure 1] A diagram showing the schematic configuration of the clinical trial system according to an embodiment of the present disclosure [Figure 2] A diagram showing the hardware configuration of the mobile terminal according to this embodiment [Figure 3] A diagram showing the hardware configuration of the blood test device according to this embodiment [Figure 4] A diagram showing the hardware configuration of the clinical trial server according to this embodiment [Figure 5] A flowchart showing the processes performed in this embodiment [Figure 6] A diagram showing a display screen of a list of search results [Figure 7] A diagram showing a display screen of route information [Figure 8] A diagram showing a display screen of precautions

Modes for Carrying Out the Invention

[0024] Embodiments of this disclosure will be described below with reference to the drawings. Figure 1 is a diagram showing the schematic configuration of the clinical trial system according to this embodiment. As shown in Figure 1, the clinical trial system 1 according to this embodiment is a system for performing blood tests on subjects who are the subject of a clinical trial, and the subject's mobile terminal 2, blood testing devices 3 installed in multiple testing facilities, and the clinical trial server 4 are connected in a state where they can communicate via a network 5. In this embodiment, the term "clinical trial" includes not only clinical trials for obtaining approval under the Pharmaceuticals and Medical Devices Act, but also clinical trials for obtaining efficacy and safety test data required when submitting notifications for Foods for Specified Health Uses and Functionally Labeled Products.

[0025] Mobile device 2 refers to smartphones and wearable devices (smartwatches, etc.) owned by subjects participating in the clinical trial. Figure 2 shows the hardware configuration of the mobile device. Mobile device 2 is a portable computer and, as shown in Figure 2, includes a CPU (Central Processing Unit) 11, non-volatile storage 13, and memory 16 as temporary storage. Mobile device 2 also includes a touch panel display 14, a GPS (Global Positioning System) 15, and a network interface 17 that wirelessly connects to network 5. Mobile device 2 also includes a camera 18. The CPU 11, storage 13, display 14, GPS 15, memory 16, network interface 17, and camera 18 are connected to a bus 19.

[0026] Storage 13 is implemented using an SSD (Solid State Drive) and flash memory, etc. Various programs 12 installed on the mobile terminal 2 are stored in storage 13 as a storage medium. The CPU 11 reads the necessary programs 12 from storage 13, expands them into memory 16, and executes the expanded programs 12. Examples of programs 12 include map applications, clinical trial applications, and payment applications. The processing performed by programs 12 will be described later. Note that CPU 11 is an example of a processor that executes programs 12.

[0027] Various programs 12 are stored on a server (not shown) in a state that allows external access, and are downloaded and installed on the mobile terminal 2 upon request.

[0028] The display 14 consists of a liquid crystal display and an organic EL display, and displays various information related to the processing performed by the mobile terminal 2. The display 14 also functions as an input device for receiving various inputs to the mobile terminal 2.

[0029] GPS15 measures the current location of mobile device 2 and derives location information. The derived location information is transmitted to clinical trial server 4.

[0030] Camera 18, at the subject's instruction, takes a photograph of the test results displayed or printed out by the blood testing device 3, which will be described later. The acquired test images are stored in storage 13 and sent to the clinical trial server 4 at the subject's instruction or without waiting for instruction.

[0031] Next, the blood testing device 3 will be described. The blood testing device 3 is installed in testing facilities that perform tests for clinical trials, such as pharmacies and hospitals. Figure 3 illustrates the hardware configuration of the blood testing device 3. As shown in Figure 3, the blood testing device 3 includes a CPU 21, non-volatile storage 23, and memory 26 as a temporary storage area. The blood testing device 3 also includes a touch panel display 24, a printer 25, a network interface 27 connected to network 5, and a sensor 28. The CPU 21, storage 23, display 24, printer 25, memory 26, network interface 27, and sensor 28 are connected to bus 29.

[0032] Storage 23 is implemented using an SSD and flash memory, etc. The storage 23, as a storage medium, stores the measurement program 22 installed in the blood testing device 3 for measuring biological information from blood. The CPU 21 reads the measurement program 22 from storage 23, expands it into memory 26, and executes the expanded measurement program 22. Note that the CPU 21 is an example of a processor that executes the measurement program 22.

