JP2003108663A - System, device, method and program for clinical trial information management, and recording medium - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a clinical trial information managing device capable of managing reliable information concerning clinical trial. SOLUTION: This clinical trial information managing device for summarizing and managing information concerning clinical trial is provided with a storage device for preserving clinical trial information and clinical trial result information. As the clinical trial information, prescribed case data and subject schedule made correspond to a subject specifying number for specifying a subject are stored. The clinical trial result information includes with the subject are stored specifying number and the prescribed case data. This device is also provided with an extracting means for extracting the prescribed case data and the subject schedule corresponding to the subject specifying number included in the clinical trial result information by retrieving clinical trial information, a judging means for judging whether or not the contents of the prescribed case data or subject schedule extracted by the extracting means are matched with the contents of the clinical trial result information, and an output means for outputting required confirmation information when it is judged that those contents are not matched by the judging means.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a clinical trial information management system, a clinical trial information management device, a clinical trial information management method, a clinical trial information management program and a storage medium, and in particular, information generated in clinical trials conducted at a plurality of medical institutions. The present invention relates to a clinical trial information management system, a clinical trial information management device, a clinical trial information management method, a clinical trial information management program, and a storage medium for consolidating and managing clinical trial information.

[0002]

2. Description of the Related Art A clinical trial is carried out at a medical institution on the request of a requesting institution (for example, a pharmaceutical company).
It will be conducted based on the content of the clinical trial protocol prepared by the requesting institution in consultation with the investigator and investigator of the medical institution. FIG. 24 is an explanatory diagram illustrating the flow of information in a conventional clinical trial.

When the clinical trial protocol is prepared, as shown in FIG. 24, the information of the subject who seems to be suitable for the clinical trial is provided from a plurality of medical institutions to the registration institution in a privacy protected state. .

[0004] At the registration institution, it is confirmed whether or not each subject satisfies the physical condition suitable for the clinical trial, and the confirmed subject is registered and notified to each medical institution. Note that FIG.
The reason why the registration agency is involved in the selection of subjects is to reduce the labor for selecting subjects at medical institutions, and when the clinical trial is a double-blind method, etc. This is for the purpose of keeping objective fairness so that the subject to whom the placebo is administered is not known to the requesting institution such as the company. Therefore, the registration authority may not be used if it is not necessary.

When a subject is registered, a doctor or the like in charge of clinical trials performs medical treatment such as medication and blood sampling while confirming the schedule planned for each subject at a medical institution. This schedule is based on the clinical trial protocol, and the type and amount of the drug to be administered, the test time, etc. are determined for each subject.

Then, the samples such as blood and urine collected at the medical institution are sent to the inspection institution for inspection. The inspection institute may be an inspection room in a medical institution, but in many cases, an external inspection center with abundant inspection equipment is used.
The test results for each subject are reported to the medical institution as test data. At the medical institution, along with other measurement results that can be performed in the medical institution, and test data such as an interview result for the subject, the inspection data from the inspection institution is recorded in the case report form (C
RF) and report the clinical trial to the requesting institution.

[0007] In order to confirm whether the clinical trial is properly and safely carried out according to the schedule defined in the clinical trial implementation plan, the clinical trial requesting organization that has requested the clinical trial frequently asks the medical institution about the examination data and the test data. Must be collected and the progress status checked.

By the way, the number of clinical trials conducted by one medical institution is not limited to one, and a plurality of clinical trials may be requested at the same time by a plurality of requesting institutions. In order to prevent confusion such as mistakes in transcription or mistakes in subjects when transcribing test data from a laboratory into a case report form (CRF), a great amount of human labor is required. Was needed. In addition, it took a great deal of labor and time to collect data individually at each medical institution.

[0009] Therefore, conventionally, even if a large amount of data is generated between a requesting institution, a medical institution, a testing institution, and a registering institution, a clinical trial can be performed without confusion such as a data transfer error. A technique of utilizing a computer (information processing device) so as to be possible has been proposed.

For example, a clinical trial support computer connected to a computer of a medical institution by a communication line is provided, and the subject's height, weight, sex, etc. of the subject are measured between the computer of the medical institution and the clinical trial support computer. A technique for managing information and test data of each subject has been proposed (for example, Japanese Patent Laid-Open No. 11-154185). With this technique, a patient can be identified by a patient ID given to each patient, and information about a clinical trial can be transmitted from a computer at a medical institution to a computer for clinical trial support. Furthermore, if the computer for clinical trial support is equipped with a function that can output documents in a prescribed format, the information stored in the computer for clinical trial support can be used as it is,
A form of a predetermined format can be output. This allows
It is possible to reduce the labor that a doctor or the like has conventionally performed to transfer inspection data to create a form, and prevent a transcription error.

[0011]

FIG. 25 is an explanatory diagram for explaining a clinical trial system using the above-mentioned conventional computer. As shown in FIG. 25, conventionally, a medical institution collects a sample, identifies the patient by the patient ID given to each subject, attaches a slip with the patient ID, etc. to the sample, and attaches it to the laboratory. To send. Then, the medical institution receives the voucher in which the examination data is entered at the examination institution and inputs the data such as the patient ID and the examination data described in the voucher into the database in the computer of the medical institution. The data input to the database in the computer of the medical institution is taken into the clinical trial database in the computer for clinical trial support of the information institution through the communication line. Computers for clinical trial support use the transmitted data to output various forms and manage information. As a result, it is possible for the doctor to eliminate the work of transcribing the inspection data and the like on the form, and the transcription error is eliminated.

However, even if the computer for clinical trial support transmits the information about the clinical trial to the computer for clinical trial support so that the computer for clinical trial support manages the information, If a patient (patient ID) is mistaken in, or if the schedule specified in the clinical trial protocol is removed, sample collection,
Even if an error occurs such as when a patient visits / interviews, or if there is an input error on the computer, information on clinical trials such as test data and test data once input to the computer of the medical institution On the other hand, since it is not checked whether the information is based on a proper clinical trial, it is considered that the data is directly treated as proper data and a problem may occur in the accuracy of the information on the clinical trial.

Further, in order to always provide information based on appropriate clinical trials, it is necessary to check that there are no mistakes in the sampling time of specimens, mistakes in patient IDs at medical institutions, and data input errors. There is a problem in that the medical staff must perform the medical treatment strictly and must spend a great deal of labor and time of the medical staff.

The present invention has been made to solve the above-mentioned problems, and an object of the present invention is to provide a clinical trial information management system, a clinical trial information management device, and a clinical trial information management system that enable reliable management of clinical trial information. An object is to provide an information management method, a clinical trial information management program, and a storage medium.

[0015]

[Means for Solving the Problems]

According to the clinical trial information management system according to the first aspect, the above-mentioned problems are operated by the clinical trial information management device operated by the information organization that collectively manages information on clinical trials and the testing organization that conducts the examination of the sample. Inspection agency computer,
In the clinical trial information management system, the examination institution computer includes examination information transmitting means for transmitting examination information including a subject identification number for identifying a subject to the clinical trial information management apparatus. Is a receiving means for receiving the examination information from the examination institution computer, clinical trial information in which at least one of predetermined case data and subject schedule corresponds to the subject identification number, and the examination institution computer Storage means for storing the examination information received from the extracting means for extracting at least one of the predetermined case data corresponding to the subject identification number included in the examination information and the subject schedule by searching the trial information. And contents of the predetermined case data and contents of the examination information extracted by the extracting means And a determination unit that determines at least one of the determination whether the content of the subject schedule extracted by the extraction unit and the content of the examination information match, The problem is solved by providing an output unit that outputs confirmation-required information when the determination unit determines that they do not match.

According to the first aspect of the present invention, the clinical trial information management device is provided with at least one of the receiving means for receiving the inspection information from the inspection institution computer, the predetermined case data and the subject schedule for the subject identification number. Storage means for storing the clinical trial information configured as described above and the medical examination information received from the laboratory computer, and the predetermined case corresponding to the subject identification number included in the medical examination information retrieved from the clinical trial information. Extraction means for extracting at least one of the data and the subject schedule,
Determination of whether or not the content of the predetermined case data extracted by the extraction means and the content of the examination information match, and the content of the subject schedule and the content of the examination information extracted by the extraction means The clinical trial information management device has a configuration including at least one of a determination unit that determines whether or not there is a match, and an output unit that outputs confirmation-required information when the determination unit determines that they do not match. so,
Information generated in clinical trials conducted at multiple medical institutions while checking whether the examination information sent to the clinical trial information management device contains data that is suspected to be incorrect data. Can be aggregated and managed.

Further, according to the clinical trial information management device according to the second aspect, the above-mentioned problem is a clinical trial information management device for consolidating and managing information on clinical trials, and for a subject identification number for identifying a subject. And a storage device for storing clinical trial information in which at least one of predetermined case data and a subject schedule is configured to correspond to each other, and clinical trial result information including the subject specific number, and the clinical trial information is searched to retrieve the clinical trial information. Extraction means for extracting at least one of the predetermined case data and the subject schedule corresponding to the subject identification number included in the result information, the content of the predetermined case data extracted by the extraction means, and the clinical trial result information The content of the subject schedule extracted by the extraction means and the content of the clinical trial result information And matching of determining whether means of at least one of the determination of the determination, is solved by providing an output means for outputting a main confirmation information when it is determined that the determination means does not match.

According to the invention of claim 2, clinical trial information in which at least one of predetermined case data and subject schedule corresponds to a subject identification number for identifying a subject, and the subject identification A storage device for storing clinical trial result information including a number is provided, and the clinical trial information is searched to extract at least one of the predetermined case data corresponding to the subject specific number included in the clinical trial result information and the subject schedule. Extraction means, determination of whether or not the content of the predetermined case data extracted by the extraction means and the content of the clinical trial result information match, and the content of the subject schedule extracted by the extraction means and the Judgment means for judging at least one of judgments as to whether or not the contents of the clinical trial result information match, and judgment means that the judgment means does not match If there is data suspected to be inappropriate data in the clinical trial result information stored in the clinical trial information management device, it is possible to include the output means for outputting confirmation-required information when While checking, information generated in clinical trials conducted at multiple medical institutions can be aggregated and managed.

Further, according to the clinical trial information management apparatus according to the third aspect of the present invention, there is provided a clinical trial information management apparatus for collecting and managing information regarding clinical trials, wherein clinical trial result information is received from an external information processing apparatus. Communication device, the clinical trial information in which at least one of predetermined case data and a subject schedule for the subject specific number for identifying the subject is configured, and clinical trial result information including the subject specific number. An extractor having a storage device for storing the extracted clinical trial information and extracting at least one of the predetermined case data and the subject schedule corresponding to the subject identification number included in the clinical trial result information; It is determined whether or not the content of the predetermined case data and the content of the clinical trial result information extracted in step 3 are matched, and the content is extracted by the extraction means. Judgment means for making at least one of the judgments as to whether the contents of the subject schedule and the contents of the clinical trial result information match, and the confirmation information is output when the judgment means judges that the contents do not match. And output means.

According to the third aspect of the present invention, at least the communication device that receives the clinical trial result information from the external information processing device, and at least the predetermined case data and the subject schedule for the subject identification number for identifying the subject. One is provided with a storage device for storing clinical trial information configured correspondingly and clinical trial result information including the subject identification number, and the clinical trial information is searched to correspond to the subject identification number included in the clinical trial result information. Extraction means for extracting at least one of the predetermined case data and the subject schedule,
Determining whether the content of the predetermined case data extracted by the extraction means and the content of the clinical trial result information match,
When it is determined that the determination means for determining at least one of the determination whether the content of the subject schedule extracted by the extraction means and the content of the clinical trial result information match, and the determination means do not match With a configuration including an output means for outputting confirmation-required information, it is checked whether the clinical trial result information transmitted to the clinical trial information management device includes data suspected to be invalid data. While performing the above, it is possible to aggregate and manage the information generated in clinical trials conducted at a plurality of medical institutions.

