JP2012248005A - Clinical trial guide method, server of intermediary, software, and recording medium - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a clinical trial guide method for putting clinical trial to a disease that a person himself or herself is not aware of, a disease in a boundary range, and a disease to possibly emerge in future.SOLUTION: Clinical trial participation is registered on receiving a personal statement of individual information including a disease that a clinical trial applicant grasps, a guidance of holding of a health measurement meeting is sent to the registrant, and a clinical trial candidate whose medical data meets examinee selection conditions while the examinee selection conditions are not included in the individual information is selected. A candidate who consents to clinical trial contents is determined as a clinical trial candidate.

Description

  This invention is for a trial investigator who has a disease in a border area that he or she is not aware of, a trial investigator who may need treatment for a specific disease in the future, or a trial with a disease (target disease) that is the subject of the trial. A trial guidance method for voluntarily encouraging these investigators to participate in clinical trials in foods, trials in pharmaceuticals and target diseases, clinical trials in cosmetics, etc. The present invention relates to a server, software, and a recording medium on which software is recorded.

  Clinical trials (hereinafter also referred to as clinical trials) are being conducted to confirm the efficacy and safety of functional health foods, foods for specified health use, supplements (nutritional supplements), health foods, pharmaceuticals, cosmetics, medical devices, etc. . In this trial, a sponsor such as a developer or distributor of food, cosmetics, pharmaceuticals, etc., decides the trial investigator (clinical trial institution) such as a medical institution that actually conducts the clinical trial. The practitioner becomes a practitioner, and the trial practitioner conducts various trials on the trial practitioner (hereinafter also referred to as a subject).

JP2002-41657 JP2008-186039

  Patent Document 1 (particularly paragraphs 0078 to 0083) as a method for selecting a subject recruits subjects by advertisement, the Internet, word-of-mouth, marginal relations, etc., selects and screens a target subject group corresponding to the contents of a clinical trial, It is shown to select with consent. Since the subject information to be collected and confirmed here differs from trial to trial, lack of subject information collection should be avoided as much as possible. Therefore, in Patent Document 1, it is necessary to establish a trust relationship between the subject and the recruiter in a short conversation and to appropriately manage the questioning method (paragraphs 0082 and 0083).

  Patent Document 2 is by the same applicant, but here, in order to select a candidate for testing, questions are presented to the trial applicant in a sequential format, and the answer to this is received as uncorrectable for each question. , To improve the reliability of answers. In addition, a final test subject (study person) is determined by examining a clinical trial candidate (a candidate who can be a test subject) at a hospital.

  According to the invention described in Patent Document 1, in order to recruit subjects, subject information is obtained through conversations with subjects, and the accuracy of acquired information is likely to vary due to compatibility with recruiters, etc. There arises a problem that the selection accuracy of the subject is lowered. Moreover, the question and answer by conversation are repeated for each subject, and the problem that efficiency is bad arises. According to the invention described in Patent Document 2, the trial candidate is determined using the self-report of the trial applicant, and the trial applicant selected as a candidate is further examined at a hospital or during a medical examination. Because the reliability of the trial was judged based on the numerical value of the report and the declaration based on the person's memory, only subjects with subjective symptoms were selected. There was a problem that the improvement was also limited.

  Here, with these conventional methods, the wishes of the investigator (student applicant), the self-report of the disease that the person is already aware of (whether or already knowing the symptoms), the examination at the hospital and health Based on the diagnosis, etc., the investigator for the food, medicine, etc. to be studied was selected. In other words, for those who wish to study, who have symptoms (such as high blood pressure, diabetes, cholesterol levels, body fat, etc.) that have been identified by the patient's wishes, self-reported diseases, and test and diagnosis results, The drug was administered to confirm the effectiveness.

  However, in this case, as a result of examination and diagnosis, it is not possible to select an investigator who is not in a disease state of a specific disease but cannot be in a healthy state, that is, in a borderline state. In addition, even if there is a risk of requiring treatment for a specific disease in the future, a person who does not have subjective symptoms cannot be selected.

  For example, as an example of a patient in the border zone, a state that seems to be high blood pressure but cannot be clearly determined as high blood pressure, a cholesterol level or a test value for diabetes is not within the abnormal range, but is close to this range, body fat Patients may have a condition where the rate is outside the standard range but only slightly off. Here, such a state is also referred to as a borderline disease. As an example of an investigator who may need treatment for a specific disease in the future, the individual test results are almost within the reference range. When it is determined that there is a fear, it may be considered. Furthermore, there may be cases where the patient has a disease (target disease) corresponding to the request content of the clinical trial requester and is not aware of the disease or does not understand the content of the clinical trial.

