JP2023032153A - Clinical trial support terminal, clinical trial support method, and clinical trial support program - Google Patents

Abstract

To suppress the possibility of fraud in a clinical trial via the Internet as much as possible.SOLUTION: A clinical trial support terminal is passed from a clinical trial operator to a clinical trial participant. The clinical trial support terminal includes: a clinical trial support function unit related to a clinical trial; an acquisition unit for acquiring biological information on a user; and an authentication unit that permits a user input in the clinical trial support function unit while biometric authentication is successful using the biological information acquired by the acquisition unit and authentication data that is data of the biological information on the clinical trial participant registered by the clinical trial operator.SELECTED DRAWING: Figure 4

Description

The present invention relates to a clinical trial support terminal, a clinical trial support method, and a clinical trial support program.

Clinical trials are conducted to confirm the safety and efficacy of newly discovered pharmaceuticals, cosmetics, health foods, etc. (hereinafter referred to as "drugs, etc."). A clinical trial is conducted at a medical institution (hereinafter referred to as a "clinical trial medical institution") that satisfies predetermined standards in consideration of the safety of trial participants and the reliability of the clinical trial. In recent years, conducting part of clinical trials via the Internet has also been considered.

Japanese Patent No. 4463300

In a clinical trial, various tasks are performed, such as, for example, creating a patient diary for recording changes in the physical condition of a clinical trial participant, consulting a doctor, and arranging for a clinical trial drug for the clinical trial participant. In addition, high reliability is required for clinical trials. Therefore, in work related to clinical trials, it is essential to perform identity verification to prevent various fraudulent acts, such as impersonating a clinical trial participant. However, when conducting clinical trials via the Internet, it is not easy to eliminate such misconduct.

One aspect of the technology disclosed herein is to minimize the possibility of fraud in clinical trials via the Internet.

One aspect of the disclosed technology is exemplified by the following clinical trial support terminal. This clinical trial support terminal is a clinical trial support terminal handed over to clinical trial participants by the clinical trial operator. This clinical trial support terminal includes a clinical trial support function unit related to clinical trials, an acquisition unit that acquires user's biometric information, the biometric information acquired by the acquisition unit, and the biometric information registered by the clinical trial operator. an authentication unit that permits user input in the clinical trial support function unit while biometric authentication using the authentication data, which is data of the biometric information of the clinical trial participant, is successful.

According to the clinical trial support terminal, user input in the clinical trial function unit is limited while biometric authentication is successful. That is, input by users other than clinical trial participants is suppressed. Therefore, according to the clinical trial terminal, it is possible to minimize the possibility of fraudulent acts in clinical trials via the Internet.

It should be noted that the term "while biometric authentication is successful" is not limited to the case where a state in which biometric authentication is successfully performed continuously is maintained, and is defined as each biometric authentication that is intermittently performed at predetermined intervals or the like. Includes successful biometric authentication. Moreover, clinical trials include, for example, clinical trials, clinical research, post-marketing surveys of drugs, and the like.

The clinical trial support terminal may further include the following features. The clinical trial support function unit includes a consent function unit that obtains the consent of the clinical trial participant, and the consent function unit succeeds in the biometric authentication performed by the authentication unit after displaying the consent statement. Consent of the above clinical trial participants will be obtained during the study period. This clinical trial support terminal can suppress consent from others who are not clinical trial participants by providing such features.

The clinical trial support terminal may further include the following features. The clinical trial support function unit includes a schedule management function unit that manages the schedule of hospital visits during the clinical trial period, and the schedule management function unit actually visits the hospital for the total number of hospital visits during the clinical trial period. Displays a sign indicating the percentage of times. With this feature, the clinical trial support terminal can visually understand the ratio of the actual number of hospital visits to the number of hospital visits during the trial period. It can increase motivation.

The clinical trial support terminal may further include the following features. The clinical trial support function unit includes a questionnaire function unit that receives answers to questionnaires related to the clinical trial, and the questionnaire function unit succeeds in the biometric authentication performed by the authentication unit after the questionnaire function unit is activated. During this period, it accepts input of responses to the questionnaires, and transmits the accepted responses to the host server. With such features, the clinical trial support can suppress responses to questionnaires by others who are not clinical trial participants.

The clinical trial support terminal may further include the following features. The clinical trial support function unit includes a reception support function unit used for receiving the delivered clinical trial drug, and the reception support function unit performs the above authentication by the authentication unit executed after the reception support function unit is activated. If the biometric authentication is successful, it outputs authentication information to be read by the terminal of the delivery company that delivers the clinical trial drug. By providing such features, this clinical trial support can make it possible to confirm that the person receiving the investigational drug is the actual clinical trial participant by the authentication information displayed when the biometric authentication is successful. .

The techniques described above can also be understood from the aspects of the clinical trial support method, the clinical trial support program, and the clinical trial support system.

According to the disclosed technique, the possibility of fraudulent acts in clinical trials via the Internet can be suppressed as much as possible.