According to the clinical trial information management method of the fourth aspect, the above-mentioned problem is a clinical trial information management method for judging whether clinical trial result information including a subject identification number for identifying a subject is appropriate. Therefore, a clinical trial information management device that collects and provides information on clinical trials is configured such that at least one of predetermined case data and subject schedule corresponds to a subject identification number for identifying a subject. The procedure for storing the information in the storage means of the clinical trial information management device is performed, the procedure for storing the clinical trial result information in the storage means is performed, the clinical trial information is searched, and the subject identification number included in the clinical trial result information is searched. The procedure of extracting at least one of the predetermined case data and the subject schedule corresponding to the predetermined case data is performed, and the predetermined step extracted by the extracting means is performed. Judgment whether the content of the case data and the content of the clinical trial result information match, and whether the content of the subject schedule extracted by the extraction means and the content of the clinical trial result information match. The problem is solved by performing a procedure of determining at least one of the two and performing a procedure of outputting confirmation-required information when it is determined that there is no match in the determination procedure.

According to the clinical trial information management method of the fifth aspect, the above-mentioned problem is a clinical trial information management method for judging whether clinical trial result information including a subject identification number for identifying a subject is appropriate. Therefore, a clinical trial information management device that collects and provides information on clinical trials is configured such that at least one of predetermined case data and subject schedule corresponds to a subject identification number for identifying a subject. The procedure for storing the information in the storage means of the clinical trial information management device is performed, the procedure for receiving the clinical trial result information from the external information processing device is performed, and the clinical trial result information received from the external information processing device is stored in the storage device. The clinical trial information is searched for and the predetermined case data corresponding to the subject identification number included in the clinical trial result information and the Performing a procedure for extracting at least one of the tester schedules, determining whether or not the content of the predetermined case data extracted by the extracting means matches the content of the clinical trial result information, and extracting by the extracting means Performed a procedure for determining at least one of the determinations as to whether or not the content of the subject schedule and the content of the clinical trial result information that were performed, and required confirmation information when it is determined that the content does not match in the determination procedure It is solved by performing the procedure of outputting.

Further, according to the clinical trial information management program according to the sixth aspect, the above-mentioned problem is clinical trial result information including a subject identification number for identifying a subject in a clinical trial information management device for collecting and providing information on clinical trials. Is a clinical trial information management program for executing the determination of whether is appropriate, the clinical trial information management device, at least one of predetermined case data and subject schedule corresponding to the subject identification number The procedure for storing the existing clinical trial information in the storage means of the clinical trial information management device, the procedure for storing the clinical trial result information in the storage means, and the subject identification number included in the clinical trial result information by searching the clinical trial information. A procedure for extracting at least one of the corresponding predetermined case data and the subject schedule; and the location extracted by the extracting means. Whether the content of the case data and the content of the clinical trial result information match, and whether the content of the subject schedule extracted by the extraction means and the content of the clinical trial result information match. This can be solved by executing a procedure of making at least one of the decisions and a procedure of outputting confirmation-required information when it is determined that they do not match in the decision procedure.

Further, according to the clinical trial information management program according to claim 7, the above-mentioned subject is clinical trial result information including a subject identification number for identifying a subject in a clinical trial information management device for collecting and providing information on clinical trials. Is a clinical trial information management program for executing the determination of whether is appropriate, the clinical trial information management device, at least one of predetermined case data and subject schedule corresponding to the subject identification number Procedure for storing the existing clinical trial information in the storage means of the clinical trial information management apparatus, a procedure for receiving the clinical trial result information from an external information processing apparatus, and the clinical trial result information received from an external information processing apparatus in the storage means And a procedure for searching the clinical trial information and the predetermined case data corresponding to the subject identification number included in the clinical trial result information and the previous data. A procedure for extracting at least one of the subject schedules, a determination as to whether the content of the predetermined case data extracted by the extraction means and the content of the clinical trial result information match, and the extraction means extracts the content. The procedure for determining at least one of the determinations as to whether the content of the subject schedule matches the content of the clinical trial result information, and the confirmation-required information is output when it is determined that the content does not match in the determination procedure. It is solved by performing the procedure and

At this time, it is preferable to configure as a storage medium in which the program according to claim 6 or 7 is stored.

[0027]

BEST MODE FOR CARRYING OUT THE INVENTION An embodiment of the present invention will be described below with reference to the drawings. In the following description, a clinical trial information management system and a clinical trial information management device according to the present invention are described. In this explanation example, the clinical trial information management method of the present invention and the clinical trial information management device relating to the clinical trial information management device perform predetermined processing. Of course, the clinical trial information management program, storage medium, etc. are included.

The configuration of the clinical trial information management system in this embodiment will be described with reference to FIGS. 1 and 2. FIG. 1 is an explanatory diagram illustrating a main configuration of a clinical trial information management system according to this embodiment.

In the present embodiment, an information institution computer 12 operated by an information institution that collects and manages information on clinical trials, an inspection institution computer 13 operated by an inspection institution that inspects a specimen 33 generated in a clinical trial, and a clinical trial. A requesting institution computer 14 operated by a requesting institution requesting
A medical institution computer 15 operated by a medical institution conducting a clinical trial on a subject and a registration institution computer 16 operated by a registrar for registering a subject to be clinically examined are connected by a communication network 1. Further, in the present embodiment, at least the information agency computer 12 has a function as a WWW server computer. Information agency computer 12, inspection agency computer 13,
Requesting institution computer 14, medical institution computer 1
5. The registration agency computer 16 corresponds to the information processing apparatus of the present invention, and the information agency computer 12 particularly corresponds to the clinical trial information management apparatus of the present invention.

In the present specification, the term "computer" is meant to include all information terminals equipped with a computing device. For example, a supercomputer, a general-purpose computer, an office computer, a control computer, a workstation, a personal computer, a personal digital assistant, a mobile phone equipped with an arithmetic unit, and the like are included.

The communication line network 1 includes the Internet, personal computer communication, each network, a cable line, a dedicated channel, and the like, and includes a packet communication network regardless of whether it is wired or wireless. For example, the inspection institution computer 13 and the information institution computer 12 may be connected by a dedicated line.

Note that, for example, the registration agency computer 16
And the requesting institution computer 14 are operated by the requesting institution, the medical institution computer 15 and the inspection institution computer are operated by the medical institution, and the registration institution computer 16 and the information institution computer 12 are operated by the information institution. The institution computer 16 and the medical institution computer 15 may be operated by a medical institution, or a plurality of computers may be operated by one institution. When a plurality of computers are operated by one institution, one computer may have the functions of the plurality of computers.

FIG. 2 is a block diagram showing a hardware configuration example of the information organization computer 12. As shown in FIG. 2, the information organization computer 12 includes a CPU 2 as a data arithmetic / control processing device, a RAM 3 as a storage device, and an RO.
The M4, the HDD 5, and the storage medium device 6 are provided.

The CPU 2, in accordance with a program stored in the ROM 4 or the HDD 5, etc., will be described later in clinical trial information creation processing, examination data input processing, test data input processing, safety confirmation processing, progress information provision processing, It executes various kinds of processing such as fixed data reporting processing and corresponds to the extracting means and the judging means of the present invention.

The storage device corresponds to the storage means of the present invention, and stores a program for executing various processes in the information institution computer 12, and clinical trial information 32 and clinical trial result information described later. . Out of storage
The storage medium device 6 is an external HDD, MO, CD-RW,
Data composed of a DVD or the like and transmitted via the communication device 7 and various data input from the keyboard 8 or the mouse 9 as an input device can be appropriately stored and read out.

The RAM 3 appropriately stores data necessary for the CPU 2 to execute various processes.
The keyboard 8 and the mouse 9 are appropriately operated when inputting a predetermined command to the CPU 2, or when inputting initial information, standard code, case data, and clinical trial result information described later.

On the display device 10, a predetermined image, for example, a WEB screen for displaying progress information described later is output and displayed.
The printer 11 outputs predetermined information from each computer on a paper surface, for example, an inspection agency processing instruction sheet, a requesting agency processing instruction sheet, a question list, etc., which will be described later. Display device 1
0 and the printer 11 correspond to the output means of the present invention.

The communication device 7 is adapted to transmit data to the communication line network 1 and receive data supplied via the communication line network 1. The communication device 7 corresponds to the receiving means of the present invention, and further, the display device 10 described above.
Etc. and the output means of the present invention.

Each of the inspection institution computer 13, the requesting institution computer 14, the medical institution computer 15, and the registration institution computer 16 has the same hardware configuration as the above information institution computer 12. Although illustration is omitted, for example, the inspection institution computer 13 also includes a communication device, and the communication device of this inspection institution computer 13 corresponds to the inspection information transmitting means of the present invention. Further, the requesting institution computer 14 and the medical institution computer 15 also include a communication device as a clinical trial result information receiving means for receiving information on a clinical trial, and a display device as a clinical trial result information displaying means for displaying information on a clinical trial. Good. As a result, the requesting institution computer 14 and the medical institution computer 15 can receive the later-described clinical trial information and clinical trial result information from the information institution computer 12, and display the received clinical trial result information on the display device. , You can check the progress of clinical trials at medical institutions and requesting institutions.

Further, all the configurations of the information institution computer 12, the inspection institution computer 13, the requesting institution computer 14, the medical institution computer 15, and the registration institution computer 16 are not necessarily installed in the facility of the institution operating each computer. Alternatively, a part of the computer, for example, the storage medium device 6 may be installed in the facility of a third-party organization capable of high-quality safety management.

FIG. 3 is a block diagram schematically showing the flow of the entire clinical trial in which the clinical trial information management system of this embodiment is used. A requesting institution such as a pharmaceutical company that requests a clinical trial submits a draft of a clinical trial implementation plan 17 and a case report form 18 to a medical institution. At the medical institution, the investigator in charge of the clinical trial, based on the original plan of the clinical trial implementation plan 17,
The clinical trial implementation plan 17 and the case report form 18 are prepared in consultation with the client organization. The created clinical trial implementation plan 17 is sent to information institutions and registration institutions in addition to medical institutions.

In the clinical trial protocol 17, the name of the medical institution, the name of the doctor, the selection criteria and exclusion criteria of the test subject, the dose of the investigational drug, the administration period, the time for collecting the specimen 33 and visiting the clinic are described in the clinical trial protocol 17. Initial information such as the prescribed clinical trial time point, examination items, and measurement items that determine the observation items of the doctor are described. The case report form sheet 18 is for the doctor to describe various data obtained from the clinical trial, and to report the results of the clinical trial to the requesting institution as a case report form 19 (CRF).

When the clinical trial implementation plan 17 is prepared, the medical institution selects subjects based on the subject selection criteria, exclusion criteria, etc. described in the clinical trial implementation plan 17. A sufficient explanation of the clinical trial will be given to the selected subject, and the clinical trial can be conducted on the subject only if the subject voluntarily consents to participate in the clinical trial. When the subject's consent is obtained, the subject is registered (case registration work) at the registration agency. The case registration task is to confirm whether or not the subject selected by the medical institution is a subject qualified for the clinical trial, and to register a qualified subject (case registration).

