JP2004029894A - Case registration system, case registration information processing apparatus, and method and program for case registration - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a case registration system capable of easily and efficiently carrying out examinee adaptability inspection and medicine allotment in a clinical examination. <P>SOLUTION: Disclosed is the case registration system which selects and registers an examinee who participates in the clinical examination. A server computer 11 which registers cases is provided and then equipped with a primary registering means of deciding whether characteristic information of a candidate for the examinee who shows an intention to participate in the clinical examination at the start of an observation period matches a first examinee adaptability standard and a secondary registering means of deciding characteristic information of the candidate for the examinee with matching information decided by the primary registering means at the end of the observation period matches a second examinee adaptability standard and registering the candidate having matching information as the examinee in a case registration storage means. <P>COPYRIGHT: (C)2004,JPO

Description

[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a case registration system, a case registration information processing apparatus, a case registration method, and a case registration program, and in particular, a case registration system, a case registration information processing apparatus, which can efficiently execute complicated case registration operations using a computer, The present invention relates to a case registration method and a case registration program.
[0002]
[Prior art]
In the process of new drug development, we conduct basic research to select compounds with high potential from new drug candidates, and then conduct non-clinical tests to examine pharmacological effects using animals. After that, clinical trials are conducted, and the results of the clinical trials are submitted to the Ministry of Health, Labor and Welfare, where they are reviewed for approval.
In clinical trials, in response to a request from a pharmaceutical company that developed a new drug, a medical institution administers the new drug to healthy adults or patients with a disease to which the new drug is applied, and sends the results of the clinical trial to the Ministry of Health, Labor and Welfare. Once submitted and reviewed for approval, new drugs can be launched once production is approved.
[0003]
The clinical test is performed on healthy adults, patients with a disease to which the new drug is applied, and the like according to the purpose of the clinical test. When starting a clinical trial, a pharmaceutical company outsources the recruitment of subjects to participate in the clinical trial to a medical institution under a contract with the medical institution.
The medical institution recruits test candidates by advertisement in a hospital or the like, and collects the number of test candidates specified in the contract by the contract date.
The physician conducts interviews, consultations, and background surveys on the collected test subjects, obtains consent, and enters the results into the “subject suitability checklist” given by the pharmaceutical company.
[0004]
Pharmaceutical company monitors receive this checklist and perform a subject compatibility test to match each subject candidate with the criteria for subject compatibility to be eligible for clinical trials.
As a result, only the test candidates that are suitable are extracted.
[0005]
The extracted test candidates are assigned to be divided into test drug and placebo groups for a double-blind test or the like. In the assignment, the subject is given a drug number so that it is not known which subject has received which medicine. The assignment table showing the correspondence between the drug number and the medicine administered is sealed, and is stored so as not to be opened except in an emergency such as when the condition of the subject suddenly changes.
Thereafter, for each subject, subject registration for registering the subject and the drug number identifying the drug, the subject's initials, and the like in a clinical trial database is performed, and the subject is used for management of the subsequent clinical trial.
[0006]
[Problems to be solved by the invention]
However, such a conventional subject compatibility test is performed manually by collating the subject compatibility checklist sheet with the subject compatibility standard sheet one by one. In addition, the assignment work was also performed by manually classifying the subjects determined to be suitable by the subject compatibility test.
Therefore, a great deal of effort and time has been spent on the subject compatibility test and the assignment work, which has been one of the causes of prolonged clinical trials and, consequently, delay in the launch of new drugs.
An object of the present invention is to solve the above-mentioned problems, and a case registration system, a case registration information processing apparatus, a case registration method, and a case that can easily and efficiently perform a subject compatibility test and a drug allocation in a clinical trial. To provide a registration program.
[0007]
[Means for Solving the Problems]
According to the first aspect of the present invention, there is provided a case registration system for selecting and registering a subject who participates in a clinical trial, comprising a server computer for performing case registration, wherein the server computer is configured to perform a clinical trial. The characteristic information at the start of the pre-observation period of the test candidate who has expressed his / her intention to participate is determined by the primary registration unit that determines whether or not the characteristic match the first subject matching criterion, and is matched by the primary registration unit The characteristic information at the end of the pre-observation period pertaining to the test candidate determined as described above is determined as to whether or not the test subject matches a second subject suitability criterion. And a secondary registration unit for registering in the registration storage unit.
[0008]
According to the third aspect of the present invention, there is provided a case registration information processing apparatus for selecting and registering a subject to participate in a clinical trial, wherein the subject registration information processing apparatus includes a subject candidate who has expressed an intention to participate in the clinical trial. Primary registration means for determining whether the characteristic information at the start of the pre-observation period matches the first subject matching criterion, and pre-observation of the test candidate determined to be matched by the primary registration means Secondary registration means for determining whether the characteristic information at the end of the period matches a second subject suitability criterion, and registering the matched test candidate in the case registration storage means as the subject, It is solved by having.
[0009]
According to the invention as set forth in claim 8, the above problem is a case registration method for selecting and registering a subject to participate in a clinical trial, wherein a pre-observation of a test subject who has expressed his / her intention to participate in the clinical trial The primary registration procedure for determining whether the characteristic information at the start of the period matches the first subject matching criterion, and the end of the pre-observation period for the subject candidate determined to match in the primary registration procedure A second registration procedure of determining whether the characteristic information at the time matches the second subject matching criterion, and registering the matching test candidate in the case registration storage means as the subject. It is solved by.
[0010]
According to the invention according to claim 13, the above-mentioned subject is to provide a case registration information processing device for selecting and registering a subject to participate in a clinical trial, and to perform a pre-observation of a test candidate who has expressed an intention to participate in the clinical trial The primary registration procedure for determining whether the characteristic information at the start of the period matches the first subject matching criterion, and the end of the pre-observation period for the subject candidate determined to match in the primary registration procedure A second registration procedure for determining whether the characteristic information at the time matches the second subject matching criterion, and registering the matching test candidate in the case registration storage means as the subject. It is solved by a program for causing
[0011]
As described above, the primary registration means for determining whether or not the characteristic information at the start of the pre-observation period of the test candidate who has expressed his / her intention to participate in the clinical trial meets the first subject suitability criterion, The characteristic information at the end of the pre-observation period for the test candidate determined to be matched by the registration means is determined as to whether it matches a second subject matching criterion, and the matched test candidate is determined. Since the subject is provided with a secondary registration means for registering the subject as the subject in the case registration storage means, after the pre-observation period, the subject non-conforming person is excluded from the test candidates by primary registration before the pre-observation period. Since subjects are narrowed down based on changes in symptoms during the period, the selection of subjects can be divided into two stages, primary registration and secondary registration. Therefore, it is possible to efficiently select the subjects, and it is not necessary to perform the secondary registration for the test candidates excluded in the primary registration. It can be suppressed.
[0012]
At this time, the secondary registration means allocates a test drug or a fake drug to be administered to the test candidate who meets the second subject matching criteria, and attaches the test drug or the pseudo drug regardless of the type of the drug to be administered. The drug identification is given, and the identification information of the test candidate is registered in the case registration storage unit in association with the drug type and the number, and the drug number is the number of the drug types to be administered. From a combination of a set for specifying a group including the subject in an integer multiple, and a number assigned to an integer multiple of the number of the drug types to be administered, in order to specify each subject included in the set. It is preferable that such a configuration be made.
[0013]
With this configuration, the selection of a subject fitter from the test candidates and the assignment of the medicine can be performed at once by the case registration information processing apparatus, and the case can be registered efficiently in a short time. .
[0014]
At this time, in the secondary registration means, among the drugs to be administered, the number of allocated subjects of the entire clinical trial is the largest number of allocated subjects, A total equal allocation means for allocating the test drug or the fake drug to the test candidate so that the difference obtained by subtracting the number of allocated subjects is less than 2, and the drug to be administered as a result of the allocation by the total equal allocation means. Among them, the difference obtained by subtracting the number of subjects assigned to the drug with the smallest number of assigned subjects at the medical institution from the number of subjects assigned to the drug with the largest number of assigned subjects at the medical institution relating to the subject candidate is 2 If it exceeds, it is preferable to provide a re-allocation unit for re-executing the allocation.
[0015]
According to the invention according to claim 6, the above problem is a case registration information processing apparatus for selecting and registering a subject to participate in a clinical trial, wherein the subject registration information processing apparatus The characteristic information determines whether or not the subject matches the criteria, and assigns a test drug or a fake drug to be administered to the test candidate that satisfies the condition, and assigns the test drug or the pseudo drug irrespective of the type of the drug to be administered. Registering means for assigning a drug number and registering the subject in the case registration storage means as the subject, wherein the drug number is for specifying a group including the subject in an integral multiple of the number of drug types to be administered. A combination of a set and a number given to an integral multiple of the number of drug types to be administered in order to identify each subject included in the set, , The clinical trial The candidate subject so that the difference obtained by subtracting the number of subjects assigned to the drug with the smallest number of assigned subjects in the entire clinical trial from the number of assigned subjects to the drug with the largest number of assigned subjects to the body is less than 2. A total equal allocation means for allocating the test drug or the fake drug to the test drug or a fake drug, and as a result of allocation by the total equal allocation means, the drug having the largest number of allocated subjects in the medical institution relating to the test candidate among the drugs to be administered If the difference obtained by subtracting the number of assigned subjects of the medicine with the smallest number of assigned subjects at the medical institution from the number of assigned subjects exceeds 2, if the difference is greater than 2, equivalence assigning means for executing assignment again is provided. It is solved by.