[0033] The display 24 consists of a liquid crystal display and an organic EL display, and displays various information related to the processing performed by the blood testing device 3 and the test results. In addition, the display 24 is a touch panel display and also functions as an input device for various inputs to the blood testing device 3.

[0034] Printer 25 prints the inspection results onto a recording medium such as paper.

[0035] Sensor 28 measures biological information about the collected blood. For example, if the biological information is blood glucose level, sensor 28 measures the blood glucose level. Blood collection can be performed by the subject using a blood collection kit, or by a nurse if one is available at the testing facility. Self-collection of blood is performed by the subject pricking their own finger or other body part.

[0036] The measurement program 22 is stored on a server (not shown) in an externally accessible state and is downloaded and installed on the blood testing device 3 upon request.

[0037] Next, we will describe the clinical trial server 4. The clinical trial server 4 is a server computer on which the clinical trial program for conducting the clinical trial is installed. The clinical trial program is stored in a storage device of a server computer connected to the network, or in network storage, in a state that is accessible from the outside, and is downloaded and installed on the clinical trial server 4 upon request. Alternatively, it may be recorded on a storage medium such as a DVD (Digital Versatile Disc) or CD-ROM (Compact Disc Read Only Memory) and distributed, and then installed on the clinical trial server 4 from that storage medium.

[0038] Figure 4 shows the hardware configuration of the clinical trial server. As shown in Figure 4, the clinical trial server 4 includes a CPU 31, non-volatile storage 33, and memory 36 as temporary storage. The clinical trial server 4 also includes a display 34 such as an LCD display, input devices 35 such as a keyboard and mouse, and a network interface 37 connected to network 5. The CPU 31, storage 33, display 34, input devices 35, memory 36, and network interface 37 are connected to bus 39.

[0039] The storage 33 is implemented using an HDD, SSD, flash memory, etc. The clinical trial program 32 is stored in the storage 33 as a storage medium. The CPU 31 reads the clinical trial program 32 from the storage 33, expands it into memory 36, and executes the expanded clinical trial program 32. Note that the CPU 31 is an example of a processor that executes the clinical trial program 32.

[0040] Furthermore, the storage 33 stores information necessary for the clinical trial as a database, including information on multiple testing facilities participating in the clinical trial, information on the types of tests that can be performed at each testing facility (e.g., blood glucose tests, lipid tests, and uric acid tests), information on how to use the blood testing equipment installed at each testing facility, subject information to identify the subjects participating in the clinical trial (name, age, sex, and pre-existing conditions, etc.), and the clinical trial plan which defines the procedures for the clinical trial. The database may also include information on the accuracy of the blood testing equipment 3 installed at the testing facility, and information on whether the blood testing equipment 3 can communicate with the clinical trial server 4.

[0041] Prior to a clinical trial, a clinical trial coordinator prepares a clinical trial plan. This plan includes the time of blood collection throughout the day. For example, the blood collection times are included in the plan, such as 9:00, 12:00, 15:00, and 18:00. The plan also includes the types of blood tests to be performed on the subjects. For example, these include tests such as blood glucose measurement, lipid measurement, and uric acid level measurement. The clinical trial plan is stored in storage 33, associated with the subjects.

[0042] Next, the processing performed in the clinical trial system 1 according to this embodiment will be described. Figure 5 is a flowchart showing the processing performed in the clinical trial system 1 according to this embodiment. Note that the flowchart shown in Figure 5 shows the processing of a clinical trial for a particular subject. First, the clinical trial server 4 starts monitoring whether a predetermined time has arrived that is earlier than the blood collection time determined based on the subject's clinical trial plan (step ST1). The predetermined time can be set in the clinical trial server 4 by presenting the subject with candidates such as 60 minutes, 30 minutes, and 15 minutes before the blood collection time in advance. It is also possible to set it to any time desired by the subject.

