JPH07110325A - Safety evaluation system - Google Patents

Abstract

PURPOSE:To grasp the history of altering data accurately by a method wherein a management program is accessed to alter test data in a data file and a series of data records containing the test data altered is stored into an altering data file. CONSTITUTION:Accompanying the execution of a data altering program, a file containing data to be altered, for example, a weight data file(DF) having the weight of a test animal stored is called up. When an altering data is inputted an altering number is attached to the final line of the weight DF to replace the weight data. In addition, an altering data file(DF) dependent thereof is provided and a data of a record number, an altering person, altering time and the like are stored thereinto. When data is altered, the new record number is attached thereto. The weight DF has the altering number attached thereto indicating the altering data to make it possible to pursue the relation to the altering DF. This facilitates the pursuing of all changes made to make it possible to learn an accurate history of changes in the data.

Description

Detailed Description of the Invention

[0001]

[Industrial field of use] A system for evaluating safety using animals, microorganisms and activated sludge. In particular, the present invention relates to a safety evaluation system capable of tracing changes in test contents up to initial data with a simple procedure.

[0002]

2. Description of the Related Art Conventionally, safety tests have been conducted such as toxicity tests to examine how food additives and the like affect the living body. This type of safety test has become more and more important in recent years, and higher reliability is required.
Against this background, a standard (hereinafter referred to as GLP) for conducting a safety test of pharmaceuticals has been announced, and it is necessary to carry out the safety test so as to meet this standard. When testing according to GLP, for example,
In case of toxicity test, body weight measurement value, food consumption, water consumption, organ weight measurement value at dissection, placenta and fetal weight measurement value, and various test measurements such as blood test and serum biochemical test from each animal It is necessary to manage information such as values, anatomical findings, histopathological findings, types of malformations, and the number of occurrences. Introduction of a computer system is indispensable to process this large amount of various information. And in the case of this kind of test, in order to ensure the high degree of reliability as described above, it should not be possible to easily modify or change the data. It should be done. Also,
It is desirable that the record of the data change can easily trace the cause of the occurrence and its progress retrospectively and can know the content of the change accurately. In the conventional system, the procedure is complicated, and it may be difficult to trace the history when the change is made twice or three times.

The present invention is constructed in view of such circumstances, and an object of the present invention is to provide a safety evaluation system capable of easily and accurately knowing the history of change data as needed.

[0004]

In order to achieve the above object, a safety evaluation system according to the present invention comprises a program executed according to a predetermined procedure for evaluating the safety of a sample, and a program being executed. A reference file for storing reference data referred to in the above, a data file for storing test data formed by execution of a test, a management program for managing the test data stored in the data file, and the management program Access means to change specific test data stored in the data file, a change data file storing the test data changed by the changing means, and test data changed every time the test data is changed A recording means for recording a data record consisting of a series of data including the above in the change data file. Characterized in that was. In a preferred mode, the data record includes change data related to a change item, as well as data indicating a change date, a change time, a change reason, a changer, and a change number.

Further, it is desirable that the change means records the change number of the changed test data in a data file. The safety evaluation system according to the present invention preferably further comprises test data output means for outputting the contents of the data file. Further, it may be configured to further include change data output means for outputting the contents of the change data file. The safety evaluation system according to the present invention is preferably an LA including a server and a plurality of terminals.
Can be configured by N. The server is an input device for inputting information, a processing device for processing input information, a large-capacity hard disk for storing information, a display device for displaying necessary information as appropriate, an output device for outputting information according to a predetermined command, a processing device. And an interface intervening between peripheral devices such as an input / output device. Multiple terminals are connected to the server via Ethernet cables. Each terminal is equipped with an input device, a computing device, a hard disk, an interface, and a display device. In some cases, the terminal is connected to an electronic balance, a colony counter, etc., so that predetermined information can be input through these devices.

