JP5073008B2 - Subject recruitment method, mediator server, software, recording medium - Google Patents

Description

  The present invention recruits subjects who voluntarily participate in clinical trials for foods, clinical trials for pharmaceuticals and target diseases, clinical trials for cosmetics, and the like, and a subject recruiting method for selecting subjects suitable for the clinical trial conditions and this method The present invention relates to an intermediary server, software, and a recording medium on which the software is recorded.

  Clinical trials (hereinafter also referred to as clinical trials) are being conducted to confirm the effectiveness and safety of health functional foods, supplements (nutritional supplements), health foods, pharmaceuticals, cosmetics, medical devices, and the like. 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 subject (hereinafter also referred to as the practitioner).

JP2002-41657 Japanese Patent Application No. 2006-355661

  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 investigator's suitability was judged based on the numerical value of this and the declaration by the person's memory, there was a problem that there was a limit in improving the accuracy of subject selection, and there was a limit in improving reliability.

  The present invention has been made in view of such circumstances, and provides a method for recruiting / selecting subjects suitable for improving subject selection accuracy and reliability, capable of efficiently selecting appropriate subjects for each clinical trial with high accuracy. This is the first purpose. 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 recruit and select subjects using a computer for introducing and selecting subjects via the Internet by an intermediary who introduces subjects who meet the selection conditions of the study to the study practitioner. In the method
a. The intermediary server stores the clinical trial selection conditions and clinical trial recruitment information in advance, and the recruitment screen presenting unit of the server displays a screen showing the stored clinical trial recruitment information for the terminal of the trial participation applicant. Process of presenting and encouraging registration,
b. The intermediary server pre-stores a diary format together with the pre-stored trial selection conditions for the trial, and the pre-stored diary format includes a column for numerical data including blood pressure and body temperature, and a subjectivity including the degree of fatigue. The ID / PW presentation section of this server has an application for registration from the terminal of the applicant who wishes to participate in the trial. Sending an ID / PW that enables reading of the previously stored diary format;
c. The diary format presentation unit of the mediator server receives the ID / PW sent from the trial applicant and sends the pre-stored diary format and the selection conditions to the trial participant's terminal.
d. The intermediary server reads the diary that is filled in the diary format periodically sent from the terminal of the trial applicant, stores the diary in the diary storage unit, and the pre-stored selection condition for the diary input information. A step of monitoring the physical condition of the applicant who wishes to participate in the trial by a physical condition monitoring unit by comparing with a set value to be detected and detecting a suitable timing for performing the trial ,
e. When the intermediary server detects this timing , the physical condition monitoring unit monitors the input information for a predetermined period of the diary sent from the terminal of the trial applicant and stored in the diary storage unit. Making it possible to read the physical condition monitoring result of the applicant who wishes to participate in the terminal of the investigator,
f. The participation confirmation / consent processing unit possessed by the server of the intermediary is a step of prompting confirmation / agreement of participation intention to a terminal of a trial applicant who meets the selection conditions stored in advance.
g. List generating unit that server of the intermediary has, the step of sending the list to the study candidate clinical trial participants who wish to obtain the confirmation / consent to the terminal of the trial practitioner,
This is achieved by a subject recruitment / selection method using a computer having the above steps a to g.

The second object is a mediator server used in the method of claim 1,
Recruitment screen presentation unit for preliminarily storing clinical trial selection conditions and clinical trial recruitment information, and presenting the stored clinical trial recruitment information to the terminals of those who wish to participate in the clinical trial,
A participation application receiving unit that receives a registration application signal input from a terminal of the trial applicant.
In addition to the pre-stored clinical trial selection conditions, a diary format having an entry field for numerical data including blood pressure and an entry field for indicating subjective sensory data including the degree of fatigue on a straight line is stored in advance, and the registration is performed. An ID / PW sending unit that accepts an application signal and sends ID / PW for reading out the format of this diary to the terminal of the applicant who is a participating applicant;
A diary format presentation unit that accepts an ID / PW and presents the format of the diary and the selection conditions on the terminal of the applicant who is the applicant for the trial ;
A diary storage unit that reads and stores diaries periodically sent from the applicant's terminal;
A physical condition monitoring unit that compares the input information of the diary with a set value that is a selection condition , monitors changes in physical condition, and detects a suitable timing for performing the trial ;
When this timing is detected , input information for a predetermined period of the diary sent from the applicant's terminal is read from the diary storage unit and sent to the trial investigator's terminal together with the physical condition monitoring result of the physical condition monitoring unit A transmission unit;
A confirmation / consent processing unit for confirming / consenting the intention to participate in the trial to the trial condition conformant sent from the terminal of the trial investigator;
An applicant who has confirmed / consented the intention to participate in the trial as a trial candidate, creates a list of trial candidates, and allows the trial investigator's terminal to view the list,
It is achieved by a subject recruitment intermediary server characterized by comprising:

A third object is computer software used in the method of claim 1, wherein the server is
Recruitment screen presentation unit for preliminarily storing clinical trial selection conditions and clinical trial recruitment information, and presenting the stored clinical trial recruitment information to the terminals of those who wish to participate in the clinical trial,
A participation application receiving unit that receives a registration application signal input from a terminal of the trial applicant.
In addition to the pre-stored clinical trial selection conditions, a diary format having an entry field for numerical data including blood pressure and an entry field for indicating subjective sensory data including the degree of fatigue on a straight line is stored in advance, and the registration is performed. An ID / PW sending unit that accepts an application signal and sends ID / PW for reading out the format of this diary to the terminal of the applicant who is a participating applicant;
A diary format presentation unit that accepts an ID / PW and presents the format of the diary and the selection conditions on the terminal of the applicant who is the applicant for the trial;
A diary storage unit that reads and stores diaries periodically sent from the applicant's terminal;
A physical condition monitoring unit that compares the input information of the diary with a set value that is a selection condition, monitors changes in physical condition, and detects a suitable timing for performing the trial ;
When this timing is detected , input information for a predetermined period of the diary sent from the applicant's terminal is read from the diary storage unit and sent to the trial investigator's terminal together with the physical condition monitoring result of the physical condition monitoring unit A transmission unit;
A confirmation / consent processing unit for confirming / consenting the intention to participate in the trial to the trial condition conformant sent from the terminal of the trial investigator;
A program for creating a list of trial candidates and making them function as a list creation section that enables the trial site to be viewed by the applicant, with applicants who have confirmed / consented the intention to participate in the trial as trial candidates. Achieved.

  The fourth object is achieved by a storage medium storing this software.

  As described above, the first invention receives the registration of the trial applicant (step a), sends the ID / PW for reading the diary format as the subject selection condition (step b), and this ID / PW In response, the journal format is sent to the trial applicant's terminal (step c), and the journal that the prospective participant periodically fills in and sends to the mediator's server is read and stored, and the journal input information is used. The physical condition of the trial applicant is monitored (step d), and the input information for a predetermined period of this diary is sent to the trial investigator together with the physical condition monitoring result (step e), and the trial practitioner determines that the selection conditions are met. After obtaining confirmation / agreement of intention to participate from the trial applicant (step f), the trial applicant who obtained the confirmation / agreement is sent as a trial candidate to the list of trial participants (step g). ) For this reason, an appropriate clinical trial candidate can be selected efficiently and reliably for each clinical trial.

  In other words, at least at the registration stage, there is no need for a conversation between the applicant (applicant) and the intermediary (recruiter), and the applicant will continue to send regularly (for example, every day) for a predetermined period. This is because the investigator can clarify the selection criteria because the investigator is selected by diary. For example, at the mediator's server (computer), whether there are any inconsistencies in the contents of the diary, whether there is any fluctuation in the contents throughout the specified period, whether there is no intentional reconciliation, etc. It can be determined from the change of the input information due to the passage of the date, and the server can easily determine whether the input is an honest input from the change of the input information. Furthermore, it becomes easier to find an incorrect entry, and the selection accuracy of trial candidates can be improved by selecting information from honest trial applicants. The diary sending period (predetermined period) on which these determinations are made may be integrated and monitored by the timer function of the server.

