Clinical trial support system, clinical trial support method, and clinical trial support program

Abstract

The system provides a mechanism that allows both clinical trial participants and the managing organizations to work efficiently with simple processes throughout the entire clinical trial flow, and to ensure that each clinical trial process is performed reliably for the same participant. [Solution] The clinical trial support system 1 includes: an application input reception unit 2 that receives input of applications to participate in a clinical trial; a clinical trial process start recording unit 3 that, at the start of each clinical trial process in the clinical trial, identifies the clinical trial participant using terminal acquisition data obtained from the clinical trial participant's user terminal, accepts input of identity document data, and records clinical trial process start data indicating the start of the relevant clinical trial process if the identity is authenticated based on the identity document data; and a clinical trial process end recording unit 4 that, at the end of each clinical trial process, identifies the clinical trial participant using terminal acquisition data and records clinical trial process end data indicating the end of the relevant clinical trial process.

Description

Technical Field

[0001] The present invention relates to a technique for assisting clinical trials by a computer system.

Background Art

[0002] A clinical trial is a clinical test for confirming the efficacy and safety of pharmaceuticals, quasi-drugs, medical devices, medical applications (medical software), health functional foods (nutritional functional foods, foods for specified health uses, foods with functional claims), supplements (nutritional supplements), health foods, or cosmetics, etc. (hereinafter referred to as pharmaceuticals, etc.). For example, an organization that develops or manufactures and sells pharmaceuticals, etc. may become a clinical trial requesting organization (clinical trial requester) and request a medical institution such as a hospital to conduct a clinical trial.

[0003] Japanese Patent Application Laid-Open No. 2011-233066 (Patent Document 1) discloses a subject recruitment and selection method using a computer for a mediator who introduces subjects who meet the selection conditions of a clinical trial to a clinical trial performer to recruit and select subjects via the Internet.

[0004] Japanese Patent Application Laid-Open No. 2003-203120 (Patent Document 2) discloses a clinical trial information management system including a clinical trial performing institution computer and a clinical trial information management computer. The clinical trial performing institution computer transmits clinical trial result information to the clinical trial information management computer. The clinical trial information management computer determines whether the personal information of the pre-stored clinical trial registration information matches the personal information of the clinical trial result information, and if they do not match, outputs confirmation required information indicating that there is suspicious data with a possible error in the clinical trial result information.

[0005] Japanese Patent Publication No. 2003-203122 (Patent Document 3) also discloses a clinical trial information management system comprising a clinical trial site computer and a clinical trial information management computer. The clinical trial information management computer receives and stores examination completion information from the clinical trial site computer, along with subject identification and examination identification, indicating that the examination has been completed. If examination completion information corresponding to a combination of subject identification and examination identification for which the scheduled examination time is before a predetermined period is not stored, progress warning information is sent to the clinical trial site computer. [Prior art documents] [Patent Documents]

[0006] [Patent Document 1] Japanese Patent Publication No. 2011-233066 [Patent Document 2] Japanese Patent Publication No. 2003-203120 [Patent Document 3] Japanese Patent Publication No. 2003-203122 [Overview of the Initiative] [Problems that the invention aims to solve]

[0007] The flow of a clinical trial for a participant is as follows: (1) The prospective participant learns about the recruitment for the clinical trial and applies to participate. (2) The participant undergoes a screening test to determine if they are suitable for the clinical trial. (3) The participant undergoes the main clinical trial. (4) After the main trial, the participant undergoes follow-up examinations. (5) The participant receives payment for their participation in the clinical trial.

[0008] The organizations that carry out each of these steps (1) to (5) are often different. For example, the acceptance of applications for participation in (1) is carried out by an intermediary specializing in recruiting clinical trial participants (participant recruitment organization), the main trial in (2) to (4) and the pre- and post-trial examinations are carried out by one or more medical institutions that are clinical trial implementing organizations, and the cooperation costs in (5) are borne by the pharmaceutical company that is the sponsoring organization of the clinical trial, and payment is made to the medical institution where the final examination was conducted.

[0009] In such cases, clinical trial participants need to communicate with different organizations at each stage to carry out various procedures and tasks. Furthermore, the recruiting organization, the clinical trial implementing organization, and the clinical trial sponsoring organization each manage communication with the participants and the progress and results of the trial. Therefore, each organization must separately and appropriately manage the personal information of the clinical trial participants and ensure that the same person is responsible for each stage of the trial to prevent impersonation or substitute participation.

[0010] Furthermore, a participant who has participated in one clinical trial cannot participate in another clinical trial until a certain period of time, i.e., a drug-free period, has passed. This drug-free period must be checked by both the recruiting organization and the clinical trial organization.

[0011] In light of the above circumstances, this application discloses a clinical trial support system, a clinical trial support method, and a clinical trial support program that enable both clinical trial participants and the operating organization to work efficiently with simple processing throughout the entire flow of one or more clinical trials, and that ensure that each clinical trial process is performed for the same clinical trial participant. [Means for solving the problem]

[0012] The clinical trial support system in the embodiment of the present invention is An application input receiving unit receives applications for participation in a clinical trial via the user terminal of a clinical trial participant, and records the clinical trial participant ID of the clinical trial participant in a storage unit, associating it with a clinical trial ID that identifies the clinical trial. A clinical trial process start recording unit, which, at the start of each clinical trial process in the clinical trial identified by the clinical trial ID, identifies the clinical trial participant using terminal acquisition data obtained from the clinical trial participant's user terminal, accepts input of identity data including personal information based on the identity card brought by the clinical trial participant, and if the participant is authenticated based on the identity card data, records clinical trial process start data indicating the start of the corresponding clinical trial process in the storage unit, associated with the clinical trial participant ID, The system includes a clinical trial completion recording unit that, at the end of each clinical trial process in the clinical trial identified by the clinical trial ID, identifies the clinical trial participant using terminal acquisition data obtained from the clinical trial participant's user terminal, and records clinical trial process completion data indicating the end of the corresponding clinical trial process in the storage unit, associated with the clinical trial participant ID. [Brief explanation of the drawing]

[0013] [Figure 1] This figure shows an example of the configuration of a clinical trial support system in an embodiment of the present invention. [Figure 2] Figure 1 shows an example of the user terminal configuration. [Figure 3] Figure 1 shows a sequence diagram illustrating an example of the operation of the clinical trial support system. [Figure 4] A diagram showing examples of clinical trial start and end data. [Figure 5] Figure 1 shows a flowchart illustrating an example of user terminal operation. [Modes for carrying out the invention]

[0014] (Composition 1) The clinical trial support system in the embodiment of the present invention is An application input receiving unit receives applications for participation in a clinical trial via the user terminal of a clinical trial participant, and records the clinical trial participant ID of the clinical trial participant in a storage unit, associating it with a clinical trial ID that identifies the clinical trial. A clinical trial process start recording unit, which, at the start of each clinical trial process in the clinical trial identified by the clinical trial ID, identifies the clinical trial participant using terminal acquisition data obtained from the clinical trial participant's user terminal, accepts input of identity data including personal information based on the identity card brought by the clinical trial participant, and if the participant is authenticated based on the identity card data, records clinical trial process start data indicating the start of the corresponding clinical trial process in the storage unit, associated with the clinical trial participant ID, The system includes a clinical trial completion recording unit that, at the end of each clinical trial process in the clinical trial identified by the clinical trial ID, identifies the clinical trial participant using terminal acquisition data obtained from the clinical trial participant's user terminal, and records clinical trial process completion data indicating the end of the corresponding clinical trial process in the storage unit, associated with the clinical trial participant ID.

[0015] According to the clinical trial support system of Configuration 1 described above, clinical trial participants can easily apply to participate in the clinical trial and perform the procedures for starting and ending each clinical trial stage via a user terminal. Furthermore, the organization managing the clinical trial can easily and reliably accept applications for participation and perform identity verification and recording at the start and end of each clinical trial stage via the user terminal. In particular, at the start of each stage, in addition to authentication of the user terminal, identity verification is performed using identity data based on the identification document brought by the clinical trial participant, thus guaranteeing that the same person is participating in each stage. As a result, throughout the entire flow of one or more clinical trials, both the clinical trial participants and the managing organization can work efficiently with simple processes, and the tasks for each stage of the clinical trial can be reliably performed for the same clinical trial participant.

[0016] A clinical trial process in a single clinical trial includes, for example, at least the main trial process, and, if necessary, at least one of pre-trial and post-trial examinations. The main trial is a clinical study of a trial participant using the drug or other substance that is the subject of the clinical trial. A single clinical trial often includes multiple clinical trial processes. When a single clinical trial includes multiple clinical trial processes, the clinical trial process start data is recorded by the clinical trial process start recording unit, and the clinical trial process end data is recorded by the clinical trial process end recording unit. The number of clinical trial processes in a single trial may be set appropriately according to the content of the trial. For example, a process performed during a single visit by a trial participant to the clinical trial site or a process performed in one day may be considered one clinical trial process, or a single dose or use of the drug or other substance may be considered one clinical trial process. Furthermore, a main trial may include multiple clinical trial processes. Similarly, pre-trial examinations and / or post-trial examinations may include multiple clinical trial processes.