FIG. 1 is a diagram showing an example of a clinical trial support system according to an embodiment. FIG. 2 is a diagram illustrating an example of a hardware configuration of a tablet terminal and a server according to the embodiment; FIG. 3 is a diagram illustrating an example of processing blocks of a server according to the embodiment; FIG. 4 is a diagram illustrating an example of processing blocks of the tablet terminal according to the embodiment; FIG. 5 is a diagram showing an example of an additional authentication management table stored in the management database in the embodiment. FIG. 6 is a diagram showing a usage example of the investigational drug delivery application in the embodiment. FIG. 7 is a diagram showing a usage example of the visit record application in the embodiment. 8 is a diagram illustrating an example of a processing flow of a server according to the embodiment; FIG. FIG. 9 is a diagram illustrating an example of an initial setting flow of the tablet terminal according to the embodiment; 10 is a diagram illustrating an example of a processing flow of the tablet terminal according to the embodiment; FIG. FIG. 11 is a diagram illustrating an example of a processing flow of additional authentication of the tablet terminal according to the embodiment; FIG. 12 is a diagram schematically showing an application example of the clinical trial support system.

<Embodiment>
The configuration of the embodiment shown below is an example, and the disclosed technology is not limited to the configuration of the embodiment. FIG. 1 is a diagram showing an example of a clinical trial support system 600 according to an embodiment. A clinical trial support system 600 includes a tablet terminal 100 and a server 500 . The tablet terminal 100 and the server 500 are communicably connected to each other via a computer network N1. The clinical trial support system 600 is an example of a "clinical trial support system."

The tablet terminal 100 is a portable information processing device. The tablet terminal 100 is, for example, a terminal handed over to a clinical trial participant who participates in a clinical trial from a clinical trial operator who conducts the clinical trial. In the tablet terminal 100 , a speaker 111 , a microphone 112 , a display 113 , a touch panel 114 and a camera 115 are provided on the front surface of the housing 110 . A touch panel 114 is provided so as to overlap the display 113 . The touch panel 114 is preferably provided so as to cover the entire surface of the display 113 . A clinical trial sponsor is an example of a "clinical trial sponsor." A clinical trial participant is an example of a "clinical trial participant."

The tablet terminal 100 is installed with a plurality of application programs (hereinafter also referred to as “apps” in this specification) used when conducting clinical trials via the Internet. An icon indicating the installed application is displayed on display 113 . In FIG. 1, a patient diary icon 201 indicating a patient diary application, an online medical examination icon 202 indicating an online medical examination application, an investigational drug delivery icon 203 indicating an investigational drug delivery application, a visit record icon 204 indicating a visit record application, and an electronic consent application. , a questionnaire icon 206 indicating a questionnaire application, and a helpdesk icon 207 indicating a helpdesk application are displayed on the display 113 . The tablet terminal 100 is an example of a "clinical trial support terminal."

The server 500 is an information processing device. The server 500 is managed by, for example, a clinical trial sponsor. The server 500 may be installed within the business site of the clinical trial sponsor. Also, the server 500 may be a server installed on the Internet (for example, a cloud server). In the server 500, clinical trial information indicating details of clinical trials in response to requests from pharmaceutical companies, university hospitals, etc. is registered. The server 500 also receives various information about the clinical trial participants from the tablet terminal 100 . The server 500 is an example of a "upper server".

A computer network N1 connects the information processing devices so that they can communicate with each other. Computer network N1 is, for example, the Internet.

FIG. 2 is a diagram illustrating an example of hardware configurations of the tablet terminal 100 and the server 500 according to the embodiment. First, the hardware configuration of the tablet terminal 100 will be described. The tablet terminal 100 includes a CPU 101 , a main memory section 102 , an auxiliary memory section 103 , a communication section 104 , a speaker 111 , a microphone 112 , a display 113 , a touch panel 114 and a camera 115 . The CPU 101, main storage unit 102, auxiliary storage unit 103, communication unit 104, speaker 111, microphone 112, display 113, touch panel 114 and camera 115 are interconnected by a connection bus B1.

The CPU 101 is also called a microprocessor unit (MPU) or processor. The CPU 101 is not limited to a single processor, and may have a multi-processor configuration. Also, a single CPU 101 connected with a single socket may have a multi-core configuration. At least part of the processing executed by the CPU 101 is performed by a processor other than the CPU 101, such as a dedicated processor such as a digital signal processor (DSP), a graphics processing unit (GPU), a numerical processor, a vector processor, or an image processor. may At least part of the processing executed by the CPU 101 may be executed by an integrated circuit (IC) or other digital circuits. Also, at least part of the CPU 101 may include an analog circuit. Integrated circuits include Large Scale Integrated Circuits (LSIs), Application Specific Integrated Circuits (ASICs), and Programmable Logic Devices (PLDs). PLDs include, for example, Field-Programmable Gate Arrays (FPGAs). CPU 101 may be a combination of a processor and an integrated circuit. A combination is called, for example, a microcontroller unit (MCU), a system-on-a-chip (SoC), a system LSI, a chipset, or the like.

The main storage unit 102 is exemplified as a storage unit directly accessed from the CPU 101 . The main storage unit 102 includes Random Access Memory (RAM) and Read Only Memory (ROM).

The auxiliary storage unit 103 stores various programs and various data in a readable and writable recording medium. The auxiliary storage unit 103 is also called an external storage device. The auxiliary storage unit 103 stores an operating system (OS), various programs, various tables, and the like. The OS includes a communication interface program for exchanging data with an external device or the like connected via the communication unit 104 . External devices and the like include, for example, other information processing devices and external storage devices connected via a computer network or the like. Note that the auxiliary storage unit 103 may be part of a cloud system, which is a group of computers on a network, for example.

The auxiliary storage unit 103 is, for example, an erasable programmable ROM (EPROM), a solid state drive (SSD), a hard disk drive (HDD), or the like.

The communication unit 104 is, for example, an interface with the computer network N1. The connection between the communication unit 104 and the computer network N1 may be wired or wireless. The communication unit 104 communicates with an external device via the computer network N1.