[0016]
According to the eleventh aspect of the present invention, there is provided a case registration method for selecting and registering a subject to participate in a clinical trial, wherein characteristic information of a test candidate who expresses his intention to participate in the clinical trial Is to determine whether or not the subject match criteria are met, and assign a test drug or a fake drug to be administered to the test candidate that matches, and a drug number assigned irrespective of the type of drug to be administered A registration procedure for registering the subject in the case registration storage unit as the subject, wherein the drug number is a group for specifying a group including the subject in an integral multiple of the number of drug types to be administered; In order to identify each of the test subjects included in the set, a number is added up to an integer multiple of the number of drug types to be administered. All assigned The test candidate is assigned to the test candidate so that the difference obtained by subtracting the number of subjects assigned to the drug having the smallest number of assigned subjects in the entire clinical trial from the number of subjects assigned to the drug having the largest number of subjects is less than 2. Or, a procedure for allocating a fake drug, and, as a result of allocating by the total allocating means, among the drugs to be administered, the number of subjects to be allocated to the drug having the largest number of allocated subjects at the medical institution relating to the test candidate. If the difference obtained by subtracting the number of allocated subjects of the medicine with the smallest number of allocated subjects at the medical institution exceeds 2, if the difference is solved by performing the allocation process again, the allocation is performed again. .
[0017]
According to the invention according to claim 16, the above object is to provide a case registration information processing apparatus for selecting and registering a subject who participates in a clinical trial, by providing characteristic information of a test candidate who has expressed his / her intention to participate in the clinical trial. Is to determine whether or not the subject match criteria are met, and assign a test drug or a fake drug to be administered to the test candidate that matches, and a drug number assigned irrespective of the type of drug to be administered A registration procedure for registering the subject in the case registration storage unit as the subject, wherein the drug number is a group for specifying a group including the subject in an integral multiple of the number of drug types to be administered; In order to identify each of the test subjects included in the set, a number is added up to an integer multiple of the number of drug types to be administered. All assigned The test candidate is assigned to the test candidate so that the difference obtained by subtracting the number of assigned subjects of the drug having the smallest assigned number of subjects in the entire clinical trial from the number of assigned subjects of the drug having the largest number of subjects is less than 2. Or, a procedure for allocating a fake drug, and, as a result of allocating by the total allocating means, among the drugs to be administered, the number of subjects to be allocated to the drug having the largest number of allocated subjects at the medical institution relating to the test candidate. If the difference obtained by subtracting the number of assigned subjects of the drug with the smallest number of assigned subjects in the medical institution exceeds 2, if the difference is more than two, a re-allocation procedure is executed again, and a program for executing Will be resolved.
[0018]
As described above, in order to equalize each administration group for each medical institution and for the entire clinical trial, first, a total equalizing means for the entire clinical trial is performed, and if the result is not equalized at the medical institution, a re-evaluation is performed. Since the re-equalization means is performed again, the administration groups can be efficiently equalized for each medical institution and for the entire clinical trial. In other words, if the result of equalization for the entire clinical trial is also equalized at the medical institution, there is no need to equalize at each medical institution. Therefore, the assignment can be performed with less labor than when equalizing each medical institution first.
[0019]
At this time, it is installed in the case registration institution requested to perform the case registration work from the new drug development institution, and means for inputting the characteristic information of the test candidate, and the characteristic information of the test candidate is installed in the case registration institution. At least one of a group including: a unit configured to receive the characteristic information of the subject from a computer installed at a medical institution that has received recruitment of subjects from the new drug development institution. It is preferable that the apparatus be configured to include the above-described means.
[0020]
With this configuration, not only is the case registration information processing device installed at the case registration institution directly input of the candidate candidate's characteristic information, but also the characteristic of the test candidate received by remote entry from the medical institution. Using the information, it becomes possible to execute the case registration of the subject and the drug allocation by the case registration information processing apparatus.
[0021]
BEST MODE FOR CARRYING OUT THE INVENTION
Hereinafter, an embodiment of the present invention will be described with reference to the drawings. The configuration and the like described below do not limit the present invention and can be variously modified within the scope of the present invention.
With the case registration system of the present invention, after receiving information on test candidates who are willing to participate in a clinical trial from a medical institution, each test candidate was checked for suitability as a subject fitter, and then judged as fit In this system, only subjects are registered while performing drug allocation.
[0022]
"Drug allocation" means that a test drug or a placebo is assigned to a test candidate determined to be suitable as a subject, and a drug number unrelated to the type of drug so that it is not possible to know which drug was administered to which subject. Means to attach
[0023]
Although the case registration system according to the present embodiment selects and registers subjects to participate in a clinical trial of a new drug, the case registration system according to the present embodiment performs a bioequivalence test for a generic drug, Continuously administer substances to humans for a certain period of time, such as a clinical utility test, post-marketing surveillance of drugs, and a test to confirm the effects of health foods, foods for specified health uses, functional foods, cosmetics, etc. Any test may be performed as long as the test is performed.
The clinical test of the new drug may be any of the first to third phases, and may be any of a clinical pharmacology test, an exploratory test, a confirmatory test, and a therapeutic test.
[0024]
In this specification, “computer” is meant to include all information terminals provided with a computing device. For example, in addition to a supercomputer, a general-purpose computer, an office computer, a control computer, a workstation, and a personal computer, a mobile information terminal, a mobile phone equipped with an arithmetic device, and the like are also included.
[0025]
As shown in FIG. 1, the case registration system according to the present embodiment includes a case registration company 1 as a case registration organization that supervises and manages the case registration system according to the present embodiment, and a pharmaceutical company as a new drug development organization that requests a clinical trial. 2 and a medical institution 3 that conducts clinical trials.
Prior to the start of the clinical trial, the case registration company 1 receives information on the test candidates who have expressed their willingness to participate in the clinical trial from the medical institution 3 and confirms that each test candidate has suitability as a subject. Is determined, and only the test subject who is suitable as a result of the determination is registered as a test subject, and a drug is assigned to a test subject fitter.
The case registration company 1 is configured as an independent organization different from the pharmaceutical company 2 and the medical institution 3.
[0026]
As shown in FIG. 1, the case registration company 1 is provided with a server computer 11 for supervising the case registration system and a terminal computer 12 used by a person in charge of the case registration company 1. Data is exchanged with the terminal computer 12.
[0027]
The pharmaceutical company 2 is an organization that develops a new drug, and requests a clinical institution 3 for a clinical test of the developed new drug. In the case where the case registration system according to the present embodiment is a test for confirming the effects of food and cosmetics, a food company, a cosmetic manufacturer, or the like is used instead of the pharmaceutical company 2.
[0028]
Upon receiving a request for a clinical trial from the pharmaceutical company 2, the medical institution 3 appoints a clinical trial supervisor in charge of the clinical trial and a clinical trial doctor in charge of assisting the clinical trial doctor. Hereinafter, a case including both a clinical trial investigator and a clinical trial doctor is referred to as “physician or the like”.
The medical institution 3 is responsible for conducting clinical trials to the extent requested. When the medical institution 3 concludes a clinical trial contract with the pharmaceutical company 2, the medical institution 3 is responsible for securing the number of subjects agreed in the contract.
The medical institution 3 gives informed consent to the test candidate who intends to participate in the clinical trial, and upon obtaining consent, conducts a medical interview, a medical examination, a background investigation, and the like. The results of the interview, consultation, background survey, and the like are transmitted by facsimile to the case registration company 1 as information on the test candidate.
[0029]
Next, each computer will be described.
The server computer 11 is a computer that is installed in the case registration company 1 and that totally manages the case registration system of the present embodiment.
FIG. 2 shows a hardware configuration of the server computer 11.
The server computer 11 includes a CPU 72 as a data calculation / control processing device (central processing unit), a RAM 73, a ROM 74, an HDD 75, and a storage medium device 76 as storage devices. Further, a communication device 77, a keyboard 78, a mouse 79, a display device 80, and a printer 81 are provided.
[0030]
The CPU 72 performs a calculation using information received from the storage device or the input device, and serves to pass a result of the calculation to the storage device or the output device. According to a program stored in the ROM 74 or the HDD 75, the CPU 72 performs various operations. Execute the process.
[0031]
The storage device stores programs and the like for executing various processes. Among the storage devices, the storage medium device 76 is configured by an external HDD, a media device such as an MO, a CD-RW, and a DVD, and is transmitted from the data transmitted via the communication device 77, the keyboard 78 and the mouse 79. Various kinds of input data can be appropriately stored and read out.
[0032]
The RAM 73 stores data and the like necessary for the CPU 72 to execute various types of processing. The keyboard 78 and the mouse 79 are appropriately operated when various commands are input to the CPU 72.
[0033]
The display device 80 is a device that displays an image or the like created by the CPU 72 according to a program stored in the ROM 74, the HDD 75, or the like. The printer 81 outputs predetermined information from each computer on paper.
[0034]
The communication device 77 transmits data to the Internet 4 or another computer, and receives data from the Internet 4 or another computer.
[0035]
The HDD 75 stores a primary registration table (not shown), a secondary registration table (not shown), and the subject matcher table 15 of FIG.
The primary registration table (not shown) is a table for storing information on the test candidates input from the terminal computer 12 at the time of the primary registration, and the test candidate primary registration data created for each test candidate is registered.
[0036]
The primary registration table (not shown) includes, as items, a clinical trial project number for specifying the clinical test, a medical institution number for specifying the medical institution 3 where the conformant person has been diagnosed, and a subject for specifying the subject. Subject identification code, the name of the physician whose subject was diagnosed, the subject's gender, primary registration date, scheduled assignment date, target selection criteria for primary registration, target exclusion criteria, input contents of consent acquisition method, conformance / non-conformity The reasons for non-conformity are included.