[0017] The process of identifying a clinical trial participant using the terminal acquisition data obtained from the user terminal may be, for example, a process of authenticating the clinical trial participant who is the user of the user terminal based on the terminal acquisition data obtained from the user terminal. The terminal acquisition data can be data unique to the user terminal, that is, data unique to the user. The process of identifying the user may be, for example, a process of identifying the user using a user ID, a user ID and a password, a phone number, a one-time password, etc. The clinical trial support system can obtain terminal acquisition data from the user terminal, for example, by wired or wireless communication with the user terminal, reading a two-dimensional code displayed on the user terminal, or transmitting the result of the user terminal reading the two-dimensional code output from the clinical trial support system. The process of identifying a clinical trial participant may be executed, for example, by comparing the terminal acquisition data obtained from the user terminal with the data of the clinical trial participant pre-recorded in the storage unit.

[0018] The authentication process of the person may be, for example, a process of determining whether the authentication of the person is possible or not based on whether the personal information recorded in the storage unit matches the personal information of the input identity card data. The clinical trial start record section may accept the input of the identity card data as an input from a staff member of the clinical trial conducting institution. As a result, the information of the identity card confirmed by the staff member of the clinical trial conducting institution is input. That is, the information of the identity card confirmed by a third party is input. The personal information of the identity card data may be, for example, the information itself recorded on the identity card such as name, date of birth, address, various identity card numbers, face photo, etc. Alternatively, the personal information of the identity card data may be information indicating that the information recorded on the identity card matches the personal information of the clinical trial participant previously recorded in the storage section, and is information input by a person other than the clinical trial participant himself / herself (for example, a staff member). In the former case, when the personal information of the identity card data matches the personal information of the clinical trial participant recorded in advance, the person is authenticated. In the latter case, the person is authenticated by the input of the identity card data by a person other than himself / herself. Alternatively, the person authentication process may be executed by collating the face image of the clinical trial participant taken by a camera with the image of the face photo on the identity card.

[0019] (Configuration 2) In the above Configuration 1, the clinical trial support system may further include a drug withdrawal period determination section that acquires information for identifying a clinical trial participant and determines a drug withdrawal period during which the clinical trial participant cannot participate in the clinical trial based on at least one of the clinical trial start data and the clinical trial end data in the most recent past clinical trial participated in by the clinical trial participant indicated by the information. <,

[0020] This allows the drug-free period to be determined based on information indicating the start or end of the clinical trial phase of the clinical trial participant's most recent past trial. Therefore, checking the drug-free period can be performed with a simple process. The drug-free period determination unit may output, as a determination result, information indicating, for example, the drug-free period of the clinical trial participant. Alternatively, the drug-free period determination unit may output, as a determination result, information indicating whether the duration of the clinical trial that the clinical trial participant intends to participate in or start overlaps with the drug-free period. The duration of the clinical trial that the clinical trial participant intends to participate in or start may be, for example, the drug administration period in the clinical trial, the entire duration of the clinical trial, or the duration of the clinical trial phase including drug administration. Information indicating the duration of the clinical trial that the clinical trial participant intends to participate in or start may be included, for example, in the clinical trial information recorded in association with the clinical trial ID.

[0021] The drug-free period determination unit may, for example, determine the drug-free period of a clinical trial participant based on at least one of the clinical trial start data and clinical trial end data of a past clinical trial in which the clinical trial participant who is applying to participate or starting the clinical trial process has most recently participated, when receiving input of an application to participate in the clinical trial or when starting the clinical trial process. This allows for a simple check of the drug-free period of a clinical trial participant who is applying to participate in a clinical trial or starting the clinical trial process. For example, the drug-free period determination unit can determine whether the duration of the clinical trial in which the clinical trial participant is applying to participate or starting the clinical trial process overlaps with the drug-free period of the clinical trial participant.

[0022] If the drug-free period determination unit determines that the duration of the clinical trial in which the participant intends to participate or start overlaps with the participant's drug-free period, it may notify the participant's user terminal that they cannot participate in the clinical trial. In other words, if the drug-free period determination unit determines that the duration of the clinical trial overlaps with the participant's drug-free period, the clinical trial support system may refuse participation so that the participant cannot participate in the clinical trial.

[0023] For example, the clinical trial process start data may include information indicating the start of the clinical trial process, and the clinical trial process end data may include information indicating the end of the clinical trial process. In this case, the drug-free period determination unit may determine the drug-free period for the clinical trial participant based on at least one of the start of the clinical trial process indicated by the clinical trial process start data and the end of the clinical trial process indicated by the clinical trial process end data.

[0024] For example, the drug-free period determination unit can determine the start time (e.g., start date) of the drug-free period based on at least one of the clinical trial start data and clinical trial end data from the clinical trial participant's most recent clinical trial, and the period from the start time until a predetermined period has elapsed may be defined as the drug-free period. The method for determining the start time of the drug-free period and the length of the period may be determined, for example, according to at least one of the clinical trials in which the clinical trial participant most recently participated or intends to participate in or start.

[0025] The drug recovery period determination unit may determine the drug recovery period for the clinical trial participant by further using at least one of the clinical trial information recorded in the storage unit in association with the clinical trial ID of the most recent clinical trial, and the clinical trial information recorded in the storage unit in association with the clinical trial ID of the clinical trial in which the clinical trial participant intends to participate or start. The clinical trial information used to determine the drug recovery period may include, for example, the drug being investigated in the clinical trial, or the duration of the clinical trial (such as the drug administration schedule in the clinical trial).

[0026] The clinical trial support system may further include a drug-free period information provision unit that receives an inquiry request regarding an individual's drug-free period, along with data identifying the individual, and outputs a determination result for the drug-free period based on at least one of the clinical trial start data and clinical trial end data from the most recent past clinical trial for the clinical trial participant corresponding to the individual, which are recorded in the storage unit.

[0027] The clinical trial support system may include a clinical trial participation information receiving unit that receives input of clinical trial participation information of clinical trials in which the clinical trial participant has previously participated, and records the clinical trial participation information in the storage unit in association with the clinical trial participant ID of the clinical trial participant. The drug-free period determination unit or the drug-free period information provision unit may determine the drug-free period of the clinical trial participant based on the clinical trial participation information.

[0028] (Composition 3) In the above configuration 1 or 2, the clinical trial support system may further include a cooperation fee calculation unit that calculates the clinical trial cooperation fee for the clinical trial participant based on the clinical trial process start data and the clinical trial process end data. This makes it possible to appropriately calculate the clinical trial cooperation fee for the clinical trial participant according to their participation status at each stage of the clinical trial.

[0029] Clinical trial cooperation fees are expenses paid to clinical trial participants, and may be referred to as honorariums or burden reduction fees. Typically, these fees are borne by the clinical trial sponsoring organization, such as a pharmaceutical company. In addition to the sponsoring organization, other parties, such as providers of clinical trial support systems, may also bear these fees. In this case, the aforementioned cooperation fee calculation unit can calculate the share of each of the multiple cost-bearers.

[0030] In any of the above configurations 1 to 3, the clinical trial support system may further include a participant evaluation unit that calculates an evaluation value for the clinical trial participant based on at least one of the clinical trial process start data and the clinical trial process end data. This allows the clinical trial participant to be evaluated according to their participation status in each clinical trial process. The cooperation cost calculation unit may calculate the clinical trial cooperation cost based on the evaluation value from the participant evaluation unit.

[0031] The clinical trial support system may notify the clinical trial participant of information about the clinical trial at the user terminal of the clinical trial participant, based on at least one of the clinical trial process start data and the clinical trial process end data. This allows the clinical trial participant to be notified of information about the clinical trial at an appropriate time according to the progress of the clinical trial process.

[0032] A clinical trial support method in an embodiment of the present invention comprises the following steps performed by a computer: An application input acceptance step, which involves receiving an application to participate in a clinical trial via the user terminal of a clinical trial participant, and recording the clinical trial participant ID of the said clinical trial participant in a storage unit, associating it with the clinical trial ID that identifies the said clinical trial; A clinical trial process start recording step is performed, in which, at the start of each clinical trial process in the clinical trial identified by the clinical trial ID, the clinical trial participant is identified using terminal acquisition data obtained from the user terminal of the clinical trial participant, and the input of identity data including personal information based on the identity card brought by the clinical trial participant is accepted, and if the person is authenticated based on the identity card data, clinical trial process start data indicating the start of the corresponding clinical trial process is recorded in the storage unit in association with the clinical trial participant ID, A clinical trial completion recording step is performed, at the end of each clinical trial process in the clinical trial identified by the clinical trial ID, using terminal acquisition data obtained from the user terminal of the clinical trial participant, to identify the clinical trial participant, and to record clinical trial process completion data indicating the completion of the corresponding clinical trial process in the storage unit in association with the clinical trial participant ID. It has.

