JP2002015061A - Clinical test performance management system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To perform a clinical test under a system control, and to make necessary information available anywhere and anytime, thereby providing a total management system for the clinical test. SOLUTION: The solution of the task of this invention is realized by constructing a total management system such that a wide area information- distributing tool is used to achieve the database of a class of various clinical test related data, further, a filter function capable of automatic evaluation is introduced to each process for data usage in order to automate the evaluation of screening, warning, abandoning, grade rating and the like, and, finally, various reports can be outputted in predetermined forms.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a total management system for conducting clinical tests in accordance with GCP and / or GPMSP in drug development and / or post-marketing surveillance.

[0002]

2. Description of the Related Art Pharmaceutical clinical trials (Phase I to IV)
(Phase IV is also called post-marketing surveillance) is a new drug conducted in cooperation with pharmaceutical manufacturers, physicians, clinical trial subjects, clinical trial (management) companies, clinical testing companies, etc., in compliance with GCP and / or GPMSP It is submitted for application for development and for evaluating the usefulness of approved drugs. When a clinical trial is selected, a clinical trial protocol that defines the entire clinical trial plan is determined. All subsequent clinical trials will be performed according to this clinical trial protocol. Once the clinical trial protocol has been determined, the clinical trial review and review by the ethics committee are conducted at the clinical trial hospital, and upon approval, a contract is concluded with the clinical trial hospital and clinical trial doctor. Implementation is bound by this agreement. When the contract is over, the company identifies the clinical trial protocol, the clinical trial physician, etc., and submits the clinical trial notification to the Ministry of Health.

[0003] Clinical trial subjects are registered through selection and informed consent to the subjects. When administering medications, clinical trial drug management, medication plans and test plans are set. After the start of the administration, the test is continuously performed, and the acquisition of clinical trial data is progressed while monitoring the efficacy and side effects.
When the clinical trial data has been sufficiently accumulated, it becomes a key open and the analysis and statistical processing of the clinical trial data are performed, and finally the clinical trial report is compiled. Clinical trials were conducted in Phase 1, Early Phase 2, Late Phase 2, Phase 3,
Although the phase is divided into the fourth phase, the procedure proceeds in substantially the same manner for each phase.

[0004] In clinical trials so far, clinical trial data management and statistical analysis processing and the like have been performed by a computer, but all of them are independent, and because of the isolation of data, the processing is repeated. Judgment based on the experience of each person was required, and the processing was complicated. Regarding the invention of data processing relating to clinical trials, a database of clinical test subjects, medication information, test information, findings information, etc. is disclosed (Japanese Patent Laid-Open No. 11-154185), data input by clinical investigators and preparation of clinical test reports. There are related to the system (Japanese Patent Laid-Open No. 10-214294) and the like, but these are not comprehensive but only local improvement measures.

[0005]

The problem to be solved by the present invention is that a clinical trial is performed under system management, and necessary information is used whenever and wherever necessary. Possible, and by providing various filter functions, problems in various elements can be presented in real time.
The aim is to provide a safe and more efficient total management system for clinical trials that can be modified.

[0006]

SUMMARY OF THE INVENTION The present invention achieves a database of various clinical test-related data by using a wide-area information transmission tool, and further provides a filter function capable of automatically evaluating data use in each process. To automate the sorting, warning, suspension, grade evaluation, etc., and finally build a total management system that enables various reports to be output in a predetermined form. That is, the present invention provides a clinical test implementation management system that uses a wide-area information transmission tool in a clinical trial operation, and that carries the following components. The present invention provides: 1) Determination of clinical trial drug (excluding Phase IV) 2) Setting of clinical trial protocol proposal based on clinical trial basic dictionary database for clinical trial drug 3) Determination of clinical trial protocol 4) Determined clinical trial protocol and Preparation of clinical trial protocol filter means based on clinical trial basic dictionary database 5) Registration of clinical trial subjects (subject registration: ID) / automatic allocation of subjects based on clinical trial protocol 6) Clinical trial based on subject profiles 7) Means for inputting medication records and subject data and clinical test data 8) Warning of abnormal values / exclusion values for clinical test data
Filter means to notify side effects 9) Abnormal value of clinical test data (abnormal test value)
Means for confirming warnings and side effects of excluded values (excluding test values) from the clinical trial basic dictionary database 10) Mathematical analysis / statistics filtering means based on clinical test data 11) Case card format output means 12) Clinical test data Means for performing tabulation work (key open) 13) Means for creating report forms. 2. The information accumulated in the clinical trial basic dictionary database includes disease names, disease states, disease state images, related organs, disease diagnostic criteria, diagnostic reference values (normal value ranges of clinical test values, abnormal value ranges),
Disability data, known drugs, doses and administration methods of known drugs, side effects of known drugs, mechanism of action of known drugs, drug-inhibited drugs and drug-inhibiting action mechanisms, side effect grade data,
3. The clinical test implementation management system according to the above item 1, 3. Individual disease names, diagnostic criteria, diagnostic reference values, known drugs,
The clinical trial implementation management described in the preceding item 2, which additionally uses a user dictionary database and / or an information database on a clinical test company, which additionally uses the dose and administration method of the known drug, the mechanism of action of the known drug, side effects of the known drug, and the like. system. 4. The clinical trial protocol database (identification of clinical trial drugs, mechanism of action, indication, subject to be selected, dosage, administration method, administration period, excluded cases, criteria for validity / ineffectiveness, etc.) is registered in the clinical trial basic dictionary database. 2. The clinical trial implementation management system according to the above item 1, wherein the system is selected and adjusted by drag-and-drop by accessing the user dictionary database with a wide area information transmission tool. 5. The decision of the clinical trial protocol determines the identification of the clinical trial drug, the mechanism of action, the indication, the subjects to be selected, the dosage, the administration method, the administration period, the excluded cases, the criteria for validity / ineffectiveness, etc. 2. The clinical trial implementation management system according to the above 1, wherein a protocol database is constructed. 6. The clinical trial implementation management described in the preceding item 5, wherein the clinical trial protocol database is prepared so as to have a function of a filter (clinical trial protocol filter) for evaluating various clinical trial data inputted in the subsequent work. system. 7. 7. The clinical trial implementation management system according to the above item 5 or 6, prepared to have a modification reporting function accompanied by a layer function of a clinical trial protocol. 8. Based on the decision of the clinical trial protocol, it was prepared to have a function to create contracts with clinical trial hospitals and to output documents such as clinical trial reports and ethics committee reports 1
The clinical trial implementation management system according to 1. 9. Registration of clinical trial subjects by inputting information such as subject background information, starting data, general laboratory test values, case reports, adverse events, discontinuations, dropouts, etc. by accessing with a wide-area communication tool Subject database 2. The clinical trial implementation management system according to the above 1, wherein the database is created as a database. 10. 10. The clinical trial implementation management system according to the preceding clause 9, wherein the registration of the clinical trial subjects in the database is made by random allocation, and the subject registration ID is automatically set. 11. Medication records of clinical trial drugs used at the start of clinical trials are entered through access through a wide-area communication tool, and use of clinical trial drugs is managed in conjunction with a separately established clinical trial drug management database. 2. The clinical trial implementation management system according to the above item 1, which has a function of outputting a clinical trial drug management record according to the following. 12. The clinical test described in the preceding item 1, wherein the clinical trial data obtained by the clinical trial is input by the subject registration ID set in the subject profile database by accessing by the wide area information communication tool, and the clinical trial data is made into a database. Implementation management system. 13. Clinical trial data includes physician findings, medication history,
13. The clinical test execution management system according to the above item 12, wherein diagnostic data, test data, and image data can be individually input. 14． While the entered clinical trial data is being registered in the database, a clinical trial is performed by a side effect filter based on the clinical trial basic dictionary database (the occurrence of side effects due to medication is determined based on the clinical trial data values and adverse events are reported). 14. The clinical test implementation management system according to the above item 12 or 13, wherein the continuation of the test / warning is performed. 15. In the process of registering the entered clinical test data in the database, a test value abnormality filter based on the clinical trial basic dictionary database (detects abnormal cases of test values and exempted cases from clinical test data values and gives a warning) 14. The clinical test implementation management system according to the above item 12 or 13, which is evaluated by: 16. 14. The clinical test execution management system according to the above item 12 or 13, wherein abnormal / deviation clinical test data is detected by a clinical test protocol filter by a clinical test protocol filter while the input clinical test data is being registered in the database. 17． In the course of registration of the entered clinical test data in the database, abnormal / deviation clinical test data is detected by a subject profile filter based on the subject profile data, and a warning is issued.
3. The clinical trial implementation management system according to 3. 18. The clinical trial implementation management system according to the above item 1, wherein the input clinical trial data is registered in a database, converted into a clinical trial database, and then output as a case card when necessary by accessing with a wide area information transmission tool. 19. After the entered clinical trial data is registered in the database and converted into a clinical trial database, the clinical trial database is accessed by the wide-area information transmission tool, and the clinical trial is performed using a mathematical analysis / statistical analysis filter based on a separately prepared mathematical analysis statistical processing database. 2. The clinical trial implementation management system according to the above item 1, wherein data is tabulated, analyzed, and a report is prepared. Consists of

