JP3291716B2 - Chemical test data management system - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a drug test data management system for recording a change in the condition of a living body when a drug is administered to the living body.

[0002]

2. Description of the Related Art The safety of humans, such as carcinogenicity and toxicity of pharmaceuticals, pesticides, food additives, and other chemical substances, is tested in clinical trials before they are marketed.
Confirmation has been performed in non-clinical tests using animals such as rats and mice.

[0003] In a safety test of a drug or the like using such an animal, toxicity is generated if the dose is administered to a single dose.
A single dose toxicity test that reveals what its toxicity characteristics are,
Repeated dose toxicity studies to characterize doses and toxicity at which no or no change in toxicity is observed during repeated administration, and to clarify the effects on parental reproduction and the development of the next generation, etc. Reproductive and developmental toxicity tests, D
Including mutagenicity tests to determine the presence or absence of substances that are harmful to NA and mutagenic properties, carcinogenicity tests, skin sensitization tests, skin photosensitization tests, dependence tests, etc. Various tests are performed.

[0004] In each of the above tests, a drug is actually administered to an animal, and the amount of body weight, food, water, urine, etc. is measured, and biochemical tests, hematological tests, observation of clinical symptoms, various pathological findings, and the like are performed. This is done by analyzing the collected data.

[0005] Such a safety test is carried out prior to a clinical test in which the drug is actually administered to the human body, and ultimately affects the human body. You need to understand and analyze the impact accurately. For this reason, computer systems have been used for data recording, management and analysis.

[0006] As described above, since drugs such as pharmaceuticals affect the human body, data management in the above-described safety test is performed so that the data is not falsified. Strict standards are set by the government and other government agencies. Such criteria are collectively referred to as “GLP (Good Laboratory Pr.)
of the computer system that manages the data and the data output from the computer system to a form or the like.
Criteria must be met.

[0007]

However, in the conventional system, all functions are packaged and introduced.
It is operated and guarantees GLP etc. in the whole package. Therefore, in order to guarantee GLP or the like, individual functions such as an output format cannot be changed. For this reason, even when there is a case where it is desired to output to a form or the like of a different format depending on the convenience of the user side, such a change cannot be performed at all while guaranteeing the GLP or the like. Under such circumstances, when it is desired to output a form in a format desired by the user, general-purpose application software or the like is separately prepared, and data is manually input and the form is output. In this case, it goes without saying that GLP is not guaranteed for the output form data. Also,
Customizing the system in a manner that guarantees the GLP would be extremely expensive.

The present invention has been made in view of such circumstances, and has as its object to provide an extremely inexpensive drug test data management system which has a high degree of freedom in a form for outputting data.

[0009]

In order to achieve the above object, a drug test data management system of the present invention is a drug test data management system for managing data such as changes in symptoms of a living body when a drug is administered to a living body. A data storage means for storing data, a spreadsheet having a template for data printing and having keywords arranged in cells of the template, and a data storage means in an area corresponding to the keyword of the spreadsheet. It is a first gist of the present invention to provide a data inserting and / or replacing means for inserting and / or replacing stored data.

A drug data management system according to the present invention is a drug test data management system for managing data such as a change in a symptom of a living body when a drug is administered to a living body, the data storing means for storing data, A word processor software having a template for data printing and a keyword arranged in a character string of the template; and inserting data stored in the data storage means into an area corresponding to the keyword of the word processor software.
Alternatively, a second gist is provided that data replacement and / or replacement means is provided.

That is, the first chemical test data management system of the present invention comprises: a data storage means for storing data;
A spreadsheet having a template for data printing and having keywords arranged in cells of the template, and data insertion for inserting and / or replacing data stored in the data storage means in an area corresponding to the keyword in the spreadsheet And / or replacement means. As described above, since data is inserted and / or replaced in the cells of the spreadsheet, the inserted and / or replaced data can be output in a free form using a spreadsheet. it can. Therefore, it is possible to output a form in a desired format desired by the user.

Further, the second chemical test data management system of the present invention comprises: a data storage means for storing data; word processor software having a data printing template and having a keyword arranged in a character string of the template; Data insertion and / or replacement means for inserting and / or replacing data stored in the data storage means is provided in an area corresponding to the keyword of the word processor software. As described above, since data is inserted and / or replaced in a character string of a template using word processor software, the inserted and / or replaced data can be recorded in a free form using a word processor. Can be output. Therefore, it is possible to output a form in a desired format desired by the user.

In the chemical test data management system of the present invention, there is provided a totalizing means for totalizing the input data, wherein the data storage means stores the totalized data totalized by the totalizing means, and the data insertion and / or When the replacement means inserts and / or replaces the total data in an area corresponding to the keyword of the template, the replacing means can output the total data in a free form using a spreadsheet or a word processor. It is very convenient.

In the chemical test data management system of the present invention, protection means for protecting data inserted and / or replaced in the template so that data cannot be changed, and protection data storage means for storing data protected by the protection means In the case where the data is provided, the output data cannot be changed, so that the GLP or the like can be reliably guaranteed by a free form using a spreadsheet or a word processor.