  In the conventional method as described above, it is determined whether or not the investigational product is effective for this disease on the premise that the subject has a predetermined disease by self-reporting including a person's hope and subjective symptoms, medical examination, etc. Therefore, there is a problem that it cannot be used in clinical trials of borderline diseases. In addition, when investigating whether or not an investigational product is effective for a disease that the investigator is already aware of (with subjective symptoms), the prejudice of the investigator affects the study results and the accuracy of the study There is also a problem that it falls. Furthermore, at the time of screening, the inspection items corresponding to the person's declaration are often inspected, and the person himself / herself becomes conscious, which may reduce the clinical trial accuracy.

  The present invention has been made in view of such circumstances, and it is possible to conduct clinical trials for diseases other than diseases (such as diseases that the individual himself / herself is not aware of) other than those that are clarified in the wishes, self-reports, and medical examinations of the investigator. Conduct clinical trials for diseases that can be performed and for diseases that are likely to develop in the future, or for diseases that are likely to develop in the future, or that have a disease (target disease) according to the request by the sponsor, and that the investigator is not aware of It is a first object of the present invention to provide a clinical trial guidance method that enables the study. A second object is to provide an intermediary server that is directly used to implement this method. It is a third and fourth object of the present invention to provide software used for implementing this method and a storage medium storing this software.

According to the present invention, a first object is to use a computer for guiding a person to participate in a clinical trial via the Internet in order to select a clinical trial candidate that matches the clinical trial content requested by the clinical trial sponsor. A guide method,
a) a step in which the intermediary server sets subject selection conditions corresponding to the content of the trial based on the request of the trial sponsor;
b) The mediator's server reports to the trial applicant's information terminal the self-declaration of personal information including the contents of the trial that the trial applicant desires and the disease that the trial applicant himself is currently aware of; Presenting a screen that prompts you to register for participation,
c) The intermediary server transmits a guidance for a medical examination measurement session to the information terminal of the registrant who has registered for clinical trial participation in step b).
d) a step of receiving and storing the medical examination data at the medical examination measurement meeting, the mediator server;
e) The intermediary server compares the personal information self-reported in step b) with the medical examination data and the subject selection conditions set in step a), and the medical examination data is subject selection conditions. Selecting a clinical trial candidate that conforms to the above and does not include the subject selection conditions in the personal information,
f) The intermediary server presents a screen for obtaining consent to the clinical trial contents to the trial candidate information terminal and obtains a reply indicating that the consent is obtained;
g) sending a list of prospective study candidates to the sponsor or the investigator;
This is achieved by a clinical trial guidance method using a computer having the steps a) to g).

The second object is a mediator server used in the method of claim 1,
An input accepting unit for accepting input of clinical trial contents;
A selection condition setting unit having software for obtaining a subject selection condition for the inputted clinical trial content;
In order to encourage the information terminals of those who wish to participate in the trial to self-report personal information including the details of the trial that the applicant wishes to participate and the disease that the applicant is currently aware of, and to register for participation in the trial Recruitment screen presentation part that presents the recruitment screen,
A registration application receiving unit that receives a registration application signal input from an information terminal of a trial applicant,
A guidance transmitter that transmits guidance for the medical examination measurement session to the information terminal of the registrant who has received the registration application signal;
A storage unit for receiving and storing medical examination data in the medical examination measurement meeting;
The self-reported personal information, the medical examination data, and the subject selection conditions are compared, and clinical trial candidates that are suitable for the subject selection conditions and whose personal information does not include the subject selection conditions are selected. An investigator selection operation unit to be selected;
An consent processing unit for obtaining a reply indicating that consent is given to the trial candidate information terminal by presenting a screen for obtaining consent for the contents of the trial,
Create a list of prospective study candidates and send them to the sponsor or sponsor,
An intermediary server characterized by comprising:
Is achieved.

  The third object is achieved by software for performing the operation of claim 1. The fourth object is achieved by a storage medium storing this software.