  In addition, the mediator's server monitors the physical condition of the applicant who wants to participate in the trial by, for example, comparing the diary input information with a set value (set range), so the change in the physical condition is detected and the timing suitable for the trial execution is known. be able to. This timing can be detected by, for example, a change in sensation, a change in numerical values such as blood pressure or uric acid level, or a change in state such as depression. When this timing is detected, the monitoring result is sent to the investigator together with, for example, diary input information up to this date, so that the investigator can efficiently select an appropriate investigator.

  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 figure which extracts and shows a part of an example of the diary format

  In the physical condition monitoring of the trial applicant who is performed in the step d, the diary input information is detected using, for example, a known statistical analysis technique to detect a change in state such as physical condition or emotion. The computer statistical analysis software used here is already provided in various ways called “SAS statistical analysis” (SAS is an abbreviation of “Statistical Analysis System”). The intermediary server 10 uses such statistical analysis software for input information for a predetermined period or all periods, for example, to obtain a deviation value of the input information, to obtain a degree of variation in data from this deviation value, By seeking the reliability of input information, it is possible to improve the detection accuracy of changes such as physical condition and emotion.

  In step g of claim 1, the trial candidate list may be browsed by the trial practitioner by accessing the mediator's server via the Internet. May be made available to the trial investigator for viewing. By sending information to the mediator's server when the submission of the diary of the applicant is delayed, such as the number of delays and the number of days delayed, it is possible to determine the enthusiasm and honesty of the applicant. Is good.

  If the applicants who have participated in the trial have previously participated in the trial, the results at that time, such as lateness in the previous trial, absence without notice, contact absence, dropout / interruption during the trial, willingness to cooperate in follow-up studies, etc. It is preferable to output data indicating the results of past participation results as a reliability evaluation material according to the list of trial candidates. In this case, it is possible to immediately know the reliability of each subject by this reliability information, and for example, it becomes one powerful reference material when a trial practitioner selects a subject or conducts a clinical trial.

  The diary format depends on the content of the trial, but blood pressure, body temperature, number of steps, body weight, visceral fat level, BMI, caloric activity, electrocardiogram, blood sugar, body fat, cholesterol, neutral fat, GOT, GPT, uric acid Either a value, Hbalc, or the like can be described (claim 2).

  These data may be recorded in the diary by the participant who wishes to read the measurement results obtained by the measuring instrument that was sent separately to the trial applicant. It may be connected to a personal computer and sent to the mediator's server together with the diary (claim 3). In addition to these, the diary format also shows subjective feelings such as the depth of sleep, the degree of depression, the degree of handing, the degree of acne, etc. on the straight line of a predetermined length. A writing field expressed as follows may be provided (claim 4).

  The broker's server monitors the physical condition by comparing the diary input information with the set value that is the selection condition, and if a change in physical condition is detected, the result is sent to the investigator's terminal together with the diary input information up to this date. (Claim 5). In this case, the investigator can select the investigator with higher accuracy by referring to the change in physical condition and other input information.

  In FIG. 1, reference numeral 10 denotes an intermediary server (computer), 12 denotes a terminal of a trial requester (study requesting institution), 14 (14A, 14B,...) Denotes a terminal of the trial practitioner (trial institution), 16 (16A, 16B,...) Are terminals of applicants who wish to participate in the clinical 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 and determines the clinical trial implementation plan (design) and summary to the clinical trial practitioner 14 (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, a procedure for selecting trial candidates is started from recruitment of clinical trial applicants according to the present invention (step S110), which will be described later. When a list of optimal clinical trial candidates appears in this step S110, the clinical trial investigator 14 examines and examines the clinical trial candidates to determine whether they are suitable for the clinical trials. After confirming that the clinical trial has been accepted and accepted, it is mutually confirmed (step S112). As a result, the trial investigator 14 determines whether or not the trial candidate can participate in the trial (step S114). This result is sent to the server of the broker 10 and stored as performance data (step S116). The result is sent from the intermediary to the applicant 10 (step S118).

The investigator 14 extracts the candidate from the list of candidates, performs a clinical trial using subjects who are finally confirmed through examination and medical examination, and monitors the progress of the clinical trial (step S120). This is the intermediary 10 and run in parallel of the trial is recorded is reported clinical trial participation of the subject 16 (step S122). In other words, the attendance status of the subject 16 is observed, and the behavior of the medication, reporting, etc. in accordance with the instructions is observed in compliance with the instructions of the trial investigator 14.