The subject whose case has been registered is notified to a medical institution and an information institution. At the medical institution, the subject registered for the case is subjected to a test according to the clinical trial implementation plan 17, and the subject is subjected to medication, blood sampling, and interview (test work). At the inspection institution, the inspection of the sample 33 collected by the medical institution is performed (inspection work). At this time, the test data generated by the medical institution and the test data generated by the inspection institution are aggregated in the information institution, and the information institution appropriately provides necessary information to each institution based on the various data collected. Perform (information management work). The requesting organization accesses various data collected in the information organization to monitor whether the clinical trial is appropriately conducted according to the clinical trial implementation plan 17 (clinical trial management work).

When the clinical trial is completed for one case, the case report form 19 for the case is prepared by the medical institution and submitted to the requesting institution. The entire clinical trial will be completed when the case report form 19 is prepared for all cases. Even before the clinical trial for one case is completed, a separate case report form 19 may be submitted each time the subject visits (examines).

As described above, a clinical trial in which the clinical trial information management system of this embodiment is used includes a requesting institution such as a pharmaceutical company requesting the clinical trial and a medical institution such as a hospital in which the clinical trial is conducted.
A registration agency that selects subjects who participate in the clinical trial, and an inspection agency that performs various tests on the specimen 33 generated in the clinical trial,
This is done through the intervention of an information agency that manages data.

In the clinical trial shown in FIG. 3, five independent medical institutions, that is, an inspection agency, an information agency, a registration agency, and a requesting agency, intervene. The clinical trial information management system is applicable without being limited to this. For example, when the requesting institution also serves as a registrar, when a medical institution has an inspection institute, or when an information institution also serves as a registrar,
The medical institution may also serve as a registration institution.

FIG. 4 is an explanatory diagram for explaining the flow of information in a clinical trial in which the clinical trial management system of this embodiment is used. In a clinical trial in which the clinical trial management system of this embodiment is used, each institution carries out its duties. It explains the flow of information exchanged between each institution.
First, the flow of information from the medical institution shown in (1) of FIG. 4 will be described. The medical institution that has received the clinical trial protocol 17 describes the subject information of the subject selected by the investigator or the like on the case registration slip 24 before providing the trial to the registered institution (see FIG. 4). (1)). The case registration form 24 is created by filling in the subject information on the case registration form 21 distributed from the information institution to each medical institution. As the number for identifying the subject in advance when the case registration card 24 is distributed, a subject identification number which is a part of a standard code described later is described.

Here, the subject information means the subject's subject ID, initials, sex, date of birth, subject's height / weight, subject's past and present medical history / physical information, subject's taking or past taking. Drug name, clinical trial number that identifies the clinical trial, medical institution performing the clinical trial, investigator name,
This is information such as the name of the investigator. The subject information contains sufficient information to determine if the subject is eligible to participate in the trial.

The standard code is a number for identifying the subject outside the medical institution while avoiding leaking the individual name of the subject to the outside of the medical institution, and for enabling accurate management of information on clinical trials. is there. In the present embodiment, the standard code is composed of a clinical trial number, a subject number, a medical institution number, and a period number. The clinical trial number is a number that identifies the clinical trial. The medical institution number is a number for identifying a medical institution. The subject number is a number for identifying the subject. The time number is a number for specifying the time (point of clinical trial) when the sample 33 is collected or visited in the clinical trial.

Therefore, if the combination of the clinical trial number, the subject number, and the medical institution number is determined, it is possible to identify one subject who is registered at a particular medical institution in a particular clinical trial. In the present embodiment, the combination of the clinical trial number, the subject number, and the medical institution number is called the subject identification number. This subject identification number serves to identify the subject.

FIG. 5 shows the structure of the standard code of this embodiment. In the present embodiment, the clinical trial number for identifying a clinical trial is 7 digits, the number for identifying each subject in the clinical trial is 4 digits, and the medical institution number for identifying the medical institution conducting the clinical trial is 4 digits. , The time number that means the time of clinical trial (the time when the sample 33 is collected and the time when the subject comes to the hospital) is defined to be represented by a three-digit number.

As described above, among the standard codes, the clinical trial number, the subject number, the medical institution number, that is, the subject identification number is described in advance on the case registration form 21 distributed by the information institution to each medical institution. Thereby, the medical institution writes the subject information on the case registration form 21 and at the same time, the subject identification number is assigned to the subject, and the information institution identifies the subject registered in each medical institution by the subject identification number. Will be able to.

The subject ID which constitutes the subject information,
It is different from the subject number constituting the subject identification number in the standard code. The subject ID is a code that each medical institution gives to each subject in order to identify the subject within the medical institution. For example, a medical record number has been conventionally used. In other words, the subject ID can identify the subject within an individual medical institution, but since it is not standardized for each medical institution, a third party collectively manages information generated at multiple medical institutions. It is difficult to use the subject code to do.

On the other hand, if the subject identification number including the subject number is used, the subjects of a plurality of medical institutions can be identified by the information institution with the individual name hidden. For this reason, if the subject identification number is used, it becomes easy for the information organization to collectively manage the information even when the clinical trials are conducted simultaneously in a plurality of medical institutions.

Next, the flow of information from the registration agency shown in (2) and (3) of FIG. 4 will be described. Upon receipt of the case registration card 24 containing the subject identification number and the subject information from the medical institution, the registration organization performs case registration work.
The case registration work is to register a subject suitable for a clinical trial, notify the medical institution of the subject, and provide case data to an information institution. Here, the case data is information such as the subject ID of the registered subject, initials, sex, date of birth, name of medical institution conducting the clinical trial, name of investigator, investigator of clinical trial, scheduled start date of clinical trial. . The scheduled clinical trial start date is the scheduled date for starting medication, etc. at a medical institution.

The registration agency computer 16 is qualified based on the suitability judgment list 20 stored in advance in the registration agency computer 16 to determine whether the subject selected by the medical institution meets the selection criteria / exclusion criteria. The sex is determined and the subject is registered. FIG. 6 is a diagram showing an example of the suitability judgment list 20 of the present embodiment. Then, the registration agency computer 16 stores the subject identification number and the case data in the registration agency computer 16, and outputs a case registration confirmation slip 25 displaying the eligibility for each subject.

On the case registration confirmation slip 25, the scheduled clinical trial start date and the subject identification number are written together with the prescribed case data, and it is determined whether the subject is eligible for the clinical trial. Gender indication is described. In the present embodiment, the predetermined case data is the subject ID, sex, and initials.

Then, the registrar sends the case registration confirmation slip 25 to the medical institution and the case registration slip 24 and the case registration confirmation slip 25 to the information institution to notify the finally selected subject (see FIG. 4). (2), (3)). Instead of sending the case registration confirmation slip 25 to the information institution, the case data of the case registration confirmation slip 25 may be directly transmitted from the registration institution computer 16 to the information institution computer 12 through the communication line network 1.

Next, the flow of information from the medical institution shown in (4) and (5) of FIG. 4 will be described. The case is registered by the registration institution computer 16, and the medical institution that receives the notification of the finally selected subject executes the test work for the registered subject. In the test work, the test is performed on the subject, the specimen 33 is sent to the inspection organization, and the test data is provided to the information organization.

At the time of the clinical trial determined by the clinical trial implementation plan 17, the investigator or the like of the medical institution accepts the visit of the test subject, administers the test drug to the test subject, collects the specimen 33 such as blood or urine, and asks questions. . In the clinical trial information management system of this embodiment, as will be described later, the medical institution computer 15
In response to a transmission request from the clinical trial protocol 17, progress information such as the visit date and measurement items of each subject based on the clinical trial protocol 17 is transmitted from the information institution computer 12 to the medical institution computer 15 through the communication network 1 (see FIG. 4). (10))
The investigator or the like can easily grasp the clinical trial schedule of each subject through the WEB screen displayed on the display device of the medical institution computer 15.

The medical institution that has collected the sample 33 sends the inspection tag 34 together with the sample 33 to the inspection institution to request the inspection ((4) in FIG. 4). At this time, the inspection form 34 is a form in which the doctor fills in the predetermined case data and the sampling date of the sample on the inspection form sheet 22 distributed in advance in a state in which the standard code is written from the information organization to each medical institution. . As described above, since the standard code includes the subject identification number for identifying the subject and the time number for identifying the clinical trial time point, the sample 3 to be sent to the laboratory is sent.
An inspection slip 34 in which the subject identification number of the subject who collected the sample 33 and the time number indicating the time of collecting the sample 33 (at the time of clinical trial) are described is attached to the item 3. Predetermined case data such as the subject's sex and initials, and the date of collection of the specimen 33 are described on the inspection sheet.

On the other hand, for the information organization, in addition to the standard code, predetermined case data and test data are provided on the survey form 23.
The survey form 35 described in (4) is provided ((5) in FIG. 4). One set of standard code, predetermined case data, and test data described in the survey form 35 is one of the clinical trial result information. In particular,
Clinical trial result information including test data is called survey information.

The survey form 23 is distributed in advance from the information institution to each medical institution, and one standard code is written on one sheet of the survey form 23 for each clinical trial. As for the survey form 35, the investigator or the like of the medical institution surveys the subject's inquiry result on the survey form 23 in which the subject identification number of the subject who has undergone the test and the time number corresponding to the time of the clinical trial are described. The data and predetermined case data are described.

In the present embodiment, the survey information is provided to the information organization by transmitting the survey form 35 by FAX. However, the survey information is input to the medical institution computer 15 and the communication network 1 is used. Then, the survey information may be directly transmitted from the medical institution computer 15 to the information institution computer 12.

Next, the flow of information from the inspection organization shown in (6) and (7) of FIG. 4 will be described. The inspection institution that has received the sample 33 and the inspection form 22 from the medical institution performs inspection work. The inspection operation is an operation of inspecting the sample 33 and providing inspection data to medical institutions and information institutions.

When the inspection of the sample 33 is completed, the inspection institution has the inspection form paper 22 in which the standard code is written in advance.
The measurement data, which is the data of each measurement item such as white blood cell count, red blood cell count, and hemoglobin value measured by the inspection institution, is written in and provided to the medical institution as the inspection slip 34 ((6) in FIG. 4). The collection date of the sample 33 and the measurement data described in the inspection form 34 constitute the inspection data of this embodiment.

The inspection data is also provided to the information organization. In the present embodiment, the standard code described in the inspection form 34, predetermined case data, and inspection data are stored in the inspection institution computer 13. Then, the inspection institution computer 13 transmits the standard code, the predetermined case data, and the inspection data stored in the inspection institution computer 13 to the database of the information institution through the communication line network 1 ((7) in FIG. 4). A set of standard codes, predetermined case data, and inspection data transmitted from the inspection organization to the information organization is one of the clinical trial result information. In particular, clinical trial result information including test data generated by a laboratory is called test information.

Next, the flow of information from the information organization shown in (8), (9) and (10) of FIG. 4 will be described. The information institution receives the case data from the registration institution, the test information from the medical institution, and the test information from the inspection institution, and performs information management work. The information management business manages information so that clinical trials can be conducted appropriately and safely based on the clinical trial implementation plan 17 received from the requesting institution, and provides necessary information to medical institutions, testing institutions, and requesting institutions. Do.

The subject identification number and the case data are described in the case registration slip 24 or the case registration confirmation slip 25 and sent from the registration organization, and are input to the information organization computer 12 and then stored. The survey information is described in the survey form 35 and sent from the medical institution to the information institution. Further, the inspection information is transmitted from the inspection institution computer 13 to the information institution computer 12 through the communication network 1 and stored in the information institution computer 12.