[0037]
The secondary registration table (not shown) is a table for storing information on the test candidates input from the terminal computer 12 at the time of the secondary registration, in which test candidate secondary registration data created for each test candidate is registered. ing.
[0038]
The secondary registration table (not shown) includes, as items, a clinical test project number for specifying the clinical test, a medical institution number for specifying the medical institution 3 where the conformant person has been diagnosed, and the subject. Subject identification code, the name of the physician who was diagnosed by the subject, the gender of the subject, the date of the secondary registration, the criteria for inclusion in the secondary registration, the input contents of the criteria for exclusion, If the reason is included.
[0039]
The subject fitter table 15 is a table for registering subject data on subjects determined to be fit by the primary registration and the secondary registration among the information on the test candidates input from the terminal computer 12 at the time of the primary registration and the secondary registration. It is.
[0040]
The subject matcher table 15 has registered therein subject data created for each subject, and includes, as items, a clinical test project number 151 for specifying the clinical test, and a medical institution 3 where the subject has been diagnosed. The medical institution number 152, the subject identification code 153 for identifying the subject, the subject number 154 assigned to the subject in the secondary registration, the name 155 of the doctor who was diagnosed by the subject, the sex 156 of the subject, A primary registration date 157, a secondary registration date 158, input contents 159 in the primary registration and the secondary registration, and an administration group 160 are included.
[0041]
The subject number 154 is a number for identifying the subject during the clinical test, and is assigned the same number as the drug number.
The drug number is a number for specifying an individual drug in a clinical test, and is represented as “M group N number (M is an integer of 1 or more, N is an integer of 1 to 6)”. The M set corresponds to the set of claims, and the Nth corresponds to the number of the claim.
The administration group 160 has P indicating the placebo administration group, L indicating the low-concentration test drug administration group, and H indicating the high-concentration test drug administration group, and the type of drug administered to the subject is registered. ing. The low-concentration test drug and the high-concentration test drug correspond to the claimed test drug, and the placebo corresponds to the claimed placebo drug.
[0042]
Here, the subject identification code is a number for identifying a test candidate. In the present embodiment, an alphabet and a numeric symbol for specifying a clinical trial, a three-digit number for specifying a medical institution 3, and a three-digit number for specifying a test candidate in the medical institution 3 And is displayed, for example, as “AnBnnnnnn” (n is a positive integer).
[0043]
The primary registration date refers to a date on which a doctor or the like performs an inquiry, diagnosis, and background investigation for determining the suitability of a subject after obtaining consent from the subject.
Also, the scheduled assignment date refers to the scheduled date of drug allocation execution, and is synonymous with the scheduled date of secondary registration.
[0044]
The period from the first registration date to the drug allocation date, that is, the second registration date, is referred to as a pre-observation period. The pre-observation period is a period for determining whether or not the test candidate has suitability as a test subject.
The pre-observation period is determined for each clinical test, and is set to 6 days in the present embodiment.
If the patient cannot be examined six days after the first registration day because of a holiday, etc., the second registration day, that is, the drug allocation date, is set for the earliest patient after six days.
[0045]
The physician conducts an interview, diagnosis, and background investigation to determine whether or not the test subject has subject suitability on the first registration day, which is the start of the pre-observation period, and compares the results with the subject suitability shown in FIG. Fill out the gender check list (for primary registration) 31 and fax it to the case registration company 1.
[0046]
Thereafter, on the assignment day, which is the end of the pre-observation period, on the second enrollment date, the symptoms of the test candidate have not recovered toward the primary enrollment date or have characteristics that the test candidate should not administer the test drug. A questionnaire, diagnosis, and background investigation are performed to determine whether or not the subject is compatible with the subject, and the results are entered into a subject compatibility checklist (not shown) (at the time of assignment) and entered into the case registration company 1. Send by fax.
The target selection criterion is a criterion that does not conform when the answer is “NO”, and the target exclusion criterion is a criterion that does not conform when the answer is “YES”. Exclusion criteria often include items related to subject safety.
[0047]
Next, a description will be given of a procedure in which the case registration system of the present embodiment determines whether or not a test candidate who intends to participate in a clinical test is a subject fitter, and allocates a drug to a subject determined to be fit.
In the case registration system of the present embodiment, first, the medical institution 3 recruits patients who intend to participate in a clinical trial by advertisement or the like.
A doctor or the like gives informed consent to the test candidate who has expressed his / her intention to participate, and obtains consent from the test candidate.
[0048]
Thereafter, the doctor or the like conducts a medical interview, diagnosis, background investigation, and the like on the subject candidate, and in the subject suitability checklist (for primary registration) 31 of FIG. Fill in the survey results. These results to be entered correspond to the characteristic information of the claim.
The subject suitability checklist (for primary registration) 31 shown in FIG. 4 includes a target selection criterion check item 311, a target exclusion criterion check item 312, a consent acquisition method check item 313, an explanation date / consent date entry column 314, and a medical It includes an institution name entry field, doctor name entry field, primary registration date entry field, subject identification code entry field, and scheduled assignment date entry field.
The date of consent is a date on which the subject agrees to be a subject of a clinical test, and the date of explanation is a date on which a doctor or the like gives informed consent to the subject, such as the content of the clinical test.
[0049]
The subject compatibility check list (for primary registration) 31 in FIG. 4 is an entry method by selecting YES and NO.
The subject selection criteria of the subject compatibility checklist (for primary registration) 31 in FIG. 4 include, for example, that the age is 20 years or older, that 3 months or more have passed since the onset, and that the sustained pain VAS is 30 or more. And criteria for the degree of symptoms of the target drug.
[0050]
VAS is an abbreviation of Visual Analog Scale, and is a numerical value indicating the degree of symptoms subjectively felt by a subject in the range of 0 to 100.
In addition, the exclusion criteria include criteria regarding whether or not the subject has characteristics that should not be administered with the test drug, such as pregnancy or the like, participation in another study within the past three months.
[0051]
Upon entry, the doctor or the like faxes the subject compatibility check list (for primary registration) 31 of FIG.
In this embodiment, the subject compatibility check list (for primary registration) 31 in FIG. 4 is transmitted by facsimile, but data is directly transmitted from the terminal computer 30 installed in the medical institution 3 to the case registration company 1. Is also good.
[0052]
Upon receiving the subject compatibility checklist (for primary registration) in FIG. 4 from the medical institution 3, the case registration company 1 performs preliminary acceptance inspections on rough bibliographic items such as whether all the entry fields are filled out. I do.
[0053]
Thereafter, the case registration company 1 connects to the server computer 11 from the terminal computer 12, and inputs and transmits the contents of the subject compatibility check list (for primary registration) 31 in FIG.
In this embodiment, the contents of the subject suitability check list (for primary registration) 31 in FIG. 4 are transmitted from the terminal computer 12 to the server computer 11, but may be directly input by the server computer 11.
When the input is completed, primary registration is automatically performed by the case registration program to automatically sort test candidates into conforming persons and non-conforming persons.
[0054]
This primary registration process will be described with reference to the flowcharts of FIGS. 6 and 7 are controlled by the CPU 72 of the server computer 11.
When the person in charge of the case registration company 1 clicks the icon of the case registration program on the screen of the terminal computer 12, the case registration program starts, the terminal computer 12 accesses the server computer 11, and the top screen 101 in FIG. .
[0055]
On the left side of the top screen 101, a menu screen 110 is displayed. On the menu screen 110, a primary registration button 112 for displaying the top screen 101 for primary registration shown in FIG. A primary registration correction button 113 for displaying a primary registration correction screen (not shown) to be corrected, a secondary registration button 114 for displaying a secondary registration screen (not shown), and the contents input on the secondary registration screen (not shown). A secondary registration correction button 115 for displaying a secondary registration correction screen (not shown) to be corrected, a menu screen 110, and a close button 116 for closing each registration screen are displayed.
[0056]
The top screen 101 is a screen in which the person in charge of the case registration company 1 performs the primary registration of the test candidate, and is used as an initial screen when the case registration program is started or the primary registration button 112 of the menu screen 110 is clicked. When displayed.
On the top screen 101, a target selection criterion tab 121 for displaying an unillustrated target selection criterion input screen, a target exclusion criterion tab 122 for displaying a not-shown target exclusion criterion input screen, a consent input screen of FIG. A consent tab 123 for displaying 130 and an other tab 124 for displaying other input screens (not shown) are included. By clicking each of the tabs 121 to 124, a corresponding input screen is displayed. Is configured.
[0057]
After inputting all items, a registration button 141 for registering the input contents and a confirmation list print button 142 for printing a primary registration result confirmation slip are included.
One screen corresponds to one test candidate on the top screen 101, and is configured to click the register button 141 to register when completing the input for one test candidate.
[0058]
When the top screen 101 of FIG. 5 is displayed on the screen of the terminal computer 12, the flowchart of FIG. 6 starts.
In step S101, it is determined whether the registration button 141 in FIG. 5 has been clicked.
If the registration button 141 has not been clicked (step S101: NO), it is determined in step S102 whether a predetermined time, for example, 15 minutes has elapsed.
[0059]
If the predetermined time has not elapsed (step S102: NO), it is determined that input is being performed, and it is determined again whether the registration button 141 has been clicked in step S101.
That is, steps S101 and S102 are repeated until the predetermined time has elapsed.
If the predetermined time has elapsed (step S102: YES), it is determined that there is no intention to input, and the process ends.
[0060]
When the registration button 141 is clicked (step S101: YES), it is determined that the person in charge of the case registration company 1 has completed the input of the subject candidate and in step S103, there is an uninput item in the required input items. judge.
In the present embodiment, all items on the top screen 101 in FIG. 5 are set as mandatory input items, and if there is at least one uninput in the top screen 101 in FIG. .