The speaker 111 is a sound source that outputs sound. The speaker 111 outputs sound such as the voice of the other party in a call using the tablet terminal 100 . A microphone 112 is a microphone that is used for making a call or acquiring audio for moving images.

A display 113 displays data processed by the CPU 101 and data stored in the main storage unit 102 . The display 113 is, for example, a Liquid Crystal Display (LCD), a Plasma Display Panel (PDP), an Electroluminescence (EL) panel, or an organic EL panel.

The touch panel 114 detects a touch operation by a user's finger or the like. There is no limitation on the method by which the touch panel 114 detects a touch operation. Examples of the method by which the touch panel 114 detects a touch operation include an electrostatic capacity method, a resistive film method, and a surface acoustic wave method. With the touch panel 114 superimposed on the display 113 , the smartphone 100 can provide the user with an intuitive operating environment.

The camera 115 is a digital camera having a Charge Coupled Device (CCD) image sensor or a Complementary Metal Oxide Semiconductor (CMOS) image sensor. Camera 115 can capture still images and moving images.

Next, the hardware configuration of server 500 will be described. The server 500 includes a CPU 101 , a main storage section 102 , an auxiliary storage section 103 and a communication section 104 . Server 500 may include speaker 111 and display 113 . The server 500 may also include input devices such as a keyboard and a mouse.

<Processing block of server 500>
FIG. 3 is a diagram illustrating an example of processing blocks of the server 500 according to the embodiment. The server 500 includes a reception unit 501 , a terminal management unit 502 and a collection unit 503 . The CPU 101 of the server 500 executes a computer program developed in an executable manner in the main storage unit 102, thereby executing processing as each unit of the server 500, such as the reception unit 501, the terminal management unit 502, and the collection unit 503. do.

The reception unit 501 receives input of clinical trial details requested by applicants such as pharmaceutical companies and university hospitals who wish to conduct clinical trials. The details of the clinical trial include the investigational drug to be administered, the administration method of the investigational drug, the ages of the clinical trial participants to be studied, and the duration of the clinical trial. The reception unit 501 is an example of a “reception unit”. An investigational drug is an example of a "clinical investigational drug."

The terminal management unit 502 provides the tablet terminal 100 with information related to clinical trial participants using the tablet terminal 100 among the clinical trial contents received by the reception unit 501 . The terminal management unit 502 displays on the display 113, for example, a list of applications used in the clinical trial indicated by the clinical trial content. The terminal management unit 502 may, for example, manage the correspondence between each item of the clinical trial content and the application in a table, and refer to the table to specify the application corresponding to the clinical trial content. In addition, the terminal management unit 502 may install, on the tablet terminal 100, an application that is used in a clinical trial in which the clinical trial participant participates. In addition, the terminal management unit 502 may register information such as the investigational drug to be tested, the administration method of the investigational drug, the duration of the clinical trial, etc. in the help desk application installed in the tablet terminal 100, for example. The terminal management unit 502 is an example of a “terminal management unit”.

The collection unit 503 receives information transmitted from the tablet terminal 100 . For example, the collection unit 503 may provide the information collected from the tablet terminal 100 to pharmaceutical companies, university hospitals, etc. that wish to conduct clinical trials. The collection unit 503 is an example of a “collection unit”.

<Processing Blocks of Tablet Terminal 100>
FIG. 4 is a diagram illustrating an example of processing blocks of the tablet terminal 100 according to the embodiment. The tablet terminal 100 includes a clinical trial support function unit 301, an acquisition unit 302, an authentication unit 303, a biological information database 304, and a management database 305 ("database" is written as "DB" in the figure). The tablet terminal 100 has the clinical trial support function unit 301, the acquisition unit 302, the authentication unit 303, and the biometric information database 304 of the tablet terminal 100 by the CPU 101 executing a computer program that is executable and developed in the main storage unit 102. , the management database 305 and the like.

In the biometric information database 304, biometric information of clinical trial participants is stored by the clinical trial sponsor. In this embodiment, face authentication is used for biometric authentication by the authentication unit 303 . Therefore, when the tablet terminal 100 is handed over to the clinical trial participant, the clinical trial sponsor takes a photograph of the clinical trial participant's face, and biometric information indicating the photographed face of the clinical trial participant is registered in the biometric information database 304 . The registered biometric information is protected by password authentication, biometric authentication, etc. so that it cannot be erased or changed by anyone other than the clinical trial sponsor. Biometric information that indicates the face of a clinical trial participant is an example of "authentication data."

The management database 305 manages the timing at which biometric authentication is performed by the authentication unit 303 in association with the application. As will be described later, the authentication unit 303 performs biometric authentication when the application is started, and also performs biometric authentication in the background while the application is running. However, when biometric authentication performed in the background is intermittently performed, the timing at which biometric authentication is desired and the timing at which biometric authentication is performed do not always match. Therefore, the management database 305 manages the timing of additionally executing biometric authentication for each application.

FIG. 5 is a diagram showing an example of the additional authentication management table 305a stored in the management database 305 in the embodiment. The additional authentication management table 305a includes items of "application" and "additional timing". “Applications” include a patient diary application 3011 , an online medical examination application 3012 , an investigational drug delivery application 3013 , and a visit record application 3014 included in the clinical trial support function unit 301 . Information indicating each of the electronic consent application 3015, questionnaire application 3016, and help desk application 3017 is stored. “Additional Timing” stores information indicating the timing for additionally performing biometric authentication. That is, the additional authentication management table 305a is a table that associates each application included in the clinical trial support function unit 301 with the timing at which additional biometric authentication is performed.