[0007]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The basic structure of the present invention is as follows: a terminal of a clinical trial company (manufacturer), a terminal of a clinical test facility (hospital), a terminal of a clinical test company, a clinical test company (a clinical trial contracting company). A) (CRO) terminals and a data center database that stores all data, and each terminal and the data center are connected by a wide area information transmission tool such as the Internet. One of the features of the present invention is that
This is to provide a database that can be called a clinical trial manual in which all information on clinical trials named the clinical trial basic dictionary database is accumulated. A second feature of the present invention is the introduction of a filter function for judging the evaluation / grade of each plan / data. Filters include clinical trial protocol filters, subject profile filters, mathematical analysis / statistical processing filters, and clinical trial data filters (abnormal test value filters / side effect filters)
Was introduced.

[0008] The present invention is characterized by the above-mentioned configuration, and has the following system. A clinical trial implementation management system using a wide-range information communication tool in a clinical trial operation, which includes the following components: 1) Determination of a clinical trial drug (excluding Phase IV) 2) Clinical Setting of a clinical trial protocol for a test drug based on the clinical trial basic dictionary database 3) Determination of the clinical trial protocol 4) Preparation of the clinical trial protocol filter means based on the determined clinical trial protocol and clinical trial basic dictionary database 5) Registration of clinical trial subjects based on clinical trial protocol (subject registration: ID conversion) / automatic allocation of subjects distributed 6) Subject selection means using clinical trial protocol filters based on subject profiles 7) Medication records, subject data and clinical Enter test data 8) Warning of abnormal value / exclusion value for clinical trial data
Filter means to notify side effects 9) Abnormal value of clinical test data (abnormal test value)
Means for confirming warnings and side effects of excluded values (excluding test values) from the clinical trial basic dictionary database 10) Mathematical analysis / statistics filtering means based on clinical test data 11) Case card format output means 12) Clinical test data Means for performing tabulation work (key open) 13) Means for creating report forms.

(Clinical trial basic dictionary database) The following information is accumulated in this database. Disease name, disease state, disease state image, related organ, disease diagnostic standard, diagnostic reference value (normal range of clinical test value, abnormal value range), disability data, known drug, dose and administration method of known drug, side effect of known drug , Known drug action mechanism, concomitant prohibited drug / combination prohibited action mechanism, side effect grade data, preclinical test data on known drugs, and the like. The disease name is adopted according to, for example, the International Classification of Diseases. At the same time, there is a description of the symptoms (conditions) of each disease, and the symptoms and the names of the diseases are associated with each other, and can be specified from both. Further, details related to the symptoms of the related organs are also linked in the content associated with the disease / medical condition. The disease diagnostic criteria are linked to the disease based on appearance, disease part, clinical examination, and the like.

As criteria for determining a disease to be a clinical test, aggressive criteria such as appearance, disease site, clinical test values, and physical condition are set. At the same time, exclusion criteria are set and adjustments are made to avoid unnecessary data confusion. These criteria are systematized and thesaurus adjusted. The diagnostic reference values based on the clinical test values are data in which the normal value range and the abnormal value range of the clinical test value are linked to the disease. In addition, the degree of disability is classified according to the disease diagnostic criteria / diagnostic criteria, and the grade is clarified. Known drugs are in a state in which drugs and diseases can be linked based on information on indications for which each drug has been approved, relevant indications, and indications under development. For each drug, information such as dosage, administration method, administration timing, contraindications for concomitant use, etc. can be linked according to age, sex, and degree of disability. In addition, for each drug, it is possible to link to data such as side effects, action mechanism, side effect mechanism, concomitant prohibited drug, concomitant prohibited action mechanism, side effect grade, and the like. Preclinical data for known drugs
It is linked to predict the development into clinical trials from the results of animal experiments.