When the terminal is activated and executes a specific routine, the server provides the terminal with information necessary for executing the routine, and this information is input to the hard disk of the terminal. The terminal executes its own routine based on the information given by the server, processes the data, and stores it in the hard disk of the terminal. The system of the present invention allows various tests for safety assessment to be performed. Safety evaluations vary from test to test, but include common content for each test. Therefore, in the present invention, work and operations that can be commonly used for various tests are used as a management program, and work required only for a specific test and operation content are used as a test program and are classified into relatively organized works or operations. It is programmed. Therefore, when the safety evaluation of a specific test is performed, the work unit necessary for executing the test is appropriately selected by the program, and the entire flow for performing the safety evaluation of the test is configured. Specifically, the selection of the test program is performed by the operator making a menu selection on the screen of the display device.

Test programs created for each work or operation unit include a grouping test program, a fasting test program in which a fasting operation procedure is programmed, a sample administration test program in which a sample administration procedure is programmed, and an animal There are a symptom observation test program in which a procedure for collecting data on symptoms that occur is programmed, a pathological observation test program in which a procedure for analyzing pathology of animals is programmed, and the like. Among them, the grouping test program is to select the animals to be used for the test from stock animals by processing the instructions of the program and input the data grouped so that the conditions between the groups are equal. . Furthermore, as a management program created for each work or operation unit, a theme management program for managing test titles, test items, etc., a protocol management program,
Test management program consisting of schedule management program, test substance management program, specimen management program consisting of control substance management program and positive substance management program, feeding management program, animal management program consisting of water supply management program, microorganism management program and activated sludge management program Consists of a test system management program, an electronic balance management program, a weight measurement management program, an organ weight measurement management program, a colony counter management program, a device analysis management program consisting of a blood analysis management program, a breeding room or various cage management programs. When preparing a facility management program, attendance management program for managing the working conditions of workers, SOP management program for managing the operating procedures of various tests, and a report on the test results It performs a total analysis, plotting optionally include report management program for performing the tabulation.

Further, a reference file referred to during execution of the program is provided. This file contains sample classification file, test classification file, product classification file,
There are a feed list file, a registered balance list file, an organ name file, a symptom list file, a pathology list file, and so on. These files are stored in the terminal, and the above programs are stored in the hard disk of the server. The hard disk of the server has a CR format for data input.
A format file to be displayed on the screen of T is provided corresponding to the input data. According to the execution of the test program through the screen display by this format file, all the input data are stored in the temporary storage data file. Then, every time the operation is completed, all the data on the hard disk of the terminal is transferred to the data file on the hard disk of the server, and at the same time, the temporarily saved data file is deleted.

[0009]

The function of the present invention will be described. The system is started by turning on the power of the server and the terminal. When the system is stopped, the data is stored in the hard disk of the server, and the data corresponding to the safety test is transmitted to the hard disk of the terminal as necessary by operating the terminal. After the necessary information is input to the terminal like this, basically,
All information processing is performed by the terminal according to the selected test program. For example, to explain the flow of the blurred vision test, when an operator operates the terminal and turns on the switch, the data in the data file in the server's hard disk is transferred to the temporary data file of the terminal as described above. To be done. The operator operates a data input format screen displayed on the CRT by calling the format file by the test program, and inputs predetermined data. When the test program is executed, the reference file is referred to as necessary to display predetermined data on the screen. Therefore, in this case, a predetermined reference file is called together with the format file.

The structure of the temporary storage data file of the terminal is the same as the data file of the hard disk of the server, and the contents of the temporary storage data file are changed by inputting new data to the terminal as the test is executed. Change. In the case of the blurred vision test, the program file requires a theme management program, a sub-theme management program, a sample management program, a test management program, a device measurement management program, etc. for managing the test to be processed by the system as a job. Also, as reference files, department list file, test item file,
A sample classification file, animal species file, work item file, bait list file, registered balance list file, and a Placido image score file that gives an evaluation of the Placido image are required. Further, a format file for displaying a screen is required for inputting data. For this purpose, a theme format file for writing job data as a management program, a sub-theme management format file for giving other document formats, a sample format file for inputting data related to samples, input / output of job introduction A project format file that gives the format for the test, a protocol format file that determines the test content,
A schedule format file for inputting a work schedule, a feeding format file for recording whether or not food is given according to the experimental procedure, a weight measurement format file for recording the weight measured by a predetermined procedure during the experiment, Furthermore, as specific to the blurred vision test, grouping, site allocation, sample instillation,
A Placido image observation format file is required. When these format files are displayed on the screen in response to the execution of the program, the operator operates the screen to input test results, introductions, and other data relating to the test. This input data is stored in the temporary storage data file.