[0061]
If there is an uninput item in the required input items (step S103: YES), the process proceeds from step B to step S121 via step B in FIG. 7, and an unillustrated error such as “There is an input error. A screen is displayed and the process ends.
If there is no uninput item in the required input items (step S103: NO), it is determined in step 104 whether the answer to the selection criterion is “NO”.
In the present embodiment, the selection criteria include that the age is 20 years or older, that 3 months or more have passed since the onset, and the like.
[0062]
If the answer to the selection criterion is “NO” (step S104: YES), it is determined that there is an item for which relevance is denied by the selection criterion, and the nonconforming item that is “NO” in step S105 is not shown Register in memory.
Next, in step S106, it is determined whether the answer to the exclusion criterion is “YES”.
[0063]
If there is no “NO” in the answer to the selection criterion (step S104: NO), it is determined that there is no answer that denies subject compatibility in all items of the selection criterion, and “YES” is set to the exclusion criterion in step S106. Determine if there is.
In the present embodiment, as shown in FIG. 4, the exclusion criteria include characteristics that should not be administered with the test drug, such as being pregnant or participating in another test within the past three months. Criteria are included.
[0064]
If the answer to the exclusion criterion includes “YES” (step S106: YES), it is determined that there is an item for which the compatibility is denied by the exclusion criterion, and the non-conforming item for which “YES” was determined in step S107 is an unconforming non-illustrated Register in memory.
Thereafter, in step S108, it is determined whether or not the answer to the consent acquisition includes "NO".
If there is no "YES" in the answer to the exclusion criteria (step S106: NO), it is determined in step S108 whether there is "NO" in the answer to obtain consent.
[0065]
If the answer to the consent acquisition is "NO" (step S108: YES), it is determined that there is a problem in the consent acquisition method, and in step S109, the nonconforming item of "YES" is registered in a nonconforming memory (not shown). . Next, in step S110, it is determined whether or not the consent date <explanation date, that is, whether or not the input consent date is earlier than the input explanation date.
[0066]
If there is no "NO" in the consent acquisition response (step S108: NO), it is determined that there is no problem in the consent acquisition method, and in step S110, the consent date <explanation date, that is, the entered consent date is input. It is determined whether it is before the explanation date.
[0067]
If the consent date is less than the explanation date (step S110: YES), that is, if the agreement date is before the explanation date, it is impossible to give consent before the explanation. Proceeding to S121, an error screen (not shown) such as "There is an input error. Please check and correct it" is displayed, and the process ends.
If the consent date is not the description date (step S110: NO), that is, if the consent date is the same as or later than the description date, it is determined that there is no problem in the relationship between the consent date and the description date, and step In S111, it is determined whether today's date <primary registration date, that is, whether the system date is before the primary registration date.
[0068]
If today's date <primary registration date (step S111: YES), it is impossible that today's date is earlier than the primary registration date, so the process proceeds from B to step S121 via B in FIG. There is an input error. Please correct it after confirmation. ", And terminate the process.
[0069]
If today's date is not the primary registration date (step S111: NO), that is, if today's date is the same as or later than the primary registration date, the relationship between today's date and the primary registration date is determined. Assuming that there is no problem, the process proceeds from A to step S112 via A in FIG. 7, and it is determined whether the consent date> the primary registration date, that is, whether the consent date is later than the primary registration date.
[0070]
If the consent date> the primary registration date (step S112: YES), the consent date cannot be later than the primary registration date, so the process proceeds to step S121, where "there is an input error. Please display an error screen (not shown) and terminate the process.
If the agreement date is not the primary registration date (step S112: NO), that is, if the agreement date is the same as or earlier than the primary registration date, there is no problem in the relationship between the agreement date and the primary registration date. In step S113, it is determined whether or not the subject identification code of the subject candidate has already been registered in the primary registration table (not shown) stored in the HDD 75.
[0071]
If the subject identification code of the test candidate has already been registered in the primary registration table (not shown) stored in the HDD 75 (step S113: YES), the user is trying to register again for the same test candidate, or is using the same subject identification code. Is determined to have been given to a plurality of test candidates in duplicate, the process proceeds to step S121, and an error screen (not shown) indicating “There is an input error. I do.
[0072]
If the subject identification code of the subject is not already registered in the primary registration table (not shown) stored in the HDD 75 (step S113: NO), there is no duplicate registration of the subject identification code of the subject. In step S114, it is determined whether the scheduled assignment date <(primary registration date + 6 days).
[0073]
If the scheduled assignment date <(primary registration date + 6 days) (step S114: YES), it is determined that the assignment date, that is, the secondary registration date is the primary registration date + 6 days, which does not conform to the rule of this test, and that the step S121 is performed. To display an error screen (not shown) such as "There is an input error. Please correct it after confirmation."
[0074]
If the scheduled assignment date is not <(primary registration date + 6 days) (step S114: NO), that is, if the scheduled assignment date is the primary registration date + 6 days or a date later than the primary registration date + 6 days, Assuming that there is no problem in relation to the primary registration date, it is determined in step S115 whether the number of assigned subjects has reached the total number of contracted cases of the entire clinical trial or the medical institution 3.
In this step, a case achievement memory (not shown) is searched using the project number of the clinical trial and the medical institution number of the medical institution 3 as keys, and a contract is made for the clinical trial itself and the medical institution 3 of the clinical trial. It is determined whether the achievement identification is registered.
[0075]
If the number of allocated subjects has reached the number of contracted cases of the entire clinical trial or the medical institution 3 (step S115: YES), it is determined in step S116 that the number of contracted cases has been reached, and The content of the nonconformity indicating which of the number 3 of contract cases has been reached is registered in a nonconforming memory (not shown). Next, in step S117, it is determined whether or not the nonconforming content is registered in a nonconforming memory (not shown).
If the allocated number of subjects has not reached the total number of contracts of the clinical trial and the medical institution 3 (step S115: NO), it is determined that the subject can still be registered for the clinical trial or the medical institution 3 and the step In S117, it is determined whether or not the nonconforming content is registered in the nonconforming memory (not shown).
[0076]
If the nonconforming content is registered in the nonconforming memory (not shown) (step S117: YES), the registered nonconforming content is extracted in step S119. For example, when the nonconforming content is registered in at least one of steps S105, S107, S109, and S116, the nonconforming content is extracted.
Next, in step S120, for this test candidate, the non-conforming content extracted from the non-conforming memory (not shown) and the content input in FIG. 5 are registered in a primary registration table (not shown) stored in the HDD 75. And outputs a not-shown primary registration result confirmation slip (non-conforming) for this test candidate.
[0077]
The primary registration result confirmation sheet (not shown) includes, for the subject candidate, whether the subject is conforming or non-conforming, in the case of non-conforming, the reason for the non-conforming, the name of the medical institution 3, the name of the doctor, etc., and the subject identification The code, scheduled assignment date, and gender are described.
After that, the process ends.
[0078]
If the nonconforming content is not registered in the nonconforming memory (not shown) (step S117: NO), the content input on the top screen 101 in FIG. The primary registration for registering in the primary registration table is performed, and a primary registration result confirmation slip (conformity) (not shown) relating to this test candidate is output.
After that, the process ends.
The processing of the flowcharts of FIGS. 6 and 7 is executed each time information about a test candidate is input and the registration button 141 is clicked.
In addition, the criterion in the determination steps in steps S104, S106, S108, and S116 corresponds to the first subject matching criterion in the claims.
[0079]
In the primary registration result confirmation form output in steps S118 and S120, the name of the doctor and the like and the FAX number are automatically output in the address column, and the case registration company 1 sends the primary registration result to the doctor and the like of the medical institution 3. FAX transmission of the confirmation slip. If necessary, the primary registration result confirmation form may be transmitted to a pharmaceutical company 2 other than a doctor or the like, a testing center (not shown), or the like.
[0080]
Further, the person in charge of the case registration company 1 may output a case-specific clinical test schedule table (not shown) after the primary registration is completed and transmit the table to the medical institution 3.
The case-by-case clinical study schedule table is a list of clinical study schedules for each subject, and the horizontal row is before the day before the start of restriction of concomitant drugs, before the 6th day of allocation, at the time of study drug allocation, and 1 week after the start of administration. , Three weeks after the start of administration, one week after the end of administration, etc., and the consent is obtained in the vertical line, concomitant drug / concomitant therapy restriction period, subject background survey, VAS survey, tactile survey, QOL survey, It describes laboratory tests, adverse event investigations, investigations of other concomitant symptoms, and administration status investigations.
In the column where the column and row intersect in the list, a mark such as a circle indicating whether or not the survey or inspection should be performed on the scheduled date is given.
[0081]
The medical institution 3 receives the primary registration result confirmation form from the case registration company 1.
Thereafter, on the scheduled second registration date, the test candidate visits the medical institution 3. The doctor or the like performs an inquiry, diagnosis, and background investigation at the end of the pre-observation period for the test candidate determined to be suitable in the primary registration processing shown in FIGS.
After performing a medical interview, diagnosis, and background investigation, the doctor and the like enter the subject candidate's interview result, which was determined to be compatible by primary registration, in the subject compatibility checklist (not assigned) prepared by the pharmaceutical Enter the results and survey results. These results to be entered correspond to the characteristic information of the claim.
[0082]
The subject compatibility checklist (not shown) includes target selection criteria check items, target exclusion criteria check items, medical institution name entry fields, doctor name entry fields, secondary registration date entry fields, subject identification code entry fields. It is included.
The secondary registration date entered in the secondary registration date entry column is synonymous with the drug allocation date, and is the end date of the pre-observation period as described above.