[0033] The clinical trial support program in embodiments of the present invention is The application input acceptance process involves receiving the application to participate in the clinical trial via the user terminal of the clinical trial participant, and recording the clinical trial participant ID of the clinical trial participant in a storage unit, associating it with the clinical trial ID that identifies the clinical trial. At the start of each clinical trial process in the clinical trial identified by the clinical trial ID, the clinical trial participant is identified using terminal acquisition data obtained from the user terminal of the clinical trial participant, and the input of identity data including personal information based on the identity card brought by the clinical trial participant is accepted. If the participant is authenticated based on the identity card data, clinical trial process start data indicating the start of the corresponding clinical trial process is recorded in the storage unit in association with the clinical trial participant ID, and the clinical trial process start recording process is performed. At the end of each clinical trial process in the clinical trial identified by the clinical trial ID, the clinical trial participant is identified using terminal acquisition data obtained from the user terminal of the clinical trial participant, and clinical trial process completion data indicating the end of the corresponding clinical trial process is recorded in the storage unit in association with the clinical trial participant ID; Have the computer execute it.

[0034] A user terminal capable of data communication with the clinical trial support system configured 1 to 3 above is also included in the embodiments of the present invention. A clinical trial application unit supplies application data, including the clinical trials that the clinical trial participant wishes to participate in and the clinical trial participant, to the clinical trial support system based on input from the clinical trial participant. A clinical trial process initiation unit, which, when it detects the start of a clinical trial process based on input from a clinical trial participant or information obtained from the clinical trial support system, supplies terminal acquisition data to identify the clinical trial participant to the clinical trial support system, The system includes a clinical trial completion unit that, when it detects the end of a clinical trial process of the clinical trial based on input from the clinical trial participant or information obtained from the clinical trial support system, supplies terminal acquisition data for identifying the clinical trial participant to the clinical trial support system.

[0035] A program that causes a user terminal capable of data communication with a clinical trial support system to execute processing is also included in the embodiments of the present invention. The program is A clinical trial participation application process that, based on input from clinical trial participants, supplies the clinical trial the participant wishes to participate in and the participant's application data to the clinical trial support system, and A clinical trial process initiation process, which, when the start of a clinical trial process is detected based on input from a clinical trial participant or information obtained from the clinical trial support system, supplies terminal acquisition data for identifying the clinical trial participant to the clinical trial support system, When the completion of the clinical trial process of the clinical trial is detected based on input from the clinical trial participant or information obtained from the clinical trial support system, the user terminal is instructed to perform a clinical trial process completion process, which involves supplying terminal acquisition data for identifying the clinical trial participant to the clinical trial support system.

[0036] (Example system configuration) Figure 1 shows an example configuration of a clinical trial support system according to an embodiment of the present invention. The clinical trial support system 1 records data for clinical trial support in the storage unit 9 by communicating data with the user terminal 10 of the clinical trial participant or the implementing agency terminal 11 at each stage of the flow of one or more clinical trials. This allows for the efficient accumulation of data necessary for clinical trial support. The clinical trial support system 1 provides clinical trial support services to both the clinical trial participant and the organization managing the clinical trial. The clinical trial support system 1 includes an application reception unit 2, a clinical trial process start recording unit 3, a clinical trial process end recording unit 4, a drug-free period determination unit 5, a cooperation cost calculation unit 6, a participant evaluation unit 7, a drug-free period information provision unit 81, and a clinical trial participation information reception unit 82. The clinical trial support system 1 can access the data in the storage unit 9. Furthermore, the clinical trial support system 1 can communicate with the user terminal 10, the implementing agency terminal 11, and the settlement system 13, for example, via a network.

[0037] The application reception unit 2 receives input from the clinical trial participant via the user terminal 10. The data entered in the application includes, for example, information identifying the clinical trial in which the participant wishes to participate and information identifying the clinical trial participant. At the time of application, the applicant is the person who wishes to participate in the clinical trial, but in this application, the term "clinical trial participant" is used to refer to both the applicant and the clinical trial participant. Based on the input, the application reception unit 2 records the clinical trial participant ID of the clinical trial participant in the storage unit, associating it with the clinical trial ID of the clinical trial in which the participant wishes to participate. The clinical trial participant ID is information for uniquely identifying the clinical trial participant, and its format is not particularly limited.

[0038] For example, a clinical trial participant may have an account to use the clinical trial support system 1's services for clinical trial participants. In this case, the clinical trial participant's account information (e.g., user ID and password) is recorded in the storage unit 9. Alternatively, user authentication using the clinical trial participant's account may be performed using an external authentication system (authentication server). For example, the clinical trial participant ID may be the user ID of the account.

[0039] The clinical trial participant ID may be associated with terminal identification data that identifies the user terminal 10 of the clinical trial participant. For example, the clinical trial participant's account information may include the clinical trial participant's terminal identification data. The terminal identification data may be, for example, the telephone number of the user terminal 10 or hardware identification information. For example, when the clinical trial support system 1 identifies the clinical trial participant using terminal acquisition data obtained from the user terminal, it can perform terminal authentication of the clinical trial participant's user terminal 10 using terminal identification data, in addition to user authentication using the clinical trial participant's account information. In this case, it can be guaranteed that the same clinical trial participant uses the clinical trial support system 1 with the same user terminal and a unique account. Note that the terminal authentication function may be omitted. In this case, the clinical trial participant can use the clinical trial support system 1 using multiple different user terminals.

[0040] The application acceptance unit 2 may display information on clinical trials that are available for application on the user terminal 10. The application acceptance unit 2 may also accept the selection of a clinical trial that the clinical trial participant wishes to participate in from among the clinical trials displayed on the user terminal 10. The application acceptance unit 2 can extract clinical trial information for clinical trial IDs that satisfy the conditions from among the clinical trial IDs pre-recorded in the storage unit 9, and display it on the user terminal 10 as information on clinical trials that are available for application. In addition, the application acceptance unit 2 may accept input of clinical trial search conditions via the user terminal 10, extract information on clinical trials that satisfy the search conditions from the storage unit 9, and display it on the user terminal 10.

[0041] The memory unit 9 stores a clinical trial ID that identifies a clinical trial, and clinical trial information associated with the clinical trial ID. The clinical trial information recorded associated with the clinical trial ID may include, for example, information on the clinical trial content (pharmaceuticals, etc.), the duration of the trial, the schedule of each clinical trial stage, the implementing organization, the location of the trial, the recruitment period, the drug-free period, the number of participants to be recruited, and the compensation for cooperation. Clinical trial participants can input at least one of the following as search criteria for a clinical trial via the user terminal 10: for example, the duration of the trial, the location of the trial, the drug-free period, and the compensation for cooperation. The application acceptance unit 2 can extract clinical trial information for clinical trials that meet the entered search criteria from the memory unit 9 and display it on the user terminal 10.

[0042] The application reception unit 2 may accept input from clinical trial participants of their responses to an initial questionnaire regarding the clinical trial they wish to participate in. The responses to the initial questionnaire are recorded in the memory unit, for example, associated with the clinical trial ID and the clinical trial participant ID. The clinical trial support system 1 supplies the results of the initial questionnaire responses to the implementing agency or clinical trial sponsoring agency, and also accepts input of participation approval from the implementing agency or clinical trial sponsoring agency. When participation approval is entered, participation in the clinical trial desired by the clinical trial participant is decided, and this fact is recorded in the memory unit 9.

[0043] The clinical trial process start recording unit 3 performs participant identification processing and participant authentication processing at the start of each clinical trial process. If authentication is successful, it records clinical trial process start data indicating the start of the clinical trial process in the storage unit 9, associated with the participant ID. The participant identification processing is performed using terminal acquisition data obtained from the user terminal 10 at the start of the clinical trial process. The terminal acquisition data may include, for example, data to identify the participant and authentication data such as a one-time password.

[0044] As an example of how the clinical trial support system 1 acquires terminal data, the user terminal 10 can read a two-dimensional code issued by the clinical trial support system 1, and the application on the user terminal 10 can decode the two-dimensional code and transmit terminal data containing the resulting information to the clinical trial support system 1. The two-dimensional code may contain, for example, a one-time password or information indicating the start of a clinical trial process. Alternatively, the reader 12 on the implementing agency terminal 11 can read the two-dimensional code displayed on the user terminal 10, and the application on the implementing agency terminal 11 can decode the two-dimensional code and transmit terminal data containing the resulting information to the clinical trial support system 1. Or, the clinical trial support system 1 can transmit authentication data such as a one-time password to the user terminal 10, and terminal data containing the authentication data may be transmitted to the clinical trial support system 1 via the user terminal 10.