In the present invention, in addition to the above-mentioned basic dictionary, a disease name, a diagnostic criterion, a diagnostic criterion value, a known drug, a dose / administration method of the known drug, an action mechanism of the known drug, a side effect of the known drug, etc. The user dictionary database to be additionally used has been set. This database is registered for each individual development company, and access to anyone other than authorized persons is prohibited in principle. As the registered contents, the same items as those in the general basic dictionary can be stored in a database. The basic dictionary also has a database of information on clinical trial-related organizations such as clinical trial companies, hospitals capable of clinical trials, and clinical test companies.

(Clinical Study Drug Selection: Excluding Phase IV) After pre-clinical studies for drug development are completed, drug candidate compounds are selected and clinical study drugs are identified. The clinical trial drug of the present invention is individually specified according to the development phase of each clinical trial.

(Clinical Test Protocol Setting) When the clinical test drug is specified, the system of the present invention is introduced below. A clinical trial protocol specifies how to conduct a clinical trial, based on the results of preclinical studies on drug classification, drug mechanism of action, drug efficacy, and side effects.
Proposals for future clinical trial protocols will be provided by linking to the clinical trial basic dictionary database.

The clinical trial protocol includes the criteria for selecting the subjects to be targeted (indications, subjects to be selected), the criteria for excluding subjects (excluded cases), the medication schedule for clinical trials, the test items, the target number of cases, the planned period of the study, Client / responsible person,
Clinical trial company (CRO), test method, clinical trial drug, dosage and administration, dosing period, contraindicated drug, concomitant licensed drug, primary evaluation item, main evaluation criteria (valid / ineffective judgment criteria), secondary evaluation item, secondary evaluation item Evaluation criteria (judgment criteria for validity / invalidity) are determined, and are adjusted by dragging and dropping on a predetermined form by comparing the above-mentioned plan with the contents of a specific clinical trial basic dictionary database.

[0015] Thus, once the clinical trial protocol is determined, the data is registered as a clinical trial protocol filter for a particular clinical trial on a database to serve as a clinical trial protocol filter. This data can be registered as a user-specific database in the data center. Changes to the clinical trial protocol can be made using authorized IDs and keywords, if deemed necessary by authorized clinical investigators, pharmaceutical manufacturers, and the like. However, the record before the change is also handled by the concept of the remaining layer (layer).

The contract, the report of the clinical trial, the report of the ethics committee, etc. are output on the system after editing by the user if desired.

(Registration of test subject) The test subject is selected by a clinical trial doctor. The clinical trial contract physician investigates and selects candidate subjects using a clinical trial protocol filter (filter function for selecting subjects: subject profile filter) based on the clinical trial protocol.

For this purpose, potential test candidates are registered in advance in a predetermined thesaurus form, such as disease, disease symptom, disease duration, treatment history, contraindicated state, age, sex, side effect history, and the like. This data can be registered as a user-specific database in the data center.

Subjects who have passed the subject profile filter are registered as subjects. Subjects include the name of the clinical trial institution, subject name, subject identification code,
The name of the investigator, age, gender, complications, medical history, consent confirmation, etc. are entered, and the subjects are randomized by means of automatic randomization of subjects (active drug subjects, placebo subjects) so that the distribution of subjects is appropriately distributed. Adjusted and registered. Registration is made to the data center by a wide area information transmission tool. At the time of this registration work, the above assignment is automatically made. The subject thus registered is given a subject registration ID and stored in the subject profile database.
Used. After the subject registration, all the information is managed only by the subject registration ID, so that the privacy of the subject is protected.

(Management of Clinical Trials) When a clinical trial is started, the usage status of the clinical trials is system-managed. Clinical trial drug management is performed by accessing the database (clinical trial drug management system) of the data center using a wide-area communication tool. This data can be registered as a user-specific database in the data center. This management must be managed for each clinical trial hospital, and must be linked with the management system in the clinical trial hospital. The clinical trial companies (manufacturers) can check the use status of clinical trial drugs at each clinical trial hospital at any time by using a wide-area communication tool. Input items necessary for this management include a drug name / code, subject registration ID, amount used, date of use, clinical physician / code used, and the like.

(Start of Administration and Input of Clinical Test Data) At the start of administration, data at the start is acquired. The findings, tests, clinical test values, and images obtained thereafter are registered in the data center's clinical trial database by a wide-area communication tool at any time in a predetermined form. This clinical trial data can be registered as a user-specific database in the data center. The input items are performed for the items determined by the clinical trial protocol, and are executed at any time according to the determined schedule. Clinical trial data is entered through clinical trial doctors and clinical trial hospital terminals.
Each person obtains, browses, and obtains the input contents of others using a wide-area information transmission tool within the previously authorized range.
It can be monitored. Clinical laboratory measurements are entered by a clinical laboratory using a wide area communication tool.

(GC for handling clinical trial data)
GCP defines the implementation standards for remote control electronic data system processing of clinical trial data, including validation, creation of procedure manuals, data modification records, security, backup, management, blindness, etc. This system naturally satisfies standards such as testability.

(Setting of data filter, its function and specific work) Clinical trial data is registered in the database after input, but before registration, abnormal values of data, occurrence of side effects, violation of clinical trial protocol, subject specific Pass through filters that set exclusion criteria for circumstances, etc.

An abnormal value of data is a numerical value set based on a difference from an initial value, a special difference from a predicted value, and the like.
Perform this check automatically in the database before registration. When an abnormal value is detected, a notification of the fact, a suggestion of a possible cause, a reasonable numerical value to be taken, and a notification of a measure / response are made.

The occurrence of side effects is detected at the opinion of a physician or by the occurrence of abnormal values of test values. Also in this case, when registering data, a notification of a side effect, a grade thereof, a predicted cause, a countermeasure and a countermeasure are made.