In the blurred vision test, when the terminal is activated, the test management program is called. by this,
First, the protocol management program is executed, and the number of test systems, that is, the number of test animals, the number of animals used per group, the administration site, the sample concentration, the sample dose, etc. are determined. In this case, the protocol format file is called and displayed so that the above-mentioned predetermined items can be input on the screen. Next, the work schedule is determined by the same procedure. When the test content is determined in this way, the animal care program is called. In this animal management program, the state of carrying in and whether or not quarantine has been completed are recorded. Next, the electronic balance management and weight measurement program is executed. In electronic balance management, the electronic balance is calibrated and adjusted, and the result is recorded. The weight measurement program is also executed to record the measurement result. At this time, the format file is called and the screen display is performed so as to input each result, as in the above case. Next, the sample management program is executed. In this program, the data for each of the test substance, control substance, and positive substance are input by screen display using a format file.

Next, the grouping and site allocation test program is executed to select the animals to be used for the test from the stock animals, the data group grouped according to the individual number is determined, and the sites are allocated and registered. Then, the eye drop test program is executed to record the situation of the eye drop treatment. Thereafter, the Placido image observation test program is executed to observe and record the results of the eye drop treatment. Next, the report management program is executed to process these data, and statistical analysis, plotting and tabulation of the data are performed as necessary to produce a report. To explain the single-dose toxicity test, the server and terminal are started to execute the test. As a result, the test program is called by the operator's selection or automatically, and by executing it, the test contents such as the protocol, that is, how the test items are to be determined, and the work schedule are determined. Is determined. Next, the test system management program is executed to input the information about the import of the animal and determine its content. This information includes, for example, the date of delivery, the type of animal, the quantity, the sex, etc. In addition, a serial number is assigned to each animal. Then, information for checking in which cage the animal is housed is input. Next, the electronic balance management program is executed. After that, the result of the weight measurement of the animal is input by executing the weight measurement management program. Next, the grouping test program is executed, the animals used for the test are selected from the stock animals, and the data grouped so that the conditions between the individual groups are equal are input. A fast test program is then run to record which animals were fasted. Next, the sample management program is executed. This controls the type and amount of the test substance, that is, the reagent to be administered to the animal.
Then, the sample administration program is started and whether or not the reagent is actually administered is input for each animal. Next, the symptom observation test program is started, and information on the result of symptom observation is input. In this case, for example, the state of the animal is visually observed and the information is input. Next, the pathological test observation program is started, and after the animal is euthanized, the animal is dissected, the tissue is observed with a microscope, and the result is input.

In this way, a series of tests are conducted, and each time,
Information about test results is entered. When all the tests of the contents determined by the protocol are completed according to the work schedule, the report management program is started as necessary, various calculations are performed on the above test result information, statistical analysis results, drawings, A report including graphs is created and output. Depending on various circumstances, it may be necessary to change the data or the processed data during or after the above safety test is performed. However, allowing such changes to be freely made impairs the reliability of the test results. Therefore, changes in data in safety tests should be rigorous and the reasons and circumstances behind them should be traced accurately and in as much detail as possible. From such a viewpoint, in the present invention, a special program for managing the change of the data of the safety test is prepared to deal with the above problem. According to the present invention, when changing data, the data changing program is executed and the file containing the data to be changed is called. Data to be changed is input in this state. In this case, a change data file is created together with this change data, and a change number associated with the change data is given. Then, a series of information such as the change number, the changer, the change item, the pre-change data, the change date, the change time, and the change reason, that is, the change data record is input to the change data file. This change number is given as a continuous number each time a change operation is performed, and is saved in correspondence with the data record.