[0045] Identity document data may be entered into the clinical trial support system 1 by, for example, the reader 12 reading the identity document brought by the clinical trial participant. In this case, in addition to the data read by the reader 12, the identity document data may also include a facial image of the clinical trial participant taken by a camera or a password entered by the clinical trial participant. If the personal information shown in the entered identity document data matches the personal information recorded in the storage unit 9, it is determined that the person has been authenticated. For example, authentication is determined by whether the personal information in the entered identity document data matches the personal information (name, date of birth, address, identity document number, etc.) that has been recorded in advance and associated with the clinical trial participant ID. Alternatively, the facial photograph on the identity document and the facial image of the clinical trial participant taken by a camera may be compared, and if they are determined to be the same person, it is determined that the person has been authenticated. At least a part of the identity authentication process may be performed using an external authentication system (authentication server).

[0046] As another example, data showing the results of verifying the identification document brought by the clinical trial participant by the clinical trial site staff may be entered as identification document data. For example, the clinical trial support system 1 may display the personal information of the clinical trial participant identified by the terminal acquisition data on the site terminal 11 and accept input of confirmation by the staff that it matches the personal information on the identification document. In this case, when the confirmation result showing that the staff verified the identity of the participant using the identification document is entered as identification document data, the participant is authenticated.

[0047] The clinical trial process start recording unit 3 records clinical trial process start data indicating the start of a clinical trial process, subject to the identification of the clinical trial participant using terminal-acquired data and authentication of the identified clinical trial participant using their identification document data. This ensures that the clinical trial participant who applied to participate in the clinical trial actually starts each clinical trial process. For example, it can prevent participation in the clinical trial by impersonation or substitutes. Furthermore, the start of each clinical trial process for each clinical trial participant can be reliably recorded. Therefore, clinical trial process management becomes easier.

[0048] Clinical trial process commencement data is data indicating that a clinical trial participant has commenced a clinical trial process. Clinical trial process commencement data is recorded in association with the clinical trial participant ID. Clinical trial process commencement data may include, for example, information indicating the clinical trial process and information indicating the commencement time of the clinical trial process.

[0049] In this way, the clinical trial process start recording unit 3 associates clinical trial process start data indicating the start of each clinical trial process with the clinical trial participant ID. That is, the clinical trial support system 1 recognizes that a clinical trial participant identified by the terminal acquisition data has started a specific clinical trial process. For example, the terminal acquisition data may include information indicating a clinical trial process, and the correspondence between the clinical trial participant and the clinical trial process may be recognized by the clinical trial support system 1 based on this information. Alternatively, the correspondence between the clinical trial participant identified by the terminal acquisition data and the clinical trial process may be recognized from the acquisition time or location where the terminal acquisition data was acquired. As a specific example, if terminal acquisition data is acquired within a certain period including the scheduled start time of the clinical trial process, the correspondence between the clinical trial participant identified by the terminal acquisition data and the start of that clinical trial process can be recognized. Alternatively, if terminal acquisition data is acquired via a reader 12 or an implementing agency terminal 11 located at a position corresponding to the start of a clinical trial process, the correspondence between the clinical trial participant identified by the terminal acquisition data and the start of that clinical trial process can be recognized. In this way, the clinical trial process start recording unit 3... Based on the information contained in the terminal acquisition data, or the time or location of acquisition, it is possible to recognize and associate the start of the clinical trial process with the clinical trial participant identified in the terminal acquisition data.

[0050] The clinical trial process completion recording unit 4 identifies the clinical trial participant using terminal acquisition data obtained from the clinical trial participant's user terminal 10 at the end of each clinical trial process, and records clinical trial process completion data indicating the end of the corresponding clinical trial process in the storage unit 9, associated with the clinical trial participant ID. Identifying the clinical trial participant using terminal acquisition data can be performed in the same manner as the clinical trial process start recording unit 3 described above. For example, terminal acquisition data can be obtained from the user terminal 10 by reading a two-dimensional code or by sending a one-time password to the user terminal 10.

[0051] Clinical trial completion data indicates that a clinical trial participant has completed a clinical trial. Clinical trial completion data is recorded in association with the participant ID. Clinical trial completion data may include, for example, information indicating the clinical trial process and information indicating the completion of the clinical trial process.

[0052] The clinical trial process completion recording unit 4 records clinical trial process start data indicating the completion of the clinical trial process, conditional on identifying the clinical trial participant using terminal-acquired data. This ensures that the completion of the clinical trial process for clinical trial participants who were authenticated at the start of the clinical trial process is reliably recorded. This facilitates clinical trial process management.

[0053] In this way, the clinical trial process completion record unit 4 associates the clinical trial process completion data indicating the completion of each clinical trial process with the clinical trial participant ID. That is, the clinical trial support system 1 recognizes that the clinical trial participant identified by the acquired terminal data has completed a specific clinical trial process. For example, if terminal data is acquired within a certain period including the scheduled end time of the clinical trial process, the correspondence between the clinical trial participant identified by the terminal data and the completion of that clinical trial process can be recognized. Alternatively, if terminal data is acquired via the reader 12 or the implementing agency terminal 11 located at the position corresponding to the completion of the clinical trial process, the correspondence between the clinical trial participant identified by the terminal data and the completion of that clinical trial process can be recognized. In this way, the clinical trial process completion record unit 4 can recognize and associate the completion of a clinical trial process with the clinical trial participant identified by the terminal data based on the information contained in the terminal data, or the time or location of its acquisition.

[0054] The drug-free period determination unit 5 acquires information that identifies the clinical trial participant and determines the drug-free period for the clinical trial participant identified by this information. This determination process is performed based on at least one of the clinical trial start data and clinical trial end data from the most recent past clinical trial in which the clinical trial participant participated. That is, the drug-free period for the clinical trial participant can be determined based on at least one of the clinical trial start data or clinical trial end data recorded in association with the clinical trial participant ID of the clinical trial participant identified by the acquired information. The information output as a result of the determination may be information indicating the drug-free period of the clinical trial participant, or it may be information indicating whether the period of the clinical trial that the clinical trial participant intends to participate in or start overlaps with the drug-free period.

[0055] For example, the drug-free period determination unit 5 determines the start time (e.g., start date) of the drug-free period for the clinical trial participant based on at least one of the start and end times of at least one clinical trial process included in the clinical trial in which the clinical trial participant most recently participated. A predetermined period starting from the start time is determined to be the drug-free period.

[0056] The method for determining the start time of drug withdrawal by the drug withdrawal period determination unit 5, and the length of the drug withdrawal period, may be fixed. Alternatively, the method for determining the start time of drug withdrawal or the length of the withdrawal period may be determined based on the clinical trial information of at least one clinical trial in which the clinical trial participant has most recently participated, or which clinical trial participant is about to participate in or start. The clinical trial information may include, for example, the details of the trial in which the clinical trial participant most recently participated (e.g., the type of drug, the drug administration schedule during the trial), or the details of the trial in which the clinical trial participant is about to participate in or start, and the above-mentioned method for calculating the start time of drug withdrawal or the length of the withdrawal period may be determined based on this information.

[0057] For example, the clinical trial information recorded in the memory unit 9 in association with the clinical trial ID may include information regarding the drug-free period. This information may include, for example, information indicating how the start date of the drug-free period is determined, or the length of the drug-free period. As an example, some clinical trials may specify a special drug-free period from the most recent clinical trial in which the participant has participated. In such cases, the length of the drug-free period specially designated for that clinical trial is recorded as clinical trial information in the memory unit 9. The drug-free period determination unit 5 can determine the drug-free period of a clinical trial participant by further using the drug-free period information in the clinical trial information associated with the clinical trial ID of the clinical trial in which the participant has most recently participated or intends to participate.

[0058] The drug-free period determination unit 5 can determine the drug-free period of a clinical trial participant whose application has been received by the application acceptance unit 2. In this case, the drug-free period determination unit 5 obtains information identifying the clinical trial participant who has applied to participate, and determines the drug-free period of that participant based on at least one of the clinical trial start data and clinical trial end data of the most recent clinical trial, which are recorded in association with the clinical trial participant ID of that participant. If it is determined that the period of the clinical trial that the participant wishes to participate in overlaps with the drug-free period, the application acceptance unit 2 or the drug-free period determination unit 5 can output a notification to the user terminal 10 indicating that the application has been rejected. This prevents a clinical trial participant who is in a drug-free period from applying to participate in a new clinical trial. In other words, it prevents double entry during the drug-free period.

[0059] The drug-free period determination unit 5 can determine the drug-free period of a clinical trial participant who is about to start a clinical trial. In this case, the drug-free period determination unit 5 obtains information on the clinical trial participant identified by the clinical trial start recording unit 3 based on terminal acquisition data, and determines the drug-free period of that clinical trial participant based on at least one of the clinical trial start data and clinical trial end data of the most recent clinical trial recorded in association with the clinical trial participant ID. If it is determined that the period of the clinical trial that the clinical trial participant is about to start overlaps with the drug-free period, the clinical trial start recording unit 3 or the drug-free period determination unit 5 can output a notification to the user terminal 10 that the application to participate is rejected. This prevents a clinical trial participant who is in a drug-free period from newly joining a clinical trial.