[0083]
After filling in a subject compatibility checklist (not shown) (at the time of assignment), the doctor or the like faxes the subject compatibility checklist (not assigned) to the case registration company 1 by facsimile.
In the present embodiment, the subject compatibility check list (not shown) is transmitted by facsimile (not shown), but the data may be directly transmitted from the terminal computer 30 installed in the medical institution 3 to the case registration company 1. .
[0084]
When the case registration company 1 receives the subject compatibility checklist (not shown) from the medical institution 3 (at the time of assignment), it performs a preliminary acceptance examination on rough bibliographic items such as whether all the entry fields are filled out I do. If the receipt is after 19:00 (17:00 on Saturday), the processing will be the next business day.
[0085]
Thereafter, the case registration company 1 connects to the server computer 11 from the terminal computer 12, and inputs and transmits the contents of the subject compatibility check list (not shown) (at the time of allocation).
When the input is completed, the case registration program automatically sorts test candidates into conformers and non-conformers, and performs secondary registration for assigning drugs to subjects determined to be conforming.
In the present embodiment, in the clinical test, six subjects are included in each set, and each set includes a high-concentration test drug administration group, a low-concentration test drug administration group, and a placebo administration group 1: 1: 1. Is randomly assigned to be the number of people.
[0086]
This secondary registration processing will be described with reference to the flowcharts of FIGS. 8 to 11 are controlled by the CPU 72 of the server computer 11.
When the person in charge of the case registration company 1 clicks the icon of the case registration program on the screen of the terminal computer 12, the case registration program starts, the terminal computer 12 accesses the server computer 11, and the top screen 101 in FIG. .
[0087]
When the top screen 101 of FIG. 5 is displayed on the screen of the terminal computer 12, the flowcharts of FIGS.
In step S201, it is determined whether the secondary registration button 114 on the menu screen 110 has been clicked.
If the secondary registration button 114 has not been clicked (step S201: NO), it is determined in step S202 whether a predetermined time, for example, 15 minutes has elapsed.
[0088]
If the predetermined time has not elapsed (step S202: NO), it is determined again in step S201 whether the secondary registration button 114 has been clicked.
That is, steps S201 and S202 are repeated until the predetermined time has elapsed.
If the predetermined time has elapsed (step S202: YES), the process ends.
[0089]
If the secondary registration button 114 is clicked (step S201: YES), in step S203, a primary registration conforming person is extracted from a primary registration table (not shown) stored in the HDD 75, and a primary registration conforming person (not shown) is extracted. Display on the list screen.
On the primary registration conforming person list screen (not shown), the subject identification codes and initials of the test candidates who have become conformable in the primary registration are displayed in a selectable list. By clicking the subject identification code, a secondary registration screen (not shown) of the test candidate corresponding to the subject identification code can be displayed.
[0090]
Next, in step S204, it is determined whether a test candidate has been selected on the primary registration conforming person list screen (not shown).
If the subject has not been selected (step S204: NO), it is again determined in step S204 whether or not a subject has been selected on the primary registration conforming person list screen (not shown). That is, step S204 is repeated until a test candidate is selected.
When a subject is selected (Step S204: YES), a secondary registration screen (not shown) is displayed in Step S205.
[0091]
The secondary registration screen is the same as the primary registration top screen 101 in FIG. 5 except that it does not include the consent tab 123 and the consent input screen 130, and thus the description is omitted.
Next, in step S206, it is determined whether a registration button (not shown) has been clicked.
If the registration button (not shown) has not been clicked (step S206: NO), the person in charge of the case registration company 1 determines that the subject is still being input, and in step S207 a predetermined time, for example, 15 minutes Is determined.
[0092]
If the predetermined time has not elapsed (step S207: NO), it is determined again at step S206 whether a registration button (not shown) has been clicked.
That is, steps S206 and S207 are repeated until the predetermined time has elapsed.
If the predetermined time has elapsed (step S207: YES), the person in charge of the case registration company 1 determines that the subject has no intention to input, and ends the process.
If a registration button (not shown) is clicked (step S206: YES), it is determined in step S208 whether or not there is an uninput item among the required input items.
In the present embodiment, all items on the secondary registration screen (not shown) are set as mandatory input items. If at least one of the secondary registration screens has not been entered, it is determined that the mandatory input items have not been entered.
[0093]
When there is an uninput item in the required input items (step S208: YES), the process proceeds from step D to step S218 via step D in FIG. 9, and an unillustrated error such as “There is an input error. A screen is displayed and the process ends.
If there is no uninput item in the required input items (step S208: NO), it is determined in step 209 whether or not the answer to the selection criterion is “NO”.
In the present embodiment, the selection criterion includes a criterion relating to the degree of symptoms of the target drug, such as a VAS of 30 or more in the pre-observation period.
[0094]
If the answer to the selection criterion is "NO" (step S209: YES), it is determined that there is an item for which relevance is denied by the selection criterion, and in step S210, the non-conforming item that is "NO" is not shown Register in memory.
Next, the process proceeds from step C to step S211 via step C2 in FIG. 9 to determine whether the answer to the exclusion criterion is “YES”.
[0095]
If there is no "NO" in the answer to the selection criterion (step S209: NO), it is determined that there is no answer that denies subject suitability in all items of the selection criterion, and the process proceeds from step C to step S211 via C in FIG. It is determined whether the answer to the exclusion criterion is “YES”.
[0096]
In the present embodiment, the exclusion criterion includes whether the continuous pain VAS at the time of allocation is recovering during the previous observation period, such as a decrease of 20% or more compared to the continuous pain VAS at the start of the previous observation period. Criteria for the presence or absence of characteristics that should not administer the test drug, such as whether the conduct of clinical trials may increase the risk to subjects or the possibility that sufficient data may not be obtained Criteria are included.
[0097]
If the answer to the exclusion criterion is “YES” (step S211: YES), it is determined that there is an item for which relevance is denied by the exclusion criterion, and the non-conforming item that was “YES” in step S212 is not shown. Register in memory.
Thereafter, in step S213, it is determined whether the number of assigned subjects has reached the entire clinical trial or the number of contracted cases of the medical institution 3.
[0098]
If the answer to the exclusion criterion is not “YES” (step S211: NO), it is determined in step S213 whether the number of allocated subjects has reached the entire clinical trial or the number of contracted cases of the medical institution 3.
In this step, a case achievement memory (not shown) is searched using the project number of the clinical trial and the medical institution number of the medical institution 3 as keys, and a contract is made for the clinical trial itself and the medical institution 3 of the clinical trial. It is determined whether the achievement identification is registered.
[0099]
If the number of allocated subjects has reached the number of contracted cases of the entire clinical trial or the medical institution 3 (step S213: YES), it is determined in step S214 that the number of contracted cases has been reached, and The content of the nonconformity indicating which of the number 3 of contract cases has been reached is registered in a nonconforming memory (not shown). Next, in step S215, it is determined whether or not the input gender matches the gender of the subject in the primary registration.
If the number of allocated subjects has not reached the number of contracted cases of the entire clinical trial and the medical institution 3 (step S213: NO), in step S215, the input gender matches the gender of the subject in the primary registration. It is determined whether to do.
[0100]
If the genders do not match (step S215: NO), it is determined that the test candidate has been mistaken or the gender of the test candidate has been incorrectly input, and the process proceeds to step S218, where "there is an input error. Please display an error screen (not shown), and terminate the process.
If the genders match (step S215: YES), it is determined that there is no mistake in inputting the gender and no mistake of the subject is found, and in step S216, whether today's date <secondary registration date, that is, the system date is It is determined whether it is before the next registration date.
[0101]
If today's date <secondary registration date (step S216: YES), it is impossible that today's date is before the second registration date, so the process proceeds to step S218, where "there is an input error. Please correct it "(not shown), and the process ends.
[0102]
If today's date is not the secondary registration date (step S216: NO), that is, if today's date is the same as or later than the secondary registration date, today's date and secondary registration date Assuming that there is no problem with the relationship, the process proceeds to step S217, and it is determined whether (primary registration date + 6 days)> secondary registration date.
[0103]
If (primary registration date + 6 days)> secondary registration date (step S217: YES), that is, if the secondary registration date is earlier than the primary registration date + 6 days, the secondary registration date is set to the primary registration date. Assuming that the rule of +6 days is not in accordance with the rule of this test, the process proceeds to step S218, and an unillustrated error screen of "There is an input error. Please correct after confirmation" is displayed, and the process ends.
[0104]
(Primary registration date + 6 days)> If not the secondary registration date (step S217: NO), that is, if the secondary registration date is the primary registration date + 6 days or a date after the primary registration date + 6 days, the assignment will be made. Assuming that there is no problem in the relationship between the date and the secondary registration date, the process proceeds from E through E in FIG. 10 to step S219, and it is determined whether or not the nonconforming content is registered in a nonconforming memory (not shown).
[0105]
If the nonconforming content is registered in the nonconforming memory (not shown) (step S219: YES), the registered nonconforming content is extracted in step S220. For example, when the nonconforming content is registered in at least one of steps S210, S212, and S214, the nonconforming content is extracted.
Next, in step S221, for this test candidate, the nonconforming content extracted from the nonconforming memory (not shown) and the content input on the secondary registration screen (not shown) are stored in the secondary registration (not shown) stored in the HDD 75. A secondary registration for registration in the table is performed, and a secondary registration result confirmation slip (unsuitable) (not shown) relating to this test candidate is output.
[0106]
In the secondary registration result confirmation form (not shown), the subject candidate is classified as conforming or non-conforming as a subject, in the case of non-conforming, the reason for non-conforming, and in the case of conforming, assigned to the subject candidate. The medicine number, the name of the medical institution 3, the name of the doctor, the subject identification code, and the sex are described.