Then, the information organization computer 12 determines whether the inspection information and the investigation information stored in the information organization computer 12 include data suspected to be improper data (confirmation required). This determination is a confirmation-requiring process, which will be described later, and is performed by comparing the contents of the clinical trial information 32 stored in advance in the information institution computer 12 with the contents of the examination information and the investigation information.

When the information organization computer 12 finds data in the inspection information or investigation information that is suspected to be improper data, the information organization computer 12 determines whether the inspection information or investigation information is proper or not. Outputs confirmation information required for confirmation to the requesting organization or medical institution. The information organization sends the outputted confirmation-required information as a confirmation-required processing instruction to the inspection organization and the requesting organization and a question list to the medical institution ((8) and (9) in FIG. 4). , (10)) and ask each institution to confirm the data.

Further, if the measured data measured by the inspection organization forming the inspection data has a value exceeding a predetermined range, the information organization computer 12 informs the requesting organization of the safety based on the safety management information list. Information is provided ((9) in FIG. 4).

Further, the information institution computer 12 responds to the request from the requesting institution computer 14 or the medical institution computer 15 for the visit date of each subject, the clinical trial schedule such as measurement items, the situation of the visit, examination data, and test data. The progress information such as is transmitted to the medical institution computer 15 and the requesting institution computer 14 through the communication network 1 ((9) and (10) in FIG. 4).

Further, the information institution computer 12 outputs a confirmation report 36 in which inspection data, test data and the like are described in response to a request from the requesting institution computer 14. The confirmation report 36 is sent to the medical institution ((9) in FIG. 4), and after the doctor confirms the contents, it is sent as a case report 19 from the medical institution to the requesting institution.

The information management work performed by the requesting institution is a work for managing whether or not the clinical trial is proceeding without delay based on the clinical trial implementation plan 17. In this embodiment, according to a request from the requesting institution computer 14, progress information such as the visit date of each subject based on the clinical trial protocol 17, examination data, and test data is communicated from the information institution computer 12 to the requesting institution computer 14. Since it is transmitted through the line network 1 ((9) in FIG. 4), the requesting organization can easily confirm the progress of the clinical trial.

The progress information transmitted from the information agency computer 12 to the requesting agency computer 14 through the communication line network 1 is displayed on the display device of the requesting agency computer 14 on the WEB screen. Therefore, the monitor who manages the entire clinical trial at the requesting institution only needs to check the inspection data and the like through the WEB screen displayed on the display device of the requesting institution computer 14, and does not need to check each medical institution individually. You can check the progress of clinical trials at medical institutions.

Next, the above case registration work executed by the registration institution computer 16 will be described with reference to FIG. FIG. 7 shows the registration agency computer 16 of the registration agency.
6 is a flowchart showing a process performed in case registration work.

Upon receipt of the case registration slip 24, the staff of the registration office inputs the clinical trial number, the subject number, the medical institution number and the subject information described in the case registration slip 24 into the registration agency computer 16. (S07.0
1).

The registration agency computer 16 of the registration agency
The input clinical trial number, subject number, medical institution number, and subject information are taken into the case registration database of the registration institution computer 16 (S07.02).

The registration agency computer 16 stores in advance the subject selection criteria / exclusion criteria described in the clinical trial implementation plan 17 as a suitability judgment list 20 as shown in FIG. The registration agency computer 16 compares the imported subject information with the adequacy determination list 20 to determine whether or not each subject identified by the standard code satisfies the selection criteria / exclusion criteria of the clinical trial protocol 17. The judgment is executed (S07.03). Then, the case registration confirmation slip 25 is output for the subject (S07.04).

Next, the contents of the information management work executed by the information organization computer 12 will be described with reference to FIGS. 8 to 17. FIG. 8 is a block diagram illustrating the flow of information management work in this embodiment. FIG. 9 is an explanatory diagram showing a screen displaying the clinical trial schedule table 26 created in the initial information input process. 10 and 11 are explanatory diagrams showing clinical trial date input screens when the subject schedule table 27 is created by the schedule creation process. FIG. 12 is an explanatory diagram showing a screen when the subject schedule table 27 is created by the schedule creation process. FIG. 13 is an explanatory diagram for explaining a determination method of requiring confirmation. 14 to 16 are explanatory diagrams of screens displaying progress information. FIG. 17 is a diagram showing an example of the confirmation report 36.

As shown in FIG. 8, the information institution that received the clinical trial implementation plan 17 distributes the case registration form 21 with one subject identification number to each medical institution. Also, the inspection form sheet 22 and the survey form sheet 23 in which one standard code determined at each clinical trial point is described are distributed.

Further, the clinical trial implementation plan 17 in which initial information is described from the requesting institution to the information institution, the case registration slip 24 in which the subject identification number and predetermined case data are described from the registration institution and the case registration confirmation When the vote 25 is sent, the information institution computer 12 performs clinical trial information creation processing. The clinical trial information creation processing includes initial information input processing, case data input processing, and schedule creation processing.

The initial information input process is a process for saving the initial information on the clinical trial described in the clinical trial implementation plan 17 in the clinical trial management computer. In the initial information input processing, the initial information such as the name of the medical institution, the name of the doctor, the selection criteria and exclusion criteria of the test subject, the dose and administration period of the investigational drug, the clinical trial time point, the measurement items, etc., described in the clinical trial protocol Are stored in the information agency computer 12.

At this time, one clinical trial number is assigned to the clinical trial that is the target of the clinical trial implementation plan 17 and registered. In addition, a specific date is not entered at the time of the clinical trial, but the number of days (or the number of days before) from the clinical trial start date when the clinical trial for the subject starts
Information such as whether there is a clinical trial point in time, ie sample 33
Is input and the relative number of days until the subject comes to the hospital. At the time of each clinical trial, one time number constituting the standard code is assigned. For example, in one clinical trial,
If there are 12 clinical trial times in total, 12 clinical trial time numbers “001” to “012” are allocated and registered.

The measurement items are stored in association with the clinical trial time points. That is, the measurement items to be implemented at the time of each clinical trial are input, and the clinical trial schedule table 26 as shown in the screen example of FIG. 9 is created. The clinical trial schedule table 26 is stored in the information institution computer 12.
The three-digit number in the clinical trial schedule table 26 illustrated in FIG. 9 represents the clinical trial time point and corresponds to the period number forming the standard code.

The case data input process is a process for saving the characteristics of the subjects participating in the clinical trial, such as the subject identification number and the case data, in the information institution computer 12. In the case data input process, the subject identification number described in the case registration slip 24 and the case registration confirmation slip 25 received from the registration institution, the case data such as the subject ID, initials, sex, scheduled start date of clinical trial are used as the information institution computer 12 Stored in.

The schedule creation process is a process for saving the clinical trial process for each subject in the information institution computer 12. In the schedule creation process, clinical trials are conducted for each subject based on the trial time point and measurement items in the initial information input in the initial information input process, and the scheduled trial start date input in the case data input process. A subject schedule table 27 representing the implementation process of is created.

In the schedule creation process, a new trial input is made using the clinical trial schedule table 26 stored in the information institution computer 12 in the initial information input process and the relative number of days based on the clinical trial start date. The clinical trial date corresponding to each period number is calculated based on the clinical trial start date of the subject, and a subject schedule table 27 as shown in the screen example of FIG. 12 is created. The subject schedule table 27 represents the correspondence relationship between the clinical trial date corresponding to each period number for each subject and the measurement items performed on the clinical trial date. The subject schedule table 27 is stored in the information organization computer 12.

In the present embodiment, the subject schedule table 27 is created using the input screens as shown in FIGS. FIG. 10 shows a clinical trial date input screen in which the clinical trial date corresponding to each period number is not displayed in the clinical trial date input field 30. When the clinical trial start date is input in the clinical trial start date input field 28 and the automatic input button 29 is pressed, the clinical trial date corresponding to each period number is calculated based on the relative number of days input in the initial information input process. FIG. 11 is a clinical trial date input screen in which the clinical trial date corresponding to each period number is displayed in the clinical trial date input field 30. When the registration button 31 is pressed in the screen example of FIG. 11, the subject schedule table 27 as shown in the screen example of FIG. 12 is created and saved in the information institution computer 12.

In the clinical trial start date input field 28 of the screen example shown in FIG. 10, initially, the planned clinical trial start date stored in the information institution computer 12 in the above-mentioned case data input processing is displayed. When the actual clinical trial start date is different from the scheduled clinical trial start date, it is convenient to input the clinical trial start date. In addition, it is preferable that the date corresponding to each period number can be freely entered in the clinical trial date input field 30 so that the schedule can be changed during the clinical trial. In this case, without using the above-mentioned automatic input button 29, directly enter the date in the clinical trial date input field 30 of FIG. 10, press the registration button 31, and then the subject schedule table as shown in the screen example of FIG. 27 is created.

Initial information input processing, case data input processing,
The information organization computer 12 creates clinical trial information 32 by performing the schedule creation process. Clinical trial information 3
2 is for determining whether or not the clinical trial result information provided by the examination institution or medical institution contains data suspected to be improper data, that is, when the information institution computer 12 performs a confirmation process described later. To use. FIG.
As shown in, the clinical trial information 32 created by the clinical trial information creating process is composed of the standard code of the subject, predetermined case data associated with the subject identification number, and the subject schedule. The predetermined case data may be any one that characterizes the subject, and in the present embodiment, for example,
The subject ID, sex, and initials.

In the clinical trial information 32, the subject number, clinical trial number, medical institution number, and predetermined case data are stored in the information institution computer 12 by the above-mentioned case data input processing. In addition, the period number is allocated by the number of clinical trial points saved in the above-mentioned initial information input process. Further, the subject schedule corresponds to the information of the subject schedule table 27 saved in the above schedule creation processing.

Each data constituting the clinical trial information 32 is used as a confirmation item. In other words, in the confirmation process described below, the clinical trial result information captured in the clinical trial database,
That is, it is used as a criterion for determining whether the inspection information or the survey information is accurate. Each confirmation item is classified into a confirmation item A, a confirmation item B, and a confirmation item C depending on how to handle the confirmation-requiring process.

Referring again to FIG. When the medical institution collects the specimen 33 from the subject, the medical examination institution sheet 22 in which the standard code for identifying the subject is described in advance shows the predetermined case data such as the subject ID, sex, and initials of the subject and the collection date of the specimen 33. It is described and sent together with the sample 33 to the inspection organization as an inspection sheet 34. The inspection organization writes the inspection data other than the sampling date of the sample 33 on the inspection sheet 34.
The standard code, predetermined case data, and inspection data written on the inspection sheet 34 are stored in the inspection institution computer 13. The standard code, the predetermined case data, and the examination data stored in the examination institution computer 13 are sent directly from the examination institution computer 13 to the information institution computer 12 periodically using the communication line network 1. Standard code stored in the laboratory computer 13, prescribed case data,
The inspection data can also be configured to be sent based on a transmission request from the intelligence agency computer 12. The standard code, predetermined case data, and inspection data transmitted from the inspection organization to the information organization are one of the clinical trial result information. In particular, clinical trial result information including test data generated by a laboratory is called test information.

Further, the medical institution forms the survey form 23 in which the subject identification number received from the information institution is described in advance.
In addition, prescribed survey data such as the subject ID, the subject's sex, and initials, and the test data such as the visit date of the subject, the result of the interview, the result of the measurement performed at the medical institution, and the like are created to create the survey form 35. The standard code, prescribed case data, and test data described in the survey form 35 are 1 of clinical trial result information.
It becomes one. Particularly, clinical trial result information including test data is called survey information. The survey information is described in the survey form 35 and sent to the information agency.