Returning to FIG. 4, the clinical trial support function unit 301 includes a plurality of applications used when conducting clinical trials via the Internet. The clinical trial support function unit 301 includes, for example, a patient diary application 3011, an online medical examination application 3012, an investigational drug delivery application 3013, and a visit record application 3014. Includes electronic consent application 3015, survey application 3016 and helpdesk application 3017.

The patient diary application 3011 is an application for recording the types and amounts of investigational drugs taken by clinical trial participants, daily changes in their physical conditions, and the like. The online medical examination application 3012 is an application used when a clinical trial participant consults a doctor via the Internet. The investigational drug delivery application 3013 is an application used for identity verification when receiving the delivered investigational drug. The electronic consent application 3015 is an application used to obtain the consent of clinical trial participants to various considerations related to clinical trials. The questionnaire application 3016 is an application for conducting questionnaires related to clinical trials using the tablet terminal 100 . The helpdesk application 3017 is an application used for inquiries about the tablet terminal 100 and the clinical trial support function unit 301 . A patient diary application 3011, an online medical examination application 3012, an investigational drug delivery application 3013, and a visit record application 3014. Information entered into electronic consent application 3015 and help desk application 3017 is transmitted to server 500 via computer network N1, for example. The clinical trial support function unit 301 is an example of a "clinical trial support function unit".

Acquisition unit 302 acquires the biometric information of the user of tablet terminal 100 . In this embodiment, face authentication is used as biometric authentication by the authentication unit 303 . Therefore, the acquisition unit 302 captures the face of the user of the tablet terminal 100 with the camera 115 and acquires biometric information indicating the face of the user from the captured face image of the user. Acquisition unit 302 is an example of an “acquisition unit”.

The authentication unit 303 performs biometric authentication based on the biometric information acquired by the acquisition unit 302 and the biometric information registered in the biometric information database 304 . In this embodiment, the authentication unit 303 performs face authentication as biometric authentication. The authentication unit 303 permits input to the clinical trial support function unit 301 when the biometric authentication is successful. Further, the authentication unit 303 prohibits input to the clinical trial support function unit 301 when the biometric authentication fails.

The authentication unit 303 continuously performs biometric authentication of the user in the background even while the clinical trial support function unit 301 is running. Here, "continuously" is not limited to continuously executing biometric authentication, but includes intermittent execution of biometric authentication at predetermined intervals or the like. The authentication unit 303 prohibits input to the clinical trial support function unit 301 when biometric authentication performed in the background fails. The acquiring unit 302 and the authenticating unit 303 may be appropriately called by the clinical trial support function unit 301 during execution.

The authentication unit 303 further refers to the additional authentication management table 305a to acquire the timing of additionally performing biometric authentication for the application being executed. For the electronic consent application 3015, for example, the authentication unit 303 performs biometric authentication not only at the time of activation and execution, but also at the timing before signing the consent document. For example, the authentication unit 303 performs biometric authentication when the online medical care application 3012 is activated and during execution, but there is no timing to perform additional biometric authentication. The authentication unit 303 is an example of an “authentication unit”.

FIG. 6 is a diagram showing a usage example of the investigational drug delivery application 3013 in the embodiment. The investigational drug delivery application 3013 is used, for example, for identity verification when receiving an investigational drug delivered by a delivery company or the like. When the investigational drug delivery application 3013 is activated, biometric authentication is performed by the authentication unit 303 . When biometric authentication by the authentication unit 303 is successful, the investigational drug delivery application 3013 causes the display 113 to display a two-dimensional code 3013 a indicating the clinical trial participant using the tablet terminal 100 . By the delivery company reading the two-dimensional code 3013a with a reading terminal, it is confirmed that the trial participant has received the trial drug. If biometric authentication by the authentication unit 303 fails, the investigational drug delivery application 3013 is terminated without displaying the two-dimensional code 3013a.

FIG. 7 is a diagram showing a usage example of the visit record application 3014 in the embodiment. The visit record application 3014 is used, for example, to record visits to the hospital for examinations related to clinical trials. When the visit record application 3014 is activated, biometric authentication is performed by the authentication unit 303 . When biometric authentication by the authentication unit 303 is successful, a visit record screen 3014 a is displayed on the display 113 . The visit record screen 3014a includes a date display 3014b and a mark display field 3014c associated with the date display 3014b. The visit record application 3014 displays a visit mark 3014d in the mark display column 3014c corresponding to the date of the hospital visit when the visit to the hospital is detected. Note that the visit record application 3014 detects that the patient visited the hospital when communication with a hospital terminal installed in the hospital is confirmed, for example. The visit mark 3014d is an example of a "code".

<Processing Flow of Server 500>
FIG. 8 is a diagram illustrating an example of the processing flow of the server 500 according to the embodiment. An example of the processing flow of the server 500 according to the embodiment will be described below with reference to FIG.

In S11, the reception unit 501 receives input of clinical trial details. The content of the received clinical trial is stored in the auxiliary storage unit 103 of the server 500, for example.

In S12, the terminal management unit 502 provides the tablet terminal 100 with the content of the clinical trial received in S11. In S12, for example, the application selected based on the details of the clinical trial accepted in S11 is installed on the tablet terminal 100. FIG. The processes of S11 and S12 are executed before the tablet terminal 100 is handed over to the trial participant.