In the data registration, violations of various clinical trial protocols such as subjects, medication schedules, contraindications, and the like are also checked before registration. In this case as well, when registering data, a notification of a clinical trial protocol violation and a notification of countermeasures and countermeasures are made.

The subject special circumstances are checked by a subject profile filter for consistency between the special circumstances in the subject profile and the data. Again,
When registering data, notice of the subject special circumstances violation, countermeasures
A notification about the response is given.

(Output of case card)
The desired ones can be prepared according to conventional foams and user requirements.

(Tallying and Mathematical Analysis / Statistical Processing Filter) When the registered data reaches a predetermined target number, a key open is performed. Key open means closing the phase of the target clinical trial and performing data aggregation, statistical analysis, and mathematical analysis. The numerical values of the obtained data are subjected to final processing such as analysis / return / analysis / report through aggregation work and mathematical analysis / statistical processing filters.

[0030]

The present invention will be described in more detail with reference to the following examples, but the present invention is not limited to these examples.

[0031]

[Example 1] Manufacturer A accesses the data center (E) via the Internet (F) when the clinical trial drug (a) is determined, and conducts the clinical trial based on the clinical trial basic dictionary (G). Create a draft protocol. The clinical trial protocol review committee (b) accesses the data center (E) via the Internet (F) for the proposed clinical trial protocol, and conducts a clinical trial based on the clinical trial basic dictionary (G). Examination / decision of test protocol (c)
do. The determined clinical trial protocol is registered in the clinical trial protocol database (H) of the data center (E). At the same time, a clinical trial protocol filter (1) is set based on the data. Once the clinical trial protocol is determined, a contract () that is output as desired
The procedure is processed using the clinical trial notification (e). Next, the clinical trial site (B) performs subject selection and registration (g) according to the clinical trial protocol, and registration is made via the Internet through a subject profile filter (2) created according to the clinical trial protocol. To go.
At this stage, warnings are given to subjects who are unsuitable for the clinical trial protocol selected by the mistake. In the registration, random allocation registration is performed in the database of the subject profile (I) through the subject registration automatic allocation means (), which achieves appropriate distribution. When the drug is administered and the data comes out, the clinical investigator (B), the clinical test company (D) (), and the clinical test company (C) enter data (h) based on the authority previously authorized, and enter the Internet. Through (F), it will be registered in the clinical trial database (J) of the data center (E). At the time of registration, all data pass through the test value filter (3) set based on the clinical trial protocol, detect abnormal data and detect excluded data, and simultaneously pass through the preset side effect filter (4). Warning and notification of important adverse events are immediately notified. The notified warning / notification is immediately transmitted to the authorized person via the Internet (F),
Clinical trial continuity / Clinical trial protocol change (d)
Enables the study of the necessity of When the clinical trial data is fully accumulated in (J), a key open (i) is declared and the data is passed through the mathematical analysis and statistical processing filter (6) of the data center (E), and the manufacturer (A) is connected to the Internet. Various desired reports (j) can be prepared via (F). Various outputs can be edited and output according to the user's request.

[0032]

[Embodiment 2] FIG. 3 shows the overall configuration of a clinical trial implementation management system, in which a pharmaceutical manufacturer, a clinical trial company, a clinical laboratory, a clinical trial protocol committee, and a clinical trial implementation facility each carry out the clinical trial of the present invention. Represents the relationship through the test execution management system. The main work items of each facility are described within the framework of each facility. 4 to 7 show screen flows of the clinical trial implementation management system. From the top screen to the authentication screen, further divided into three screens: user registration screen, clinical test system top screen, and authentication error screen. The clinical test system top screen is a clinical trial execution plan screen, an informed consent form screen, Registration status list screen (FIGS. 4 and 5)
).

The clinical trial implementation plan screen is to the clinical trial implementation plan detail screen, the informed consent form screen is to the informed consent screen and consent form screen (FIG. 4), and the registration status list screen is the test center result report screen.・
The screen branches to an agreement confirmation screen, a subject profile registration screen, and a case card cover screen (FIGS. 5 and 6). The test center result report screen is divided from the blood chemistry test result screen 1 to a clinical test error screen 1 and a clinical test screen 1, and from the biochemical test result screen 1 to a clinical test error screen 1 and a clinical test screen 1. The subject profile registration screen branches from the subject profile confirmation screen to the subject consent confirmation screen, the subject profile error screen, and the disease name search screen 1 to the disease name search screen 2 (FIG. 5).

From the case card cover screen, the subject background screen, clinical evaluation screen 1, clinical evaluation input screen 1, clinical evaluation screen 2, clinical evaluation input screen 2, clinical evaluation screen 3, clinical evaluation input screen 3, clinical examination screen・ Clinical test result report screen of examination center ・ X-ray image screen ・ Side effect grade list screen ・
Separated from the protocol confirmation screen, the clinical evaluation input screen 2 changes from the drug name search screen 1 to the drug name search screen 2, and the test center clinical test result report screen changes from the hematology search screen 2 to the causal relationship report screen. 2 to a causal relationship report screen (FIG. 6).

FIG. 7 shows a top screen. This screen is displayed by inserting a key disk (for example, a CD-ROM). Clicking the image transitions to the authentication screen.

FIG. 8 shows an authentication screen. A new user performs user registration with the user registration button. Users who have registered as users can use this system by entering their ID and password. Transit to user registration screen by pressing user registration button. User authentication is performed by pressing the send button. If OK, the screen transitions to the clinical test system top screen, and if NG, the screen transitions to an authentication error screen.

FIG. 9 shows an authentication error screen. Displayed when user authentication is error on the authentication screen.

FIG. 10 shows a user registration screen. CD-R
Serial No. attached to OM. , Input an arbitrary ID and password to perform user registration. By pressing the registration button, transition to the user registration confirmation screen.

FIG. 11 shows a user registration confirmation screen.
Serial No. entered on the user registration screen , ID,
Display password. When the OK button is pressed, the screen transits to the clinical test system top screen.