In the drug test data management system of the present invention, when used for a toxicity test of a drug using an animal as a living body, the toxicity test of the drug using an animal as a living body is enormous and various. Since there is data and the type of data required often differs depending on the user and the type of test, the effect of the present invention that increases the degree of freedom of the form to be output using commonly used software is remarkable and effective It is. In addition, for the user, the number of operations to be newly learned is significantly reduced, so that the efficiency of work can be improved.

[0016]

Next, embodiments of the present invention will be described in detail.

FIG. 1 is a system configuration diagram showing one embodiment of the chemical test data management system of the present invention. This system measures the weight of a drug when it is actually administered to an animal,
The system includes a data input unit 9 for inputting various data such as amounts of food, water, urine, etc. and various pathological findings, and an input data storage unit 8 for temporarily storing data input to the data input unit 1. . In the figure, 11 is a storage device such as a hard disk, and 12 is a computer device provided with a central processing unit, a memory, and the like.

The system includes a data extraction means 2 for extracting and totaling data from the data stored in the input data storage section 8 under desired conditions, an extraction condition for extracting data by the data extraction means, and the like. And condition input means 1 for inputting

The system has a template 13 for printing data on a form.
3 is provided with a spreadsheet 5 in which a keyword (KW) is arranged in the cell 14, and an insertion / insertion for inserting and / or replacing the extracted data extracted by the data extracting means 2 in an area corresponding to the keyword of the spreadsheet 5. Substitution means 6 is provided.

A plurality of types of the templates 13 are prepared according to the type of the form to be output. For example, a template as shown in FIG. 2 is used. In this example, "@HEAD:" and "@SQL:" are arranged in column A in order from the second row.
The keywords “$ DATA:”, “$ FOOT:”, and “$ END:” are arranged. In this example, "@HE
“AD:” indicates a header line, and “$ SQL:” specifies a title to be output to a header or footer line by a field name of a database. “$ FOOT:” indicates a footer row, and “$ END:” indicates the end of a control row. “$ DATA:” indicates a data row, and is an area where total data and the like are inserted.

In the first row, "@H
EAD: "@ SQL:" @ DATA: "Foo
The keywords “T:” and “@END:” are arranged. In this example, "@HEAD:" indicates a header column,
In “$ SQL:”, a title to be output in a header or footer column is specified by a database field name.
"@FOOT:" indicates a footer row, and "@EN
"D:" indicates the end of the control sequence. And "@DAT
“A:” indicates a data string, and is an area where total data and the like are inserted.

In the above template, each cell has:
In addition, necessary keywords, for example, as described below are arranged according to the type of necessary data and the like, and data and the like are inserted and / or replaced in an area corresponding to the arranged keywords. The keywords are not limited to those described below, and various keywords can be used. ¥ Fate: Outputs the selected death. ¥ Syuyou: Outputs the status of the selected tumor flag. ¥ Siin: Outputs the status of the selected cause of death flag. ¥ PrjNo: Outputs the test number. ¥ PrjName: Outputs the test name. Output ¥ SknKind: Outputs the finding type. ¥ MacMic: Outputs the finding type. ¥ ZokiName: Outputs the organ name. ¥ Syounin: Outputs the approval status. Name ＠FateShort: Short display name of dying person ＠SexLong: Display name of long gender ＠SexShort: Display name of short gender ＠SexMark: Symbol indicating gender

The spreadsheet 5 is provided with a protection mechanism 7 for protecting the inserted tally data and the like so that the data cannot be changed. The protection mechanism 7 protects data according to an instruction from the insertion / replacement means 6. Further, the system is provided with a protected data storage unit 10 for storing the protected data protected by the protection mechanism 7.

When reading the protected data protected by the protection mechanism 7 from the protected data storage unit 10, for example, a predetermined password input screen is displayed, and the data cannot be read unless an accurate password is input. ing. Also,
Even after reading, the protected data cannot be changed.

Further, the system is provided with a printing means (for example, a printer) 3 for printing the data and the like inserted in the spreadsheet 5 as a form, and displays the data and the like inserted in the spreadsheet 5. A display means (for example, a display) 4 for displaying data and other necessary information at the time of data input or data aggregation is provided.

Next, the operation of the chemical test data management system will be described with reference to the flowchart shown in FIG. In the figure, "S" means a step.

Data such as body weight, amount of food, water, urine and the like and observation findings of pathological symptoms when the medicine is actually administered to the animal are previously input to the data input means 1, and the data is stored as input data. It is stored in the unit 8.

When totalizing the input data, first, an extraction condition is input to the condition input means 1 (S
1) A desired template is selected from a plurality of prepared templates (S2).

Next, the data extraction means 2 extracts data from the data stored in the input data storage section 8 in accordance with the input extraction conditions (S3). At this time, for example, for the amount of body weight, food, water, urine, etc.,
Numerical values of the respective items are totaled over time, and for pathological findings, counts and the like are calculated for each input pathological symptom.