[0043] If step ST1 is confirmed, the clinical trial server 4 obtains location information representing the subject's current location from the subject's mobile device 2 (step ST2). Based on the obtained location information and the subject's clinical trial plan, the clinical trial server 4 searches for a laboratory capable of performing the subject's blood test within a predetermined range relative to the subject's current location (step ST3). The predetermined range should be the distance within which the subject can reach the laboratory from their current location between the current time and the time of blood collection. At this time, the subject may also transmit information about their mode of transportation (walking, cycling, car, etc.) from the mobile device 2 to the clinical trial server 4 and search for laboratory facilities considering this transportation information. Furthermore, the search for laboratory facilities should include all laboratory facilities capable of performing all blood tests to be performed on the subject.

[0044] The clinical trial server 4 determines whether or not a testing facility capable of performing blood tests on the subjects has been found (step ST4). If step ST4 is confirmed, the clinical trial server 4 sends the search results for the testing facilities to the mobile terminal 2 (step ST5).

[0045] If step ST4 is rejected, the blood test cannot be performed according to the clinical trial plan. Therefore, if step ST4 is rejected, the clinical trial server 4 modifies the clinical trial plan and sets the test time and other settings again (step ST6), and returns to processing step ST1. Note that the modification of the clinical trial plan may be performed by the clinical trial program installed on the clinical trial server 4, or the clinical trial coordinator in charge of the subject may modify the clinical trial plan and set it on the clinical trial server 4. In this case, the administrator of the clinical trial server 4 should search for the clinical trial coordinator in charge of the subject and contact the found clinical trial coordinator. The administrator of the clinical trial server 4 sends the subject's information, the subject's current location information, and the clinical trial plan to the clinical trial coordinator. Note that if step ST4 is rejected, the clinical trial server 4 may notify the clinical trial coordinator by email or other means that the blood test cannot be performed according to the clinical trial plan. The clinical trial coordinator modifies the clinical trial plan based on this notification and sends it to the clinical trial server 4. Furthermore, if Step ST4 is rejected, notification may be sent to the physician, nurse, and other healthcare professionals involved in the clinical trial instead of the clinical trial coordinator.

[0046] It is preferable that the clinical trial server 4 notifies the subjects by sending information to the mobile terminal 2 if the clinical trial plan is modified. It is also preferable that if the clinical trial coordinator modifies the clinical trial plan, the clinical trial coordinator contacts the subjects to notify them of the change in the clinical trial plan.

[0047] The mobile terminal 2 displays the search results for testing facilities on the display 14 (step ST7). Figure 6 is a diagram showing the search results for testing facilities. As shown in Figure 6, the search results 40 show three testing facilities A to C as an example. When the subject selects a desired testing facility from the search results displayed on the mobile terminal 2, the mobile terminal 2 displays route information from the subject's current location to the selected testing facility on the display 14 (step ST8).

[0048] Figure 7 shows route information to the selected testing facility. As shown in Figure 7, the route information 41 displays a mark 42 indicating the subject's current location, a mark 43 indicating the selected testing facility, and two routes 44A and 44B from the subject's current location to the selected testing facility. It is possible to display routes to other testing facilities by selecting a different testing facility. The subject can move to the selected facility according to the desired route from the displayed routes 44A and 44B.

[0049] In addition, a guidance button 45 is displayed on the display 14 of the mobile terminal 2 along with route information 41. When the subject selects the guidance button 45, information regarding the operation of the blood testing device 3 installed at the selected testing facility is displayed on the display 14 and provided to the subject. The information regarding operation includes the testing method and precautions to take when performing the test using the blood testing device 3. The display may be text that explains the testing method step by step, or it may be still images or moving images including animation that show the testing method step by step. Alternatively, or in addition to the display, information regarding the operation of the blood testing device 3 may be provided to the subject by voice.

[0050] Furthermore, there may be cases where subjects do not understand the content of the guidance. For this reason, a button to contact a clinical trial coordinator may be displayed on the screen that displays the guidance. In this case, when a subject operates the button, they can contact the clinical trial coordinator by phone or email from their mobile device 2, and the clinical trial coordinator can directly lecture them on the guidance of the blood testing device 3. Alternatively, guidance may be provided by an automated voice instead of by a clinical trial coordinator.