After that, the process ends.
[0107]
If the nonconforming content is not registered in the nonconforming memory (not shown) (step S219: NO), the subject candidate is determined to be a subject conformant, and in step S222, the number of subjects to whom the drug has been assigned in each administration group up to that point Pc, Lc, and Hc are acquired from the subject fitter table 15 shown in FIG.
Pc is the number of subjects in the placebo administration group, Lc is the number of subjects in the low-concentration test drug administration group, and Hc is the number of subjects in the high-concentration test agent administration group.
[0108]
In this step, first, the administration group 160 of the subject matcher table 15 is searched using “P” as a key, and the number Pc of subjects to which “P” is attached is acquired. Next, the administration group 160 in the subject matcher table 15 is searched using “L” as a key, the number Lc of subjects with “L” is obtained, and the subject matcher table 15 in “H” is used as a key. The administration group 160 is searched, and the number Hc of subjects to which "H" is assigned is acquired.
[0109]
Next, in step S223, Pc, Lc, and Hc are applied to Ac, Bc, and Cc (Ac ≦ Bc ≦ Cc).
Note that Ac is any of the placebo administration group Pc, the low-concentration test drug administration group Lc, and the high-concentration test drug administration group Hc, and a group having the smallest value among Pc, Lc, and Hc, and Cc Any of the placebo administration group Pc, the low-concentration test drug administration group Lc, and the high-concentration test drug administration group Hc, the group having the largest value among Pc, Lc, and Hc, and Bc is Pc, Lc, It is a group other than Ac and Cc among Hc.
[0110]
In step S223, a group Σmin having the minimum value among Pc, Lc, and Hc is acquired. Next, it is determined whether the number of Δmin is three. If there are three Σmins, と し て min = Pc = Lc = Hc, and three Σmins are randomly applied to Ac, Bc and Cc. In this case, Ac = Bc = Cc.
[0111]
If the number of Σmin is not three, it is determined whether the number of Σmin is two. If there are two Δmins, the two Δmins are randomly applied to Ac and Bc, and the remaining group is applied to Cc. In this case, Ac = Bc <Cc.
If the number of Σmin is not two, it is determined that there is only one Σmin, and Σmax having the largest value among two groups other than Σmin is acquired. Σmin is applied to Ac, Σmax to Cc, and the remaining group different from Σmin and Σmax to Bc. In this case, Ac <Bc <Cc.
[0112]
Next, in step S224, it is determined whether Ac <Bc.
If Ac <Bc (Step S224: YES), Ac <Bc = Cc or Ac <Bc <Cc, and the Ac group among Ac, Bc, and Cc is the minimum number. The Ac group that has the smallest number at that time is assigned to the candidate.
Thereafter, in step S229, the group assigned to the test candidate is stored in a memory (not shown) as Xc.
[0113]
If Ac <Bc is not satisfied (step S224: NO), it is determined in step S226 that Ac = Bc, and it is determined whether Bc <Cc.
When Bc <Cc (step S226: YES), Ac = Bc <Cc, and the Ac group and the Bc group among Ac, Bc, and Cc are the minimum number of the same number. Therefore, in step S227, the test candidate is determined. One of the Ac group or the Bc group, which is the smallest number at that time, is randomly assigned to the person.
Thereafter, in step S229, the group assigned to the test candidate is stored in a memory (not shown) as Xc.
[0114]
If Bc <Cc is not satisfied (step S226: NO), Ac = Bc = Cc, and the number of subjects in each group of Ac, Bc, and Cc is the same. , Bc group, or Cc group is randomly assigned.
Thereafter, in step S229, the group assigned to the test candidate is stored in a memory (not shown) as Xc.
Steps S224 to S229 are processes configured to target Ac, Bc, and Cc (Ac ≦ Bc ≦ Cc) after the test candidate assignment so that the difference Cc−Ac is less than 2.
[0115]
Next, in step S230, the number Ps, Ls, and Hs of the drug-assigned subjects of each administration group up to that point in the medical institution 3 where the subject candidate is diagnosed is obtained from the subject fitter table 15 shown in FIG. I do.
Ps is the number of subjects in the placebo administration group in the medical institution 3 where the test candidate is diagnosed, Ls is the number of subjects in the low concentration test drug administration group in the medical institution 3 where the test candidate is diagnosed, Hs Is the number of subjects in the high-concentration test drug administration group in the medical institution 3 where the subject is diagnosed.
[0116]
In this step, first, the medical institution number of the medical institution 3 is obtained from the input contents regarding the subject. Next, the subject matching table 15 is searched for the administration group 160 using “P” as a key and the medical institution number 152 using the acquired medical institution number as a key. Get the number Ps. Similarly, a search is performed by changing the keyword for searching the administration group 160 to “L” and “H”, and Ls and Hs are acquired.
[0117]
Next, in step S231, Ps, Ls, and Hs are applied to As, Bs, and Cs (As ≦ Bs ≦ Cs).
In addition, As is any of the placebo administration group Ps, the low-concentration test drug administration group Ls, and the high-concentration test drug administration group Hs, and a group having the smallest value among Ps, Ls, and Hs, and Cs A placebo administration group Ps, a low-concentration test drug administration group Ls, or a high-concentration test drug administration group Hs, wherein Ps, Ls, and Hs have the largest value among the groups, and Bs is Ps, Ls, Hs is a group other than As and Cs.
This step S231 is executed by performing the same procedure as step S223 for Ps, Ls, and Hs.
[0118]
Next, the process proceeds from step F to step S232 through step F232 in FIG. 11 to determine whether Cs−As <2.
If Cs-As <2 (step S232: YES), the results of the assignment evenly among all the assigned subjects participating in the clinical trial show that the assigned results are even among assigned subjects of the medical institution 3 where the subject candidate is diagnosed. Assuming that they are equally allocated, in step S236, it is determined whether the number of allocated subjects in the allocated administration group has reached the contracted number of cases.
[0119]
If Cs-As <2 is not satisfied (step S232: NO), the difference between Cs and As is 2 or more, and the assignment is made equally among all assigned subjects participating in the clinical trial, but the subject candidate is diagnosed. In the assigned subject of the medical institution 3 which is to be received, it is not evenly allocated, and for the purpose of re-equalization, it is determined in step S233 whether Bs> As.
[0120]
If Bs> As (Step S233: YES), As <Bs ≦ Cs and Cs−As ≧ 2, so that in order to equalize within the medical institution 3, in Step S234, Steps S222 to S228 were performed. Clear assignment Xc and assign As group.
In addition, as a case where the determination result of step S233 is NO, for example, a case where Bs-As is 1 and Cs-As is 2, a case where Bs-As is 2 and Cs-As is 2, etc.
Next, in step S236, it is determined whether the assigned number of subjects in the assigned administration group has reached the contracted number of cases.
[0121]
If Bs> As is not satisfied (step S233: NO), As = Bs <Cs, Cs−As ≧ 2, so that it is possible to equalize within the medical institution 3 by assigning to As and Bs other than Cs, and in step S235 , The assignment Xc performed in steps S222 to S228 is cleared, and one of the As group and the Bs group is randomly assigned.
Note that the result of the determination in step S233 is YES in the case where Bs-As is 0 and Cs-As is an integer of 2 or more.
[0122]
Next, in step S236, it is determined whether the assigned number of subjects in the assigned administration group has reached the contracted number of cases.
In this step, a case achievement memory (not shown) is searched using the project number of the clinical trial and the name of the administration group as keys, and it is determined whether a contract achievement identification is registered for the administration group of the clinical trial.
If the number of assigned subjects of the assigned administration group has reached the contracted number of cases (step S236: YES), it is determined that the administration group cannot be further assigned to this administration group, and in step S237, the assigned administration group is assigned. The content of nonconformity indicating that the number of completed subjects has reached the number of contracted cases is registered in a case achievement memory (not shown).
[0123]
Next, in step S238, the non-conforming contents extracted from the non-conforming memory (not shown) and the contents input on the secondary registration screen (not shown) are stored in the secondary registration table (not shown) stored in the HDD 75 for this test candidate. Then, a secondary registration result confirmation sheet (non-conforming) (not shown) relating to this test candidate is output.
After that, the process ends. A secondary registration table (not shown) corresponds to the case registration storage unit in the claims.
[0124]
If the number of assigned subjects in the assigned administration group does not attain the contracted number of cases (step S236: NO), the contents entered on the secondary registration screen (not shown) for this test candidate in step S239 Is registered in a secondary registration table (not shown) stored in the HDD 75, and subject registration for storing the subject candidate as a subject matcher in the subject matcher table 15 of FIG.
[0125]
In subject registration, a drug number, that is, a subject number is assigned to the subject. In assigning a drug number, the subject matching person table 15 is first searched by a medical institution name, and the largest drug number “Mmax group N” among the hit subjects is extracted. Next, a drug number “Mmax group N + 1” obtained by adding 1 to the number “N” of the extracted drug number “Mmax group N” is given to the subject. If the number “N + 1” is larger than 6, 1 is added to the set “Mmax”, and “Mmax + 1 set 1st” with the number “1” is assigned.
[0126]
Next, in step S240, it is determined whether the number of allocated subjects of the medical institution 3 is the remaining two cases.
In this step, the subject matching person table 15 is searched using the medical institution number of the medical institution 3 as a key, and the number of assigned subjects of the medical institution 3 is obtained. Further, the number of contracted cases of the medical institution 3 registered in a case achievement memory (not shown) in advance is obtained, and a difference obtained by subtracting the number of assigned subjects from the number of contracted cases is obtained. It is determined whether this difference is 2.