[0060] The drug-free period information provision unit 81 receives an inquiry request regarding an individual's drug-free period and outputs information regarding the individual's drug-free period. The inquiry request includes data that identifies the individual being inquired about. The data that identifies the individual may include, for example, personal information corresponding to personal information recorded in the storage unit 9. This allows the individual's clinical trial participant ID to be identified by the data that identifies the individual. The drug-free period information provision unit 81 determines the individual's drug-free period based on at least one of the clinical trial start data and clinical trial end data from the most recent past clinical trial, which are recorded in association with the clinical trial participant ID of the individual being inquired about, and outputs the determination result. The determination result may include, for example, information indicating the individual's drug-free period, and at least one of information indicating whether the period of the clinical trial in which the individual intends to participate or start overlaps with the drug-free period.

[0061] The drug-free period information provision unit 81 can, for example, receive drug-free period inquiry requests from systems outside the clinical trial support system 1. For example, it can accept input of personal information as a drug-free period inquiry request from an external system. For example, a computer at a facility that does not support the clinical trial support system 1 may be configured to allow input of at least a portion of the personal information that the clinical trial participant has presented at the counter to the drug-free period information provision unit 81 as a drug-free period inquiry request.

[0062] The clinical trial participation information reception unit 82 receives input of clinical trial participation information of clinical trials that clinical trial participants have previously participated in, and records the clinical trial participation information in the storage unit 9, associating it with the clinical trial participant ID of the clinical trial participant. The drug-free period determination unit 5, or the drug-free period information provision unit 81, can determine the drug-free period of the clinical trial participant based on the clinical trial participation information stored in the storage unit 9. This makes it possible to acquire and record information indicating participation in clinical trials conducted outside of the clinical trial support system 1. Therefore, information regarding drug-free periods can be recorded, and drug-free period checks can be made more accurate.

[0063] Clinical trial participation information includes information indicating the clinical trial in which the participant participated and the time period in which the participant participated. For example, clinical trial participation information may include information indicating at least one start and end time for each stage of the clinical trial. In this case, clinical trial participation information can be recorded as clinical trial stage start data and / or clinical trial stage end data. The clinical trial participation information receiving unit 82 may also accept input of information for identifying the clinical trial participant (e.g., clinical trial participant ID or personal information) along with the clinical trial participation information.

[0064] The cooperation cost calculation unit 6 calculates the clinical trial cooperation cost for the clinical trial participant based on the clinical trial process start data and clinical trial process end data. If a clinical trial participant participates in all clinical trial processes in a single clinical trial, the clinical trial process start data and clinical trial process end data for each clinical trial process are recorded. If a clinical trial participant participates in only some of the clinical trial processes in a single clinical trial and then withdraws, and does not participate in the remaining clinical trial processes, the clinical trial process start data and clinical trial process end data for the partial clinical trial processes are recorded, while the clinical trial process start data and clinical trial process end data for the remaining clinical trial processes are not recorded. Therefore, after all clinical trial processes have been completed, the cooperation cost calculation unit 6 can determine which clinical trial processes the participant participated in, i.e., their participation record for each clinical trial process, based on the clinical trial process start data and clinical trial process end data associated with the clinical trial participant ID. For example, the clinical trial cooperation cost may be calculated based on the participant's participation record for each clinical trial process. For example, the cost of participating in a clinical trial may be calculated such that the cost of participating in the entire clinical trial is lower than the cost of participating in only some of the clinical trial stages.

[0065] The memory unit 9 may pre-record, for example, actual cost correspondence data showing the relationship between clinical trial participation results, determined based on clinical trial start data and clinical trial end data, and clinical trial cooperation costs. The cooperation cost calculation unit 6 can use the actual cost correspondence data to calculate clinical trial cooperation costs based on clinical trial start data and clinical trial end data. The actual cost correspondence data may be recorded for each clinical trial, i.e., for each clinical trial ID. This makes it possible to set clinical trial cooperation costs for each clinical trial according to participation results.

[0066] The cooperation cost calculation unit 6 may calculate the clinical trial cooperation cost using data other than the clinical trial process start data and clinical trial process end data. For example, the clinical trial cooperation cost may be calculated using data of the evaluation results of clinical trial participants by the participant evaluation unit 7, which will be described later. Alternatively, additions or subtractions may be made to the clinical trial cooperation cost based on the clinical trial process start data and clinical trial process end data due to special factors. Special factors may include, for example, additional costs set to provide incentives to clinical trial participants. For example, participation in the clinical trial can be encouraged by providing incentives through additional cooperation costs to clinical trial participants whose evaluation results meet certain conditions, or to urgent recruitment with a short period until the application deadline. Data indicating special factors may be recorded for each clinical trial.

[0067] The cooperation cost calculation unit 6 may calculate the clinical trial cooperation cost for each of the multiple organizations that bear the cooperation cost. For example, the clinical trial cooperation cost to be borne by at least two of the organizations among the clinical trial sponsoring organization, clinical trial implementing organization, participant recruitment organization, and clinical trial support system provider may be calculated. The clinical trial cooperation cost for one of the multiple organizations may be calculated based on clinical trial process start data and clinical trial process end data, while the clinical trial cooperation costs for the other organizations may be calculated based on pre-recorded cost data. This allows, for example, the clinical trial cooperation cost borne by one organization (e.g., the clinical trial sponsoring organization) to be calculated according to participation record, and the clinical trial cooperation cost borne by other organizations (e.g., participant recruitment organization or clinical trial support system provider) to be calculated based on incentives provided by those other organizations for clinical trial participants to participate in or use the system.

[0068] The clinical trial support system 1 may, for example, perform payment processing for clinical trial participation fees. For example, the clinical trial support system 1 may output the clinical trial participation fee calculated by the participation fee calculation unit 6 to the user terminal 10, and when the clinical trial participant approves the clinical trial participation fee input to the user terminal 10, it may perform payment processing for the clinical trial participation fee. For example, payment processing using an electronic payment service via the user terminal 10, or instructions for transfer processing to the clinical trial participant's account may be executed.

[0069] The participant evaluation unit 7 calculates an evaluation value for the clinical trial participant based on at least one of the clinical trial process start data and the clinical trial process end data. The evaluation value is recorded in the storage unit 9 in association with the clinical trial participant ID. The evaluation value of the clinical trial participant calculated by the participant evaluation unit 7 may also be output to the clinical trial participant's user terminal 10. For example, the evaluation value of the clinical trial participant can be calculated based on at least one of the start and end times of at least one clinical trial process in the clinical trial. As an example, an evaluation value indicating whether or not the clinical trial participant was late, or the degree of lateness, can be calculated based on the start time of the clinical trial process and the degree of delay from the scheduled time. Alternatively, the process time spent on the clinical trial process may be calculated based on the start and end times of the clinical trial process, and an evaluation value indicating the degree of speed or delay of the clinical trial participant may be calculated according to the process time. Furthermore, in addition to at least one of the clinical trial process start data and clinical trial process end data, the participant evaluation unit 7 may also calculate the evaluation value based on evaluation data entered by, for example, the clinical trial organization. This allows, for example, subjective evaluations by the clinical trial organization to be reflected in the evaluation value.

[0070] The cooperation cost calculation unit 6 may calculate the clinical trial cooperation cost based on the evaluation value calculated by the participant evaluation unit 7. For example, the cooperation cost calculation unit 6 may adjust the clinical trial cooperation cost calculated based on the clinical trial start data and clinical trial end data using the evaluation value.

[0071] The clinical trial support system 1 can notify the clinical trial participant of information about the clinical trial to the clinical trial participant's user terminal based on at least one of the clinical trial participant's clinical trial process start data and clinical trial process end data. The information about the clinical trial to be notified may include, for example, guidance, instructions, or information about the clinical trial results. For example, at the start and before the end of a clinical trial process, information about the ongoing clinical trial process may be notified to the user terminal 10. Alternatively, if the clinical trial process start data or clinical trial process end data for a clinical trial process has not been recorded after a predetermined time has elapsed from the start or end time of that clinical trial process, a reminder may be notified to the user terminal 10. Alternatively, guidance for that clinical trial process may be notified to the user terminal 10 upon the start of the clinical trial process, i.e., upon the recording of the clinical trial process start data. Alternatively, guidance for the next clinical trial process may be notified to the user terminal 10 upon the end of the clinical trial process, i.e., upon the recording of the clinical trial process end data. Alternatively, after the completion of all clinical trial procedures, the clinical trial cooperation fee calculated by the cooperation fee calculation unit 6, or the evaluation value calculated by the participant evaluation unit 7, may be notified to the user terminal 10.

[0072] The clinical trial support system 1 can be constructed using one or more computers. The functions of the application acceptance unit 2, the clinical trial process start recording unit 3, the clinical trial process end recording unit 4, the drug withdrawal period determination unit 5, the cooperation cost calculation unit 6, the participant evaluation unit 7, the drug withdrawal period information provision unit 81, and the clinical trial participation information acceptance unit 82 can be realized by the computer processor executing a predetermined program. Such a program, or a non-transitory recording medium on which the program is recorded, are also included in embodiments of the present invention. The storage unit 9 is composed of a recording device accessible by the computers constituting the clinical trial support system.