As shown in FIG. 8, in the information institution that has received the inspection information from the inspection institution and the inspection information from the medical institution, the information institution computer 12 performs the inspection data input process and the test data input process. Inspection data input processing and test data input processing are carried out by the computer 1
2 is a process for storing inspection information and survey information, respectively. In the inspection data input processing and the test data input processing, the inspection information and the investigation information are stored in the information institution computer 12, and further the confirmation-required processing is executed for the stored inspection information and the investigation information, that is, the clinical trial result information. .

The confirmation-requiring process is a process for determining whether the inspection information or the investigation information does not include data suspected to be improper data, and the examination information is improper data. There is a check information required confirmation process for determining whether the data is suspicious and a survey information required confirmation process for determining whether the survey information is suspected to be improper data.

As shown in FIG. 13, in the confirmation-requiring process, the above-mentioned clinical trial information 32 stored in the clinical trial database of the information institution computer 12, the examination information, the survey information,
That is, it is compared with clinical trial result information. In the clinical trial information management system according to the present embodiment, the standard code is used as a clue to determine whether or not there is data suspected to be incorrect data in the examination information or the survey information.

In the confirmation-requiring process, the information institution computer 12 searches the clinical trial information 32, and the subject identification number (clinical trial number, subject number, medical institution) included in the examination information and survey information stored in the information institution computer 12 is searched. Predetermined case data and subject schedule corresponding to the number combination) are extracted. The information institution computer 12 compares the content of the extracted predetermined case data with the content of the predetermined case data included in the examination information or the survey information, and determines whether the two match. The information agency computer 12 also compares the content of the extracted subject schedule with the content of the inspection data included in the inspection information and the survey information, and determines whether the two match.

As a case where the confirmation-requiring process is performed for the content of the extracted predetermined case data and the content of the examination information, for example, the confirmation-requiring process may be performed for the initial of the examination information. The clinical trial information 32 stored in the information institution computer 12 includes the subject identification number and the subject's initials input in the case data input process for the subject identification number. Here, as illustrated in FIG. 13, the examination information in which the clinical trial number is “0012003”, the subject number is “0001”, and the medical institution number is “0045”, that is, the subject identification number is “001200”.
If the inspection information of “300010045” is transmitted from the inspection institution computer 13 to the information institution computer 12 through the communication line network 1 and is taken in and stored in the information institution computer 12, the information institution computer 12
Searches the clinical trial information 32, and the subject identification number "0
The initial “SK” is extracted as the content of the predetermined case data corresponding to “0120030010045”.

The information institution computer 12 determines whether or not the initials of the extracted clinical trial information and the initials of the examination information match. In the example of FIG. 13, the former is “S
While the latter is “SK”, it is determined that the two match. As a result, the information agency computer 12 has no doubt that the initials of the inspection information are incorrect, that is, the initials of the contents of the inspection information are not required to be confirmed.

On the other hand, for example, when the confirmation-requiring process is performed on the initials of the survey information shown in FIG. 13, the initials of the survey information are “KK”. In this case, it is determined that the initials of the extracted clinical trial information do not match. Thereby, the information organization computer 12 determines that the initials of the investigation information are incorrect, that is, the initials of the contents of the inspection information require confirmation. The cause of such initial disagreement is that the subjects are mistaken in a medical institution or the questionnaire 35
It is possible that there is a mistake in filling in the form, a mistake in the survey form 35, or the like.

Further, as a case of performing the confirmation-requiring process regarding the content of the extracted subject schedule and the content of the inspection information, for example, the confirmation-requiring process regarding the date of collecting the inspection information may be performed. The clinical trial information 32 stored in the information institution computer 12 includes a subject specific number and a subject schedule in which the clinical trial date (time number) for the subject specific number is associated. Here, as illustrated in FIG. 13, the clinical trial number is “0012003”, the subject number is “0001”, the medical institution number is “0045”,
The inspection information having the time number “002”, that is, the inspection information having the standard code “001200300010045002” is transmitted from the inspection institution computer 13 to the information institution computer 12 through the communication network 1, and is taken in by the information institution computer 12. Saved as
The information institution computer 12 retrieves the clinical trial information 32 and uses this standard code “001200300010045”.
The subject schedule corresponding to “002” is extracted. According to the subject schedule illustrated in FIG. 13, the clinical trial date “2001/8/15” corresponding to the period number “003” is extracted as the subject schedule content.

The information institution computer 12 determines whether or not the extracted clinical trial date and the sampling date (clinical trial date) which is the contents of the examination information match. In the example of FIG. 13, the former is “20
01/8/15 ”, while the latter is“ 2001
/ 8/23 ", and it is determined that the two do not match because there is a shift of 8 days. As a result, the information organization computer 12 determines that the clinical trial date of the examination information is inappropriate, that is, the clinical trial date of the confirmation items requires confirmation.

Since clinical trials may not be performed according to the clinical trial schedule due to the reasons of medical institutions and test subjects, it is necessary to judge whether the clinical trial dates match within a predetermined range. Good to do. For example, even if there is a deviation of ± 7 days, it is determined that the clinical trial dates match.

[0108] Further, as a case where confirmation processing is required for the extracted subject schedule content and survey information content, for example, confirmation processing may be performed for the presence or absence of data regarding measurement items of the survey information. The clinical trial information 32 stored in the information institution computer 12 includes a subject identification number, a trial date (time number) for the subject identification number, and a subject schedule associated with measurement items to be performed on the trial date. . Here, as illustrated in FIG. 13, the clinical trial number is “0012003”,
Subject number is "0001" and medical institution number is "004"
5 ”and the period number is“ 003 ”, that is, the standard code is“ 00120030001004500 ”
When the investigation information of “3” is taken in and saved in the information agency computer 12, the information agency computer 12
The clinical trial information 32 is searched, and this standard code “00120
The subject schedule corresponding to "0300010045003" is extracted. According to the subject schedule illustrated in FIG. 13, as the contents of the subject schedule,
The measurement item corresponding to the time number “003” is extracted.

The information organization computer 12 determines whether or not the survey information has data regarding the extracted measurement item. In the example of FIG. 13, the survey information does not include “weight” data. In this case, the information institution computer 12 determines that the confirmation is necessary because the extracted subject schedule contents and the clinical trial result information contents do not match.
This is because the content of the subject schedule requires that the data of "weight" must be present at the time number "003".

[0110] In addition to the initial disagreement, the disagreement of the clinical trial date, the presence or absence of data on the measurement items, the determination of whether confirmation is necessary is also made on the presence or absence of the standard code, the coincidence of the subject ID and sex, and the presence or absence of the clinical trial date. Can be done.

Further, as the contents of the subject schedule,
The clinical trial information 32 has time numbers “001”, “002”, “0”.
In the clinical trial with "03", the period number is "00" after the examination information whose period number is "001" is transmitted to the information institution computer 12 as the contents of the examination information.
Although the inspection information of "2" has not been transmitted to the information agency computer 12, the period number is "00" first.
When the inspection information of “3” is transmitted, it is possible to determine that the inspection information of the period number “003” requires confirmation. This is because it can be determined that the clinical trial result information with the period number “002” is missing.
Further, if the case data is provided with information on whether or not the clinical trial has been discontinued for the subject, when the examination information or survey information of the subject whose clinical trial has been discontinued is taken into the information institution computer 12, etc. It is also possible to determine that confirmation is required.

Although the above-mentioned clinical trial information 32 includes predetermined case data and a subject schedule for the subject identification number, it is possible to provide only one of the predetermined case data and the subject schedule. Good. In this case, the above-described confirmation-necessary determination is made only for the content related to either the test information or the test data included in the survey information or the subject schedule.

That is, when the clinical trial information 32 includes only the subject identification number and the case data for the subject identification number, in any of the above-described examination information confirmation confirmation process or survey information confirmation confirmation process, Only the contents of the case data need to be confirmed. Clinical trial information 32
If the test subject identification number and the subject schedule for the subject identification number only are provided, in either case of the examination information confirmation confirmation process or the survey information confirmation confirmation process described above, it is determined whether confirmation is required only for the contents of the subject schedule. Do.

If the information institution computer 12 determines that the contents of the predetermined case data or the contents of the subject schedule do not match the contents of the examination information or survey information, whether the examination information or survey information is appropriate. Outputs the confirmation required information for confirming to the testing organization, requesting organization, or medical institution. The confirmation-requiring information is information that indicates a confirmation item determined to require confirmation in the clinical trial result information or informs a subject who has the confirmation item determined to require confirmation.

As will be described later, the confirmation-required information is output by being written on a paper medium such as an inspection agency processing instruction sheet, a requesting agency processing instruction sheet, and a question list, and the communication line network 1 Is used to output required confirmation information from the information institution computer 12 to the inspection institution computer 13, the requesting institution computer 14, and the medical institution computer 15, and the inspection institution computer 13, the requesting institution computer 14, and the medical institution. There may be a case where a display of the confirmation required information is output to the display device of the computer 15.

In this embodiment, when the confirmation-required information is output, the information organization requests the inspection organization, the requesting organization, or the medical institution to confirm the inspection information or the investigation information. In the confirmation item A, after first confirming with the inspecting organization, if the confirmation is still required, the requesting organization is confirmed. In confirmation item B,
Check with the requesting organization from the beginning. Confirmation item C asks the medical institution for confirmation. Such confirmation is performed until confirmation information is no longer output.

By performing the examination information confirmation processing in the examination data input processing in this way, the subject ID is obtained at the medical institution.
If the mistake is made, or if the sample 33 is collected at a time other than the time specified in the clinical trial protocol 17, or if there is a data input error in the laboratory, the data is correct. Since it is checked whether or not the inspection information transmitted from the inspection organization is treated as accurate data as it is, it is possible to avoid the situation.

Further, by performing the survey information confirmation process in the test data input process, if the subject ID is mistaken at the medical institution, or if the subject comes to the hospital outside the period specified in the clinical trial implementation plan 17. Even if the data is obtained, it is checked whether the data is appropriate, so it is possible to avoid the situation where the investigation information sent from the medical institution is directly treated as accurate data.

In the inspection data input process and the test data input process, the clinical trial result information sent to the information institution using the information institution computer 12 includes data suspected to be improper data. Therefore, it is not necessary to spend a great deal of labor and time of the medical staff at the medical institution to check the data, so that the medical institution can concentrate on the original medical work. In addition, when the clinical trial result information stored in the information institution computer 12 includes inappropriate data, it is possible to prevent the clinical trial result information from being treated as proper clinical trial result information, and to improve reliability. It is possible to manage certain clinical trial result information.

As described above, in the present embodiment, the investigation information confirmation processing is performed in order to determine whether the inspection information or the investigation information is data suspected to be improper data. . However, the survey information is not directly fetched from the medical institution computer 15 to the information institution computer 12 by using the communication network 1, but the survey information described in the survey form 35 sent from the medical institution is stored in the information institution of the information institution. When the information is input by the staff, the staff of the information organization should visually check whether the information is suspected to be invalid data before inputting the investigation information into the information organization computer 12. it can. Therefore, in such a case, in the test data input process, it is possible to use the information agency computer 12 so as not to carry out the survey information confirmation process (the confirmation item C is not confirmed). .

Returning to FIG. 8, description will be made again. As shown in FIG. 8, the information institution computer 12 uses the information in the clinical trial database obtained by the inspection data input process and the test data input process to perform the safety confirmation process, the progress information provision process, and the confirmation data report. Perform processing. The safety confirmation process is a process for confirming whether an abnormal value has occurred in the inspection data. The information institution computer 12 stores in advance a clinical test value range table indicating the range (upper limit value or lower limit value) allowed for the safety of the human body regarding the measurement data measured by the inspection facility.