  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 S124). Further, the mediator 10 reports the clinical trial participation status of the subject 16 to the clinical trial client 12 or the clinical trial practitioner 14, and calculates and charges a fee such as a mediation fee (step S126).

(Subject recruitment procedure)
Next, the procedure for recruiting clinical trial applicants (step S110) will be described with reference to FIGS. The mediator 10 sets subject selection conditions (step S200) based on the meeting (step S108) with the above-described clinical trial requester 12 and the clinical trial practitioner 14, and presents this on the mediator's 10 homepage (HP). (Step S202). The applicant (applicant) 16 who wishes to participate in the clinical trial confirms this and applies (registers) to participate in the clinical trial (step S204). Prior to this application, it may be possible to accept (pre-registration) the application of the trial applicant 16 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 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.

  When the trial applicant (clinical trial participant) confirms the recruitment site of the mediator 10 (step S202 in FIG. 3) and applies (step S204), the mediator 10 is the applicant (student applicant). ID and PW are sent to (step 206). The trial participant 16 sends the sent ID / PW to the server of the mediator 10 (step S208), and the mediator server 10 sends the diary format to the trial participant 16 (step S210). ). At this time, the selection conditions for the investigator will also be sent. For example, the selection condition is a condition such as a subject of a clinical trial, that is, a clinical trial rule, a schedule, a region, whether or not to go to hospital. This selection condition includes a period required for selection (that is, a period during which the diary is continuously sent).

The diary format is, for example, a part extracted and shown in FIG. In this diary, the applicant's living conditions such as breakfast and wake-up time are entered, and the physical condition of the day (degree of fatigue) is entered in a linear position. That is, the left end A of this straight line is “no fatigue” and the right end B is “substantially tired”, so that the current state of attachment is represented by a position C between A and B.

  If the trial applicant 16 accepts this selection condition, he / she enters (inputs) necessary information in the diary format and periodically (for example, every day) sends it to the server of the mediator 10 (step S212). The server of the broker 10 checks and confirms the input status of this diary (step S214). Further, the physical condition of the trial applicant 16 is monitored from the input information of the diary (step S216). For example, it is possible to determine abnormalities and changes in physical condition by inputting selection conditions in advance as set values (including a set range) and comparing the diary input information with the set values.

  Then, the input information is collected for a predetermined period, and further sent to the terminal of the investigator 14 together with the physical condition monitoring result, or in a readable state (step S218). In this case, diary input information up to the time when this change in physical condition is detected is sent together with the physical condition monitoring result to the investigator so that the investigator can use it as data for selecting an appropriate investigator. The input information to be sent here may be sent for the entire period required for the selection set in the selection condition in step S210, or for a certain period at a midpoint. Since the period required for selection is set to several weeks, several tens of days, several months, etc., in the case of a long period, input information may be sent together during the period.

  The trial investigator 14 selects an applicant (applicant for clinical trial participation) 16 that matches the target clinical trial from this input information and notifies the mediator 10 (step S220). The intermediary 10 performs a process for confirming and obtaining consent for the clinical trial participation candidate 16 selected in response to this notification (step S222), and obtaining confirmation and consent for the trial participation candidate 16 (step S224). The trial applicant who obtained this confirmation / agreement is confirmed as a trial candidate (step S226), and the list of trial candidates is sent to the trial practitioner 14 (step S228). In other words, the trial investigator 14 makes this list available for browsing. It should be noted that when selecting the trial candidate, the mediator 10 server determines whether there is no contradiction in the input information of the diary for a predetermined period or whether the information is honest, and so on, and it is preferable to consider the reliability.

  The investigator 14 accesses the intermediary server 10 through the Internet 18 and browses and confirms the list of candidate candidates. This list may be sent from the intermediary 10 to the trial investigator 14 by other methods such as e-mail, facsimile, mail, etc. so that the list can be viewed. Then, the trial investigator 14 examines the test candidates 16 who visit the hospital on the scheduled date and time based on this list, and finally judges the suitability for the trial (step S112 in FIG. 2).