  As described above, the first invention memorizes the contents of the clinical trial desired by the applicant for clinical trial participation and the self-report of personal information including the currently known disease (disease with subjective symptoms), and stores this in the clinical trial. Compared to the conditions for selecting a candidate, candidates for clinical trials that meet the conditions for selecting the subject and are not included in the personal information self-reported, those who are likely to require treatment for a specific disease in the future, Or, because candidates for clinical trials who have a disease (target disease) that is the subject of the trial but are not aware of this disease (or who do not understand the target disease) are selected, those who wish to participate are not aware (noticing) (I don't understand, don't understand). For this reason, it is possible to conduct a highly accurate clinical trial that does not involve the preconception of the clinical trial person. In addition, it is possible to conduct clinical trials for diseases such as border areas that are not recognized by the person without making the person aware of it. For this reason, the effect of the trial product can be confirmed with high accuracy.

  In the case of a medical examination conducted at a specific medical institution, only the medical institution possesses examination numerical values (test results and medical examination data). For this reason, this test value cannot be used in other medical institutions. However, according to the present invention, when a medical examination measurement session is performed, the medical examination result is stored in the mediator's server, and can be provided to each desired medical institution after obtaining the consent of the investigator. Become. For this reason, it is not necessary to repeat the same examination over and over, and the medical examination result can be effectively used.

  In addition, by participating according to the guidance of such a medical examination measurement meeting, it is possible to track the symptoms that the person is not aware of and the changes in the numerical values (health examination data), which makes it possible to detect lifestyle-related diseases and serious illnesses early. Will be able to discover. Even if treatment is made by early detection of a lifestyle-related disease or serious disease that has been discovered, it will lead to shortening of the treatment period and reduction of treatment costs. By carrying out the medical examination measurement meeting in this way, various effects such as suppression of medical expenses, maintenance of the health of the person, and guidance to new development of pharmaceuticals are expected, and the ripple effect is extremely large.

  According to the second aspect of the invention, an intermediary server that is used directly in the implementation of the first aspect of the invention is obtained. According to the third aspect, software for performing the operation of claim 1 is obtained. According to the fourth invention, a storage medium storing this software, for example, an optical disk is obtained.

The block diagram which shows one Example of this invention Flow chart of overall operation Flow chart of subject recruitment operations Figure showing signal and data transmission / reception Mediation server configuration diagram

  The test subject selection condition may be to select a test subject who has a disease in a border area that the clinical trial applicant himself / herself is not aware of (Claim 2). The test subject selection condition may select a test subject who may need treatment for a specific disease in the future (claim 3). The test subject selection condition may be to select a test subject who has a disease (target disease) according to the request content of the clinical trial requester and is not aware of the disease or does not understand the clinical trial content (request) Item 4).

  The personal information of step b) in claim 1 includes name, date of birth, address, telephone number, gender, desired clinical trial content, known disease, occupation as required, and numerical values of past test results. (Claim 5). The name, date of birth, address, phone number, and gender are necessary to identify the study registrant. For example, if the address is changed, it is confirmed that the person is the same person, and is stored as examination data for the same person. It is to keep. By doing this, it becomes possible to continue monitoring the progress of diseases and the like that the clinical trial registrant is not aware of.

  The screening data in step d) is a blood pressure, body temperature, body weight, BMI, blood sugar level, body fat, cholesterol level, neutral fat, GOT, GPT, uric acid level, Hba1c, uric acid level, visual acuity, allergy. (Claim 6). Although it is desirable to increase the number of examination items as much as possible for the purpose of tracking the progress of a disease having no future subjective symptoms, the number of examination items may be limited to an appropriate number.

  If the meeting for the medical examination measurement in step d) is performed at multiple venues, and the applicants who wish to participate can select a venue that is close to the address, it is convenient to select a venue that is close to the applicant when the applicant changes their address. In addition, by continuously storing medical examination data of the same person, it can be easily used for tracking the progress of a disease without subjective symptoms (claim 7).

  As described above, the following step h) is preferably added after step g) in order to monitor the progress of the disease that the clinical trial registrant is not aware of. That is, h) The intermediary server compares the medical examination data stored in the memory in the step d) with the past medical examination data of the same applicant who wishes to participate, so that the investigator is not aware of the change of the disease. It is preferable to add a step of tracking the time and outputting the tracking progress in a timely manner.

  In step g of claim 1, the trial candidate list may be viewed by an investigator or trial requester by accessing the mediator's server via the Internet, but the mediator may send an email, facsimile, mail, etc. May be sent to the clinical trial practitioner or clinical trial sponsor so that the clinical trial practitioner or clinical trial sponsor can view it.