[0073] The user terminal 10 comprises one or more computers. The user terminal 10 has an application installed for data communication with the clinical trial support system 1. The application on the user terminal 10 may be a general-purpose application such as a browser, or it may be a dedicated application for communication with the clinical trial support system 1. The program for the dedicated application on the user terminal 10, that is, a program that causes the computer of the user terminal 10 to execute processing, is also included in embodiments of the present invention.

[0074] Figure 2 is a functional block diagram showing an example configuration of the user terminal 10. The user terminal 10 has a clinical trial application unit 21, a clinical trial process start unit 22, and a clinical trial process end unit 23. These functional units are realized, for example, by the computer of the user terminal 10 executing processes according to the program of the installed application. As an example, the system is configured so that clinical trial participants can use each function of the application by logging in by entering their account information, such as a user ID and password.

[0075] The clinical trial application unit 21 supplies application data to the clinical trial support system 1 based on input from the clinical trial participant. For example, if a clinical trial participant inputs the clinical trial they wish to participate in, the clinical trial application unit 21 sends application data to the clinical trial support system 1, including information indicating the clinical trial they wish to participate in and the clinical trial participant. The clinical trial application unit 21 may also supply the clinical trial support system 1 with, for example, the responses to the initial questionnaire of the clinical trial the clinical trial participant wishes to participate in, as application data. In this case, the user terminal 10 may receive and display the result of whether or not the participant is eligible to participate in the clinical trial (approved or disapproved) based on the responses to the initial questionnaire from the clinical trial support system 1.

[0076] The clinical trial process initiation unit 22, based on input from the clinical trial participant or information obtained from the clinical trial support system, supplies terminal acquisition data to the clinical trial support system 1 to identify the clinical trial participant when it detects the start of the clinical trial process. For example, the start of the clinical trial process is detected when a clinical trial participant performs an input operation on the user terminal 10 instructing it to start the clinical trial process. Alternatively, the start of the clinical trial process may be detected when the user terminal 10 obtains information regarding the start of the clinical trial process by reading a two-dimensional code issued by the clinical trial support system 1 or by receiving data from the clinical trial support system 1 via the network.

[0077] The clinical trial completion unit 23, based on input from the clinical trial participant or information obtained from the clinical trial support system, supplies terminal acquisition data to the clinical trial support system 1 to identify the clinical trial participant when it detects the completion of the clinical trial process. For example, the completion of the clinical trial process is detected when the clinical trial participant performs an input operation on the user terminal 10 instructing it to complete the clinical trial process. Alternatively, the completion of the clinical trial process may be detected when the user terminal 10 reads a two-dimensional code issued by the clinical trial support system 1 or receives data from the clinical trial support system 1 via the network to acquire information regarding the completion of the clinical trial process.

[0078] The terminal data supplied to the clinical trial support system 1 at the start or end of the clinical trial process may include, for example, information that identifies the clinical trial participant. For example, the terminal data may include the clinical trial participant's account information, personal information, or information that identifies the user terminal. Alternatively, authentication data such as a one-time password obtained from the clinical trial support system 1 at the start of the clinical trial process may be included in the terminal data. Furthermore, the terminal data may include information indicating the start of the clinical trial process or information indicating the end of the clinical trial process.

[0079] (Example of how the clinical trial support system works) Figure 3 is a sequence diagram showing an example of the operation of the clinical trial support system 1 shown in Figure 1. In the example in Figure 3, the operation of the clinical trial support system 1 includes the phases of participation application, clinical trial process, and payment of cooperation fees, and the clinical trial process includes the screening test process, the main trial process, and the post-main trial testing process.

[0080] [Registration] In the application phase, the application reception unit 2 of the clinical trial support system 1 receives input for clinical trial participation application from the user terminal 10 (S1). The application reception unit 2 obtains information from the user terminal 10 indicating the clinical trial the participant wishes to participate in and the clinical trial participant. The clinical trial ID of the clinical trial the participant wishes to participate in is recorded in association with the clinical trial participant ID (S2). In addition, during the application process, the responses to the initial questionnaire entered from the user terminal 10 may be made viewable by the clinical trial implementing agency or clinical trial sponsoring agency, and a process for accepting input of approval / disapproval of participation may be executed. In this case, the result of approval / disapproval of participation is notified to the user terminal 10. If approved, the clinical trial ID of the clinical trial in which the participant has been approved to participate is recorded in association with the clinical trial participant ID as a clinical trial in which the participant can participate.

[0081] Before or after the application for participation is submitted, the clinical trial support system 1 receives the personal information of the clinical trial participant from the user terminal 10 (S3), and records it in the storage unit 9 in association with the clinical trial participant ID (S4). The personal information includes, for example, at least one of the following: name, date of birth, address, various identification card numbers, etc. The personal information may also include terminal identification information such as a telephone number that identifies the user terminal 10. The personal information may also be entered by reading the clinical trial participant's identification card with the user terminal 10. Alternatively, the personal information may be entered into the clinical trial support system 1 by reading the identification card brought by the clinical trial participant with the reader device 12 of the implementing agency terminal 11.

[0082] [Screening Test Process] In the screening test process, clinical trial participants visit the implementing institution to undergo testing. At the starting point of the clinical trial process (screening test process) at the implementing institution, the clinical trial participant performs a check-in operation using the user terminal 10. As part of the check-in operation, the clinical trial participant has the user terminal 10 read a two-dimensional code (e.g., a QR code®) issued by the clinical trial support system 1. The two-dimensional code is displayed, for example, on the implementing institution terminal 11 at the starting location of the clinical trial process. The two-dimensional code may include information indicating the start of the clinical trial process (screening test process) and authentication information such as a one-time password. The user terminal 10 transmits terminal acquisition data, including the authentication information obtained by decoding the two-dimensional code and information identifying the clinical trial participant, to the clinical trial support system 1 via the network (S5). The clinical trial process start recording unit 3 of the clinical trial support system 1 identifies the clinical trial participant by performing an authentication process using the terminal acquisition data (S6).

[0083] Once a clinical trial participant is identified, the clinical trial support system 1 displays the personal information recorded in association with the clinical trial participant ID of the identified participant on the implementing agency terminal 11 located at the start of the clinical trial process (screening test process) (S7). The staff of the implementing agency at the start of the clinical trial process (screening test process) confirms whether the personal information written on the identification card brought by the clinical trial participant matches the personal information displayed on the implementing agency terminal 11. The staff also confirms whether the face on the identification card matches the face of the clinical trial participant. The staff inputs into the implementing agency terminal 11 that the personal information matches and the face matches the face photo. This input constitutes the input of identification card data (S8), and the clinical trial process start recording unit 3 performs identity verification based on the identification card data (S9). Once the identification of the clinical trial participant in S6 and the identity verification in S9 are performed, the clinical trial process start data is recorded in association with the clinical trial participant ID (S10). This process ensures that personal information verified by a third party other than the clinical trial participant (in this example, a staff member) is recorded in the memory unit 9, guaranteeing that the clinical trial participant undergoing the clinical trial process is indeed the person matching the personal information. Furthermore, if the personal information on the identification document differs from the displayed personal information (for example, if the recorded personal information is incomplete, incorrect, or outdated), the staff member can update the personal information in the memory unit 9 via the implementing agency terminal 11.

[0084] At the end of the screening test process, the clinical trial participant performs a checkout operation using the user terminal 10. As part of the checkout operation, the participant, for example, has the user terminal 10 read a two-dimensional code issued by the clinical trial support system 1. The two-dimensional code is displayed, for example, on the implementing agency terminal 11 at the location where the clinical trial process ends. The two-dimensional code may include information indicating the completion of the clinical trial process (screening test process) and authentication information such as a one-time password. The user terminal 10 transmits the authentication information obtained by decoding the two-dimensional code and terminal acquisition data, including information identifying the clinical trial participant, to the clinical trial support system 1 via the network (S11). The clinical trial process completion recording unit 4 of the clinical trial support system 1 identifies the clinical trial participant by performing an authentication process using the terminal acquisition data (S12). The clinical trial process completion data is recorded in the storage unit 9, associated with the clinical trial participant ID of the identified clinical trial participant (S13).

[0085] The processing in S5 to S13 records data indicating the start and end of the clinical trial process (screening test process) in the storage unit 9. This allows the clinical trial support system 1 to manage information such as the start and end of the clinical trial process, or whether it was terminated prematurely. Although not shown in Figure 3, the clinical trial support system 1 may also accept input of the results of the clinical trial process (e.g., pass / fail of the screening test) via the implementing agency terminal 11. After the completion of the clinical trial process, the clinical trial support system 1 may notify the user terminal 10 of the results of that clinical trial process (screening test results). For example, if the screening test result is a failure, subsequent clinical trial processes (main trial process and post-main trial testing process) will not be performed for that clinical trial participant. This fact will be notified to the user terminal 10. In addition, the fact that the participant will not participate in subsequent clinical trial processes may be recorded in association with the clinical trial participant ID.