[0051] Alternatively, the clinical trial program may be installed on mobile terminal 2, and steps ST1 to ST6 may be performed on mobile terminal 2. In this case, if step ST4 is rejected, information indicating that no testing facilities could be found will be displayed on display 14 instead of a list of search results. Furthermore, the subject will notify the clinical trial server 4 of this fact from mobile terminal 2. The clinical trial server 4 will revise the clinical trial plan, set the examination time and other details again, and send the set examination time to mobile terminal 2. Mobile terminal 2 can then search for testing facilities again according to the set examination time. This process should be continued until a testing facility is found.

[0052] Furthermore, in addition to displaying information that a testing facility could not be found on the mobile device 2, a contact button for contacting the clinical trial coordinator may also be displayed. In this case, the subject can select the contact button to call the clinical trial coordinator and have the clinical trial plan revised.

[0053] The subject, upon arriving at the testing facility, either performs self-blood collection using a blood collection kit provided at the facility, or requests blood collection from a doctor or nurse at the facility. The collected blood is then placed in the blood testing device 3, and a command is given to the blood testing device 3 to start the test. The blood testing device 3 then performs the test (step ST9) and outputs the test results (step ST10). The test results may be displayed on the display 24 or printed from the printer 25.

[0054] The subject takes a picture of the outputted test result using the camera 18 of the mobile terminal 2 and sends the captured image along with subject information that identifies the subject to the clinical trial server 4 (test result transmission: step ST11). Alternatively, communication may be established between the mobile terminal 2 and the blood testing device 3 so that the mobile terminal 2 can receive the test results from the blood testing device 3. In this case, the mobile terminal 2 sends the test results received from the blood testing device 3 along with the subject information to the clinical trial server 4. Alternatively, the blood testing device 3 may communicate with the clinical trial server 4 so that the blood testing device 3 can send the test results to the clinical trial server 4. In this case, the blood testing device 3 sends the test results along with the subject information that performed the test to the clinical trial server 4.

[0055] When the clinical trial server 4 receives the test results, it determines whether or not the test results are abnormal (step ST12). Here, "abnormal" does not mean that the test results are outside the normal range, but rather that the test results are impossible to obtain due to a malfunction or measurement error in the blood testing device 3. The clinical trial server 4 may also store the subject's past blood test results and refer to them to determine whether or not there are abnormalities. Furthermore, cases where no test results are obtained are also included as abnormalities. Alternatively, instead of determining whether or not there are abnormalities in the test results, when the blood testing device 3 detects an abnormality, it may send information indicating the abnormality, such as an error code, to the clinical trial server 4, and the clinical trial server 4 may determine that there was an abnormality in the test results based on the information received from the blood testing device 3.

[0056] If step ST12 is confirmed, the clinical trial server 4 searches for another testing facility (step ST13) and returns to processing step ST5. As a result, the search results for another testing facility are sent to the mobile terminal, and the other testing facility is displayed on the mobile terminal 2, prompting the subject to undergo re-examination. Preferably, the mobile terminal 2 also displays that there was an abnormality in the test result. The subject can then move to the other testing facility and undergo the examination. If there are multiple testing devices within the same testing facility, another testing device within the same facility may be searched. In that case, the subject can undergo the examination using the other testing device within the same testing facility without having to move.

[0057] If step ST12 is rejected, the clinical trial server 4 registers the test results in the database, associating them with the subject information (step ST14).

[0058] Here, tests conducted at a testing facility incur testing costs. These costs are borne by the testing institution conducting the clinical trial, and the subjects are not required to pay them. In this case, it is possible for subjects to pay the costs upfront at the testing facility, but this incurs a financial burden on the subject, even if only temporarily, and requires subsequent billing, which is a significant burden on the subject.

[0059] Therefore, the clinical trial server 4 settles the examination costs based on the subject information (step ST15) and terminates the process. Alternatively, the server may notify the facility where the mobile terminal 2 and blood testing device 3 are installed that the settlement is complete and the examination is finished. Alternatively, instead of the clinical trial server 4, the settlement may be performed on the mobile terminal 2 using the clinical trial application installed on the mobile terminal 2.