It should be noted that the original data file is provided with a change number indicating the changed data so that the relationship with the changed data file can be traced.
Even if the same data is changed twice or three times, a change data record with the change number is additionally recorded in the change file every time a change occurs, so all changes can be easily made by referring to the change file. Can be tracked and know the exact history of data changes.
You can also output a change file. in this case,
The file can be opened only when a keyword or a predetermined code number is input so that only a specific person can refer to the changed file. This makes it possible to create a highly reliable change data record.

[0015]

Embodiments of the present invention will be described below with reference to the drawings. Referring to FIG. 1, there is shown a schematic block diagram of a hardware configuration of a safety test system of the present invention.
The safety evaluation system of this example is composed of a LAN system including a server 1 and four terminals 2, 3, 4 and 5. The server 1 includes an input device 6, an arithmetic device 7 for processing input information, a large-capacity hard disk 8 for storing information, a display device 9 for appropriately displaying necessary information, and an output device 10 for outputting information according to a predetermined command. An interface 11 is provided between the arithmetic unit 7 and peripheral devices such as input / output devices. The above-mentioned four terminals 2, 3, 4 and 5 are connected to the server 1 via a data bus 12. Each terminal 2, 3, 4 and 5
Is an input device 13, an arithmetic unit 14, a hard disk 15,
The interface 16 and the display device 17 are provided. The terminal device 3 of this example is connected to the electronic balance 18 and the terminal device 4 is connected to the colony counter 19, so that information can be input from these devices. When the server 1, 2, 3, 4 or 5 is activated and executes a predetermined routine, the server 1 provides the terminal 2 with information necessary for executing the routine, and this information is used for the terminal. It is input to the second hard disk 15. The terminal 2 independently executes a routine based on the information given from the server 1, processes the information, and stores the data in the hard disk 15 of the terminal 2.

Referring to FIG. 2, the hard disk of the server has a data file in which data generated by various tests are stored, a program file in which various programs are stored, and a format screen for inputting test data on the screen. And a format file for storing information. In addition, the hard disk of the terminal is provided with a reference file for storing the reference data and a temporary storage data file for storing test data input by operating the format screen. The temporary storage data file stores the data input through the format screen, and the electronic balance 18,
Data directly input from an analytical instrument such as the colony counter 19 is stored. A program is created for each work unit or operation unit that is relatively organized, and a management program that is relatively commonly used for various safety evaluation tests and a test program that is applied only to specific safety evaluation tests. Is roughly divided into The data includes reference data necessary for executing the test and test data relating to the test result and the like that accompany the test.

As a test for safety evaluation, a single-dose toxicity test for evaluating toxicity when a sample is administered once to an animal, and a repeated test for repeatedly administering a sample to an animal and evaluating its toxicity Dose toxicity test, Blurred eye test that evaluates the phenomenon that things appear to be blurred depending on the sample that entered the eye, Skin irritation test that evaluates the effects (redness, swelling) when the sample comes into contact with skin, sample As a result of repeated contact with the skin, a skin sensitization test that evaluates the phenomenon (allergy) that a strong skin reaction occurs even when a small amount is contacted with the sample again after a certain period of time Irritation test,
Mutagenicity test that predicts the possibility of carcinogenicity or genotoxicity (malformation, DNA abnormality) as a result of the influence of the gene on the sample, when organic matter is released into the environment, water and carbon dioxide are changed by microorganisms There is a degradability test to evaluate the ease of decomposition. The system is started by turning on the power of the server and the terminal. When the system is stopped, the data is stored in the hard disk of the server, and the data corresponding to the safety test is transmitted to the hard disk of the terminal as necessary by operating the terminal.

After the necessary information is input to the terminal, the information processing is basically performed by the terminal according to the selected test program. The structure of the temporary storage data file of the terminal is the same as the data file of the server hard disk, and the content of the temporary storage data file changes as new data is input to the terminal as the test is performed. . Table 1 shows the data files required on the hard disk of the server in the case of the blurred vision test.
Also, in the program file on the terminal,
As shown in Table 2, a theme management program, a sub-theme management program, a sample management program, a test management program for managing the tests to be processed by the system as jobs,
A device measurement management program is required. Also, as reference files, department list file, test item file,
A sample classification file, an animal species file, a work item file, a bait list file, a registered balance list file, and a Placido image score file that gives an evaluation of the Placido image are required. Further, a format file for displaying a screen is required for inputting data.