FIGS. 12 and 13 show registration status list screens. This screen displays a list of subject profiles and case card input status for each subject. The contents of the items on this screen are as follows. Subject registration ID: An ID assigned by subject registration automatic assignment of this system. Drug number: This is a number obtained by random allocation of medication in this system. Initials: Initials of the subject. Date of birth: The subject's date of birth. Gender: The gender of the subject. Initial enrollment date: The date on which the subject begins conducting the clinical trial.
Last update date: The date on which the subject completed the clinical trial. Profile: The subject profile input status is displayed with a mark. Blue means filter pass, red means filter error. Consent: Displays the consent of the subject with a mark. Blue means agreed, yellow means unconfirmed, red means denied. Inspection result: A mark indicates whether the inspection result from the inspection center was opened or transcribed. Open blue indicates that the measurement result has been opened, red indicates that the measurement result has not been opened, blue indicates that the measurement result has been posted on the case card, and red indicates that the measurement result has been recorded on the case card. Means unposted.
Status: Displays the clinical trial status with a mark. Blue indicates that the clinical trial has been completed, yellow indicates that the clinical trial is ongoing, and red indicates that the clinical trial has been discontinued. Subject identification code: Chart number of subject It is. Pressing the new button at the bottom center of the screen transits to the subject profile registration screen and performs new registration processing. When the inspection center result report on the right side of the screen is pressed, the screen transits to the inspection center result report screen, and the inspection result can be opened or transcribed. When a case card on the rightmost side of the screen is pressed, a transition is made to a case card cover screen.

FIG. 14 shows a clinical test system top screen. When the clinical trial plan is pressed, the screen transitions to the clinical trial plan screen. When the informed consent form is pressed, the screen transitions to the informed consent form screen. When a case report is pressed, the screen transitions to a registration status list screen.

FIG. 15 is a clinical trial execution plan screen. The table of contents of the clinical trial protocol is displayed, and details are displayed by pressing the respective items. Pressing the return button at the bottom of the screen transits to the clinical test system top screen.

FIG. 16 is a detailed screen of the clinical trial execution plan. The details of the item pressed on the clinical trial implementation plan screen are displayed. This screen is a display of the clinical trial summary. The screen transitions to the clinical trial execution plan screen by pressing the back button.

FIG. 17 shows an informed consent form screen. When the informed consent is pressed, the screen transits to the informed consent screen. When the consent form is pressed, the screen transits to the consent form screen. When the back button is pressed, the screen transitions to the clinical test system top screen.

FIG. 18 shows an informed consent screen. This screen displays the contents of the informed consent. Press the back button to transit to the informed consent agreement screen.

FIG. 19 shows a consent form screen. This screen is
Display the contents of the agreement. In addition, it is possible to print and hand it to the subject. To return, use the browser's return button.

FIGS. 20 and 21 show subject profile registration screens. On this screen, the subject profile is input and the consistency is checked by the subject profile filter of this system. The function of the subject profile filter performs individual checks and related checks on the screen items such as age and complications. This screen is used for subject selection. Enter your date of birth and your age will be displayed automatically. The date input can be selected from a pull-down menu. In the complication input area, an input field can be arbitrarily added by inputting the number of fields to be added and pressing an add button. When the search button in the disease name column is pressed, a disease name search screen is displayed in a separate window, and when the relevant disease name is selected, it is transcribed to the disease name input area. When the registration button is pressed, the subject profile of the input data is checked. If the subject profile check is normal, the screen transitions to the subject profile registration confirmation screen. If the subject profile check is abnormal, the screen transitions to a subject profile error screen. If the subject profile check is normal and the consent has not been obtained, the screen transitions to the subject consent confirmation screen.

FIGS. 22 and 23 show subject profile confirmation screens. This screen is displayed when the subject profile check is normal. The subject registration ID is assigned by the subject registration automatic assignment function of the present system. O
The screen transitions to the registration status list screen by pressing the K button. In this case, the mark of the profile on the registration status list screen is displayed in blue.

FIGS. 24 and 25 show subject profile error screens. This screen is displayed when the subject profile check is abnormal. At the error location, a mark is displayed in the item column, and the details of the error are displayed at the bottom of the screen.
When the correction button is pressed, the screen transitions to the subject profile registration screen, and the error location can be corrected. By pressing the stop button, it can be excluded from the subject selection. In this case, the profile mark on the registration status list screen is displayed in red.

FIGS. 26 and 27 are subject confirmation confirmation screens. This screen is displayed when the profile check on the profile registration screen is normal and the consent has not been obtained. When the consent is obtained from the subject, the consent button is pressed and the screen transitions to the subject profile confirmation screen. In this case, the agreement on the registration status list screen is marked in blue. If the consent of the subject is rejected, the user presses the reject button to transit to the subject profile error screen. In this case, the agreement on the registration status list screen is marked in red. If the consent of the subject has not been confirmed, the user presses the unconfirmed button to transit to the registration status list screen. In this case, the agreement on the registration status list screen is marked yellow.

FIG. 28 shows a disease name search screen 1. This screen is displayed by pressing the search button on the subject profile registration screen. When a part or all of the disease name is entered in the text area and the search button is pressed, the corresponding disease name is picked up from the disease name database, and the screen transitions to the disease name search screen 2.

FIG. 29 shows a disease name search screen 2. This screen displays a list of searched disease names. By checking and selecting the radio button, it is transcribed to the disease name input area on the subject profile registration screen.

FIG. 30 shows an agreement confirmation screen. This screen is displayed when the consent status mark is red or yellow on the registration status list screen and is displayed by clicking the mark.
You can select rejected or unconfirmed. When the consent button is pressed, the screen transitions to the subject profile confirmation screen. If you press the unconfirmed button, the screen will move to the registration status list screen.

FIG. 31 shows an inspection center result report screen. In this screen, when the inspection result at the inspection center has been completed, the result can be browsed from the registration status list screen. still,
The available categories are divided into blood tests and biochemical tests. In addition, an event indicating that the test result has been completed is notified to a doctor in charge of the clinical trial, a pharmaceutical manufacturer, or the like by email or a mobile phone. When a blood test is pressed, the screen transits to the hematology test result screen 1. When a biochemical test is pressed, the screen transits to the biochemical test result screen 1. When the return button is pressed, the screen is transited to a registration status list screen.

FIG. 32 shows a hematology test result screen 1.
This screen displays the blood test results from the test center. If an abnormal test value occurs, the corresponding item is displayed as an error, and the clinical physician confirms the content and transfers it to the case card. When the transfer button is pressed, the transfer is made to the case card, and the screen transitions to the clinical test screen 1 or the clinical test error screen. When the return button is pressed, the screen transits to the inspection center result report screen.