[0127]
If the number of allocated subjects of the medical institution 3 is the remaining two cases (step S240: YES), in step S241, "Please contact the following medical institution, and the number of remaining contracted cases is now two. . "And an alarm document in which the name of the medical institution 3 is described.
Next, in step S244, it is determined whether the number of allocated subjects of the administration group registered in step S239 is the remaining five cases.
[0128]
If the number of assigned subjects of the medical institution 3 is not the remaining two cases (step S240: NO), it is determined in step S242 whether the number of assigned subjects of the medical institution 3 is the number of contracted cases.
In this step, it is determined whether or not the difference obtained by subtracting the number of allocated subjects from the number of contracted cases obtained in step S240 is zero.
[0129]
If the number of assigned subjects of the medical institution 3 is not the number of contracted cases (step S242: NO), it is determined in step S244 whether the number of assigned subjects of the administration group registered in step S239 is the remaining five cases.
[0130]
If the allocated number of subjects of the medical institution 3 is the number of contracted cases (step S242: YES), in step S243, "I will contact you because the number of contracted cases has expired at the following medical institution." A message and an alarm document describing the name of the medical institution 3 are output, and a contract achievement identification indicating that the medical institution 3 has attained the contracted number of cases is registered in a case achievement memory (not shown).
Next, in step S244, it is determined whether the number of allocated subjects of the administration group registered in step S239 is the remaining five cases.
[0131]
In this step, the subject matching table 15 is searched using the administration group name assigned to the subject as a key, and the number of assigned subjects in the administration group is obtained. Further, the total number of contracted cases registered in advance in a memory (not shown) is obtained, and the difference obtained by subtracting the number of assigned subjects from the value obtained by dividing the total number of contracted cases by 3 is obtained. It is determined whether this difference is 5.
[0132]
When the number of assigned subjects in the administration group is the remaining 5 cases (step S244: YES), in step S245, "In the following group, the number of remaining contracted cases is 5 cases, so let me know." And an alarm document with the name of the group described.
Next, the process proceeds from G to G in FIG. 12 to step S246, and it is determined whether the number of allocated subjects in the administration group is the number of contracted cases.
[0133]
If the number of assigned subjects in the administration group is not the remaining 5 cases (step S244: NO), the process proceeds from G to step S246 via G in FIG. 12, and determines whether the number of assigned subjects in the administration group is the number of contracted cases. I do.
In this step, it is determined whether the difference obtained by subtracting the number of assigned subjects from the value obtained by dividing the total number of contracted cases obtained in step S244 by 3 is zero.
[0134]
If the number of assigned subjects in the administration group is not the number of contracted cases (step S246: NO), it is determined in step S248 whether the number of assigned subjects in the entire clinical trial is the remaining 5 cases.
[0135]
If the number of assigned subjects in the administration group is the number of contracted cases (step S246: YES), in step S247, a message saying, "In the following group, the number of contracted cases has expired, please contact us." An alarm document describing the name of the group is output, and a contract achievement identification indicating that the administration group has achieved the number of contract cases is registered in a case achievement memory (not shown).
In step S248, it is determined whether the number of assigned subjects in the entire clinical trial is the remaining five.
[0136]
In this step, the number of all assigned subjects registered in the subject matcher table 15 is acquired. Further, the total number of contracted cases registered in advance in a memory (not shown) is obtained, and the difference obtained by subtracting the number of all assigned subjects from the total number of contracted cases is obtained. It is determined whether this difference is 5.
[0137]
If the number of assigned subjects in the entire clinical trial is the remaining 5 cases (step S248: YES), in step S249, "the number of remaining contracted cases has reached 5 through all medical institutions, so let us know. . "Is output.
Next, in step S250, it is determined whether the number of assigned subjects in the entire clinical trial is the number of contract cases.
[0138]
If the number of assigned subjects in the entire clinical trial is not the remaining five (step S248: NO), it is determined in step S250 whether the number of assigned subjects in the entire clinical trial is the number of contracted cases.
In this step, it is determined whether or not the difference obtained by subtracting the number of all assigned subjects from the total number of contract cases obtained in step S248 is 0.
[0139]
If the number of assigned subjects in the entire clinical trial is not the number of contracted cases (step S250: NO), a secondary registration result confirmation slip (conformity) is output in step S252.
[0140]
If the number of assigned subjects in the entire clinical trial is the number of contracted cases (step S250: YES), then in step S251, "I will contact you because the number of contracted cases has expired through all medical institutions." An alarm document in which the message is described is output, and a contract achievement identification indicating that the clinical test has achieved the contracted number of cases is registered in a case achievement memory (not shown).
[0141]
Next, in step S252, a secondary registration result confirmation slip (conformity) (not shown) relating to the subject is output, and the process ends.
If the process is abnormally terminated for any reason between steps S201 and S237, the contents of each table and memory are all rolled back. Only when it is processed normally until the end is reflected in each table. Thereby, it is possible to maintain the matching.
[0142]
When the processing is completed, the person in charge of the case registration company 1 sends a secondary registration result confirmation form to the medical institution together with the alarm document when an alarm occurs.
The person in charge of the case registration company 1 sends a subject registration checklist (at the time of assignment), a secondary registration result confirmation slip, and a case registration work record that records the primary registration and the secondary registration work.
Only the subject conformant sends the secondary registration result confirmation form to the testing center that tests the sample collected at the medical institution 3.
[0143]
It is preferable that the information registered through the primary registration and the secondary registration can be corrected by using the correction function of the case registration system only for a portion that is not related to the determination of the suitability of the subject.
The correction is configured to be performed on the screen displayed by clicking the primary registration correction button 113 or the secondary registration correction button 115 on the menu screen 110.
In addition, the determination criteria in the determination steps of steps S209, S211, S213, and S236 correspond to the second subject matching criteria in the claims.
[0144]
【The invention's effect】
As described above, according to the present invention, the characteristic information at the start of the pre-observation period of the test candidate who has expressed his / her intention to participate in the clinical trial is primarily determined to determine whether or not it meets the first subject suitability standard. Registering means, and determining whether or not the characteristic information at the end of the pre-observation period for the test candidate determined to be matched by the primary registration means matches a second subject suitability criterion; Since the test candidate has been registered, the secondary registration means for registering in the case registration storage means as the subject, after excluding non-conforming subjects from the test candidate by primary registration before the pre-observation period, After the observation period, the subjects can be narrowed down based on changes in symptoms during the pre-observation period or the like, so that the selection of the subjects can be performed in two stages of primary registration and secondary registration. Therefore, it is possible to efficiently select a subject, and to reduce the labor of the subject candidate in the medical institution, such as background examination of the subject.
[0145]
In order to equalize each administration group for each medical institution and for the entire clinical trial, first perform the overall equalization means for the entire clinical trial, and if the results are not equalized at the medical institution, re-equalize again. Since the equal allocation means is used, each administration group can be efficiently equalized in each medical institution and in the entire clinical trial. In other words, if the result of equalization for the entire clinical trial is also equalized at the medical institution, there is no need to equalize at each medical institution. Therefore, the assignment can be performed with less labor than when equalizing each medical institution first.
[Brief description of the drawings]
FIG. 1 is an explanatory diagram showing the overall configuration of a case registration system according to an embodiment of the present invention.
FIG. 2 is an explanatory diagram showing a hardware configuration of a server computer of the case registration system according to one embodiment of the present invention.
FIG. 3 is an explanatory diagram showing a configuration of a subject matcher table.
FIG. 4 is an explanatory diagram showing a subject compatibility check list.
FIG. 5 is an explanatory diagram showing an input screen of the case registration system according to one embodiment of the present invention.
FIG. 6 is a flowchart showing a flow of a primary registration process according to an embodiment of the present invention.
FIG. 7 is a flowchart illustrating a flow of a primary registration process according to an embodiment of the present invention.
FIG. 8 is a flowchart illustrating a flow of a secondary registration process according to an embodiment of the present invention.
FIG. 9 is a flowchart illustrating a flow of a secondary registration process according to an embodiment of the present invention.
FIG. 10 is a flowchart illustrating a flow of a secondary registration process according to an embodiment of the present invention.
FIG. 11 is a flowchart illustrating a flow of a secondary registration process according to an embodiment of the present invention.
FIG. 12 is a flowchart illustrating a flow of a secondary registration process according to an embodiment of the present invention.