In the safety confirmation process executed by the information institution computer 12, every time the inspection data is transmitted from the inspection institution, the measurement data constituting the inspection data stored in the clinical trial database is converted into the range of the clinical inspection value range table. If it is out of the specified range, the safety information is output to inform the requesting organization that an abnormal value has occurred in the measured data. In this embodiment, the safety information is written in the safety management information list and output. The safety management information list is sent to the requesting institution, and the type of the safety management information list that is output differs depending on the state of the confirmation-requiring flag regarding the confirmation item A or confirmation item B described above. .

In the present embodiment, even if a clinical trial is conducted in a plurality of medical institutions, the inspection data generated in each medical institution is collected in the information institution via the inspection institution. Therefore, if the measurement data out of the predetermined range is generated for a certain one subject, the information management organization sends the safety management information list. Therefore, the requesting institution can easily check whether or not the inspection is safely performed without individually monitoring the inspection data for each medical institution. Then, the requesting institution can immediately grasp the abnormal value in the measurement data of the subject at one medical institution, and promptly and appropriately process the other clinical institution such as notification of the discontinuation of the clinical trial. Can be done.

The progress information providing process is a process for providing the doctor of the medical institution and the monitor of the requesting institution with information regarding the clinical trial such as the progress of the clinical trial. In the progress information providing process, the information institution computer 12 responds to a request from the medical institution computer 15 or the requesting institution computer 14,
A clinical trial progress information such as a list of subjects who come to the hospital, visit dates and measurement items of each subject, examination data, test data, and visit situation is transmitted to the medical institution computer 15 and the requesting institution computer 14 through the communication network 1. The medical institution computer 15 and the requesting institution computer 14 display the transmitted progress information on a display device on a WEB screen.

Thus, the doctor can refer to the list of subjects scheduled to visit the hospital, the scheduled visit date of each subject, and the measurement items on that day through the WEB screen displayed on the display device of the medical institution computer 15. By doing so, the clinical trial schedule can be easily confirmed. Also,
Since the requesting organization can refer to the test data, test data, and visit situation of each subject through the WEB screen displayed on the display device of the requesting organization computer 14,
It is possible to save the effort of individually inquiring about the progress of the clinical trial from all the medical institutions in which the clinical trial is conducted.

FIG. 14 is an example of a screen display when a list of subjects scheduled to visit the hospital is displayed on a display device such as a medical institution computer. FIG. 15 is an example of a screen display when the visit situation is displayed on a display device such as a requesting institution computer. FIG. 16 is an example of a screen display when the test data and test data of each subject are displayed on a display device such as a requesting institution computer. Further, the scheduled visit date of each subject and the measurement items on that day can be displayed on the screen of a display device such as a medical institution computer as in FIG.

The confirmation data report processing is a processing for providing the confirmation data of the clinical trial to the clinical trial requesting institution. Here, the fixed data refers to inspection information (inspection data) or investigation information (test data) that is not determined as data suspected to be improper data in the above confirmation-requiring process. In the confirmed data reporting process, the information agency computer 1
2 responds to the request from the requesting institution computer 14
A confirmation report 36 in which inspection data, test data, etc. are described is output. FIG. 17 is a diagram showing an example of the confirmation report.
In the present embodiment, there are two types of finalized report 36, a temporary finalized report and a final finalized report, as described below.

As a result, it is not necessary for each medical institution to prepare the definitive report 36 individually, and even if a plurality of medical institutions are conducting clinical trials, the definitive report 36 is issued only from one information institution. Therefore, the client organization can easily manage the confirmation report 36.

Next, based on FIGS. 18 to 23,
The clinical trial information management process executed by the information institution computer 12 will be described. FIG. 18 is a flowchart showing the clinical trial information management process of this embodiment performed for each case.

The information organization performs the clinical trial information creation process of S18.01 to S18.10 before the clinical trial is conducted on the subject. In this clinical trial information creation processing, initial information input processing (S18.01 to S18.03) for registering initial information regarding the clinical trial in the clinical trial management computer and the characteristics of the subjects participating in the clinical trial are stored in the information institution computer 12. Case data input process (S18.04 to S1
8.06) and a schedule creation process (S18.07 to S18.10) for storing the clinical trial implementation process for each subject in the information institution computer 12. By storing various data in the information institution computer 12 in the initial information input process, the case data input process, and the schedule creation process, the clinical trial information 32 to be used in the later confirmation required process is created.

In the initial information input process of S18.01 to S18.03, first, the input of the initial information described in the clinical trial implementation plan 17 is accepted (S18.01). In the present embodiment, the staff of the information institution inputs the initial information described in the clinical trial implementation plan 17 received from the requesting institution. Then, the input initial information is taken in and saved in the information agency computer 12 (S18.02).

The stored initial information is output to the display device 10 of the information organization computer 12 or in a paper medium (S18.
03) and finishes the initial information input process. The staff of the information organization visually compares the output initial information with the initial information of the clinical trial implementation plan 17 to see if there is a difference, and checks whether there is an input error or the like. If there is an input error or the like as a result of collation and data correction is required, S18.01 to S18.03.
Is performed again and the corrected data is stored in the information agency computer 12 as initial information. At this time, the information organization computer 12 does not delete the already stored initial information (there was an input error or the like), but saves it as the correction history together with the reason for the correction.

In the case data input processing of S18.04 to S18.06, first, the input of the subject identification number for identifying the subject out of the standard codes of each subject and the case data is accepted (S18.04). In this embodiment, the staff of the information organization inputs the subject identification number and the case data described in the case registration slip 24 and the case registration confirmation slip 25 received from the registration organization.

Then, the entered subject identification number and case data are fetched and saved in the information institution computer 12 (S18.05). The stored case data and the like are output to the display device 10 of the information institution computer 12 or in a paper medium (S18.06), and the case data input process ends.
The staff of the information organization visually compares the output case data and the like with the case data and the like described in the case registration slip 24 and the case registration confirmation slip 25 to visually check whether there is an input error or the like. . If there is an input error or the like as a result of collation and the data needs to be corrected, S18.04 to S18.06 are performed again and the corrected data is stored in the information institution computer 12 as case data. At this time, the information organization computer 12 does not delete the case data and the like that has already been saved (there was an input error, etc.), but saves it as a correction history together with the reason for correction.

When the subject identification number and the predetermined case data are stored in the information institution computer 12 in the case data input process, the subject identification number and the predetermined case data are in a state in which the predetermined case data corresponds to the subject identification number. Clinical trial information 3
It forms part of 2.

In the schedule creation processing of S18.07 to S18.10, first, the input of the clinical trial start date of the subject is accepted (S18.07). After that, based on the relative number of days based on the clinical trial start date already stored in the information institution computer 12 in the initial information input process and the clinical trial start date of each subject input in S18.07, the clinical trial time point (time number) ) Is calculated (S18.08).
Then, with reference to the clinical trial schedule table 26 showing the correspondence between the period number and the measurement items performed at the time of the clinical trial specified by the period number, the measurement item to be performed on the clinical trial day of the period number is determined. Then, a subject schedule table 27 for each subject as shown in the screen example of FIG. 12 is created (S
18.09). The subject schedule table 27 is stored in the information organization computer 12 (S18.10).

When the subject schedule table 27 is saved in the information institution computer 12 in the schedule creation process,
The subject schedule table 27 constitutes a part of the clinical trial information 32 as a subject schedule in a state corresponding to the subject identification number.

After the clinical trial information creation processing of S18.01 to S18.10, the examination data input processing for storing the examination information in the information institution computer 12 each time the examination information is transmitted from the examination institution for each subject. Is performed (S18.11). Also, every time the survey information is sent from the medical institution, a test data input process for storing the survey information in the information institution computer 12 is performed (S18.
12). In the inspection data input process and the test data input process, a confirmation process is performed to determine whether or not the investigation information includes data suspected to be improper data.

Further, the information agency computer 12 carries out a safety confirmation process every time the inspection information is sent from the inspection agency to confirm whether or not an abnormal value has occurred in the inspection data (S18.13). . Further, the information institution computer 12 performs a progress information providing process in order to provide the doctor of the medical institution and the monitor of the requesting institution with information regarding the clinical trial such as the progress of the clinical trial (S18.14). In addition, the information institution computer 12 performs a confirmed data report process to provide the confirmed data of the clinical trial to the requesting institution (S1).
8.15).

FIG. 19 is a flow chart of the above-mentioned inspection data input process executed by the information organization computer 12. The information agency receives the inspection information transmitted from the inspection agency (S19.01). Then, the received inspection information is fetched and stored in the information agency computer 12 (S19.02). Subsequently, based on the imported inspection information, the confirmation required process (inspection information required confirmation process) is S19.0.
3 to S19.19.

In the inspection information confirmation processing, first, the confirmation item A
Alternatively, it is determined whether the confirmation item B requires confirmation (S1).
9.03). Both confirmation item A and confirmation item B are confirmation items included in the inspection information. And confirmation item A
If an item is suspected to be improper data, it first asks the inspection agency if the data is appropriate, and if it is still not clear, asks the requesting agency. Is an item defined in advance. On the other hand, confirmation item B
Is an item defined from the beginning to inquire the requesting organization about the appropriateness of the data.

The determination in S19.03 is made using the clinical trial information 32 stored in the clinical trial database, as already described with reference to FIG. Here, S19.0
If it is not determined in 3 that the confirmation is necessary, the process proceeds to S19.15 described later. On the other hand, when the confirmation-requiring item is found in the confirmation item A or the confirmation item B, it is determined whether or not the confirmation-requiring flag has already been set (S19.04). If the confirmation flag is not set, the confirmation flag is set (S19.05).

Then, it is determined whether or not confirmation is required for confirmation item A (S19.06). If the confirmation item A requires confirmation, the inspection institution processing instruction sheet in which the confirmation required information is described is output to the inspection institution to confirm the appropriateness of the data (S19.07). The staff of the information organization sends the output inspection agency processing instruction to the inspection agency.

Upon receipt of the inspection agency processing instruction from the inspection agency, the staff of the information agency inputs the handling method described in the inspection agency processing instruction into the information agency computer 12.
Then, it is determined whether or not the coping method of the input inspection period processing instruction is data correction (S19.08). In the case of data correction, the corrected correction data (inspection information) is transmitted from the inspection institution computer 13 to the information institution computer 12, so the corrected data is taken in and stored in the clinical trial database of the information institution computer 12 (S1).
9.09). At this time, the information agency computer 12
The inspection information that has already been saved is not erased but saved as a correction history together with the reason for correction.

On the other hand, when it is determined in S19.06 that the confirmation item A does not require confirmation, or in S19.08.
If it is determined that the data is not corrected in step S1, the requesting institution processing instruction sheet in which the confirmation required information is described is output to the requesting institution in order to confirm the adequacy of the data (S19.10). S1
When it is determined in 9.06 that confirmation is not required for confirmation item A, the requesting agency processing instruction is output in S1.
Since it has been confirmed in 9.03 that at least either confirmation item A or confirmation item B requires confirmation, it is determined in step S19.06 that confirmation item A does not require confirmation. This means that confirmation is required for confirmation item B.

If it is determined in S19.08 that the data has not been corrected, the requesting agency processing instruction is to output the data to the requesting agency if the inspection agency cannot correct the confirmation item A (it was not clear). This is because it is supposed to inquire about the appropriateness of.