[0086] [Main Test Process] In this trial phase, clinical trial participants visit the implementing facility and undergo examinations. At the start of this trial phase, the acquisition of terminal data accompanying the check-in operation, identification of clinical trial participants using the terminal data, acceptance of input of identity document data, authentication of the participant based on the identity document data, and recording of clinical trial phase start data are performed in the same manner as in S5 to S10 above. At the end of this trial phase, the acquisition of terminal data accompanying the check-out operation, identification of clinical trial participants using the terminal data, and recording of clinical trial phase end data are performed in the same manner as in S11 to S13 above.

[0087] [Inspection process after the main test] In the post-trial inspection process, clinical trial participants visit the implementing institution to undergo inspections. At the start of the post-trial inspection process, the acquisition of terminal data accompanying the check-in operation, identification of clinical trial participants based on the terminal data, authentication of the participant based on the ID data, and recording of the clinical trial process start data are performed in the same manner as in S5-S10 above. Similarly, at the end of the post-trial inspection process, the acquisition of terminal data accompanying the check-out operation, identification of clinical trial participants based on the terminal data, and recording of the clinical trial process end data are performed in the same manner as in S11-S13 above. Upon completion of the clinical trial process for this trial, the clinical trial is considered complete, and the completion of the clinical trial is recorded in association with the clinical trial participant ID. Note that depending on the type of clinical trial, there may be no post-trial inspection process. In that case, the clinical trial is considered complete upon completion of the clinical trial process for this trial.

[0088] [Payment of clinical trial participation fees] After the completion of all clinical trial stages, the cooperation cost calculation unit 6 calculates the clinical trial cooperation cost based on the clinical trial stage start data and clinical trial stage end data for the screening test stage, the main test stage, and the post-main test test stage (S14). For example, the cooperation cost calculation unit 6 determines the actual amount of participation by the clinical trial participant out of the planned amount of participation in the clinical trial, based on the clinical trial stage start data and clinical trial stage end data of the clinical trial participant, and calculates the clinical trial cooperation cost according to this actual amount. For example, the number of clinical trial stages in which the clinical trial participant actually participated out of the total number of planned clinical trial stages is determined based on the clinical trial stage start data and clinical trial stage end data. Alternatively, the percentage of the planned commitment amount of the clinical trial (hospitalization period, number of visits, etc.) that the clinical trial participant was able to complete may be determined based on the clinical trial stage start data and clinical trial stage end data. For example, if a clinical trial participant drops out after completing 50% of the planned commitment amount, the clinical trial cooperation cost is calculated as 50% of the full amount. The cooperation cost calculation unit 6 may, for example, accept input for adjustments to the calculated clinical trial cooperation costs from the implementing agency terminal 11.

[0089] Furthermore, in the calculation of clinical trial costs in S14, in addition to the clinical trial cooperation fee based on the amount of participation, an additional clinical trial cooperation fee for incentives may also be calculated. The additional clinical trial cooperation fee may be calculated, for example, based on the evaluation value calculated by the participant evaluation unit 7. Alternatively, an additional clinical trial cooperation fee predetermined for each clinical trial may be calculated. The sum of the clinical trial cooperation fee based on the amount of participation and the additional clinical trial cooperation fee may be calculated as the final clinical trial cooperation fee. In this way, by calculating an additional clinical trial cooperation fee, for example, a person or organization other than the clinical trial sponsoring organization that bears the clinical trial cooperation fee based on the amount of participation, such as a participant recruitment organization, a clinical trial support system provider, or a clinical trial implementing organization, can independently provide incentives to clinical trial participants.

[0090] The clinical trial support system 1 displays the clinical trial cooperation fee calculated by the cooperation fee calculation unit 6 on the user terminal 10 (S15), and receives approval input for the clinical trial cooperation fee from the clinical trial participant (S16). Once approval input is received, the clinical trial support system 1 executes payment processing (S17). Payment processing is performed, for example, by notifying the settlement system 13 of the information indicating the bank account to which the clinical trial participant should transfer the payment, obtained from the user terminal 10, and the clinical trial cooperation fee, and requesting a transfer.

[0091] The above process ensures that all aspects of the clinical trial, including application, screening, main trial, post-trial examination, and payment of participation fees, are carried out for the same clinical trial participant. In particular, at the start of each clinical trial stage—screening, main trial, and post-trial examination—identity verification is performed, preventing participants from being mistaken for others. Personal information for identity verification is managed by the clinical trial support system 1, so there is little to no personal information that needs to be managed by each of the multiple organizations involved in the clinical trial, such as the sponsoring organization, the implementing organization, and the participant recruitment organization. Furthermore, throughout the entire clinical trial flow, participants can perform procedures with the clinical trial support system 1 using the user terminal 10, thus increasing the efficiency of the participants' work.

[0092] [Example Data] Figure 4 shows examples of clinical trial process start and end data. In the example in Figure 4, the clinical trial ID, process number, start or end date, and start or end time are recorded, associated with the clinical trial participant ID. In this way, information indicating the start and end of each clinical trial process in which each clinical trial participant has participated is recorded. This makes it easy to manage each clinical trial participant's participation status in past and present clinical trials. By using the clinical trial process start and end data, it is possible to efficiently perform tasks such as determining the participant's drug-free period, evaluating participants, or notifying participants of the progress of the clinical trial process.

[0093] [Examples of determining the drug-free period] In the example operation shown in Figure 3, when the user terminal 10 receives input for participation in a clinical trial in S1, the drug-free period determination unit 5 may determine whether the drug-free period overlaps with the duration of the clinical trial in which the participant wishes to participate. If it is determined that the drug-free period overlaps with the duration of the clinical trial, the application acceptance unit 2 displays this fact on the user terminal 10 and does not record the participation application information in the storage unit 9. This prevents double entry during the drug-free period. Furthermore, if a clinical trial participant is identified by terminal acquisition data at the start of at least one of the screening test process, the main test process, and the post-main test test process, the drug-free period determination unit 5 may determine whether the drug-free period overlaps with the duration of the clinical trial in which the participant wishes to start. If it is determined that the drug-free period overlaps with the duration of the clinical trial, the application acceptance unit 2 displays this fact on the user terminal 10 and does not record the clinical trial process start data. This prevents the start of the clinical trial process during the drug-free period.

[0094] The drug-free period determination unit 5 determines the start time of the drug-free period using the clinical trial start data and / or clinical trial end data from the most recent past clinical trial, which are associated with the clinical trial participant ID. For example, the start time of the drug-free period can be either the start time indicated by the clinical trial start data or the end time indicated by the clinical trial end data of the clinical trial process including drug administration (e.g., the main trial process) of the most recent past clinical trial. Alternatively, the start time of the drug-free period may be a predetermined point in time or day between the start and end of the clinical trial process including drug administration. How the start time is determined using the clinical trial start data and / or clinical trial end data of the most recent past clinical trial may be determined, for example, based on the clinical trial information. The drug-free period determination unit 5 sets the drug-free period to a predetermined length from the start time of the drug-free period. This predetermined period length may be determined based on the clinical trial information of at least one clinical trial in which the clinical trial participant most recently participated, and of any clinical trial in which they intend to participate or start.

[0095] [Examples of evaluations of clinical trial participants] In the example operation shown in Figure 3, the participant evaluation unit 7 may calculate the participant's evaluation value when, for example, the completion data for each clinical trial process—the screening test process, the main test process, and the post-main test test process—is recorded. Alternatively, the participant evaluation unit 7 may calculate the evaluator's evaluation value after the completion of all clinical trial processes and before the calculation of the clinical trial cooperation fee (S14). The participant evaluation unit 7 can calculate the participant's evaluation value based, for example, on the degree of delay from the scheduled disclosure at the start of each clinical trial process, as indicated by the clinical trial process start data for each clinical trial process recorded in association with the participant ID.

[0096] [Other variations] In the example shown in Figure 3, for all clinical trial processes included in the trial, the start data for the clinical trial process is recorded, subject to participant identification using terminal data and identity verification using ID card data. As a variation, for some clinical trial processes included in the trial, identity verification using ID card data may be omitted, and participant identification using terminal data may be performed, and the start data for the clinical trial process may be recorded. For example, if a clinical trial process includes a process where identity verification is not important, identity verification using ID card data may be omitted for that clinical trial process to prioritize work efficiency.

[0097] (Example of user terminal operation) Figure 5 is a flowchart illustrating an example of application processing on the user terminal 10. In the example in Figure 5, when the application is launched, a menu screen is displayed, for example, to accept instructions from the user. The application becomes available when logged in with the clinical trial participant's account. In the example in Figure 5, the user can instruct one of the following: input participation application, start the clinical trial process, end the clinical trial process, display a notification, or exit the application. Here, the user may be able to instruct the start and end of the clinical trial process only if certain conditions are met. For example, the user may be able to select the start or end of the clinical trial process within the scheduled period for the start or end of the clinical trial process, or when information indicating the start or end of the clinical trial process is obtained from the clinical trial support system 1. Alternatively, the clinical trial support system 1 may instruct the user terminal 10 to start or end the clinical trial process based on input from the clinical trial organization.