FIG. 33 shows a biochemical test result screen. This screen displays the biochemical test results from the test center. If an abnormal test value occurs, the corresponding item is displayed as an error, and the clinical physician confirms the content and transfers it to the case card. When the transfer button is pressed, the transfer is made to the case card, and the screen transitions to the clinical test screen 1 or the clinical test error screen. When the return button is pressed, the screen transits to the inspection center result report screen.

FIG. 34 shows the clinical examination screen 1. This screen is displayed when the transcription button is pressed from the blood test result screen and the biochemical test screen. When the return button is pressed, the screen transits to the inspection center result report screen.

FIGS. 35 and 36 show a clinical test error screen 1.
It is. This screen is displayed when there is an abnormality in the test value by the protocol check after pressing the transcription button on the hematology test screen 1 and the biochemical test screen 1. Further, details of the abnormality test value are displayed at the top of the screen. For example, in the figure, "The hematology RBC is abnormal. Discontinue medication immediately. Pharmaceutical manufacturer, clinical trial company (CRO)
And report to the Protocol Review Committee physician. Check the causal relationship with the drug. Is displayed. An abnormal test value is displayed in bold red, and a radio button for causal relationship check is displayed. When the send button is pressed, the checked causal relationship is transmitted, and the screen changes to the inspection center result report screen.

FIG. 37 shows * of compound A-25 (IFT).
Phase III Study for Sexual Pain (Comparison with ####)
It is a case card cover screen about. This screen is displayed when a case card on the registration status list screen is pressed. The data entered in the case card passes through the clinical trial data filter of this system, and alerts / notifications of important adverse events are immediately notified. When the cover at the bottom of the screen is pressed, the screen transits to the case card cover screen. At the stage where the clinical examination has been completed on the cover of the case card on the case report, the clinical physician can stamp the pre-registered imprint. When the confirmation of the subject profile / exclusion criteria at the bottom of the screen is pressed, the screen transitions to the subject background screen. When the test value / comment within 2 weeks of registration at the bottom of the screen is pressed, the screen transitions to the clinical evaluation screen 1 or the clinical evaluation input screen 1. When the pre-treatment analgesic / surgical treatment / other treatment / concomitant drug / comment is pressed at the bottom of the screen, the screen transitions to the clinical evaluation screen 2 or the clinical evaluation input screen 2. When the administration / dropout of XX at the bottom of the screen is pressed, the screen transitions to the clinical evaluation screen 3 or the clinical evaluation input screen 3. When a clinical test at the bottom of the screen is pressed, the screen transits to a clinical test screen 2. When the X-ray inspection at the bottom of the screen is pressed, the screen transits to the X-ray screen. When the test center clinical test result report at the bottom of the screen is pressed, the screen is changed to the test center clinical test result report screen. When the side effect grade list at the bottom of the screen is pressed, the screen transitions to the side effect grade list screen. When the protocol confirmation at the bottom of the screen is pressed, the screen transits to the protocol confirmation screen.
When the registration status list at the bottom of the screen is pressed, the screen transitions to the registration status list screen.

FIGS. 38 and 39 show that Compound A-25 (IF
It is a subject background screen about the phase III test (comparison test with ###) for * sexual * pain of T). This screen is
Displays the content entered on the subject profile registration screen. This screen is for display only.

FIG. 40 shows * of compound A-25 (IFT).
Phase III Study for Sexual Pain (Comparison with ####)
9 is a clinical evaluation screen 1 for the. This screen is displayed only when a comment has been registered, by pressing any of the inspection values and comments within 2 weeks of registration of the content frame. Press the change button to transition to the clinical evaluation input screen 1,
The registered contents can be changed.

FIG. 41 shows * of compound A-25 (IFT).
Phase III Study for Sexual Pain (Comparison with ####)
7 is a screen for inputting clinical evaluation for. This screen is displayed when any of the inspection values and comments within two weeks of registration of the content frame is pressed when there is no comment input. After the comment is registered, the clinical evaluation screen 1 is displayed first, and this screen is displayed when the change button is pressed. The test values within two weeks of registration are transcribed by using the transcript button on the hematology / biochemistry test screen of the test center clinical test result report. When the registration button is pressed, the input content is registered, and the screen transitions to the clinical evaluation screen 1.

FIG. 42 shows * of compound A-25 (IFT).
Phase III Study for Sexual Pain (Comparison with ####)
9 is a clinical evaluation screen 2 for the. This screen is displayed when any one of the items is entered by clicking any of the pre-treatment analgesics / surgical treatments and other treatments / concomitant medications / comments in the content frame. When the change button is pressed, the screen transits to the clinical evaluation input screen 2 and the registered contents can be changed.

FIGS. 43 and 44 show compounds A-25 (IF
It is a clinical evaluation input screen 2 about the phase III test (comparison test with ###) for * sexual * pain of T). In this screen, if even one item is not registered, pre-treatment analgesic / surgical treatment and other treatment / concomitant drug /
Displayed when any comment is pressed. When a drug name search button is pressed, a “drug name search screen 1” is displayed in another window. When you select a drug,
The data is transcribed to the dose list area, and the corresponding amount is selected. When the registration button is pressed, the screen transits to the clinical evaluation screen 2 and the input contents are registered.

FIG. 45 shows * of compound A-25 (IFT).
Phase III Study for Sexual Pain (Comparison with ####)
13 is a clinical evaluation screen 3 for the. This screen displays XX of the content frame if any one of the items has been registered.
It is displayed when either of administration or dropout of XX is pressed.
When the change button is pressed, the screen transitions to the clinical evaluation input screen 3,
The registered contents can be changed.

FIG. 46 shows * of compound A-25 (IFT).
Phase III Study for Sexual Pain (Comparison with ####)
9 is a clinical evaluation input screen 3 for. This screen displays the content frame XX when all of the items have not been registered.
It is displayed when any of the administration and dropouts of ○ is pressed. When the registration button is pressed, the screen transits to the clinical evaluation screen 3 and the input content is registered.

FIG. 47 shows * of compound A-25 (IFT).
Phase III Study for Sexual Pain (Comparison with ####)
9 is a clinical test screen for. This screen displays the inspection date
Until the test value is transcribed from the hematology / biochemistry test screen of the test center clinical test result report, it is blank. If the inspection value is abnormal, the corresponding item is displayed in bold red.