[Explanation of symbols]
1 Case registration company
2 Pharmaceutical companies
3 medical institutions
11 Server computer
12 Terminal computer
15 Applicable Person Table
30 Terminal computer
31 Subject suitability checklist (for primary registration)
72 CPU
73 RAM
74 ROM
75 HDD
76 Storage media device
77 Communication device
78 keyboard
79 mouse
80 Display device
81 Printer
101 Top screen
110 Menu screen

Claims (17)

A case registration system for selecting and registering subjects to participate in a clinical trial,
Equipped with a server computer for case registration,
The server computer is a primary registration unit that determines whether the characteristic information at the start of the pre-observation period of the test candidate who has expressed the intention to participate in the clinical trial matches the first subject suitability criterion,
The characteristic information at the end of the pre-observation period for the test candidate determined to be matched by the primary registration means is determined as to whether it matches a second subject suitability criterion, and the matched Secondary registration means for registering a test candidate as the subject in a case registration storage means. The server computer is installed in a case registration institution requested to register a case from a new drug development institution, and means for inputting characteristic information of the test candidate, and the characteristic information of the test candidate is stored in the case registration institution. Means for receiving from a computer installed in another, and means for receiving the characteristic information of the test candidate from a computer installed in a medical institution entrusted with the recruitment of the subject from the new drug development institution, 2. The case registration system according to claim 1, further comprising at least one of the means. A case registration information processing device for selecting and registering a subject to participate in a clinical trial,
Characteristic information at the start of the pre-observation period of the test candidate who has expressed his intention to participate in the clinical trial, primary registration means for determining whether or not the first subject suitability criteria,
The characteristic information at the end of the pre-observation period for the test candidate determined to be matched by the primary registration means is determined as to whether it matches a second subject suitability criterion, and the matched Secondary registration means for registering a test candidate in the case registration storage means as the subject. The secondary registration means allocates a test drug or a fake drug to be administered to the test candidate meeting the second subject matching criterion, and a drug attached regardless of the type of the drug to be administered. Assigning a number, the test candidate specific information, registered in the case registration storage means in association with the drug type and the number,
The drug number is a set for specifying a group including the subject, which is an integral multiple of the number of the drug types to be administered, and the number of the drug types to be administered for specifying each subject included in the set. 4. The case registration information processing apparatus according to claim 3, wherein the case registration information processing apparatus comprises a combination of a number up to an integer multiple of. In the secondary registration means, among the drugs to be administered, the number of allocated subjects in the clinical trial as a whole is determined from the number of allocated subjects in the clinical trial as a whole from the number of allocated subjects in the clinical trial as a whole. The difference obtained by subtracting 2 is less than 2, and the entire equal allocation means for allocating the test drug or the fake drug to the test candidate,
As a result of allocation by the overall equal allocation means, among the drugs to be administered, the number of allocated subjects at the medical institution related to the test candidate is the largest number of allocated subjects at the medical institution. 5. The case registration information processing apparatus according to claim 4, further comprising: if the difference obtained by subtracting the number of subjects to which a small number of drugs is assigned exceeds 2, re-allocation means for re-executing the assignment. A case registration information processing device for selecting and registering a subject to participate in a clinical trial,
It is determined whether or not the characteristic information of the test candidate who has expressed his / her intention to participate in the clinical trial meets the subject eligibility criteria. Registering means for assigning a drug number attached regardless of the type of drug to be administered, and registering the subject as a subject in a case registration storage means,
The drug number is a set for specifying a group including the subject, which is an integral multiple of the number of the drug types to be administered, and the number of the drug types to be administered for specifying each subject included in the set. Consisting of a combination of
In the registering means, of the drugs to be administered, the number of allocated subjects of the drug having the largest number of allocated subjects of the entire clinical trial is subtracted from the number of allocated subjects of the drug having the smallest number of allocated subjects of the entire clinical trial. Total difference allocation means for allocating the test drug or the fake drug to the test candidate so that the difference is less than 2,
As a result of allocation by the overall equal allocation means, among the drugs to be administered, the number of allocated subjects at the medical institution related to the test candidate is the largest number of allocated subjects at the medical institution. If the difference obtained by subtracting the number of subjects to which a small number of drugs is assigned exceeds 2, if necessary, a re-allocation unit for re-executing the assignment is provided. It is set up at a case registration institution that has been requested to register cases by a new drug development institution,
Means for inputting the property information of the test candidate, means for receiving the property information of the test candidate from another computer installed in the case registration institution, and the property information of the test candidate in the new drug development institution 7. A case registration information processing apparatus according to item 3 or 6, further comprising: means for receiving from a computer installed in a medical institution that has accepted the recruitment of test subjects from the group. A case registration method for selecting and registering subjects to participate in a clinical trial,
Characterization information at the start of the pre-observation period of the test candidate who has expressed the intention to participate in the clinical trial, a primary registration procedure for determining whether or not the first subject eligibility criteria are met,
The characteristic information at the end of the pre-observation period of the test candidate determined to be matched in the primary registration procedure, determines whether or not the second subject suitability criterion is met, and the matched Performing a secondary registration procedure of registering a test candidate as the subject in a case registration storage unit. In the secondary registration procedure, a test drug or a fake drug to be administered is allocated to the test candidate meeting the second subject matching criteria, and a drug attached regardless of the type of the drug to be administered. Assigning a number, performing the procedure of registering the test candidate specific information in the case registration storage unit in association with the drug type and the number,
The drug number is a set for specifying a group including the subject, which is an integral multiple of the number of the drug types to be administered, and the number of the drug types to be administered for specifying each subject included in the set. 9. The case registration method according to claim 8, comprising a combination of a number given up to an integer multiple of. In the secondary registration procedure, among the drugs to be administered, from the number of assigned subjects of the drug having the largest number of assigned subjects of the entire clinical trial, the number of assigned subjects of the drug having the smallest assigned number of subjects of the entire clinical trial is determined. The difference obtained by subtracting less than 2, the entire equal allocation procedure of allocating the test drug or fake drug to the test candidate,
As a result of the allocation in the overall equal allocation procedure, among the medicines to be administered, the number of allocated subjects at the medical institution relating to the test candidate is the largest number of allocated subjects at the medical institution. 10. The case registration method according to claim 9, wherein if the difference obtained by subtracting the number of subjects to which a small number of drugs is assigned exceeds 2, a re-allocation procedure is performed again to execute the allocation again. A case registration method for selecting and registering subjects to participate in a clinical trial,
It is determined whether or not the characteristic information of the test candidate who has expressed his / her intention to participate in the clinical trial meets the subject eligibility criteria. At the same time, a drug number is given regardless of the type of drug to be administered, and a registration procedure for registering the subject in the case registration storage unit is performed.
The drug number is a set for specifying a group including the subject, which is an integral multiple of the number of the drug types to be administered, and the number of the drug types to be administered for specifying each subject included in the set. Consisting of a combination of
In the registering procedure, of the drugs to be administered, the number of allocated subjects of the clinical trial as a whole is subtracted from the number of allocated subjects of the drug having the largest allocated number of subjects in the clinical trial. Difference, the total equal allocation procedure of allocating the test drug or the fake drug to the test candidate so as to be less than 2,
As a result of allocation by the overall equal allocation means, among the drugs to be administered, the number of allocated subjects at the medical institution related to the test candidate is the largest number of allocated subjects at the medical institution. If the difference obtained by subtracting the number of subjects to which a small number of drugs is assigned exceeds 2, a re-allocation procedure is performed to re-execute the allocation. Before the registration procedure,
A step of inputting the characteristic information of the test candidate, a step of receiving the characteristic information of the test candidate from another computer installed in the case registration institution, and a step of receiving the characteristic information of the test candidate by the new drug development institution 12. The case registration method according to 8 or 11, wherein the procedure includes receiving from a computer installed in a medical institution that has been commissioned to recruit subjects from the group. A case registration information processing device that selects and registers subjects to participate in clinical trials,
Characterization information at the start of the pre-observation period of the test candidate who has expressed the intention to participate in the clinical trial, a primary registration procedure for determining whether or not the first subject eligibility criteria are met,
The characteristic information at the end of the pre-observation period of the test candidate determined to be matched in the primary registration procedure, determines whether or not the second subject suitability criterion is met, and the matched And a secondary registration procedure for registering the test candidate in the case registration storage means as the subject. In the secondary registration procedure, a test drug or a fake drug to be administered is allocated to the test candidate meeting the second subject matching criteria, and a drug attached regardless of the type of the drug to be administered. Giving a number, performing a procedure of registering the test candidate specific information in the case registration storage means in association with the drug type and the number,
The drug number is a set for specifying a group including the subject, which is an integral multiple of the number of the drug types to be administered, and the number of the drug types to be administered for specifying each subject included in the set. 14. The case registration program according to claim 13, comprising a combination of numbers up to an integer multiple of. In the secondary registration procedure, among the drugs to be administered, from the number of assigned subjects of the drug having the largest number of assigned subjects of the entire clinical trial, the number of assigned subjects of the drug having the smallest assigned number of subjects of the entire clinical trial is determined. The difference obtained by subtracting less than 2, the entire equal allocation procedure of allocating the test drug or fake drug to the test candidate,
As a result of the allocation in the overall equal allocation procedure, among the medicines to be administered, the number of allocated subjects at the medical institution relating to the test candidate is the largest number of allocated subjects at the medical institution. 15. The case registration program according to claim 14, wherein when the difference obtained by subtracting the number of subjects to which a small number of drugs is assigned exceeds 2, a re-allocation procedure for re-executing the allocation is performed. A case registration information processing device that selects and registers subjects to participate in clinical trials,
It is determined whether or not the characteristic information of the test candidate who has expressed his / her intention to participate in the clinical trial meets the subject eligibility criteria. At the same time, a drug number is given regardless of the type of drug to be administered, and a registration procedure for registering the subject in the case registration storage unit is performed.
The drug number is a set for specifying a group including the subject, which is an integral multiple of the number of the drug types to be administered, and the number of the drug types to be administered for specifying each subject included in the set. Consisting of a combination of
In the registering procedure, of the drugs to be administered, the number of allocated subjects of the clinical trial as a whole is subtracted from the number of allocated subjects of the drug having the largest allocated number of subjects in the clinical trial. Difference, the total equal allocation procedure of allocating the test drug or the fake drug to the test candidate so as to be less than 2,
As a result of allocation by the overall equal allocation means, among the drugs to be administered, the number of allocated subjects at the medical institution related to the test candidate is the largest number of allocated subjects at the medical institution. If the difference obtained by subtracting the number of subjects to which a small number of drugs is assigned exceeds 2, a case registration program for executing the re-allocation procedure again and the equal allocation procedure again. Before the registration procedure,
A step of inputting the characteristic information of the test candidate, a step of receiving the characteristic information of the test candidate from another computer installed in the case registration institution, and a step of receiving the characteristic information of the test candidate by the new drug development institution 17. The case registration program according to claim 13 or 16, wherein at least one procedure from a group including a step of receiving from a computer installed in a medical institution entrusted with recruitment of a subject from the group is executed.

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