In S<b>13 , the collection unit 503 receives information transmitted from the tablet terminal 100 . For example, the tablet terminal 100 receives various types of information input to the clinical trial support function unit 301 by a clinical trial participant, and transmits the input information to the server 500 . When the information input by the clinical trial participant is received from the tablet terminal 100 , the collection unit 503 stores the information in the auxiliary storage unit 103 . The processing of S13 is executed after the tablet terminal 100 is handed over to the clinical trial participant.

<Processing Flow of Tablet Terminal 100>
FIG. 9 is a diagram illustrating an example of an initial setting flow of the tablet terminal 100 according to the embodiment. The initial setting flow of FIG. 9 is performed when the tablet terminal 100 is handed over to the clinical trial participant. The place where the initial setting flow of FIG. 9 is executed is, for example, within the office of the clinical trial sponsor. An example of the initial setting flow of the tablet terminal 100 will be described below with reference to FIG. 9 .

In S<b>21 , the clinical trial support function unit 301 is installed in the tablet terminal 100 . This process corresponds to S12 in FIG. 8, for example. That is, the clinical trial support function part 301 is installed in the tablet terminal 100 by the server 500 that executes the process of S12 in FIG.

In S22, biometric information indicating the face of the trial participant photographed by the trial sponsor is registered in the biometric information database 304. FIG. The camera 115 of the tablet terminal 100 may be used for photographing the face of the clinical trial participant, or another camera may be used.

FIG. 10 is a diagram illustrating an example of a processing flow of the tablet terminal 100 according to the embodiment. The processing flow of FIG. 10 is an example of the processing flow executed when the clinical trial participant operates the tablet terminal 100 . An example of the processing flow of the tablet terminal 100 according to the embodiment will be described below with reference to FIG. 10 .

In S31, one of the applications in the clinical trial support function unit 301 is activated. An application is activated, for example, by tapping an icon displayed on the display 113 .

In S32, the acquiring unit 302 causes the camera 115 to photograph the face of the user who operates the tablet terminal 100, and acquires biometric information indicating the face of the user. The authentication unit 303 performs biometric authentication based on the biometric information acquired by the acquisition unit 302 and the biometric information registered in the biometric information database 304 . If biometric authentication is successful (YES in S33), the process proceeds to S34. If biometric authentication fails (NO in S33), the process proceeds to S37, and the started application is terminated.

In S34, the clinical trial support function unit 301 activated in S31 is operated. In the background where the clinical trial support function unit 301 is being operated, the acquisition unit 302 captures the user's face and acquires biometric information, and biometric authentication is continuously performed by the authentication unit 303 based on the acquired biometric information. . Note that additional authentication for an application whose addition timing is specified in the additional authentication management table 305a will be described later with reference to FIG.

When the operation on the clinical trial support function unit 301 has ended (YES in S35), the process proceeds to S37, and the activated application is ended. When the end of the operation on the clinical trial support function unit 301 is detected, for example, when the tap operation on the end button is detected. If the operation on the clinical trial support function unit 301 has not ended (NO in S35), the process proceeds to S36.

FIG. 11 is a diagram illustrating an example of a processing flow of additional authentication of the tablet terminal 100 according to the embodiment. The process of FIG. 11 is performed in S34 of FIG. An example of the processing flow of additional authentication of the tablet terminal 100 according to the embodiment will be described below with reference to FIG. 11 .

In S41, the authentication unit 303 refers to the additional authentication management table 305a of the management database 305, and acquires the additional authentication timing associated with the application started in S31 of FIG.

In S<b>42 , the authentication unit 303 determines whether or not it is time for additional authentication of the application being executed. If it is the additional authentication timing (YES in S42), the process proceeds to S43. If it is not the additional authentication timing (NO in S42), the process proceeds to S44.

In S43, the authentication unit 303 performs biometric authentication. If biometric authentication is successful (YES in S43), the process proceeds to S44. If biometric authentication fails (NO in S43), the process proceeds to S45.

In S44, the process proceeds to S35 in FIG. In S45, the process proceeds to S37 in FIG.

If the biometric authentication performed by the authentication unit 303 in the background is successful (YES in S36), the process proceeds to S34, and the operation of the application can be continued. On the other hand, if the biometric authentication performed by the authentication unit 303 in the background fails (NO in S36), the process proceeds to S37, and the started application is terminated.

<Application Example of Clinical Trial Support System 600>
An application example of the clinical trial support system 600 described above will be described. FIG. 12 is a diagram schematically showing an application example of the clinical trial support system 600. As shown in FIG. An application example of the clinical trial support system 600 will be described below with reference to FIG.

At T1, a pharmaceutical company 2 requests a clinical trial sponsor 1 to conduct a clinical trial. The pharmaceutical company 2 informs the clinical trial sponsor 1 of the details of the clinical trial, which are exemplified by the subject investigational drug, the administration method of the investigational drug, the age of the subject clinical trial participant, the clinical trial period for which the clinical trial is to be conducted, and the like.

At T2, the clinical trial provider staff 11 inputs the details of the clinical trial received from the pharmaceutical company 2 into the server 500 (S11 in FIG. 8). The terminal management unit 502 of the server 500 installs, for example, an application used in the clinical trial indicated by the clinical trial content on the tablet terminal 100 (S21 in FIG. 9). The clinical trial operator staff member 11 photographs the face of the clinical trial participant 31 who satisfies the conditions such as the age indicated in the clinical trial content, and registers the biometric information indicating the face of the trial participant 31 in the biometric information database 304 of the tablet terminal 100. (S22 in FIG. 9). The clinical trial participant 31 brings back to his/her home 3 the tablet terminal 100 in which an application related to the clinical trial is installed and biometric information indicating the face of the clinical trial participant 31 is registered.