FIG. 48 shows * of compound A-25 (IFT).
Phase III Study for Sexual Pain (Comparison with ####)
5 is a test center clinical test result report screen for the test center.
This screen is displayed when the inspection result at the inspection center has been completed. The browsable categories are divided into blood tests and biochemical tests. In addition, an event indicating that the test result has been completed is notified to a doctor in charge of the clinical trial, a pharmaceutical manufacturer, or the like by email or a mobile phone. When the blood test is pressed, the screen transits to the hematology test result screen 2. When the biochemical test is pressed, the screen transits to the biochemical test result screen 2.

FIG. 49 shows that * of compound A-25 (IFT).
Phase III Study for Sexual Pain (Comparison with ####)
9 is a hematology test result screen 2 for the sample. This screen displays the blood test results from the test center. If an abnormal test value occurs, the corresponding item is displayed as an error, and the clinical physician confirms the content and transfers it to the case card. When the transcription button is pressed, the transcription is made on the case card, and the screen transits to the clinical result screen.

FIG. 50 shows * of compound A-25 (IFT).
Phase III Study for Sexual Pain (Comparison with ####)
13 is a biochemical test result screen 2 for the sample. This screen displays the biochemical test results from the test center. If an abnormal test value occurs, the corresponding item is displayed as an error, and the clinical physician confirms the content and transfers it to the case card. When the transcription button is pressed, the transcription is made on the case card, and the screen transits to the clinical result screen.

FIG. 51 shows that * of compound A-25 (IFT).
Phase III Study for Sexual Pain (Comparison with ####)
7 is a list screen of side effect grades for the. This screen is
When an item is selected from the pull-down menu, a list of side effect grades for the selected item is displayed.

FIG. 52 shows a protocol confirmation screen. This screen is displayed when a protocol check error occurs during case card input. When the clinical test button is pressed, the screen transits to a clinical test error screen for checking the causal relationship with the drug.

FIG. 53 is a causal relationship report screen. This screen is displayed when there is an abnormality in the test value due to the protocol check after the transcription button is pressed on the hematology test screen 2 and the biochemical test screen 2. The abnormal test value is displayed in bold red, and a radio button for causality check is displayed. When the transmission button is pressed, the checked causal relationship is transmitted and registered.

FIG. 54 shows a drug name search screen 1. This screen is displayed when the search button is pressed in the medicine name input field. By a part or all of the drug name, a part or all of the medicinal group, or a combination of the two, the corresponding drug is picked up from the drug database by pressing the search button, and the screen transitions to the drug name search screen 2.

FIG. 55 shows a drug name search screen 2. This screen displays a list of contents that match the search conditions on the drug name search screen 1. When the radio button of the corresponding drug name is checked, it is transcribed to the list area of the drug name / dose. When this button is pressed, the screen closes.

The system according to the present invention performs clinical clinical trials under system management, and makes necessary information available at any time, anywhere, anytime, and a total management system for clinical trials. Succeeded in providing.

[Brief description of the drawings]

FIG. 1 is an overall configuration diagram of a system of the present invention.
(A), (B), (C), (D), (E), and (F) are basic configurations, and (G) to (L) are configurations of filters.

FIG. 2 is a flowchart of the clinical test execution management system of the present invention.

FIG. 3 shows a correlation of a clinical test execution management system configuration.

FIG. 4 shows a screen flow of the clinical trial implementation management system.

FIG. 5 shows a screen flow of the clinical trial implementation management system.

FIG. 6 shows a screen flow of the clinical test implementation management system.

FIG. 7 shows a top screen of the clinical trial implementation management system.

FIG. 8 shows an authentication screen of the clinical trial implementation management system.

FIG. 9 shows an authentication error screen of the clinical trial implementation management system.

FIG. 10 shows a user registration screen.

FIG. 11 shows a user registration confirmation screen.

FIG.

FIG. 13 shows a registration status list screen.

FIG. 14 is a clinical test system top screen.

FIG. 15 shows a clinical trial protocol screen.

FIG. 16 shows a clinical trial protocol detail screen.

FIG. 17 shows an informed consent agreement screen.

FIG. 18 shows an informed consent screen.

FIG. 19 shows a consent form screen.

FIG.

FIG. 21 shows a subject profile registration screen.

FIG.

FIG. 23 shows a subject profile confirmation screen.

FIG. 24

FIG. 25 shows a subject profile error screen.

FIG. 26

FIG. 27 shows a subject consent confirmation screen.

FIG. 28 shows a disease name search screen 1.

FIG. 29 shows a disease name search screen 2.

FIG. 30 shows an agreement confirmation screen.

FIG. 31 shows an inspection center result report screen.

FIG. 32 shows a hematology test result screen 1.

FIG. 33 shows a biochemical test result screen.

FIG. 34 shows a clinical test screen 1.

FIG. 35

FIG. 36 shows a clinical test error screen 1.

FIG. 37 shows a case card cover screen.

FIG. 38

FIG. 39 shows a subject background screen.

FIG. 40 shows a clinical evaluation screen 1.

FIG. 41 shows a clinical evaluation input screen.

FIG. 42 shows a clinical evaluation screen 2.

FIG. 43

FIG. 44 shows a clinical evaluation input screen 2.

FIG. 45 shows a clinical evaluation screen 3.

FIG. 46 shows a clinical evaluation input screen 3.

FIG. 47 shows a clinical test screen.

FIG. 48 shows an inspection center clinical test result report screen.

FIG. 49 shows a hematology test result screen 2;

FIG. 50 shows a biochemical test result screen 2.

FIG. 51 shows a side effect grade list screen.

FIG. 52 shows a protocol confirmation screen.

FIG. 53 shows a causal relationship report screen.

FIG. 54 shows a drug name search screen 1.