[0060] Alternatively, instead of settling the examination fee on the clinical trial server 4, payment information may be provided to the mobile terminal 2 after step ST14. A two-dimensional barcode, such as a QR code (registered trademark), can be used as the payment information. In this case, the subject displays the two-dimensional barcode on the mobile terminal 2 and presents it at the cash register of the examination facility where the examination was performed to pay the examination fee. The payment information may also be information that notifies the mobile terminal 2's NFC (Near Field Communication) of permission to pay. In this case, the subject uses the NFC on the mobile terminal 2 to make the payment at the cash register of the examination facility.

[0061] In this embodiment, route information to at least one testing facility where the subject can undergo blood testing, which is searched based on the subject's clinical trial plan and location information, is displayed on the mobile terminal 2. Therefore, the subject can travel to the testing facility according to the route information and undergo blood testing for the clinical trial.

[0062] This allows subjects to undergo blood tests without having to send their blood samples to a testing facility or be hospitalized and confined to a testing facility all day. Therefore, the burden on subjects undergoing tests for clinical trials can be reduced. Furthermore, it becomes easier for testing facilities to recruit subjects, increasing the sample size for clinical trials and consequently improving the reliability of the trials. In addition, if the testing facility is located in a remote area, the cost of transportation for subjects is eliminated, thus reducing the cost of the clinical trial. Moreover, in situations where infectious diseases are prevalent, waiting for long periods in the waiting room of a testing facility or staying at a testing facility all day carries a high risk of infection, but this embodiment can reduce such a risk of infection.

[0063] In the above embodiment, the test facility is searched based on the subject's current location, but this is not the only way. The mobile terminal 2 may be configured so that the subject specifies a location before the test date, and the test facility is searched based on the location information of the specified location. For example, if the subject has plans to go out on the test day, the test facility may be searched based on the location information of their destination the day before or while traveling by train or other means on the day of the test. This allows the subject to know in advance which test facility they can be tested at, making it easier for them to plan their activities on the test day.

[0064] Furthermore, in the above embodiment, the mobile terminal 2 may be used to notify the subject of precautions regarding the examination. For example, if eating or drinking is prohibited before a predetermined time before the examination, the mobile terminal 2's display 14 may be used to display precautions regarding the examination, such as "Please do not eat or drink after 7:00 AM," before the predetermined time before the examination, as shown in Figure 8. In this case, the display of precautions may be performed by the clinical trial program installed on the mobile terminal 2, or the clinical trial program 32 installed on the clinical trial server 4 may notify the mobile terminal 2, and the mobile terminal 2 may perform the action based on the notification.

[0065] Furthermore, in the above embodiment, for example, the hardware structure of the Processing Unit that executes various processes performed by the mobile terminal 2, the blood testing device 3, and the clinical trial server 4 can be the following types of processors. As mentioned above, these types of processors include a CPU, which is a general-purpose processor that executes software (programs) and functions as various processing units, as well as a Programmable Logic Device (PLD), which is a processor whose circuit configuration can be changed after manufacturing, such as an FPGA (Field Programmable Gate Array), and a dedicated electrical circuit, which is a processor with a circuit configuration specifically designed to execute a particular process, such as an ASIC (Application Specific Integrated Circuit).

[0066] A single processing unit may consist of one of these various processors, or it may consist of a combination of two or more processors of the same or different types (for example, a combination of multiple FPGAs or a combination of a CPU and an FPGA). Alternatively, multiple processing units may be composed of a single processor.

[0067] Examples of configuring multiple processing units with a single processor include, firstly, a configuration where one or more CPUs and software combine to form a single processor, as exemplified by client and server computers, and this processor functions as multiple processing units. Secondly, a configuration using a processor that realizes the functions of the entire system, including multiple processing units, on a single IC (Integrated Circuit) chip, as exemplified by System-on-a-Chip (SoC). Thus, various processing units are configured, in terms of hardware structure, using one or more of the above-mentioned processors.