In T3, study participant 31 takes study drug at home 3 . The clinical trial participant 31 inputs, for example, the administration time of the investigational drug, daily changes in physical condition, etc. to the patient diary application 3011 . When the patient diary application 3011 is activated, biometric authentication is performed by the authentication unit 303, and when the biometric authentication is successful, the patient diary application 3011 becomes browsable (S31-S37 in FIG. 10). Since the additional authentication timing of the patient diary application 3011 is set to before inputting the diary in the additional authentication management table 305a, the authentication unit 303 performs biometric authentication before the input operation for the patient diary is performed (FIG. 11). Note that biometric authentication by the authentication unit 303 is executed in the background even while the patient diary is being entered, and if the biometric authentication fails, the patient diary application 3011 is terminated (S34-S37 in FIG. 10).

The clinical trial participant 31 activates the online medical care application 3012 at the specified timing or when he feels uneasy about his physical condition. As with the patient diary application 3011, the online medical examination application 3012 also performs biometric authentication by the authentication unit 303 at the time of activation and during execution. This prevents others from impersonating the clinical trial participant 31 and receiving online medical care. The online medical examination application 3012 makes it possible to receive medical examination via the Internet. In addition, since the additional authentication timing of the online medical care application 3012 is not set in the additional authentication management table 305a, biometric authentication by the authentication unit 303 is not performed at startup and other than in the background (in S42 of FIG. 11, " NO").

When the clinical trial participant 31 receives the delivered clinical trial drug at home 3 or the like, the clinical trial participant 31 activates the clinical trial drug delivery application 3013 . The investigational drug delivery application 3013 displays a two-dimensional code 3013a upon successful biometric authentication by the authentication unit 303 at the time of activation (S31-S34 in FIGS. 6 and 10). Also, the investigational drug delivery application 3013 is terminated without displaying the two-dimensional code 3013a if biometric authentication by the authentication unit 303 fails at the time of activation (S33 "NO" to S37 in FIG. 10). In addition, since the additional authentication timing of the investigational drug delivery application 3013 is set to no in the additional authentication management table 305a, biometric authentication by the authentication unit 303 is not performed at startup and other than in the background (in S42 of FIG. 11). "NO"). The investigational drug delivery application 3013 is an example of the "receipt support function unit".

The clinical trial participant 31 can go to the hospital 4 designated in the clinical trial at the designated timing or when he feels uneasy about his physical condition. As the hospital 4, for example, a hospital closest to the home 3 among the hospitals corresponding to the clinical trial support system 600 is specified. When visiting a hospital, the visit record application 3014 is activated, and a mark display column 3014c is recorded on a visit record screen 3014a as illustrated in FIG. The visit record application 3014 also performs biometric authentication by the authentication unit 303 at the time of activation and during execution in the same manner as the patient diary application 3011 . In addition, since the additional authentication timing of the visit record application 3014 is set to "No" in the additional authentication management table 305a, biometric authentication by the authentication unit 303 is not performed at startup and other than in the background (in S42 of FIG. 11, " NO"). The visit record application 301 is an example of a “schedule management function unit”.

The clinical trial participant 31 can activate the help desk application 3017 and inquire at the help desk of the clinical trial operator 1 if there is an unclear point in the operation of the tablet terminal 100 or the like while participating in the clinical trial. The clinical trial support function unit 301 installed in the tablet terminal 100 is managed by the clinical trial sponsor 1 . Therefore, inquiries from the tablet terminal 100 can be centralized to the help desk application 3017 . The helpdesk application 3017 also performs biometric authentication by the authentication unit 303 at the time of activation and during execution in the same manner as the patient diary application 3011 . Therefore, it is possible to prevent others from pretending to be the clinical trial participant 31 and making inquiries to the help desk of the clinical trial sponsor 1 . In addition, since the additional authentication timing of the help desk application 3017 is set to no in the additional authentication management table 305a, biometric authentication by the authentication unit 303 is not performed at startup and other than in the background (in S42 of FIG. 11, " NO").

Consent for the clinical trial may be obtained from the clinical trial participant 31 at the start of the clinical trial or during the clinical trial period.
In such a case, electronic consent application 3015 is activated. As with the patient diary application 3011, the electronic consent application 3015 also undergoes biometric authentication by the authentication unit 303 at the time of activation and during execution. This prevents others from impersonating the clinical trial participant 31 and giving their consent. Further, since the additional authentication timing of the electronic consent application 3015 is set to be before the signature in the additional authentication management table 305a, the authentication unit 303 displays the consent document explaining the content of the consent, and after the clinical trial participant 31 Biometric authentication is also performed immediately before the signature is entered (Fig. 11). Therefore, it is more strongly guaranteed that the person who signed is the clinical trial participant 31 . Electronic consent application 3015 is an example of a “consent function”.

At the end of the clinical trial or during the clinical trial period, a questionnaire regarding the clinical trial is conducted. In the questionnaire, for example, the ease of participation in the clinical trial, the ease of understanding the consent document displayed by the electronic consent application 3015, the convenience of online medical treatment, the change in physical condition due to participation in the clinical trial, the tablet terminal 100 The presence or absence of operational inconvenience, etc. are confirmed. When the questionnaire application 3016 is activated, biometric authentication is performed by the authentication unit 303 at the time of activation and during execution in the same manner as the patient diary application 3011 . In addition, since the additional authentication timing of the questionnaire application 3016 is set to before inputting the answer in the additional authentication management table 305a, the authentication unit 303 performs biometric Authenticate (Fig. 11). Then, the questionnaire application 3016, for example, transmits the answers to the questionnaire to the server 500. FIG.