[0019]

[Table 1]

[0020]

[Table 2]

For this purpose, a theme format file for writing job data as a management program, a sub-theme management format file for giving other document formats, a sample format file for inputting data on a sample, an introduction to the job A project format file that gives a format for inputting and outputting, a protocol format file that determines the test content, a schedule format file that inputs a work schedule, and a feeding format file that records whether bait is fed according to the experimental procedure. , A weight measurement format file for recording the weight measured by a predetermined procedure during the experiment, and grouping, site assignment, specimen Eyes, it is necessary placido image observation format file. When these format files are displayed on the screen in response to the execution of the program, the operator operates the screen to input test results, introductions, and other data relating to the test. This input data is stored in the temporary storage data file. Hereinafter, with reference to FIG. 3 and FIG. 4, a procedure for performing a blurred vision test and a flow of inputting data thereof will be described.

In the haze test, when the operator operates the terminal to turn on the switch, the menu of the safety evaluation system is displayed, and the management or test program is executed by selecting it, and the format file is called. Then, a predetermined screen is displayed on the CRT of the terminal. In this case, first the screen shown in FIG. 5 is displayed on the CRT,
When an operator operates a keyboard as an input device and inputs predetermined data such as a test title, a department in charge, a person in charge, a product classification, and the presence or absence of an information survey, the screens shown in FIG. 6 are sequentially displayed on the CRT. Is displayed in. The operator inputs a personal identification number in accordance with the displayed format and then inputs predetermined data as shown in FIG. Further, on the screen display of FIG. 6, in this example, the type of test to be performed is selected from the 22 types of tests. The test type screen is displayed by referring to the reference file. A test number, which is a number for identifying a job in the system, is automatically added in the system. Next, the project management program is executed, the format is called in this program, and the screen shown in FIG. 10 is displayed. Then, when a predetermined input is made on this screen, the screen of FIG. 11 is subsequently displayed.

Further, when an animal species is selected, a window as shown in FIG. 12 is displayed by operating the window on the screen. On this screen, you can select the animal species, strain, grade, and supplier. Next, the protocol management program is executed, and the protocol management program shown in FIG.
The screen shown in is displayed. By inputting according to this screen, the data of the test system, that is, the number of groups of test animals, the number of animals used per group, the administration site, the sample concentration, the sample dose, etc. are input to the file. Further, the work schedule can be input using the screen as shown in FIG. For example, in the example of FIG. 13, work schedules for carrying in animals, observing health conditions, measuring weight, and feeding are input.
As described above, the test items, the test facility, the test start date, the test end date,
You can enter work schedules such as implementation start date, implementation end date, feed and number of cages. Next, the animal care program is executed. In this program, the screen as shown in FIG. 14 is displayed by calling the format file. Using this screen, the operator confirms the lot number of the imported animal and inputs data on whether or not feeding was performed. Next, the format screen shown in FIG. 15 is called and displayed, and the operator is input. Next,
Screens such as those shown in FIGS. 16, 17, and 18 are sequentially displayed, and data relating to breeding of a carried-in animal such as a breeding place is input. In the examples shown in FIGS. 17 and 18, the rack number of the 27th breeding room and the individual number corresponding thereto are displayed, and the loading state of the animal is input.