  In FIG. 1, reference numeral 10 denotes an intermediary server (computer), 12 denotes a terminal (computer) of a trial requester (study requesting institution), and 14 (14A, 14B,...) Denotes a terminal of the trial practitioner (trial institution). Machines (computers) 16 (16A, 16B,...) Are terminals (computers) of applicants who wish to participate in the trial. These are connected to each other via the Internet 18. Here, each of the terminals 12, 14, and 16 is also simply referred to as a clinical trial requester (institution), a clinical trial practitioner (institution), and a trial participation applicant (applicant).

  The investigator's terminal 14 has a dedicated application that enables connection with the mediator's server 10 and enhances the function of maintaining the confidentiality of the data of the trial participant 16 that transmits / receives data to / from the server 10. Note that data transmission / reception between the server 10 and the clinical trial requester 12, the clinical trial practitioner 14, and the clinical trial participant 16 is performed using encrypted communication, ID (authentication code), and PW (password), thereby maintaining confidentiality. Is further raised.

  The clinical trial requester (producer or seller of pharmaceuticals or the like) 12 determines the clinical trial practitioner 14 when developing a new drug, a new food, a supplement, or the like (step S100 in FIG. 2). In some cases, the clinical trial requester 12 becomes the clinical trial practitioner 14 (step S102 in FIG. 2). The clinical trial client 12 presents the clinical trial implementation plan (design) and summary to the clinical trial practitioner 14 and determines the clinical trial content (step S104).

  In other words, the selection of the investigator, the preparation of the study plan, the selection of the conducting medical institution, etc. are planned. In this design creation, the trial sponsor 12 or the trial practitioner 14 creates materials for obtaining approval from the partner medical institution ethics committee (IRB) and operates the IRB secretariat (step S106). As a result, when the IRB approval procedure is completed, the mediator 10 makes a meeting with the trial investigator 14 or the trial sponsor 12 as necessary (step S108). In this meeting, the intermediary 10 and the trial investigator 14 or, as necessary, the trial sponsor 12 and a confidentiality agreement or a business consignment agreement are concluded, the outline of the trial (examination) is confirmed, and the number of people, days, and clinical trials required. The cost is estimated in consideration of the difficulty.

  Next, trial candidate selection processing starts from recruitment of trial applicants according to the present invention (step S110). This procedure will be described later. When the list of optimal clinical trial candidates comes out in this step S110, the mediator 10 explains the clinical trials in detail to the clinical trial candidates, and confirms and agrees with each other that they are satisfied with the clinical trial (step S110). S110j). If consent is obtained as a result (step S110k), the mediator 10 finalizes trial candidates (step S110l), and a list of the confirmed trial candidates is sent to the trial investigator 14 and the trial sponsor 12 if necessary. Send (S110m).

  The trial investigator 14 conducts the trial with the subjects extracted from the candidate list and monitors the progress of the trial (step S120). When the clinical trial is completed, the trial investigator 14 or the mediator 10 creates a clinical trial result and submits it to the clinical trial requester 12 (step S122). Further, the mediator 10 reports the clinical trial participation status of the subject 16 to the clinical trial client 12 or the clinical practitioner 14, and calculates and charges a fee such as a mediation fee (step S124).

(Overall procedure for selecting clinical trial candidates)
Next, the entire procedure (step S110) for selecting the clinical trial candidate will be described in detail with reference to FIGS. This procedure includes a candidate recruitment procedure (first half procedure, steps S110a to 110d) and a trial candidate selection procedure (second half procedure, steps S110e to S110e) for selecting trial candidates suitable for the trial from the recruited subject applicants. 110k). First, the applicant recruitment procedure will be explained.

(Procedure for recruiting applicants, first half procedure)
In this test applicant recruitment procedure, the intermediary 10 reads and stores the results of the discussion with the above-described clinical trial requester 12 and the clinical trial practitioner 14 as clinical trial contents (steps S108 and S110a). The clinical trial content is read via the clinical trial content receiving unit 10A of the intermediary server 10. The server 10 sets the subject selection condition in the selection condition setting unit 10B based on the read clinical trial contents (step S110b), stores this in the selection condition storage unit 10C, and the recruitment screen presenting unit 10D displays the recruitment screen. Is presented on the homepage (HP) of the mediator 10 (step S110c). The applicant (applicant) 16 who wishes to participate in the clinical trial confirms this and applies (registers) to participate in the clinical trial (FIG. 3, step S110d).