[0068] Furthermore, the hardware structure of these various processors can more specifically utilize electrical circuits (Circuitry) that combine circuit elements such as semiconductor elements. [Explanation of symbols]

[0069] 1. Clinical Trial System 2 Mobile devices 3. Blood testing equipment 4. Clinical trial server 5 Network 11,21,31 CPU 12 Various Programs 13,23,33 storage 14, 24, 34 displays 15 GPS 16,26,36 memory 17, 27, 37 Network I / F 18 Cameras Buses 19, 29, 39 22 Measurement Program 25 Printers 28 sensors 32 Clinical Trial Programs 40 search results 41 Route Information 42,43 marks Routes 44A and 44B 45 Guidance Buttons 50. Screen displaying warnings

Claims

1. The mobile device possessed by the subject, A blood testing device installed in each of several testing facilities capable of performing blood tests on the aforementioned subjects, The clinical trial server stores the test results of the subject obtained by the blood testing device in association with subject information that identifies the subject, Based on the subject's clinical trial plan and the subject's location information, search for at least one testing facility capable of performing the subject's blood test, located within a predetermined range from the location represented by the subject's location information. If at least one testing facility is found within a predetermined range from the location represented by the location information of the subject, route information to the found at least one testing facility is displayed on the mobile terminal. If the testing facility is not found within a predetermined range from the location represented by the location information of the subject, the clinical trial server sets up a new clinical trial plan for the subject. A clinical trial system that searches for the aforementioned testing facility based on the aforementioned new clinical trial plan and the location information of the subject.

2. The mobile device possessed by the subject, A blood testing device installed in each of several testing facilities capable of performing blood tests on the aforementioned subjects, The clinical trial server stores the test results of the subject obtained by the blood testing device in association with subject information that identifies the subject, Based on the subject's clinical trial plan and the subject's location information, search for at least one testing facility capable of performing the subject's blood test, located within a predetermined range from the location represented by the subject's location information. If at least one testing facility is found within a predetermined range from the location represented by the location information of the subject, route information to the found at least one testing facility is displayed on the mobile terminal. A clinical trial system that notifies the clinical trial personnel if the aforementioned testing facility cannot be found within a predetermined range from the location represented by the location information of the subject.

3. The mobile device possessed by the subject, A blood testing device installed in each of several testing facilities capable of performing blood tests on the aforementioned subjects, The clinical trial server stores the test results of the subject obtained by the blood testing device in association with subject information that identifies the subject, The mobile terminal displays route information to at least one testing facility where the subject's blood test can be performed, which is retrieved based on the subject's clinical trial plan and the subject's location information. The mobile terminal or the blood testing device transmits the subject's test results and subject information to the clinical trial server. If there are abnormalities in the aforementioned test results, a new testing facility will be searched for. A clinical trial system that displays route information to the new testing facility on the mobile terminal.

4. The clinical trial server searches for at least one of the multiple testing facilities based on the subject's clinical trial plan and the subject's location information, and transmits the search results for the testing facilities to the mobile terminal. The clinical trial system according to any one of claims 1 to 3, wherein the mobile terminal displays route information to the searched testing facility.

5. The clinical trial system according to any one of claims 1 to 3, wherein the mobile terminal searches for at least one of the plurality of testing facilities based on the subject's clinical trial plan and the subject's location information, and displays route information to the searched testing facility.

6. The clinical trial system according to any one of claims 1 to 5, wherein the location information of the subject represents the current location of the subject.

7. The clinical trial system according to any one of claims 1 to 6, wherein the mobile terminal provides the subject with information regarding the handling of the blood testing device installed in the searched testing facility.

8. The mobile terminal or the blood testing device transmits the subject's test results and subject information to the clinical trial server. The clinical trial system according to any one of claims 1 to 7, wherein after the transmission of the test results, the mobile terminal or the clinical trial server settles the test costs based on the subject information.

9. The mobile terminal or the blood testing device transmits the subject's test results and subject information to the clinical trial server. The clinical trial system according to any one of claims 1 to 7, wherein after the transmission of the test results, the clinical trial server provides the mobile terminal with payment information for settling the test costs.

10. The clinical trial system according to any one of claims 1 to 9, wherein the mobile terminal notifies the subject of precautions regarding the examination.

Images