Note that the questionnaire by the questionnaire application 3016 may be conducted multiple times during the clinical trial period. The questionnaire application 3016 outputs, for example, a multiple-choice questionnaire for the first questionnaire during the clinical trial period, and a descriptive questionnaire for asking for more detailed answers than the first questionnaire for the second questionnaire. The questionnaire application 3016 may guide a face-to-face questionnaire such as an online meeting via the Internet for the questionnaire at the end of the clinical trial period. The questionnaire application 3016 is an example of a “questionnaire function unit”.

<Action and effect of the embodiment>
Applications related to clinical trials conducted via the Internet were provided by various vendors, and the terminals used were not standardized. Therefore, for the clinical trial participant 31, neither the terminal to be used nor the inquiry contact for the application is unified, which makes it very difficult to use. In this embodiment, applications related to clinical trials, such as a patient diary application 3011, an online medical examination application 3012, an investigational drug delivery application 3013, a visit record application 3014, an electronic consent application 3015, a questionnaire application 3016, and a helpdesk application 3017, are installed on one tablet terminal. 100 installed. Therefore, the clinical trial participant 31 can unify the terminal used in the clinical trial and the contact information regarding the clinical trial, and can reduce the labor involved in the clinical trial participation of the clinical trial participant 31 .

In this embodiment, biometric authentication is performed by the authentication unit 303 when the clinical trial support function unit 301 is activated and during execution. If the biometric authentication fails, the clinical trial support function unit 301 is terminated. Therefore, according to the present embodiment, it is possible to prevent others from impersonating the clinical trial participant 31 and inputting information to the clinical trial support function unit 301 .

In this embodiment, the electronic consent application 3015 performs biometric authentication by the authentication unit 303 after displaying the consent document and immediately before the signature of the clinical trial participant 31 is entered. Therefore, according to the present embodiment, it is suppressed that another person impersonates the clinical trial participant 31 and gives consent.

In this embodiment, the visit record application 3014 displays a visit mark 3014d in the mark display field 3014c corresponding to the date of hospital visit. From this visit mark 3014d, the ratio of the actual number of times of hospital visits to the number of times of hospital visits during the clinical trial period (the number of the mark display column 3014c) can be visually understood. The display of such a visit mark 3014d can increase the willingness of the clinical trial participant 31 to visit the hospital. A character popular with children may be adopted as the visit mark 3014d. In addition, since biometric authentication is performed by the authentication unit 303 when the visit record application 3014 is activated and during execution, even if someone else impersonates the clinical trial participant 31 and goes to the hospital 4 carrying the tablet terminal 100, the visit record can be recorded. Recording of the mark display field 3014c on the screen 3014a is suppressed.

In this embodiment, biometric authentication is performed by the authentication unit 303 when the questionnaire application 3016 is activated and during execution. Furthermore, in the questionnaire application 3016, biometric authentication is performed by the authentication unit 303 even before answering the questionnaire. Therefore, according to the present embodiment, it is possible to suppress responses to questionnaires by persons other than the clinical trial participant 31 .

In this embodiment, the server 500 may provide the pharmaceutical company 2 with information that the clinical trial participant inputs to the clinical trial support function unit 301 and that is collected by the collection unit 503 . Here, in the present embodiment, the information input to the clinical trial support function unit 301 is the information input by the clinical trial participant 31 himself/herself through biometric authentication by the authentication unit 303 when the clinical trial support function unit 301 is activated and during execution. One thing can be made more certain. That is, according to the present embodiment, even in a clinical trial conducted via the Internet, it is more certain that the input was made by the clinical trial participant 31 himself/herself, excluding impersonation of the clinical trial participant 31 by others. Information related to clinical trials can be provided to the pharmaceutical company 2 . In addition, the server 500 may attach a guarantee mark to the information provided from the server 500 to the pharmaceutical company 2 to guarantee that the information was entered by the clinical trial participant 31 himself. The endorsement mark may be attached as a watermark to information provided to the pharmaceutical company 2, for example.

In this embodiment, the investigational drug delivery application 3013 displays a two-dimensional code 3013a on the display 113 when biometric authentication by the authenticating unit 303 is successful at startup. Then, the two-dimensional code 3013a is read by the reading terminal of the delivery company that delivered the investigational drug, thereby confirming that the person who received the investigational drug is the clinical trial participant 31. Therefore, according to the present embodiment, it is suppressed that another person impersonates the clinical trial participant 31 and receives the investigational drug.

<Modification>
In the embodiments described above, face authentication is employed as biometric authentication, but biometric authentication other than face authentication may be employed. Examples of biometric authentication other than face authentication include iris authentication and fingerprint authentication.

Although the tablet terminal 100 is used in the embodiment described above, a smart phone may be used instead of the tablet terminal 100 .

In the embodiment described above, the authentication unit 303 terminates the clinical trial support function unit 301 if biometric authentication fails during execution of the clinical trial support function unit 301. You don't have to. For example, the authentication unit 303 may prohibit input to the clinical trial support function unit 301 when biometric authentication fails. The authentication unit 303 may output a warning message when prohibiting input to the clinical trial support function unit 301 .