  When the application is recognized by the mediator 10 via the clinical trial participation application unit 10E, the mediator 10 prompts the applicant to input personal information and stores the input personal information in the personal information storage unit 10F. Here, the personal information includes name, date of birth, address, telephone number, gender, desired clinical trial contents, known disease, and numerical values of past test results. If there is a disease you are aware of, enter this. Thus, the registration of the applicant for examination is completed by submitting the personal information.

  This applicant recruitment procedure may be performed in advance. In other words, prior to the application (step S110d), the application of the applicant 16 may be accepted in advance (pre-registration). In this case, the intermediary 10 revises the homepage (HP) based on the business consignment contract received in response to the recruitment of the trial applicants from the trial sponsor 12 or the trial practitioner 14, and participates in the trial that has been pre-registered. Present to the applicant and encourage participation. In FIG. 4, the trial participation applicant 16 is pre-registered, and the description of the trial participation application including the registration of personal information (test applicant recruitment procedure, step S110d in FIG. 3) is omitted.

  In addition, in the transmission and reception of data through the Internet 18 between the trial investigator 14 and the mediator 10, the security function is enhanced by using dedicated application software. That is, dedicated communication application software is previously input to the terminal of the trial investigator 14 and the server of the intermediary 10, respectively, so that it cannot be read by other terminals. For data transmission / reception between the subject 16, the mediator 10, and the trial investigator 14 via the Internet 18, a commonly used encryption communication function, ID (personal authentication), PW (password), or the like is used.

(Clinical trial candidate selection procedure, second half procedure)
If the applicant wishes to participate in the trial confirms the recruitment site of the mediator 10 (step S110c in FIG. 3) and enters personal information (step S110d), or if pre-registered, then the candidate for the trial is selected. Enter the procedure. The intermediary 10 sends a medical examination measurement meeting holding notice to the applicant (applicant for clinical trial participation) 16 from the medical examination measurement meeting holding guidance transmission unit 10G (step 110e). This medical examination measurement meeting is held all over the country, and the applicant 16 makes an application to participate in a place convenient for him (step S110f).

  The applicant 16 attends a medical examination measurement meeting at the place of application (step S110g), and receives a predetermined medical examination (medical examination) here. That is, blood pressure, body temperature, body weight, BMI, blood sugar level, body fat, cholesterol level, neutral fat, GOT, GPT, uric acid level, Hba1c, uric acid level, visual acuity, and allergy are examined (health checkup). The medical examination data including the numerical value that is the result of the medical examination is detected (step S110h). This medical examination data is stored in the medical examination data storage unit 10H of the server 10.

The intermediary server 10 is based on the subject selection conditions stored in the selection condition storage unit 10C, the personal information stored in the personal information storage unit 10F, and the medical examination data stored in the medical examination data storage unit 10H. Is elected. That is, the trial candidate selection unit 10I
a) The medical examination data conforms to the conditions for selecting subjects.
b) The subject selection conditions are not included in the personal information,
Applicants satisfying these two conditions are selected and set as trial candidates (step S110i).

  The selected candidate is notified of the selection and the contents of the clinical trial, obtained confirmation from the individual, and agreed to participate in the clinical trial (step S110j). The consent processing unit 10J of the server 10 performs the process for obtaining the consent. By obtaining consent (step S110j), a trial candidate is determined (step S110l). A list of clinical trial candidates is created by the list creation / transmission unit 10K of the server 10, and sent to the clinical trial practitioner or the clinical trial requester as necessary (step S110m).

  When the trial candidate is selected as described above, the actual trial is entered as described above (step S120). The result of the clinical trial is reported to the trial investigator and the mediator 10 (step S122), and the clinical trial is terminated after a fee is charged by the mediator 10 (step S124) (FIG. 2).

  In Example 1 described above, it is also possible to track changes in diseases that the investigator is not aware of using past examination data. In this case, in the first aspect of the invention, finally, the past medical examination data of the same applicant who wants to be stored stored in the medical examination data storage unit 10H is read out and compared with the latest medical examination data. Just do it. That is, the intermediary server 10 stores the past medical examination data of the applicant who wishes to participate, thereby effectively utilizing this data. In this case, the intermediary server 10 is provided with a transition tracking unit 10L for performing this process.