Next, the selected template is opened (S4), and a search for a keyword in the opened template is performed (S5). Then, the data extracted by the data extracting means 2 is inserted and / or replaced in a certain area including the cell 14 in which the searched keyword exists (S6).

Then, a sheet name input screen is displayed on the display means 4 to request input of a new sheet name, and a new sheet name is set in the template into which the total data is inserted (S7).

Next, a password setting screen is displayed on the display means 4, and a new sheet in which a new sheet name is set is displayed.
A password is set to protect the data from being changed (S8). Then, the protected new sheet (protected data) is stored in the protected data storage unit 10 and printed on a form (S9).

As described above, according to the above-mentioned system, since the extracted data is inserted and / or replaced in a certain area including the cell 14 of the spreadsheet 5, the data is inserted and / or replaced. The extracted data is
The form can be output in a free format using the spreadsheet 5. In addition, since the output total data cannot be changed, GLP or the like can be reliably guaranteed by a free-form form using the spreadsheet 5.

The above system is suitably used for a toxicity test of a drug using an animal as a living body. Toxicological tests of drugs using animals as living organisms are enormous and diverse, and the types of required data often differ depending on the user. This is because it is remarkable and effective.

The spreadsheet is not particularly limited. For example, various types of spreadsheets such as Excel (trade name of Microsoft Corporation), Lotus 123 (trade name of Lotus Corporation), and Sanshiro (trade name of Just System Corporation) can be used. Spreadsheet software and spreadsheet database software are used.

FIG. 4 is a system configuration diagram showing an embodiment of the chemical test data management system of the present invention. This system includes word processor software 15 instead of spreadsheet 5. Then, a keyword is arranged in a character string in the template 13 of the word processor, and the extracted data is inserted and / or replaced in a certain area including the keyword. The other parts are the same as those in the first embodiment, and the same parts are denoted by the same reference numerals. This system also has the same operation and effect as the first embodiment.

The word processor software is not particularly limited. For example, various software such as Word (trade name of Microsoft Corporation) and Ichitaro (trade name of Just System Corporation) can be used.

In the present invention, the drug is not limited to a drug, but includes various chemical substances such as agricultural chemicals, food additives, and external preparations for skin.

Further, the system of the present invention is not limited to a toxicological test of a drug using an animal as a living body, but also a pharmacodynamic test, a general pharmacology test, a pharmacodynamic test, or a drug pharmacology test before entering an animal safety test. Can be applied to clinical tests and the like in which is administered to the human body. In addition, it can be applied to non-GLP tests. Even in these cases, the same operation and effect can be obtained.

[0040]

As described above, according to the first medicine data management system of the present invention, the cells of the spreadsheet
Since the data is inserted, the inserted data can be output in a free form using a spreadsheet. Therefore, it is possible to output a form in a desired format desired by the user. Also,
According to the second medicine data management system of the present invention, the character string of the template using the word processor software is
Since the data is inserted and / or replaced, the inserted and / or replaced data can be output in a free form using a word processor. Therefore, it is possible to output a form in a desired format desired by the user.

[Brief description of the drawings]

FIG. 1 is a system configuration diagram showing one embodiment of a chemical test data management system of the present invention.

FIG. 2 is an explanatory diagram illustrating an example of a template.

FIG. 3 is a flowchart illustrating the operation of the chemical test data management system.

FIG. 4 is a system configuration diagram showing a second embodiment of the chemical test data management system of the present invention.

[Explanation of symbols]

 5 Spreadsheet 6 Data insertion means 9 Total data storage unit 13 Template 14 cell

──────────────────────────────────────────────────続 き Continued on the front page (58) Field surveyed (Int. Cl. ⁷ , DB name) G01N 33/15 G06F 19/00

Claims (5)

(57) [Claims] 1. A medicine test data management system for managing data such as a change in a symptom of a living body when a medicine is administered to a living body, comprising: a data storage means for storing data; a data printing template; A spreadsheet with keywords in the cells of the template,
In the area corresponding to the keyword in the above spreadsheet,
A drug test data management system, comprising: data insertion and / or replacement means for inserting and / or replacing data stored in data storage means. 2. A medicine test data management system for managing data such as changes in symptoms of a living body when a medicine is administered to a living body, comprising a data storage means for storing data, a data printing template, and Word processor software in which a keyword is arranged in a character string of a template, and data insertion and / or replacement means for inserting and / or replacing data stored in a data storage means in an area corresponding to the keyword in the word processor software A chemical test data management system. 3. A totalizing means for totalizing the input data, wherein the data storage means stores the totalized data totalized by the totalizing means, and the data inserting and / or replacing means includes a keyword for the template. 3. The chemical test data management system according to claim 1, wherein the aggregation data is inserted and / or replaced in a corresponding area. 4. A protection device for protecting data inserted and / or replaced in a template so that data cannot be changed, and protected data storage means for storing data protected by the protection device. 4. The chemical test data management system according to any one of claims 3 to 3. 5. The drug test data management system according to claim 1, which is used for a toxicity test of a drug using an animal as a living body.