  The results of this examination are totaled and sent from the trial investigator 14 to the mediator server 10 by appropriate means such as e-mail, facsimile, or the Internet (step S116 in FIG. 2). This report may be received from the subject 16. The mediator 10 creates a list of subjects based on this report and notifies the trial candidates (step S118 in FIG. 2).

  The practitioner 14 conducts a clinical trial for the successful candidate (step S120 in FIG. 2), the result is reported to the mediator 10 (step S122), and the mediator 10 charges a fee (step S126). Results are received from the implementer 14.

  In the creation of the test candidate list performed in step S228 of FIG. 3, the mediator 10 may read the record data about the test experienced person from the server and write the record data about the subject 16 together. This is because the reliability of the individual subject 16 can be confirmed from the result data, and the reliability of the clinical trial results can be improved by using data obtained from highly reliable and honest participants.

(Server configuration)
Next, the configuration of the mediator server 10 shown in FIG. 1 will be described with reference to FIG. The server 10 has various functional units configured by software in order to perform the above-described processing. That is, it has a recruitment screen presentation unit 50 that presents clinical trial recruitment information corresponding to step S202 shown in FIG. 3 and prompts registration, a participation application reception unit 52 corresponding to step S204, and an ID / PW sending unit 54 corresponding to step S208.

  Further, a diary format presentation unit 56 corresponding to step S210, a diary storage unit 58 periodically sent from the applicant, a physical condition monitoring unit 60 that detects changes in the physical condition of the applicant from input information of the diary, and a predetermined period of time. Input information transmission unit 62 for sending log entry information to the trial practitioner 14, confirmation / consent processing unit 64 for confirming the intention of participation of the trial condition conformant selected by the trial practitioner 14, and confirmation of participation intention A list creation unit 66 for creating a list of clinical trial candidates who have obtained consent. Note that the memory for the recruitment screen, diary format, completed diary, etc., and the memory required for various processes may be common.

10 Broker (server)
12 Clinical trial client (terminal)
14 Clinical trial operator (terminal)
16 Trial applicant or applicant (terminal)
18 Internet

Claims (8)