10 Broker (server)
10B Selection condition setting unit 10D Recruitment screen presentation unit 10E Registration application reception unit 10G Medical examination measurement session holding guidance transmission unit 10H Medical examination data storage unit 10I Clinical trial candidate selection unit 10J Consent processing unit 10K List creation / transmission unit 10L Transition tracking unit 12 Clinical trial client (terminal)
14 Clinical trial operator (terminal)
16 Trial applicant or applicant (terminal)
18 Internet S110 Overall procedure for selecting clinical trial candidates S110a-110d Recruitment procedure for applicants (first half procedure)
S110e-110k Clinical trial candidate selection procedure (second half procedure)

Claims (12)

A clinical trial guidance method using a computer for guiding to participate in a clinical trial via the Internet in order to select trial candidates that match the clinical trial content requested by the clinical trial sponsor,
a) a step in which the intermediary server sets subject selection conditions corresponding to the content of the trial based on the request of the trial sponsor;
b) The mediator's server reports to the trial applicant's information terminal the self-declaration of personal information including the contents of the trial that the trial applicant desires and the disease that the trial applicant himself is currently aware of; Presenting a screen that prompts you to register for participation,
c) The intermediary server transmits a guidance for a medical examination measurement session to the information terminal of the registrant who has registered for clinical trial participation in step b).
d) a step of receiving and storing the medical examination data at the medical examination measurement meeting, the mediator server;
e) The intermediary server compares the personal information self-reported in step b) with the medical examination data and the subject selection conditions set in step a), and the medical examination data is subject selection conditions. Selecting a clinical trial candidate that conforms to the above and does not include the subject selection conditions in the personal information,
f) The intermediary server presents a screen for obtaining consent to the clinical trial contents to the trial candidate information terminal and obtains a reply indicating that the consent is obtained;
g) sending a list of prospective study candidates to the sponsor or the investigator;
A clinical trial guidance method using a computer having the steps a) to g).   2. The clinical trial guidance method using a computer according to claim 1, wherein the test subject selection condition is to select a test subject having a disease in a border area that the clinical trial applicant himself / herself is not aware of.   2. The clinical trial guidance method using a computer according to claim 1, wherein the test subject selection condition is to select a test subject who is likely to require treatment for a specific disease in the future.   2. The clinical trial guidance method using a computer according to claim 1, wherein the test subject selection condition is to select a test subject having a disease to be studied.   The computer of claim 1 wherein the personal information in step b) includes name, date of birth, address, telephone number, gender, desired clinical trial content, known disease, and numerical values of past test results. Clinical trial guidance method.   The medical examination data of step d) is any of blood pressure, body temperature, body weight, BMI, blood glucose level, body fat, cholesterol level, neutral fat, GOT, GPT, uric acid level, Hba1c, uric acid level, visual acuity, allergy A clinical trial guidance method using a computer according to claim 1.   The clinical trial guidance method using a computer according to claim 1, wherein the medical examination measurement meeting of step d) is performed at a plurality of venues, and those who wish to participate can select a venue that is convenient for them. Following step g), the following step h),
h) The intermediary server tracks changes in the disease that the investigator is not aware of by comparing the medical examination data stored in the memory in step d) with the past medical examination data of the same applicant. And a process of outputting the tracking progress in a timely manner,
A clinical trial guidance method using the computer according to claim 1. An intermediary server used in the method of claim 1,
An input accepting unit for accepting input of clinical trial contents;
A selection condition setting unit having software for obtaining a subject selection condition for the inputted clinical trial content;
In order to encourage the information terminals of those who wish to participate in the trial to self-report personal information including the details of the trial that the applicant wishes to participate and the disease that the applicant is currently aware of, and to register for participation in the trial Recruitment screen presentation part that presents the recruitment screen,
A registration application receiving unit that receives a registration application signal input from an information terminal of a trial applicant,
A guidance transmitter that transmits guidance for the medical examination measurement session to the information terminal of the registrant who has received the registration application signal;
A storage unit for receiving and storing medical examination data in the medical examination measurement meeting;
Comparing the self-reported personal information with the subject selection conditions, selecting a trial candidate that matches the subject selection conditions and is not included in the personal information, and is a trial candidate selection operation unit;
An consent processing unit for obtaining a reply indicating that consent is given to the trial candidate information terminal by presenting a screen for obtaining consent for the contents of the trial,
Create a list of prospective study candidates and send them to the sponsor or sponsor,
An intermediary server characterized by comprising:   The intermediary server of claim 8 further reads the past medical examination data of the same applicant who wants to participate from the storage unit and compares it with the latest medical examination data, thereby tracking the transition of the disease, The intermediary server according to claim 8, further comprising a transition tracking unit that outputs in a timely manner.   Software for performing the operation of claim 1.   A storage medium storing the software of claim 10.