In the embodiment described above, the authentication unit 303 refers to the additional authentication management table 305a to acquire the timing of additional authentication, and performs additional authentication. However, the timing of additional authentication need not be managed by the additional authentication management table 305a. For example, each of the applications included in the clinical trial support function unit 301 manages the timing of additional authentication of its own application,
At the timing of additional authentication, the authentication unit 303 may be called to perform biometric authentication.

The embodiments and modifications disclosed above can be combined.

<Computer-readable recording medium>
An information processing program that causes a computer or other machine or device (hereinafter referred to as a computer or the like) to implement any of the functions described above can be recorded in a computer-readable recording medium. By causing a computer or the like to read and execute the program of this recording medium, the function can be provided.

Here, a computer-readable recording medium is a recording medium that stores information such as data and programs by electrical, magnetic, optical, mechanical, or chemical action and can be read by a computer, etc. Say. Examples of such recording media that can be removed from a computer or the like include flexible discs, magneto-optical discs, Compact Disc Read Only Memory (CD-ROM), Compact Disc-Recordable (CD-R), and Compact Disc-ReWritable. (CD-RW), Digital Versatile Disc (DVD), Blu-ray Disc (BD), Digital Audio Tape (DAT), 8 mm tape, memory cards such as flash memory, and the like. In addition, there are a hard disk, a ROM, and the like as recording media fixed to a computer or the like.

1. Clinical trial provider 2. Pharmaceutical company 3. Home 4. Hospital 11. Clinical trial provider staff 31. Clinical trial participant 41. Doctor 100. Tablet terminal 101. CPU
102 Main storage unit 103 Auxiliary storage unit 104 Communication unit 110 Housing 111 Speaker 112 Microphone 113 Display 114 Touch panel 115 Camera 201 Patient diary icon 202 Online medical examination icon 203 Investigational drug delivery icon 204 Visit record icon 205 Electronic consent icon 206 Questionnaire icon 207 Help desk icon 301 Clinical trial support function unit 302 Acquisition unit 303 Authentication Part 304... Biometric information database 305... Management database 305a... Additional authentication management table 500... Server 600... Clinical trial support system 3011... Patient diary application 3012... Online medical treatment application 3013... Investigational drug delivery application 3014. Visit record application 3015 Electronic consent application 3016 Questionnaire application 3017 Help desk application 3013a Two-dimensional code 3014a Visit record screen 3014b Date display 3014c Mark display field 3014d Visit mark 501 Reception unit 502 Terminal management unit 503 Collection unit B1 Connection bus N1 Computer network

Claims (8)

A clinical trial support terminal provided by a clinical trial operator to a clinical trial participant,
A clinical trial support function department related to clinical trials,
an acquisition unit that acquires user's biometric information;
While biometric authentication using the biometric information acquired by the acquisition unit and authentication data, which is data of the biometric information of the clinical trial participant registered by the clinical trial operator, is successful, the an authentication unit that permits user input in the clinical trial support function unit;
Clinical trial support terminal. The clinical trial support function unit includes a consent function unit that obtains the consent of the clinical trial participant,
The consent function unit acquires the consent of the clinical trial participant while the biometric authentication performed by the authentication unit is successful after the text regarding the consent is displayed.
The clinical trial support terminal according to claim 1. The clinical trial support function unit includes a schedule management function unit that manages the schedule of hospital visits during the clinical trial period,
The schedule management function unit displays a sign indicating the ratio of the actual number of hospital visits to the total number of hospital visits during the clinical trial period,
The clinical trial support terminal according to claim 1 or 2. The clinical trial support function unit includes a questionnaire function unit that receives answers to questionnaires related to the clinical trial,
The questionnaire function unit
Receiving input of answers to the questionnaire while the biometric authentication by the authentication unit executed after activation of the questionnaire function unit is successful,
transmitting the accepted answer to a higher server;
The clinical trial support terminal according to any one of claims 1 to 3. The clinical trial support function unit includes a receipt support function unit used for receiving the delivered clinical trial drug,
When the biometric authentication performed by the authentication unit after activation of the receipt support function unit is successful, the receipt support function unit outputs authentication information to be read by a terminal of a delivery company that delivers the clinical trial drug.
The clinical trial support terminal according to any one of claims 1 to 4. A computer given to a clinical trial participant by a clinical trial operator
Acquisition processing for acquiring biometric information of a user;
While biometric authentication using the biometric information acquired in the acquisition process and authentication data, which is data of the biometric information of the clinical trial participant registered by the clinical trial operator, is successful, the an authentication process that permits user input in the clinical trial support function unit, which is a function unit realized by a computer;
Clinical trial support methods. Computers provided to clinical trial participants by the clinical trial operator,
Acquisition processing for acquiring biometric information of a user;
While biometric authentication using the biometric information acquired in the acquisition process and authentication data, which is data of the biometric information of the clinical trial participant registered by the clinical trial operator, is successful, the an authentication process that permits user input in the clinical trial support function unit, which is a function unit realized by a computer;
Clinical Trial Support Program. A clinical trial support system managed by a clinical trial operator,
a reception unit that receives the input of clinical trial details requested by an applicant who wishes to conduct a clinical trial;
A terminal management unit that provides information related to clinical trial participants among the clinical trial contents to the clinical trial participant terminal;
During successful biometric authentication using the user's biometric information acquired by the clinical trial terminal and the authentication data, which is the data of the clinical trial participant's biometric information registered by the clinical trial business operator a collecting unit that collects user input information received by the clinical trial terminal as clinical trial information from the clinical trial terminal;
Clinical trial support system.

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