The staff of the information organization sends the outputted requesting agency processing instruction to the requesting agency. According to the instruction from the requesting institution, the staff of the information institution inputs the instruction data (inspection information) described in the requesting institution processing instruction into the information institution computer 12 in order to correct the data (S19.1).
1). The input instruction data is transmitted to the inspection agency computer 13 for confirmation by the inspection agency (S19.1).
2), the inspection organization confirms the transmitted instruction data, and when it approves that the data is corrected with the content of the instruction data, it transmits an approval signal to the information agency computer 12. When the approval signal is received in S19.13, the input instruction data is taken into the clinical trial database and saved (S
19.14). At this time, the information agency computer 12
Saves the inspection information that has already been saved as a correction history together with the reason for the correction, without erasing it.

When the correction data and the instruction data are fetched in S19.09 and S19.14, it is determined again in S19.03 whether the confirmation item A or the confirmation item B is the confirmation required.
If the data is properly corrected, it is determined here that confirmation is not required, and then it is determined whether the confirmation flag is set or cleared (S19.
15). Here, if it is set, it is known in S19.03 that the confirmation items A and B do not require confirmation, so the confirmation flag needs to be cleared.

By the way, when the confirmation item C, which is a confirmation item other than the confirmation item A and the confirmation item B, is in the confirmation required state, the confirmation flag cannot be cleared.
In 19.16, it is confirmed whether or not the confirmation item C requires confirmation.
The confirmation item C is an item included in the survey information sent from the medical institution. If it is confirmed that the confirmation item C is not confirmation required, the process proceeds to S19.17.

In S19.17, S19.03 and S1
Since it is known in 9.16 that not all confirmation items require confirmation, the confirmation flag is cleared and the inspection data input processing ends. If the confirmation item C is required to be confirmed in S19.16, the inspection data input process is ended with the confirmation required flag being set. If the confirmation item C is not required to be confirmed, S1
9.16 is omitted.

FIG. 20 is a flow chart of the above-mentioned test data input processing executed by the information organization computer 12. When the information organization receives the survey form 35 from the medical institution, the survey information described in the survey form 35 is input by the staff of the survey organization (S20.01). Then, the input survey information is fetched and stored in the information agency computer 12 (S20.02). Next, based on the saved survey information, confirmation processing (survey information confirmation processing) is required.
20.03 to S20.11.

In the investigation information confirmation processing, first, the confirmation item C
It is determined whether is required to be confirmed (S20.03). The confirmation item C is a measurement item included in the survey information. And
The confirmation item C is a pre-defined item for inquiring a medical institution as to whether or not the data is appropriate when it is suspected that the data is incorrect.

The determination in S20.03 is made using the clinical trial information 32 stored in the clinical trial database, as already described with reference to FIG. Where S20.0
If it is not determined that the confirmation is required in 3, the process proceeds to S20.09 described below. On the other hand, when the confirmation-requiring item is found in the confirmation item C, it is determined whether or not the confirmation-requiring flag has already been set (S20.04). If the confirmation flag is not set, the confirmation flag is set (S20.05).

Then, in order to confirm the adequacy of the data to the medical institution, the question list in which the confirmation required information is described is output (S20.06). The staff of the information organization sends the output question list to the medical institution.

Here, the doctor or the like of the medical institution surveys the confirmation items described in the question list, writes the corrected data (survey information) in the survey form 35, and sends it to the information institution. When the survey form 35 in which the correction data is described is sent to the information organization, the staff of the information organization inputs the correction data (S20.07), and the inputted instruction data is taken into the clinical trial database and saved (S20.08). ). At this time, the information agency computer 12 does not delete the already saved investigation information, but saves it as a correction history together with the reason for correction.

When the correction data is fetched in S20.08, it is again determined in S20.03 whether the confirmation item C requires confirmation. If the data is properly corrected, it is determined here that confirmation is not required, and then it is determined whether the confirmation flag is set or cleared (S20.09). If set here,
Since it is known in S20.03 that the confirmation item C does not require confirmation, it is necessary to clear the confirmation flag.

By the way, the confirmation flag cannot be cleared when the confirmation item A or the confirmation item B other than the confirmation item C is in the confirmation required state.
In 20.10, it is confirmed whether the confirmation item A or the confirmation item B requires confirmation. When it is confirmed that the confirmation item A or the confirmation item B is not required, the process proceeds to S20.11.

In S20.11, S20.03 and S2
Since it is known that all the confirmation items are not required to be confirmed at 0.10, the confirmation required flag is cleared and the inspection data input process is ended. If the confirmation item A or the confirmation item B is required to be confirmed in S20.10, the test data input process is terminated with the confirmation required flag being set.

In this embodiment, since the survey information is provided by transmitting the survey form 35 by FAX, the staff of the survey organization inputs the survey information described in the survey form 35 in S20.01. Alternatively, the survey information may be input to the medical institution computer 15 and transmitted directly from the medical institution computer 15 to the information institution computer 12 using the communication network 1. In this case, S20.01 is omitted, and the survey information is sent to the information agency computer 12 using the communication network 1 in S20.02.
And save it.

The survey form 3 sent from the medical institution
When the staff of the information organization inputs the investigation information described in 5, and the staff of the information organization visually confirms whether the investigation information is suspected to be invalid data. Can be configured so that the survey information confirmation process is not performed (confirmation item C is not confirmed). In that case, S20.03 to S20.1
1 is omitted.

FIG. 21 is a flowchart of the above-mentioned security management process executed by the information organization computer 12. The information institution computer 12 transmits the inspection data from the inspection institution, and each time the inspection data is saved in the information institution computer 12, the clinical test value range table stored in advance in the information institution computer 12 and each saved inspection It is confirmed whether the measured data is within the range of the clinical test value range table by comparing it with the measured data constituting the data (S
21.01).

For example, if the lower limit value of white blood cell count is defined as 3000 and the upper limit value is 10,000 in the clinical test value range table, and if the measured data regarding the white blood cell count falls within the range of 3,000 or more and 10,000 or less, However, if it is smaller than 3000 or larger than 10000, it is judged to be out of range.

If there is no measurement data determined to be out of the range in S21.01, the safety management process ends. However, when measurement data outside the range is found in S21.01, the process proceeds to S21.02 and the R value is calculated. The R value is the difference between the measured data value and the upper or lower limit value of the range. In the measurement data for which the upper limit value is set in the clinical test value range table, when the value of the test data exceeds the upper limit value, the R value is the difference between the measured data value and the upper limit value. Further, in the measurement data having the lower limit value set in the clinical test value range table, when the value of the measurement data exceeds the lower limit value, the difference between the measured data value and the lower limit value becomes the R value.

Subsequently, in S21.03, the grade value is calculated. As the grade value, a predetermined value is predetermined for each measurement item and is stored in the information organization computer 12. Then, in S21.04, the magnitude of the R value and the grade value are compared. As a result, if the grade value is larger, the safety management process is ended.

The grade value has the meaning of defining a predetermined range (allowable value) in which the value of the measurement data is allowed to deviate from the range of the clinical test value range table, in consideration of the characteristics of the clinical trial. The grade value for each measurement data can be set to an arbitrary value in advance before starting a clinical trial for each subject, and is stored in the computer of the information organization.

When it is determined in S21.04 that the R value is larger, the process proceeds to the process of outputting the safety management information list in S21.05 to S21.07. The safety management information list includes safety information notifying that an abnormal value has occurred in the measurement data. The requesting organization looks at the safety management information list and, if it judges that it is necessary, immediately discontinues the clinical trial. In the present embodiment, the type of the safety management information list to be output differs depending on whether the confirmation-requiring flag related to the confirmation item A or the confirmation item B is set or cleared. .

Confirmation item A or confirmation item B in S21.05
If it is determined that the confirmation-required flag regarding the status is cleared, a formal safety management information list is output (S2
1.07). The fact that the confirmation-required flag is cleared means that there is no doubt that the inspection data at the time of the clinical trial is invalid data, and is treated as official data. On the other hand, check item A in S21.05
Alternatively, if it is determined that the confirmation-required flag regarding the confirmation item B is set, a temporary safety management information list is output (S21.06). If the confirmation required flag is set, it means that the test data at the time of the clinical trial is suspected to be incorrect, so it is necessary to treat the stored test information as temporary data. This is because it is difficult.

The formal safety management information list and the temporary safety management information list that have been output are sent to the requesting institution. Instead of sending the safety management information list containing the safety information, the communication device 7 may be used to output the safety information from the information agency computer 12 to the requesting agency computer 14.

In the present embodiment, as described above, S2
In 1.04, the safety management information list is output only when the grade value is smaller than the R value, and the grade value can be arbitrarily set for each measurement data. Therefore, the safety management information list is not necessarily output when the measured data values are all outside the range of the clinical test value range table.

Since the grade value can be set to an arbitrary value, there is an advantage that one type of clinical test value range table stored in advance in the information institution computer 12 is sufficient. That is, only the standard clinical laboratory value range table is stored in the information institution computer 12, and the grade value is normally set to 0. When performing a clinical trial in which it is unavoidable that certain measurement data deviates from the range of the clinical test value range table within a certain range, a grade value is set to a desired value as initial information of the clinical trial. This eliminates the need to create a separate clinical test value range table for each clinical trial, and requires only one type of clinical test value range table when multiple clinical trials are being conducted at the same time.

Furthermore, it is not necessary to change the range itself of the stored clinical test value range table, and it is possible to prevent the mistake of forgetting to return the range to the original value when performing another new clinical test. it can. If different grade values can be set for each subject, an abnormal value can be found on a different basis for each subject.

Further, in the present embodiment, the type of the safety management information list to be output depends on whether the confirmation flag for the confirmation item A or confirmation item B is set or cleared. To change, even if you suspect that the inspection data is incorrect data,
Just in case, the provisional information can inform the requesting agency that an abnormal value has occurred in the measurement data, and the requesting agency can take prompt and appropriate action.

FIG. 22 is a flowchart of the above-mentioned progress information providing process executed by the information organization computer 12. In the progress information providing process, first, the information institution computer 12 confirms acceptance of a request from the medical institution computer 15 or the requesting institution computer 14 (S22.0).
1). Upon accepting the request, a list of subjects to visit, visit date and measurement items of each subject, test data, test data,
Output clinical trial progress information such as visit status (S22.0
2), the medical institution computer 15 through the communication network 1.
Or to the requesting institution computer 14. The medical institution computer 15 and the requesting institution computer 14 can confirm the transmitted progress information on the WEB screen.

FIG. 23 is a flowchart of the confirmed data reporting process executed by the information organization computer 12. In the confirmation data reporting process, the information institution computer 12 first receives a provisional confirmation report creation request signal from the requesting institution computer 14 (S23.01). Next, the state of the above-mentioned confirmation required flag is determined (S23.02).
When the confirmation-required flag is set, it has been confirmed that some data is suspected to be incorrect data in the confirmation-requiring process, so clinical trial result information has not yet been confirmed. is there. In this state, neither a final confirmation report nor a final confirmation report can be prepared. The reason for this is that if data that is suspected to be improper data is used as definitive data, it may interfere with proper clinical trials.

If it is confirmed in S23.02 that the confirmation flag is clear, a provisional confirmation report is output (S2).
3.03). The output tentative confirmation report is sent to the doctor of the medical institution and checked by the doctor. If the doctor's check result data is not corrected (S23.04), S2
Proceeding to step 3.12, it is confirmed whether or not there is a final confirmation report creation request from the requesting institution, and in step S23.13 a final confirmation report is created and the finalized data report processing ends.

On the other hand, as a result of the doctor's check, if it is determined that the data of the tentative confirmation report requires correction (S23.04), the process proceeds to S23.05 to correct the data. The correction of the data is performed by the staff of the information organization inputting the data into the information organization computer 12 based on the instruction of the doctor. At this time, the information organization computer 12 does not erase the data before being corrected, but saves it as a correction history together with the reason for the correction. It is also possible for the doctor to input the data to be corrected from the computer of the medical institution through the WEB screen.