Next, a screen as shown in FIG. 19 is displayed to observe the health condition of the animal. In this case, the observation data can be recorded for each individual number. Regarding the observation items and abnormal findings, Items can be selected by operating the window. in this case,
The observation item and the abnormal finding item are displayed by calling the reference file. Next, after making predetermined adjustments such as calibration of the balance for each animal,
The weight is measured and the result is input. In this case as well, data is input corresponding to the individual number of the animal by the same procedure as above. At this time, the format file is called and the screen display is performed so as to input each result, as in the above case. Next, the sample management program is executed. In this program, access the format file and
A screen as shown in 0 is displayed. The operator inputs predetermined items on the screen. This data is stored in the temporary storage data file. The data includes the test number,
Test substance (specimen) number, specimen substance name, type, input person,
Input date etc. are included. When inputting the type of sample, the list of sample types in the reference file is referred to and displayed on the screen by the window operation, and the operator selects the name of the corresponding sample from this list.

The same operation is performed for the control substance and the positive substance, that is, the known substance to be compared with the administration result of the test substance of the test substance. The format is called and the screen as shown in FIG. 21 is displayed. Next,
Enter the confirmation data regarding whether the quarantine of the test animal has been completed. Therefore, the format file is called and the file as shown in FIG. 22 is displayed on the screen. Next, a grouping test program and a site allocation test program, which are specific test items in the haze test, are executed. By executing this program, the animals to be used for the test are selected from the stock animals, the data group grouped according to the individual number is determined, and the sites are assigned and registered. For this work, first, see FIG.
The screen shown in is displayed with reference to the format file. An animal is selected by the operator inputting predetermined items on this screen. Then, the eye drop treatment test program is executed to record the situation of the eye drop treatment. For this purpose, the format file is referred to and shown in FIG.
A screen as shown in 5 is displayed on the CRT.

Then, the operator inputs the confirmation data for the left and right eyes of each individual when the eye drop processing is performed. For example, in this example, referring to FIG. 25, it is found that individual numbers 930001, 930002, and 930003 have been subjected to eyedrop treatment for the right eye. After that, the Placido image observation test program is executed to observe and record the results of the eyedrop treatment every predetermined time. in this case,
With reference to the format file, a screen as shown in FIG. 26 is displayed on the CRT. The operator selects the corresponding time displayed on this screen. As a result, FIG.
The screen shown in is displayed. This observation result is input by calling the reference file by the window operation, displaying the list of findings on the screen, and selecting the corresponding evaluation. In this example, this observation is performed for 120 minutes at predetermined time intervals. Next, the report management program is executed to process these data, and statistical analysis, plotting and tabulation of the data are performed as necessary to produce a report. In creating the report, the worker accesses the format file to display a screen as shown in FIG. 28 and inputs predetermined items.

The output format of this report can be output as shown in FIG. Further, the data to be attached to the report can be output by the operator's selection.
For example, when the above Placido image observation record is attached, it is possible to output the form as shown in FIG. In this case, the temporary storage data file and the format file are called. When the work on the terminal is completed and the registration key is pressed on the terminal, the data of the temporary storage data file is added to the data file of the server and updated. Then, when working on the terminal, the contents of the data file of the server are transmitted to the temporary storage data file. Therefore, when the work is started on the terminal, the work can be automatically started with the latest data file. As described above, in the configuration of this example, data can be input and output for a wide range of tests by accessing the reference file, the format file, and the temporary storage data file. This operation can be performed similarly for a single dose toxicity test, for example.

The work flow of the single dose toxicity test will be described with reference to FIG. In order to execute the program associated with the execution of this test and input and output the data, the server and the terminal are activated as described above. by this,
The test management program is called by the operator's selection or automatically, and by executing it, the test contents such as the protocol, that is, the test items, are determined, and the work schedule is determined. To be done. Next, the test system management program is executed to input the information about the import of the animal and determine its content. This information includes, for example:
Includes date of delivery, animal type, quantity, sex, etc. In addition, a serial number is assigned to each animal. Then, information for checking in which cage the animal is housed is input. Next, the electronic balance management program is executed. After that, the result of the weight measurement of the animal is input by executing the weight measurement management program. Next, the grouping test program is executed, the animals to be used for the test are selected from the stock animals, and the grouped data are input so that the conditions between the groups are equal. A fast test program is then run to record which animals were fasted. Next, the sample management program is executed. This controls the type and amount of the test substance, that is, the reagent to be administered to the animal. Next, the sample administration test program is started and whether or not the reagent is actually administered is input for each animal. Next, the symptom observation test program is started, and information on the result of symptom observation is input. In this case, for example, the state of the animal is visually observed and the information is input. Next, the pathological observation test program is started, the animal is euthanized, then dissected, the tissue is observed under a microscope, and the result is input.