[0098] If the user is instructed to enter an application to participate (YES in S20), the user terminal 10 displays the application screen and accepts the application (S21). The application screen may accept input of search criteria for clinical trials, for example. The search criteria may include, for example, the duration of the clinical trial, the content of the clinical trial, and the cost of participating in the clinical trial. The user terminal 10 sends the entered search criteria to the clinical trial support system 1 and receives the search results. The search results display a list of clinical trials that match the search criteria in a selectable format. The user can enter an application to participate in a clinical trial by selecting one.

[0099] When a user inputs an instruction to start the clinical trial process, the user terminal 10 detects the start of the clinical trial process (YES in S22) and executes the clinical trial process start processing (S23). In S23, the user terminal 10 supplies terminal acquisition data to the clinical trial support system 1. The terminal acquisition data includes information for identifying the clinical trial participant. The terminal acquisition data may also include information indicating the start of the clinical trial process. In S23, for example, the user terminal 10 outputs a message instructing the user to read a two-dimensional code issued by the clinical trial support system 1 and activates the camera for reading. In this case, the user terminal 10 transmits terminal acquisition data, including authentication information obtained by decoding the read two-dimensional code, to the clinical trial support system 1. Alternatively, the user terminal 10 may display the two-dimensional code on the screen and output a message instructing the implementing agency terminal 11 to read the two-dimensional code. In this case, the two-dimensional code contains the information from the terminal acquisition data. Furthermore, the detection of the start of the clinical trial process in S22 may be detected not by user input, but by a clinical trial process start instruction supplied from the clinical trial support system 1 to the user terminal 10 based on input from the implementing agency, for example.

[0100] When the user inputs an instruction to terminate the clinical trial process, the user terminal 10 detects the termination of the clinical trial process (YES in S24) and executes the clinical trial termination process (S25). In S25, the user terminal 10 supplies terminal acquisition data to the clinical trial support system 1. The terminal acquisition data includes information for identifying the clinical trial participant. The terminal acquisition data may also include information indicating the termination of the clinical trial process. The supply of terminal acquisition data in S25 can be performed, for example, in the same way as in S23. Note that the detection of the termination of the clinical trial process in S24 may be detected not by an instruction input from the user, but by a clinical trial termination instruction supplied from the clinical trial support system 1 to the user terminal 10 based on input from the implementing agency, for example.

[0101] If there is an unread notification from the clinical trial support system 1 to the user terminal 10, when the application is launched, a message indicating that there is an unread notification will be displayed. In this case, the user can instruct the user terminal 10 to display the notification. If the user instructs the notification to be displayed (YES in S26), the content of the notification will be displayed on the screen of the user terminal 10 (S27). If the user performs an operation to terminate the application (YES in S28), the application will terminate.

[0102] Although embodiments of the present invention have been described above, the embodiments described above are merely examples for carrying out the present invention. Therefore, the present invention is not limited to the embodiments described above, and it is possible to carry out the present invention by appropriately modifying the embodiments described above without departing from the spirit of the invention. [Explanation of Symbols]

[0103] 1: Clinical trial support system, 2: Application reception department, 3: Clinical trial process start record department, 4: Clinical trial process end record department, 5: Drug withdrawal period determination department, 6: Cooperation cost calculation department, 7: Participant evaluation department, 81: Drug withdrawal period information provision department, 82: Clinical trial participation information reception department, 9: Memory department

Claims

1. An application input receiving unit receives applications for participation in a clinical trial via the user terminal of a clinical trial participant, and records the clinical trial participant ID of the clinical trial participant in a storage unit, associating it with a clinical trial ID that identifies the clinical trial. A clinical trial process start recording unit, which, at the start of each clinical trial process in the clinical trial identified by the clinical trial ID, identifies the clinical trial participant using terminal acquisition data obtained from the user terminal of the clinical trial participant, accepts input of identity data including personal information based on the identity card brought by the clinical trial participant, and if the person is authenticated based on the identity card data, records clinical trial process start data indicating the start of the corresponding clinical trial process in the storage unit, associated with the clinical trial participant ID, A clinical trial completion recording unit identifies the clinical trial participant using terminal acquisition data obtained from the user terminal of the clinical trial participant at the end of each clinical trial process in the clinical trial identified by the clinical trial ID, and records clinical trial process completion data indicating the end of the corresponding clinical trial process in the storage unit in association with the clinical trial participant ID. A clinical trial support system equipped with the following features.

2. A clinical trial support system according to claim 1, A clinical trial support system further comprising a drug-free period determination unit that acquires information identifying clinical trial participants and determines a drug-free period during which the clinical trial participant is unable to participate in a clinical trial, based on at least one of the clinical trial start data and the clinical trial end data from the most recent past clinical trial in which the clinical trial participant indicated by said information participated.

3. A clinical trial support system according to claim 1 or 2, A clinical trial support system further comprising a cooperation cost calculation unit that calculates the clinical trial cooperation cost for the clinical trial participant based on the clinical trial process start data and the clinical trial process end data.

4. A computer-based method for supporting clinical trials, An application input acceptance step, which involves receiving an application to participate in a clinical trial via the user terminal of a clinical trial participant, and recording the clinical trial participant ID of the said clinical trial participant in a storage unit, associating it with a clinical trial ID that identifies the said clinical trial; A clinical trial process start recording step is performed, in which, at the start of each clinical trial process in the clinical trial identified by the clinical trial ID, the clinical trial participant is identified using terminal acquisition data obtained from the user terminal of the clinical trial participant, and the input of identity data including personal information based on the identity card brought by the clinical trial participant is accepted, and if the person is authenticated based on the identity card data, clinical trial process start data indicating the start of the corresponding clinical trial process is recorded in the storage unit in association with the clinical trial participant ID, A clinical trial completion recording step is performed, at the end of each clinical trial process in the clinical trial identified by the clinical trial ID, using terminal acquisition data obtained from the user terminal of the clinical trial participant, to identify the clinical trial participant, and to record clinical trial process completion data indicating the completion of the corresponding clinical trial process in the storage unit, associated with the clinical trial participant ID. A clinical trial support method having the following characteristics.

5. The application input acceptance process involves receiving an application to participate in a clinical trial via the user terminal of the clinical trial participant, and recording the clinical trial participant ID of the clinical trial participant in a storage unit, associating it with the clinical trial ID that identifies the clinical trial. At the start of each clinical trial process in the clinical trial identified by the clinical trial ID, the clinical trial participant is identified using terminal acquisition data obtained from the user terminal of the clinical trial participant, and the input of identity data including personal information based on the identity card brought by the clinical trial participant is accepted. If the participant is authenticated based on the identity card data, clinical trial process start data indicating the start of the corresponding clinical trial process is recorded in the storage unit in association with the clinical trial participant ID, and the clinical trial process start recording process is performed. At the end of each clinical trial process in the clinical trial identified by the clinical trial ID, the clinical trial participant is identified using terminal acquisition data obtained from the user terminal of the clinical trial participant, and clinical trial process completion data indicating the end of the corresponding clinical trial process is recorded in the storage unit in association with the clinical trial participant ID; A clinical trial support program that has a computer execute commands.

6. A user terminal capable of data communication with the clinical trial support system described in claim 1 or 2, A clinical trial application unit supplies application data, including the clinical trials that the clinical trial participant wishes to participate in and the clinical trial participant, to the clinical trial support system based on input from the clinical trial participant. A clinical trial process initiation unit, which, when it detects the start of a clinical trial process based on input from a clinical trial participant or information obtained from the clinical trial support system, supplies terminal acquisition data to identify the clinical trial participant to the clinical trial support system, A user terminal comprising: a clinical trial completion unit that, when it detects the completion of a clinical trial process of the clinical trial based on input from a clinical trial participant or information obtained from the clinical trial support system, supplies terminal acquisition data for identifying the clinical trial participant to the clinical trial support system.

7. A program that causes a user terminal capable of data communication with a clinical trial support system to execute processing, A clinical trial participation application process that, based on input from clinical trial participants, supplies the clinical trial the participant wishes to participate in and the participant's application data to the clinical trial support system, and A clinical trial process initiation process, which, when the start of a clinical trial process is detected based on input from a clinical trial participant or information obtained from the clinical trial support system, supplies terminal acquisition data for identifying the clinical trial participant to the clinical trial support system, A program that causes the user terminal to execute a clinical trial completion unit, which, when it detects the completion of a clinical trial process of the clinical trial based on input from the clinical trial participant or information obtained from the clinical trial support system, supplies terminal acquisition data for identifying the clinical trial participant to the clinical trial support system.

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