In the method of recruiting and selecting subjects using a computer, an intermediary that introduces subjects who meet the clinical trial selection conditions to the trial investigator recruits and selects subjects via the Internet.
a. The intermediary server stores the clinical trial selection conditions and clinical trial recruitment information in advance, and the recruitment screen presenting unit of the server displays a screen showing the stored clinical trial recruitment information for the terminal of the trial participation applicant. Process of presenting and encouraging registration,
b. The intermediary server pre-stores a diary format together with the pre-stored trial selection conditions for the trial, and the pre-stored diary format includes a column for numerical data including blood pressure and body temperature, and a subjectivity including the degree of fatigue. The ID / PW presentation section of this server has an application for registration from the terminal of the applicant who wishes to participate in the trial. Sending an ID / PW that enables reading of the previously stored diary format;
c. The diary format presentation unit of the mediator server receives the ID / PW sent from the trial applicant and sends the pre-stored diary format and the selection conditions to the trial participant's terminal.
d. The intermediary server reads the diary that is filled in the diary format periodically sent from the terminal of the trial applicant, stores the diary in the diary storage unit, and the pre-stored selection condition for the diary input information. A step of monitoring the physical condition of the applicant who wishes to participate in the trial by a physical condition monitoring unit by comparing with a set value to be detected and detecting a suitable timing for performing the trial ,
e. When the intermediary server detects this timing , the physical condition monitoring unit monitors the input information for a predetermined period of the diary sent from the terminal of the trial applicant and stored in the diary storage unit. Making it possible to read the physical condition monitoring result of the applicant who wishes to participate in the terminal of the investigator,
f. The participation confirmation / consent processing unit possessed by the server of the intermediary is a step of prompting confirmation / agreement of participation intention to a terminal of a trial applicant who meets the selection conditions stored in advance.
g. List generating unit that server of the intermediary has, the step of sending the list to the study candidate clinical trial participants who wish to obtain the confirmation / consent to the terminal of the trial practitioner,
A subject recruitment / selection method using a computer having the steps a to g. The diary format is any of blood pressure, body temperature, number of steps, weight, visceral fat level, BMI, caloric activity, electrocardiogram, blood glucose level, body fat, cholesterol level, neutral fat, GOT, GPT, uric acid level , Hba1c, etc. The method for recruiting and selecting subjects according to claim 1, including an entry field.   Step d. 3. The method for recruiting and selecting subjects according to claim 2, wherein the intermediary server reads the measurement result by the measuring instrument separately sent to the trial applicant from the trial applicant's terminal together with the diary.   The diary format further includes a writing field for inputting a subjective feeling at any one of the following states: sleep depth, degree of depression, degree of rough hand, and degree of acne. Selection method.   Step d. If a change in physical condition is detected at the mediator's server, step e. The method for recruiting and selecting subjects according to claim 1, wherein the diary input information and physical condition monitoring results up to the date of detection are collectively sent to the terminal of the trial investigator. An intermediary server used in the method of claim 1,
Recruitment screen presentation unit for preliminarily storing clinical trial selection conditions and clinical trial recruitment information, and presenting the stored clinical trial recruitment information to the terminals of those who wish to participate in the clinical trial,
A participation application receiving unit that receives a registration application signal input from a terminal of the trial applicant.
In addition to the pre-stored clinical trial selection conditions, a diary format having an entry field for numerical data including blood pressure and an entry field for indicating subjective sensory data including the degree of fatigue on a straight line is stored in advance, and the registration is performed. An ID / PW sending unit that accepts an application signal and sends ID / PW for reading out the format of this diary to the terminal of the applicant who is a participating applicant;
A diary format presentation unit that accepts an ID / PW and presents the format of the diary and the selection conditions on the terminal of the applicant who is the applicant for the trial ;
A diary storage unit that reads and stores diaries periodically sent from the applicant's terminal;
A physical condition monitoring unit that compares the input information of the diary with a set value that is a selection condition , monitors changes in physical condition, and detects a suitable timing for performing the trial ;
When this timing is detected , input information for a predetermined period of the diary sent from the applicant's terminal is read from the diary storage unit and sent to the trial investigator's terminal together with the physical condition monitoring result of the physical condition monitoring unit A transmission unit;
A confirmation / consent processing unit for confirming / consenting the intention to participate in the trial to the trial condition conformant sent from the terminal of the trial investigator;
An applicant who has confirmed / consented the intention to participate in the trial as a trial candidate, creates a list of trial candidates, and allows the trial investigator's terminal to view the list,
A server for recruiting intermediaries for subjects. Computer software used in the method of claim 1, wherein the server is
Recruitment screen presentation unit for preliminarily storing clinical trial selection conditions and clinical trial recruitment information, and presenting the stored clinical trial recruitment information to the terminals of those who wish to participate in the clinical trial,
A participation application receiving unit that receives a registration application signal input from a terminal of the trial applicant.
In addition to the pre-stored clinical trial selection conditions, a diary format having an entry field for numerical data including blood pressure and an entry field for indicating subjective sensory data including the degree of fatigue on a straight line is stored in advance, and the registration is performed. An ID / PW sending unit that accepts an application signal and sends ID / PW for reading out the format of this diary to the terminal of the applicant who is a participating applicant;
A diary format presentation unit that accepts an ID / PW and presents the format of the diary and the selection conditions on the terminal of the applicant who is the applicant for the trial;
A diary storage unit that reads and stores diaries periodically sent from the applicant's terminal;
A physical condition monitoring unit that compares the input information of the diary with a set value that is a selection condition, monitors changes in physical condition, and detects a suitable timing for performing the trial ;
When this timing is detected , input information for a predetermined period of the diary sent from the applicant's terminal is read from the diary storage unit and sent to the trial investigator's terminal together with the physical condition monitoring result of the physical condition monitoring unit A transmission unit;
A confirmation / consent processing unit for confirming / consenting the intention to participate in the trial to the trial condition conformant sent from the terminal of the trial investigator;
A program for functioning as a list creation unit that creates a list of clinical trial candidates and allows the trial applicant to view the trial candidates with the applicants who have confirmed / consent the intention to participate in the trial as clinical trial candidates. A computer-readable storage medium storing the program according to claim 7.