In this way, a series of tests are performed, and each time,
Information about test results is entered. When all the tests decided by the protocol are completed according to the work schedule, the report management program is started and various calculations are performed on the above test result information, including statistical analysis results, drawings, graphs, etc. A report is created and printed. The work in the above single-dose toxicity test includes some that are partially common with the haze test,
Therefore, some work units can be used in common with the blurred vision test. Therefore, in the system of this example, for example, the test plan management program, the animal management program, and the weight measurement management program can be commonly used. In this way, in the system of this example, a program is created for each work unit, commonality is achieved as much as possible, and the worker appropriately selects the program for each work unit, thereby performing the necessary processing for the test that he is in charge of. You can do it. Therefore, it is possible to prevent the program from becoming bloated and complicated, and it is possible to configure a highly versatile system. Further, with such a configuration, it is possible to extremely efficiently perform operations such as input, output, and save for various safety tests, and it is possible to save the storage capacity of the computer.

In the program processing of such a safety test, it may be necessary to change the data or the processed data depending on various circumstances when or after the test is carried out. However, allowing such changes to be freely made impairs the reliability of the test results. Therefore, data changes in safety tests should be rigorous,
It must be possible to trace the reasons and circumstances accurately and in as much detail as possible. From such a viewpoint, in the present invention, a special program for managing the change of the data of the safety test is prepared to deal with the above problem. Hereinafter, with reference to FIG. 32, a procedure for changing data afterwards in the system of this example will be described. In the system of this example, when changing data, a data changing program is executed. In this case, the file containing the data to be changed is called. For example, when changing the weight data of the test animal, first,
A weight data file as shown in 2 is called. This weight data file constitutes a part of the temporary storage data file.

In this example, as shown in FIG. 33, the weight data file stores the weight data of the test animals of individual numbers 930001 to 930005. It is assumed that the body weight of the test animal of individual number 930002 is to be changed and used. The system of this example also includes an independent modified data file that also forms part of the temporary save data file. For example, as shown in FIG. 34, this change data file stores records including all predetermined items when a change operation is performed. In this example, the record includes a record number, a changer, a change date, a change time, a file name, a field (item), a type (a data type, for example, a number,
Includes raw data (indicating letters, dates, computational types of logic). In the case shown in FIG. 34, the operation of changing the presence or absence of feeding and quarantine has already been performed twice in the past.
Indicates that it was done. In this state, the data to be changed is input to the weight data file. As a result, as shown in FIG. 35, the change number is added to the last line of the record related to the change, the weight after the change is input, and the old data is replaced. On the other hand, as shown in FIG. 36, a new record number is attached to the change data file, and predetermined data for one record relating to the change to the weight data file is created and added.

It should be noted that the original data file is provided with a change number indicating the changed data so that the relation with the changed data file can be traced.
Even if the same data is changed twice or three times, a change data record with the change number is additionally recorded in the change file every time a change occurs, so all changes can be easily made by referring to the change file. Can be tracked and know the exact history of data changes.
You can also output a change file. in this case,
The file can be opened only when a keyword or a predetermined code number is input so that only a specific person can refer to the changed file.

[0033]

As described above, in the safety evaluation system according to the present invention, a modularized program is created for each work unit so that the work can be shared as much as possible, and the worker can appropriately install the program for each work unit. By selecting, you can carry out the necessary processing for your test. Therefore, it is possible to prevent the program from becoming bloated and complicated, and to configure a highly versatile system. In addition, when changing data, a record including all predetermined items is created and an independent change data file is created. Then, when there is a change in the data, the change number is added without fail, and a series of change data records including the change data is stored. Therefore, even if the same data is changed twice or three times, each time a change occurs, the change data record with the change number is additionally recorded in the change data file, so it is easy to refer to the change data file. You can track all changes to and get an accurate history of data changes.