FIG. 55 shows a drug name search screen 2;

[Explanation of symbols]

 A: Manufacturer B: Clinical trial facility (hospital) C: Clinical trial company (CRO) D: Clinical laboratory company (Clinical testing center) E: Data center F: Internet G: Basic dictionary for clinical trial H: Clinical trial protocol I: Subject profile J: Clinical trial data K: Clinical trial drug management record L: Statistical analysis database a: Clinical trial drug b: Clinical trial protocol review committee c: Clinical trial protocol decision d: Clinical trial protocol modification e: Clinical trial notification f : Various formats output g: Subject registration h: Data entry i: Key open j: Report 1: Clinical trial protocol filter 2: Subject profile filter 3: Test value filter 4: Side effect filter 5: Protocol violation transcription mistake filter 6: Mathematical Analysis / statistics processing filter: Contract: Automatic allocation means: Clinical Laboratory Center

Claims (19)

[Claims] 1. A clinical test implementation management system in a clinical trial operation (phases I to IV) using a wide-area information transmission tool, the clinical trial implementation management system having the following components: 1) Clinical trial drug (Excluding Phase IV) 2) Setting of a clinical trial protocol based on the clinical trial basic dictionary database for clinical trial drugs 3) Determination of clinical trial protocol 4) Determined clinical trial protocol and clinical trial basic dictionary database 5) Preparation of clinical test protocol filter means based on 5) Registration of clinical test subjects (subject registration: ID conversion) / automatic allocation of subjects based on clinical test protocol 6) Subjects by clinical test protocol filter based on subject profiles Selection means 7) Medication record and subject data And warning of outliers and exclusion value of the means 8) clinical trial data to input the clinical trial data
Filter means to notify side effects 9) Abnormal value of clinical test data (abnormal test value)
Means for confirming warnings and side effects of excluded values (excluding test values) from the clinical trial basic dictionary database 10) Mathematical analysis / statistics filtering means based on clinical test data 11) Case card format output means 12) Clinical test data Means for performing tabulation work (key open) 13) Means for creating report forms. 2. The information accumulated in the clinical trial basic dictionary database includes a disease name, a disease state, a disease state image, a related organ, a disease diagnostic criterion, a diagnostic criterion value (a normal value range of a laboratory test value, an abnormal value range), and a disability degree data. 2. Clinical study implementation management according to claim 1, wherein the information includes: a known drug, a dose and a method of administration of the known drug, a side effect of the known drug, a mechanism of action of the known drug, a combination prohibited drug / combination prohibited action mechanism, and side effect grade data. system. 3. The disease name, diagnostic standard, diagnostic standard value,
3. The method according to claim 2, further comprising using a user dictionary database and / or an information database on a clinical test company that additionally uses a known drug, a dose / administration method of the known drug, an action mechanism of the known drug, and side effects of the known drug. Clinical trial implementation management system. 4. A clinical trial protocol (identification of a clinical trial drug, mechanism of action, indication, subject to be selected, dosage, administration method, administration period, excluded cases, criteria for validity / ineffectiveness, etc.) The clinical trial implementation management system according to claim 1, wherein the clinical trial basic management database and the user dictionary database are selected and adjusted by drag-and-drop according to access by a wide area information transmission tool. 5. Determination of a clinical trial protocol, identification of a clinical trial drug, mode of action, indication, subject to be selected,
The clinical trial implementation management system according to claim 1, wherein the dose, the administration method, the administration period, the excluded cases, the validity / invalidity criterion, and the like are determined, and the clinical trial protocol database is constructed. 6. The clinical trial protocol database according to claim 5, wherein the clinical trial protocol database is prepared so as to have a function of a filter (clinical trial protocol filter) for evaluating various clinical trial data input in the subsequent work. Clinical trial implementation management system as described. 7. The clinical trial implementation management system according to claim 5, wherein the clinical trial implementation management system is prepared to have a modification reporting function accompanied by a layer function of a clinical trial protocol. 8. The method according to claim 1, wherein, based on the decision of the clinical trial protocol, the system is prepared to have a function of creating a contract with a clinical trial hospital and a function of outputting a document such as a report of a clinical trial and a report of an ethics committee. Clinical trial implementation management system as described. 9. Registering clinical trial subjects by entering information such as subject background information, starting data, general laboratory data, case reports, adverse events, discontinuations, dropouts, etc. by accessing with a wide-area communication tool. The clinical test implementation management system according to claim 1, wherein the database is created as a subject profile database. 10. The clinical trial implementation management system according to claim 9, wherein the registration of the clinical trial subjects in the database is performed by random allocation, and the subject registration ID is automatically set. 11. The use record of a clinical trial drug used by the start of a clinical trial is input by a wide-area information communication tool, and is linked with a separately set clinical trial drug management database to manage the use of the clinical trial drug. 2. The clinical trial implementation management system according to claim 1, wherein the system has a function of outputting a clinical trial drug management record as necessary. 12. The clinical trial data obtained by the clinical trial is input by the subject registration ID set in the subject profile database by accessing by the wide area information transmission tool, and the clinical trial data is made into a database. 2. The clinical test implementation management system according to 1. 13. The clinical trial data includes a doctor's observation,
13. The clinical test implementation management system according to claim 12, wherein a medication history, diagnostic data, test data, and image data can be individually input. 14. While the entered clinical test data is being registered in the database, a side effect filter based on the clinical trial basic dictionary database (the occurrence of side effects due to medication is determined based on the clinical test data value, and an adverse event is reported. 14. The clinical test implementation management system according to claim 12, wherein a warning is issued as to whether or not the clinical test can be continued. 15. When the entered clinical test data is registered in the database, a test value abnormality filter (abnormal test value example and test exclusion example from the clinical test data value, 14. An alert is given) to make an evaluation.
The clinical trial implementation management system according to 1. 16. When the entered clinical trial data is registered in the database, abnormal / deviation clinical trial data is detected by a clinical trial protocol filter.
14. The clinical trial implementation management system according to claim 12, wherein a warning is issued. 17. The method according to claim 12, wherein the entered clinical test data is detected in the course of registration in the database by the subject profile filter based on the subject profile data to detect abnormal / deviation clinical test data and issue a warning. Clinical trial implementation management system as described. 18. After the entered clinical trial data is registered in a database and made into a clinical trial database,
The clinical trial implementation management system according to claim 1, wherein the system can be output as a case card when necessary by accessing with the wide area information transmission tool. 19. After the entered clinical test data is registered in a database and made into a clinical trial database,
By accessing the wide-area information transmission tool, the mathematical analysis / statistical analysis filter based on the separately prepared mathematical analysis / statistics processing database allows the tabulation and aggregation of clinical trial data.
2. The clinical trial implementation management system according to claim 1, wherein analysis / report creation processing is performed.