When the correction of the data is completed, it is determined in S23.06 whether or not the confirmation item requires confirmation, as in the above-mentioned confirmation required processing. If you judge that the confirmation item requires confirmation,
In step S23.07, the state of the confirmation required flag is confirmed.
If the confirmation flag is clear, S2
At 3.08, the confirmation flag is set and the process proceeds to S23.09. If the confirmation flag has already been set, S as it is
Proceed to 23.09. In S23.09, a question list is output in order to confirm with the medical institution about the items requiring confirmation generated by the data correction in S23.05.

The list of questions is sent to the doctor at the medical institution,
Ask your doctor to correct the data. And again S23.0
At 5 the data is modified. After that, S23.05 to S23.09 until there are no more items to be confirmed in S23.06.
repeat. If it is determined in S23.06 that there is no item requiring confirmation, the process proceeds to S23.10. In S23.10, the state of the confirmation flag is confirmed. Here, if the confirmation flag is in the clear state, the process directly proceeds to S23.12. If the confirmation flag is set, S
Since it is confirmed in 23.06 that there is no item requiring confirmation, the confirmation flag is cleared in S23.11 and S23.
Proceed to 12.

In S23.12, it is confirmed whether or not there is a request from the requesting institution to create the final confirmation report, and S23.13.
Then, the final confirmation report is created and the confirmation data report processing is ended. As described above, in this embodiment, before the final confirmation report is output, the provisional confirmation report is checked by the doctor to ensure the accuracy of the clinical trial to the maximum, and the confirmation flag is set. Since there is data suspected to be improper data in this state, it is possible not to interfere with proper clinical trials by not creating a final confirmation report.

[0180]

As described above, according to the present invention, by using the clinical trial information management device of the information institution, the data that is suspected to be improper data in the clinical trial result information sent to the information institution. Since it is checked whether or not is included, it is not necessary for medical institutions to spend a great deal of labor and time on the medical staff to check the data, and it becomes possible to concentrate on the original medical work. In addition, if the clinical trial result information stored in the clinical trial information management device contains incorrect data, it is possible to prevent the clinical trial result information from being treated as proper clinical trial result information, and It is possible to manage certain clinical trial result information.

[Brief description of drawings]

FIG. 1 is an explanatory diagram illustrating a main configuration of a clinical trial information management system according to this embodiment.

FIG. 2 is a block diagram showing a hardware configuration example of a clinical trial information management device.

FIG. 3 is a block diagram schematically showing the flow of the entire clinical trial.

FIG. 4 is an explanatory diagram illustrating a flow of information in a clinical trial in which the clinical trial management system of this embodiment is used.

FIG. 5 is an explanatory diagram showing a configuration of a standard code.

FIG. 6 is a diagram showing an example of a suitability determination list.

FIG. 7 is a flowchart showing a process performed in case registration work.

FIG. 8 is a block diagram illustrating a flow of information management work according to the present embodiment.

FIG. 9 is an explanatory diagram showing a screen displaying a clinical trial schedule table created in an initial information input process.

FIG. 10 is an explanatory diagram showing a clinical trial date input screen when a subject schedule table is created in the schedule creation process.

FIG. 11 is an explanatory diagram showing a clinical trial date input screen when a subject schedule table is created in the schedule creation process.

FIG. 12 is an explanatory diagram showing a screen when a subject schedule table is created in the schedule creation process.

FIG. 13 is an explanatory diagram illustrating a determination method of confirmation required.

FIG. 14 is an explanatory diagram of a screen displaying progress information.

FIG. 15 is an explanatory diagram of a screen displaying progress information.

FIG. 16 is an explanatory diagram of a screen displaying progress information.

FIG. 17 is a diagram showing an example of a confirmation report.

FIG. 18 is a flowchart showing clinical trial information management processing of the present embodiment.

FIG. 19 is a flowchart of inspection data input processing.

FIG. 20 is a flowchart of a test data input process.

FIG. 21 is a flowchart of safety management processing.

FIG. 22 is a flowchart of a progress information providing process.

FIG. 23 is a flowchart of a confirmed data reporting process.

FIG. 24 is an explanatory diagram illustrating a flow of information in a conventional clinical trial.

FIG. 25 is an explanatory diagram illustrating a clinical trial system using a conventional computer.

[Explanation of symbols]

1 communication network 2 CPU 3 RAM 4 ROM 5 HDD 6 Storage media device 7 Communication device 8 keyboard 9 mice 10 Display 11 Printer 12 Information organization computer (clinical trial information management device) 13 Inspection computer 14 Client computer 15 Medical institution computer 16 Registration agency computer 17 clinical trial implementation plan 18 Case Report Form 19 Case Report Form 20 Applicability judgment list 21 Case Registration Form 22 Inspection form 23 Survey Form 24 Case Registration Form 25 Case Registration Confirmation Form 26 Clinical Trial Schedule 27 Subject Schedule 28 Clinical trial start date input field 29 Automatic input button 30 Clinical trial date input field 31 Register button 32 clinical trial information 33 specimens 34 Inspection sheet 35 questionnaire 36 Final Report

Claims (8)

[Claims] 1. A clinical trial information management system comprising: a clinical trial information management apparatus operated by an information organization that collectively manages information on clinical trials; and an examination institution computer operated by an examination organization that tests specimens. The examination institution computer includes examination information transmitting means for transmitting examination information including a subject identification number for identifying a subject to the clinical trial information management device, and the clinical trial information management device includes the examination information from the examination institution computer. Receiving means for receiving, clinical trial information in which at least one of predetermined case data and subject schedule corresponds to the subject identification number, and storage for storing the examination information received from the examination institution computer Means and the location corresponding to the subject identification number included in the examination information by searching the clinical trial information Extracting means for extracting at least one of the case data and the subject schedule; determining whether the content of the predetermined case data extracted by the extracting means and the content of the examination information match; The determination means for determining at least one of the determinations as to whether the content of the subject schedule extracted by the extraction means and the content of the examination information match, and the determination means required when the determination means determines that they do not match. An clinical trial information management system, comprising: an output unit that outputs confirmation information. 2. A clinical trial information management device for collecting and managing information on clinical trials, wherein at least one of predetermined case data and subject schedule corresponds to a subject identification number for identifying a subject. Provided clinical trial information, and a storage device for storing clinical trial result information including the subject identification number, the predetermined case data corresponding to the subject identification number included in the clinical trial result information by searching the clinical trial information Extracting means for extracting at least one of the subject schedules, and determining whether the content of the predetermined case data extracted by the extracting means and the content of the clinical trial result information match.
When the determination means determines at least one of the determination whether the content of the subject schedule extracted by the extraction means and the content of the clinical trial result information match, and the determination means does not match And a means for outputting confirmation-required information, and a clinical trial information management device. 3. A clinical trial information management device for collecting and managing information on clinical trials, comprising: a communication device for receiving clinical trial result information from an external information processing device; and a subject identification number for identifying a subject. At least one of predetermined case data and subject schedule is configured to correspond to the trial information, and a storage device for storing trial result information including the subject identification number is provided, and the trial information is searched to retrieve the trial result. Extraction means for extracting at least one of the predetermined case data and the subject schedule corresponding to the subject identification number included in the information; the content of the predetermined case data extracted by the extraction means and the clinical trial result information. Judging whether or not the contents match,
When the determination means determines at least one of the determination whether the content of the subject schedule extracted by the extraction means and the content of the clinical trial result information match, and the determination means does not match And a means for outputting confirmation-required information, and a clinical trial information management device. 4. A clinical trial information management method for determining whether clinical trial result information including a subject identification number for identifying a subject is appropriate, wherein a clinical trial information management device for collecting and providing information on clinical trials is provided. , Performing a procedure of storing in the storage means of the clinical trial information management device, clinical trial information in which at least one of predetermined case data and a subject schedule for a subject identification number for identifying a subject is configured. Performing a procedure of storing the clinical trial result information in the storage means, searching the clinical trial information, and extracting at least one of the predetermined case data corresponding to the subject identification number included in the clinical trial result information and the subject schedule. And the content of the predetermined case data extracted by the extraction means matches the content of the clinical trial result information. Whether or not the determination,
The procedure of determining at least one of the determinations as to whether the content of the subject schedule extracted by the extraction means and the content of the clinical trial result information match is performed, and it is determined that the content does not match in the determination procedure. A clinical trial information management method characterized in that a procedure for outputting confirmation-required information is sometimes performed. 5. A clinical trial information management method for determining whether clinical trial result information including a subject identification number for identifying a subject is appropriate, wherein a clinical trial information management device for collecting and providing information on clinical trials is provided. , Performing a procedure of storing clinical trial information in which at least one of predetermined case data and a subject schedule corresponding to a subject identification number for identifying a subject is configured to be stored in a storage unit of the clinical trial information management device, Performing a procedure of receiving the clinical trial result information from an external information processing apparatus, performing a procedure of storing the clinical trial result information received from an external information processing apparatus in the storage means, searching the clinical trial information, and performing the clinical trial result. A procedure for extracting at least one of the predetermined case data and the subject schedule corresponding to the subject identification number included in the information No, a determination of whether the contents of the given case data extracted by the extraction means and the content of the trial result information match,
The procedure of determining at least one of the determinations as to whether the content of the subject schedule extracted by the extraction means and the content of the clinical trial result information match is performed, and it is determined that the content does not match in the determination procedure. A clinical trial information management method characterized in that a procedure for outputting confirmation-required information is sometimes performed. 6. A clinical trial information management program for causing a clinical trial information management device for collecting and providing information on clinical trials to determine whether clinical trial result information including a subject identification number for identifying a subject is appropriate. A procedure for storing, in the clinical trial information management device, clinical trial information in which at least one of predetermined case data and a subject schedule corresponding to the subject identification number is configured to be stored in a storage unit of the clinical trial information management device; , A procedure of storing the clinical trial result information in the storage means, and extracting at least one of the predetermined case data corresponding to the subject identification number included in the clinical trial result information and the subject schedule by searching the clinical trial information Whether the contents of the predetermined case data extracted by the extracting means and the contents of the clinical trial result information match. And judgment of,
A procedure for determining at least one of the determinations as to whether the content of the subject schedule extracted by the extraction means and the content of the clinical trial result information match, and when it is determined that they do not match in the determination procedure A clinical trial information management program for executing the procedure for outputting confirmation required information to. 7. A clinical trial information management program for causing a clinical trial information management device for collecting and providing information on clinical trials to judge whether clinical trial result information including a subject identification number for identifying a subject is appropriate. A procedure for storing, in the clinical trial information management device, clinical trial information in which at least one of predetermined case data and a subject schedule corresponding to the subject identification number is configured to be stored in a storage unit of the clinical trial information management device; A procedure for receiving the clinical trial result information from an external information processing apparatus, a procedure for storing the clinical trial result information received from an external information processing apparatus in the storage means, and a search for the clinical trial information to obtain the clinical trial result information. A procedure for extracting at least one of the predetermined case data and the subject schedule corresponding to the included subject identification number; And determining whether the match contents of content as the trial result information of the given case data extracted by means,
A procedure for determining at least one of the determinations as to whether the content of the subject schedule extracted by the extraction means and the content of the clinical trial result information match, and when it is determined that the content does not match in the determination procedure. A clinical trial information management program for executing the procedure for outputting confirmation required information to. 8. A storage medium in which the program according to claim 6 or 7 is stored.