This makes it possible to create a highly reliable change data record.

[Brief description of drawings]

FIG. 1 is a block diagram of a safety evaluation system according to the present invention,

FIG. 2 is a block diagram showing the file relationship of the safety evaluation system,

FIG. 3 is a flowchart of a blurred vision test,

FIG. 4 is a block diagram showing a flow of a blurred vision test,

FIG. 5 is a diagram showing an example of a screen display based on a format file,

FIG. 6 is a diagram showing an example of a screen display based on a format file,

FIG. 7 is a diagram showing an example of the contents of a data file,

FIG. 8 is a diagram showing an example of a screen display based on a format file,

FIG. 9 is a diagram showing an example of a screen display based on a format file,

FIG. 10 is a diagram showing an example of a screen display based on a format file,

FIG. 11 is a diagram showing an example of a screen display based on a format file,

FIG. 12 is a diagram showing an example of a screen display based on a format file,

FIG. 13 is a diagram showing an example of a screen display based on a format file,

FIG. 14 is a diagram showing an example of a screen display based on a format file,

FIG. 15 is a diagram showing an example of a screen display based on a format file,

FIG. 16 is a diagram showing an example of a screen display based on a format file,

FIG. 17 is a diagram showing an example of a screen display based on a format file,

FIG. 18 is a diagram showing an example of a screen display based on a format file,

FIG. 19 is a diagram showing an example of a screen display based on a format file,

FIG. 20 is a diagram showing an example of a screen display based on a format file,

FIG. 21 is a diagram showing an example of a screen display based on a format file,

FIG. 22 is a diagram showing an example of a screen display based on a format file,

FIG. 23 is a diagram showing an example of a screen display based on a format file,

FIG. 24 is a diagram showing an example of a screen display based on a format file,

FIG. 25 is a diagram showing an example of a screen display based on a format file,

FIG. 26 is a diagram showing an example of a screen display based on a format file,

FIG. 27 is a diagram showing an example of a screen display based on a format file,

FIG. 28 is a diagram showing an example of a screen display based on a format file,

FIG. 29 is a diagram showing an example of data output,

FIG. 30 is a diagram showing an example of data output,

FIG. 31: Single dose toxicity test flow chart,

FIG. 32 is a flowchart of a data change operation,

FIG. 33 is a view showing the contents of a data file before data change related to data change;

FIG. 34 is a diagram showing the contents of a change data file before input of change data;

FIG. 35 is a diagram showing the contents of the data file after the data is changed,

FIG. 36 is a diagram showing the contents of a change data file after input of change data.

[Explanation of sign]

1 server 1 and a LAN system including four terminals 2, 3, 4 and 5 2 terminals, 3 terminals, 4 terminals, 5 terminals, 6 input devices, 7 arithmetic devices, 8 hard disks, 9 Display device, 10 output device, 11 interface, 12 data bus, 13 input device, 14 arithmetic device, 15 hard disk, 16 interface, 17 display device, 18 electronic balance, 19 colony counter.

Claims (5)

[Claims] 1. A program executed in accordance with a predetermined procedure for evaluating the safety of a specimen, a reference file storing reference data referred to during the execution of the program, and formed with the execution of a test. Data file for storing the stored test data, a management program for managing the test data stored in the data file, and changing means for accessing the management program and changing specific test data stored in the data file A change data file for storing the test data changed by the changing means, and a recording means for recording a data record consisting of a series of data including the changed test data in the change data file each time the test data is changed. A safety evaluation system comprising: 2. The safety according to claim 1, wherein the data record includes change data related to a change item and data indicating a change date, a change time, a change reason, a changer and a change number. Sex evaluation system. 3. The safety evaluation system according to claim 1, wherein the changing means records the change number of the changed test data in a data file. 4. A safety evaluation system according to any one of claims 1 to 3, further comprising test data output means for outputting the contents of the data file. 5. The safety evaluation system according to any one of claims 1 to 4, further comprising a change data output means for outputting the contents of the change data file.